Pharmacy Prior Authorization Non-Formulary and Prior

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Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Non-Formulary Requests for Non-Formulary Medications that do not have specific Prior Authorization Initial Approval: Medication Guidelines will be reviewed based on the following: • Minimum of 3 months, Guideline • An appropriate diagnosis/indication for the requested medication, depending on the • An appropriate dose of medication based on age and indication, diagnosis, to determine • Documented trial of 2 formulary agents for an adequate duration have not been effective or adherence, efficacy and tolerated patient safety monitoring OR • All other formulary medications are contraindicated based on the patient’s diagnosis, other Renewal: medical conditions or other medication therapy, • Minimum of 6 months OR • Maintenance medications • There are no other medications available on the formulary to treat the patient’s condition may be approved Indefinite

Maryland Physicians Care determines patient medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. Medications Requests for Medications requiring Prior Authorization (PA) will be reviewed based on the PA As documented in the requiring Prior Guidelines/Criteria for that medication. Scroll down to view the PA Guidelines for specific individual guideline Authorization medications. Medications that do not have a specific PA guideline will follow the Non-Formulary Medication Guideline. Additional information may be required on a case-by-case basis to allow for adequate review. Medications Medications that require Step Therapy (ST) require trial and failure of formulary agents prior to their Initial Approval: requiring Step authorization. If the prerequisite medications have been filled within the specified time frame, the Indefinite Therapy prescription will automatically process at the pharmacy. Prior Authorization will be required for prescriptions that do not process automatically at the pharmacy. Refer to the Step Therapy Requirements document.

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Brand Name Maryland Physicians Care requires use of generic agents that are considered therapeutically Initial Approval: Medication equivalent by the FDA. For authorization of a brand name medication, please submit a copy of the Indefinite Requests FDA MedWatch form detailing trial and failure of, or intolerance/adverse side effect to generic formulations made by 2 different manufacturers. The completed form should also be submitted to the FDA. The FDA MedWatch form is available Here.

Chemotherapy All requests for chemotherapeutic and radiation agents must now be submitted via Eviti, a web- N/A based oncology support tool for evidence-based cancer treatment guidelines. Please redirect your request to Eviti at www.eviti.com Mental Health Medications on the mental health formulary are carved out and are not covered by Maryland N/A Medications Physicians Care. All requests for medications on the mental health formulary should be requested via the state’s pharmacy claims processor, Xerox (800-932-3918) HIV Medications HIV agents are carved out and are not covered by Maryland Physicians Care. All requests for HIV N/A agents should be requested via the state’s pharmacy claims processor, Xerox (800-932-3918).

Substance Abuse Substance Abuse and smoking cessation agents are carved out and are not covered by Maryland N/A Medications Physicians Care. All requests for these agents should be requested via the state’s pharmacy claims processor, Xerox (800-932-3918). Hepatitis C Agents Maryland Physicians Care follows the Hepatitis C Clinical Criteria set forth by the DHMH. Please N/A refer to the plan website for the criteria Here.

Actemrai General Criteria for All Indications: Initial Approval: • Patient is NOT on another biological DMARD or other anti-TNF agent 4 months • Prescribed by, or consultation with, a rheumatologist • Patient is up to date with all recommended vaccinations Renewal: • Patient has been screened for latent TB and hepatitis B Indefinite

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Requirements Duration of Approval if Guideline Requirements Are Met • Patient has an absolute neutrophil count (ANC) >2000 per mm3. • Patient has a platelet count >100,000 per mm3. Requires: • Patient does NOT have elevated ALT or AST >1.5× ULN. • At least 20% symptom improvement Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA): • ANC >500 per mm3 • Patient is at least 2 years old • Platelets >50,000 per mm3 • Patient has continued synovitis in >1 joint despite treatment for at least 1 • ALT and AST are <5× ULN month with methotrexate or leflunomide • Request is for IV use (SQ use is not FDA approved for this indication) Dosing: • SJIA (<30kg): 12mg/kg Additional Criteria for Polyarticular Juvenile Idiopathic Arthritis (PJIA): every 2 weeks • Patient is at least 2 years old • SJIA (>30kg): 8mg/kg every • Patient has moderate to severe disease despite an adequate 3-month trial of methotrexate and a 2 weeks formulary anti-TNF • PJIA (<30kg): 10mg/kg • Request is for IV use (SQ use is not FDA approved for this indication) every 2 weeks • PJIA (>30kg): 8mg/kg every Additional Criteria for Rheumatoid Arthritis (RA): 2 weeks • Patient is at least 18 years old • RA (IV infusion): initial is • Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the 4mg/kg every 4 weeks. Can following: be increased to 8mg/kg o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) given every 4 weeks unless contraindicated) • RA (SQ, <100kg): 162mg • Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF) every other week. Can be • Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, increased to weekly. MTX+SSZ, SSZ+HCQ • RA (SQ, >100kg): 162mg o ONE formulary anti-TNF (Note: anti-TNF’s require PA) weekly

Last Update: 11/30/2017

Note: Less than 50% of patients respond to treatment Anticoagulants - Fragmin, fondaparinux, and enoxaparin should pay at the point of sale for an initial Initial Approval: Injectableiii duration of 21 days without a PA. • Prophylaxis post ortho surgery) - Up to 35 days Enoxaparin For prescriptions of enoxaparin, fondaparinux, and Fragmin that do not pay at the point of • Prophylaxis (non-ortho Fondaparinux sale, prior authorization requests can be authorized for the following indications: surgery and major trauma) Fragmin • All 3 agents: - Up to 14 days Iprivask o VTE prophylaxis in patients undergoing hip or knee replacement or hip fracture • Prophylaxis (post-surgery o VTE treatment in patients who are taking warfarin until the INR is in therapeutic with CA)- 4 weeks range for 2 days • VTE treatment, bridge o Bridge therapy for perioperative warfarin discontinuation therapy, acute illness -10 o Prophylaxis or treatment of thrombotic complications in a high risk pregnancy days or as requested o VTE prophylaxis in patients with restricted mobility during acute illness • High risk pregnancy - Until o Treatment of superficial vein thrombosis (SVT) of the lower limb of at least 5 cm in length 6 weeks after delivery (EDC o Treatment of acute upper-extremity DVT (UEDVT) that involves the axillary or more required for authorization) Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met proximal veins • Prophylaxis in cancer - 6 months • Fragmin and enoxaparin only: • Upper extremity DVT - 3 o VTE treatment after trial and failure of warfarin or for patients who are not months candidates for warfarin • Lower-limb SVT - 45 days o VTE treatment in patients who have cancer • VTE treatment for warfarin o VTE prophylaxis in cancer patients with solid tumors who are at high risk of failure or in cancer - 6 thrombosis (i.e., previous VTE, immobilization, hormonal therapy, months angiogenesis inhibitors, thalidomide, and lenalidomide) o VTE prophylaxis in patients with AFib undergoing cardioversion (up to 3 weeks Renewal: before and 4 weeks after) Length of renewal o VTE prophylaxis in patients with acute ischemic stroke and restricted mobility authorization based on o VTE prophylaxis in patients undergoing general and abdominal-pelvic surgery who are anticipated length of therapy, at moderate to high risk for VTE indication and/or recent INR o VTE prophylaxis in patients with major trauma if on warfarin Iprivask may be authorized if all the following criteria are met: • VTE prophylaxis in patients undergoing hip replacement surgery • Patient had therapeutic failure or intolerance to enoxaparin, Fragmin, and fondaparinux OR • Patient has contraindication to enoxaparin, fondaparinux, and Fragmin (i.e., allergic to pork, history of heparin induced thrombocytopenia) For patients that meet all of the following: Initial Approval: Anticoagulants - iv • Oral Atrial fibrillation - • Patient is at least 18 years old Indefinite • No evidence of moderate to severe liver impairment or severe renal impairment (refer Eliquis • Knee replacement surgery - to FDA label for specific CrCl cutoff and dosing) Pradaxa Up to 12 days from the day • If used in combination with an antiplatelet (i.e., aspirin, clopidogrel) the prescriber has Xarelto Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Savaysa determined that the benefit outweighs the increased risk of bleeding of surgery • Has one of the following indications: • Hip replacement surgery 1. Non-valvular atrial fibrillation - Up to 35 days from the 2. Prophylaxis of venous thromboembolism (VTE) after hip or knee replacement day of surgery 3. Treatment of VTE and one of the following: • Tx of VTE (not prophy) - 3 A. Considered a poor candidate for warfarin months a. Unable to achieve therapeutic INR on warfarin b. Concern of drug interaction with warfarin Renewals: OR • Tx of VTE (not prophy) - 3 B. Member has been started and needs continuation of therapy upon hospital discharge months • CHEST recommends 3 month duration for most VTE tx.

Consider extended duration for unprovoked DVT especially if patient is at low/mod risk of bleed or if previous VTE Anti-TNF’s Enbrel, Humira, Remicade, Cimzia, Simponi See Detailed document.

v ARBs Non-preferred ARBs can be approved for members who have failed THREE formulary Initial approval: preferred ARBs AND meet ONE of the following: Indefinite Benicar Edarbi 1. Treatment of HTN with chronic kidney disease (CKD); Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Eprosartan OR Telmisartan 2. Treatment of HTN without CKD for patients who have failed a trial with a formulary agent from another class that is considered a first-line treatment per JNC8 (i.e., thiazide-type diuretic, calcium channel blocker, angiotensin-converting enzyme inhibitor) or require combination therapy to achieve BP goal

Preferred ARBs include: • Losartan (or losartan/HCTZ) • Irbesartan (or irbesartan/HCTZ) • Candesartan (or candesartan/HCTZ) • Valsartan (or valsartan/HCTZ, valsartan/amlodipine, or valsartan/amlodipine/HCTZ) Botulinum Toxins Botox, Myobloc, Dysport, Xeomin See Detailed document.

Cambiavi For patients who meet the following: Initial approval: • Patient has a diagnosis of migraine headaches Indefinite • Patient is 18 years of age or older • Tried and failed at least 2 formulary triptans (e.g., sumatriptan, naratriptan) QLL: 9 packets (1 box or has a contraindication to triptans per month) • Tried and failed at least 2 formulary NSAIDs (e.g., Ibuprofen, naproxen, diclofenac)

Celecoxib[i] Celecoxib should pay at the point of sale when ONE of the following step therapy criteria Initial Approval: are met without requiring a PA: Indefinite • Patient has filled 3 formulary NSAIDs or tramadol in the previous 180 days

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Patient has filled a PPI, H2 receptor antagonist, prednisone, warfarin, Xarelto, Pradaxa, or Dose limits: Eliquis in the previous 90 days • OA: 200 mg/day • RA, acute pain, Prescriptions that do not pay at the point of sale require prior authorization and may be dysmenorrhea, ankylosing authorized for patients who meet the following criteria: spondylitis, psoriatic • No recent history (in the past 6 months) of acute coronary syndrome (ACS) or CABG arthritis: 400 mg/day • Age >2 years old for juvenile rheumatoid arthritis (JRA) OR >18 years old for all other indication • JRA: • Patient meets ONE of the following: o >25 kg: 100mg BID o Was unable to achieve clinical benefit with 3 formulary NSAIDs o 10-25 kg: 50mg BID o Has a history of NSAID-induced gastritis confirmed by EGD o Is at high-risk for adverse GI events (e.g., >65 years of age, concomitant corticosteroid or anticoagulant use, or history of GI bleed, PUD, GERD, or gastritis) AND not currently taking a daily aspirin Cialisvii For male patients who meet the following: Initial Approval: 3 months • Diagnosis of BPH • Trial and failure of ALL of the following: Renewal: 6 months o Alfuzosin o Tamsulosin Requires: o Finasteride (for at least 6 months) in combination with an alpha-blocker (e.g., alfuzosin, Demonstration of tamsulosin, doxazosin, terazosin) unless the patient is unable to tolerate an alpha-blocker improvement in BPH symptoms

NOTE: Use of Cialis for treatment of erectile dysfunction is not a covered benefit. QLL: 2.5mg or 5mg; #30 tablets per 30 days (Note: 10mg and 20mg are not indicated for BPH and not covered) Colony- • For oncology-related indications and Myelodysplastic Syndrome, Colony-Stimulating Factors (CSFs) Initial Approval: Stimulating require authorization through EVITI. Please redirect your request to Eviti at www.eviti.com 3 months Factors (CSF)viii • For non-oncology use, CSFs are reviewed for FDA-approved indications. Requests are reviewed for Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met appropriate dosing, timing restrictions, and contraindications. CSFs for non-FDA Renewal: Neupogen approved indications require medical literature/clinical studies from peer-reviewed 1 year Zarxio journals with safety, efficacy and dosing information for the intended use. Requires: Severe chronic congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia: Recent ANC and platelet count • Recent absolute neutrophil count (ANC) <500/mm3 • Patient has ONE of the following: o Evidence of inadequate bone marrow reserve (e.g., recurrent fevers, splenomegaly, mucosal ulcers, abdominal pain) o High risk for developing serious bacterial infection (e.g., primarily severe neutropenia, indwelling venous catheters, prior serious infections) o Current bacterial infection

Neutropenia related to HIV: • Recent absolute neutrophil count (ANC) <500/mm3 • Patient has ONE of the following: o Evidence of inadequate bone marrow reserve (e.g., recurrent fevers, splenomegaly, mucosal ulcers, abdominal pain) o High risk for developing serious bacterial infection (e.g., primarily severe neutropenia, indwelling venous catheters, prior serious infections) o Patient has a documented bacterial infection • Patient is taking antiretroviral therapy regimen that does NOT contain zidovudine • Patient is NOT taking sulfamethaxazole/trimethoprim. NOTE: Patients who require pneumocystis prophylaxis should be switched to atovaquone or dapsone (unless contraindicated)

Cystic Fibrosis Pulmozyme: Initial Approval: • Age >/= 5 years (Per label: Pulmozyme was studied in patients 3 months to 5 years of age; while (pulmonary) Kalydeco and Orkambi: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Medicationsix clinical trial data are limited in patients <5 years, the use of Pulmozyme should be considered for • 3 months pediatric patients with CF who may experience potential benefit in pulmonary function or who Pulmozyme may be at risk of respiratory tract infection. All others Tobi Podhaler • Diagnosis of moderate to severe cystic fibrosis • Indefinite Bethkis OR Cayston • Diagnosis of mild cystic fibrosis after failure of inhaled hypertonic saline Renewal: Kalydeco Kalydeco and Orkambi: Orkambi Tobramycin inhalation solution (generic for Tobi): • 6 months • Diagnosis of cystic fibrosis • Age >/= 6 years Orkambi requires • FEV1 between 25-80% predicted documentation to support • Sputum cultures positive for P.aeruginosa response to therapy including • Not colonized with Burkholderia cepacia current lab results to support ALT/AST and bilirubin levels Tobi Podhaler or Bethkis: • Must meet criteria listed above for tobramycin inhalation solution, PLUS patient must have contraindication/intolerance to or failure of tobramycin nebulizer solution (generic)

Cayston will be authorized for patients that meet the following: • Diagnosis of cystic fibrosis • Age >/= 7 years • FEV1 between 25-75% predicted • Sputum cultures positive for P.aeruginosa • NOT colonized with Burkholderia cepacia • Contraindication/intolerance to tobramycin

Kalydeco can be recommended for approval for patients who meet the following: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Diagnosis of cystic fibrosis with one of the following CFTR gene mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H • NOT homozygous for the F508del mutation in the CFTR gene • Age >2 years • Note: all reviews must be sent to MDR for final decision • NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase alpha, tobramycin, hypertonic saline, or Cayston)

Orkambi can be recommended for approval for patients who meet the following: • Prescribed by a pulmonologist • Member is 12 years of age and older • Diagnosis of Cystic Fibrosis and lab results to support homozygous F508Del at the CFTR gene. (If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene) • Current lab results to support ALT/AST and bilirubin • NOT used with strong CYP3A inducers such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort • NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase alpha, tobramycin, hypertonic saline, or Cayston) • Note: all reviews must be sent to MDR for final decision x Daliresp For patients who meet all of the following: Initial Approval: • Adult 40 years of age or older 6 months • Prescribed by or in consultation with a pulmonologist • Diagnosis of severe COPD with chronic bronchitis with FEV1<50% predicted based on post- Renewals: bronchodilator FEV1 Indefinite; requires • Documented symptomatic exacerbations within the last year while compliant with dual long- improvement in the number of COPD exacerbations acting bronchodilator treatment [long-acting beta-agonist (LABA) plus long-acting muscarinic Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met antagonist (LAMA)] for at least 3 months • Daliresp will be used in conjunction with a LABA and LAMA unless contraindicated/intolerant • Will not be used in combination with theophylline Daraprimxi Daraprim may be authorized for the treatment and secondary prevention of Toxoplasmosis in Initial Approval: patients with HIV: • Acute Toxoplasmosis - 6 • Dose for initial treatment of Toxoplasmosis is 50-75mg per day for 6 weeks weeks • Dose for secondary prophylaxis after completing initial 6-week treatment is 25-50mg per day • Acute PCP - 21 days to prevent relapse. • PCP prophylaxis - 3 months • Secondary prophylaxis may be discontinued when the following apply: o Patient is asymptomatic Renewals: o Patient is receiving antiretroviral therapy (ART) • Secondary Prophylaxis o Patient has a suppressed HIV viral load after Acute Toxoplasmosis o Patient has maintained a CD4 count >200 cells/microL for at least six months treatment - 6 months • Maintenance therapy may be reinitiated if the CD4 cell count declines to <200 cells/microL • PCP prophylaxis - 3 month; If CD4 count is <200 or Daraprim may also be authorized for Pneumocystis Pneumonia (PCP) when the following CD4 count % is <14% criteria are met: • Patient is allergic to sulfa or has another contraindication to TMP/SMX use • For PCP prophylaxis in patients with HIV: o Patient has ONE of the following: • CD4 count <200 cells/microL • Oropharyngeal candidiasis • CD4 count percentage <14 percent • CD4 cell count between 200 and 250 cells/microL when frequent monitoring (e.g., every three months) of CD4 cell counts is not possible o Patient has a trial and failure or contraindication to atovaquone AND dapsone • For PCP treatment: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met o Patient is diagnosed PCP infection o Patient has a trial and failure or contraindication to atovaquone

Daraprim is not covered for treatment or prevention of malaria: • Daraprim is no longer recommended for malaria treatment or prophylaxis. • Treatment of malaria is VERY individualized. • Refer to the CDC website for recommendations for acute treatment of malaria. o Malaria Treatment Algorithm o Malaria Treatment (United States) o Guidelines for Malaria Treatment in the United States • Refer to the CDC website for recommendations for prevention of malaria o Malaria Information by Country Diabetic Testing Diabetic Test Strip and Glucometer Quantity Limits: Initial Approval: Supplies • All diabetic test strips are limited to 150ct/30 days 1 year • Glucometers are limited to 1 glucometer/12 months

Criteria to Receive Non-Formulary Diabetic Supplies • Member with hematocrit level that is chronically less than 30% or greater than 55% o Accu-Chek Aviva Plus and Nano SmartView are accurate for Hct 10-65% o One Touch Verio IQ is accurate for Hct 20-60% • Member with physical limitation (manual dexterity or visual impairment) that limits utilization of formulary product • Member with an insulin pump that requires a specific test strip

Criteria to Receive >150 Test Strips Per Month • Members newly diagnosed with diabetes or with gestational diabetes • Children with diabetes (age ≤ 12 )

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Members on insulin pump • Members on high intensity insulin therapy with documentation of need to routinely test more than 4-5 times daily

Criteria to Receive >1 Glucometer Per Year • Current glucometer is unsafe, inaccurate, or no longer appropriate based on patients medical condition • Current glucometer no longer functions properly, has been damaged, or was lost or stolen. Direct Renin For patients that meet the following: Initial Approval: Inhibitorsxii • Treatment of HTN Indefinite • At least 18 years old Tekturna • Inadequate response or inability to tolerate a trial of a formulary ARB AND an ACE Tekturna HCT inhibitor and at least one other formulary antihypertensive agent from a different class: Tekamlo o Thiazide-type diuretic Amturnide o Calcium channel blocker o Beta-blocker • Will not be used in combination with an ACE inhibitor or an ARB

Note: The long-term benefit on major cardiovascular or renal outcomes with direct renin inhibitors in the treatment of HTN has not been established, therefore it is recommended to use medications from other classes first. Duaveexiii Duavee can be approved for adult women under the age of 75 who have an intact uterus Initial Approval: and who meet the following criteria based on indication: • 5 years • Treatment of vasomotor symptoms associated with menopause (VMS): o Patient has failed or has an intolerance to at least 2 formulary estrogen/progestin products (e.g., estradiol tablets/patch, Prempro, Estrace) • Prevention of postmenopausal osteoporosis: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met o Patient has tried and failed (or has contraindication/intolerance to) raloxifene AND alendronate o Patient has osteopenia (T-score between -1.0 and -2.5) OR is at high risk for OP fracture (as defined by any of the following): • FRAX risk ≥3.0% for hip fracture OR ≥20% for any major OP-related fracture; OR • Patient has >1 risk factor for fracture: a. low body mass index b. previous fragility fracture c. parental history of hip fracture d. glucocorticoid treatment e. current smoking f. alcohol intake of 3 or more units per day g. rheumatoid arthritis h. secondary causes of osteoporosis

Egrifta May be authorized for treatment of excess abdominal fat in HIV-infected patients Initial Approval: with lipodystrophy when the following are met: 1 year • Patient is 18-65 years of age • No evidence of active neoplastic disease Renewal: • No evidence of acute critical illness 3 years with documentation • No disruption of the hypothalamic-pituitary axis (e.g. hypothalamic-pituitary-adrenal (HPA) of a clinical response suppression) due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, radiation therapy of the head or head trauma • Patient is not using Egrifta for weight loss • Patient is at risk for medical complications due to excess abdominal fat • If female, patient is not pregnant and is using a reliable form of birth control (pregnancy category X) Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Erythropoiesis Epogen, Procrit, Aranesp - Stimulating Agents See Detailed document.

Growth Hormone Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin, Zorbtive See detailed document.

Growth Hormone See Detailed document. Antagonists GnRH Analogsxiv For patients who meet the following based on diagnosis: Initial Approval: Central Precocious Puberty Leuprolide acetate Endometriosis • Supprelin LA: 12 months Lupron Depot (Lupron Depot, Synarel, Zoladex [3.6 mg dose only]) • All others: 6 months Lupron Depot-PED • Prescribed by or in consultation with a gynecologist or obstetrician Synarel • 18 years of age or older Endometriosis Supprelin LA • Trial and failure of at least one formulary hormonal cycle control agent (such as • 6 months Zoladex Portia, Ocella, Previfem), medroxyprogesterone, or Danazol • Patient is not pregnant or breastfeeding Uterine Leiomyoma (fibroids) • 6 months Uterine Leiomyoma (fibroids)

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met (Lupron Depot, Synarel, Zoladex [3.6 mg dose only]) Dysfunctional uterine bleeding • Prescribed by or in consultation with a gynecologist or obstetrician • 2 months • 18 years of age or older • Prescribed to improve anemia and/or reduce uterine size for 3-6 months prior to planned Renewal: surgical intervention Central Precocious Puberty • Patient is not pregnant or breastfeeding • 6 months - 1 year (up to age 11 for females and age Dysfunctional Uterine Bleeding 12 for males) (Zoladex [3.6mg dose only]) • Prescribed by or in consultation with a gynecologist or obstetrician Requires: • 18 years of age or older • Clinical response to • Prescribed to thin endometrium prior to planned endometrial ablation or hysterectomy within treatment (i.e., pubertal the next 4-8 weeks slowing or decline, height • Patient is not pregnant or breastfeeding velocity, bone age, LH, or estradiol and testosterone Central Precocious Puberty (CPP) level) (Lupron Depot-PED, leuprolide acetate solution, Synarel, Supprelin LA) • Prescribed by, or in consultation with an Endocrinologist Endometriosis Retreatment • MRI or CT Scan has been performed to rule out lesions • Lupron only (treatment • Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males with Synarel and Zoladex • Response to a GnRH stimulation test (or if not available, other labs to support CPP such as not recommended beyond luteinizing hormone levels, estradiol and testosterone level) 6 months): 6 months • Bone age advanced 1 year beyond the chronological age • Baseline height and weight Requires: • Age restriction (leuprolide acetate solution for injection [once daily regimen]): must be at least • Bone mineral density 1 year old within normal limits • Age restriction (Lupron Depot-Ped [1-month or 3-month regimen]): must be at least 2 years old • Use in combination with norethindrone acetate Last Update: 11/30/2017

Uterine Leiomyoma (fibroids) or Dysfunctional Uterine Bleeding • Long-term use is not recommended • Retreatment may be considered on a case by case basis Hetliozxv For patients that meet all of the following: Initial Approval: • At least 18 years old Indefinite • Diagnosis of non-24 sleep-wake disorder • Completely blind with NO light perception • History of at least 3 months of difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness • No other concomitant sleep disorder (i.e., sleep apnea, insomnia) HP Acthar can be authorized for adults when the following criteria are met: Initial Approval: HP Acthar for MSxvi • Prescribed by a neurologist 3 weeks • Prescribed for ACUTE exacerbation of MS HP Acthar • Symptoms of current exacerbation include functionally disabling symptoms with objective Prolonged use may lead to evidence of neurologic impairment such as loss of vision, motor symptoms (i.e., partial or adrenal insufficiency or full paralysis, spasticity, clonus), and/or cerebellar symptoms (i.e., gait imbalance, difficulty recurrent symptoms which with coordinated movement, slurred speech, intention tremor, nystagmus) make it difficult to stop the • Patient meets ONE of the following: treatment, therefore treatment o Continues to have functionally disabling symptoms despite a 7 day course of high dose IV beyond 3 weeks for the same corticosteroids (i.e., methylprednisolone 1000mg per day) for the CURRENT exacerbation episode is not recommended. o Had significant side effects with high dose IV corticosteroids

Last Update: 11/30/2017

Hyperlipidemia Rosuvastatin can be approved when the following criteria are met: Initial Approval: Medicationsxvii • Patient is at least 10 years old; AND Juxtapid, Kynamro: • Patient has failed to achieve LDL goal on a compliant regimen of maximum tolerated dose of • 3 months Rosuvastatin atorvastatin; • All others: 6 months OR Lovaza • Patient requires a high intensity statin (i.e., diagnosis of familial hypercholesterolemia or Renewal: Vascepa high ASCVD risk per provider evaluation) AND patient had a trial and failure of atorvastatin Juxtapid, Kynamro: Epanova • 6 months Non-formulary medications for hypertriglyceridemia (Lovaza, Vascepa, and Epanova) • All others: indefinite Juxtapid can be approved when the following criteria are met: Kynamro • Patient is at least 18 years old Renewals require: • Drug will be used as an add-on to lifestyle interventions to include diet and exercise Improvement in fasting lipids • Treatment of severe hypertriglyceridemia (triglyceride level greater than or equal to 500 mg/dL) and documentation of • Trial and failure of OTC fish oil and at least ONE other formulary medication such as recommended safety fenofibrate, fenofibric acid, gemfibrozil, or niacin or contraindication to all formulary agents monitoring parameters (such as liver enzymes) Juxtapid and Kynamro can be approved when ALL of the following criteria are met: • Diagnosis of homozygous familial hypercholesterolemia with a documented LDL of >300 mg/dl (within the past 90 days) • Failure of a compliant, 60 day trial of 2 different high potency statins* (atorvastatin and rosuvastatin) at maximum tolerated doses used in combination with Zetia, niacin, or a bile acid sequestrant • Juxtapid or Kynamro will be used in combination with maximum tolerated doses of a statin* in combination with Zetia, niacin, or a bile acid sequestrant AND lifestyle interventions to include diet and exercise (low-fat diet recommended, <20% of calories from fat) • Patient has tried and failed or is not a candidate for LDL apheresis

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Patient is at least 18 years old • Recommended baseline labs are submitted: Fasting lipid panel, ALT, AST, alk phos, total bili, and negative pregnancy test (if applicable) • Patient does not have moderate to severe hepatic impairment (Child-Pugh B or C) or active liver disease

NOTE: All requests must be forwarded to MDR for final approval

* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at least one trial being a moderate to high potency statin). Documentation will include chart notes supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued; and documentation the member has been rechallenged at a lower dose or with a different statin. Idiopathic Non-formulary use of Esbriet or Ofev can be approved when the following are met: Initial Approval: Pulmonary • Diagnosis of mild to moderate idiopathic pulmonary fibrosis 3 months Fibrosis Agentsxviii o Confirmed by high resolution computed tomography (HRCT), lung biopsy, or bronchoscopy Renewal: Esbriet o Interstitial lung disease cannot be attributed to another cause (i.e., rheumatoid 6 months Ofev arthritis, lupus, systemic sclerosis, asbestos exposure, or hypersensitivity pneumonitis) o Forced vital capacity (FVC) between 50 and 80% predicted Criteria for renewal: • Documentation of baseline liver function tests (LFT’s) prior to initiating treatment • Documentation of stable • Patient age must be 18 years or greater FVC (recommended to • Patient is not a current smoker discontinue if there is a • Prescribed by, or in consultation with, a pulmonologist >10% decline in FVC over a 12 month period) Note: There is no conclusive evidence to support the use of any drugs to increase • Attestation that LFT’s are the survival of people with idiopathic pulmonary fibrosis. being monitored Ilarisxix General Criteria for All Indications: Initial Approval:

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Patient is NOT on another biological DMARD or other anti-TNF agent 4 months • Prescribed by, or consultation with, a rheumatologist • Patient is up to date with all recommended vaccinations Renewal: • Patient has been screened for latent TB and hepatitis B 2 years

Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA): Requires: • Patient is at least 2 years old At least 20% symptom • Patient weighs at least 7.5kg improvement • Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis) Dosing/QLL: • Patient has continued synovitis in >1 joint despite treatment for at least 1 month with Kineret CAPS (>40 kg): 150mg every 8 or Actemra AND methotrexate or leflunomide (Note: both Kineret and Actemra are also non- weeks, 1 vial per 56 days formulary and require PA) CAPS (<40 kg): 2mg/kg every 8 weeks, 1 vial per 56 days. Dose Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS) may be increased to 3mg/kg • Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation given every 8 weeks • Patient is at least 4 years old SJIA: 4mg/kg (max 300mg) every 4 weeks • Patient weighs at least 15kg • Patient has failed a 3-month minimum trial of Kineret (Note: Kineret is also non-formulary and • QLL for <180mg: 1 vial per 28 days requires PA) • QLL for >180mg: 2 vials per 28 days IL-17 May be authorized for Plaque Psoriasis when the following criteria is met: Initial Approval: xx Antagonists • Patient is at least 18 years old 6 months • Prescribed by a dermatologist Renewal: Cosentyx • Patient is up to date with all recommended vaccinations 2 years • Patient has been screened for latent TB Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Symptoms are not controlled with topical therapy • Disease has a significant impact on physical, psychological or social wellbeing Criteria for renewal: Clinical • Patient has failed a 3-month compliant trial with MTX or cyclosporine or has notes documenting an a true contraindication to both improvement (e.g., • Psoriasis is severe and extensive (for example, more than 10% of body surface area reduction in PASI, decreased affected or a PASI score of more than 10) swollen/painful joints) • Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is defined as greater than 50% of baseline disease severity within 3 months) • Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF

Increlex May be authorized for patients at least 2 years old when the following criteria is met: Initial Approval: • Prescribed by or in consultation with pediatric endocrinologist • 6 months • No evidence of epiphyseal closure • No evidence of neoplastic disease Renewal: • Documentation supports diagnosis of GH gene deletion and neutralizing antibodies 6 months if at least to GH OR doubling of • Documentation supports a diagnosis of Severe, Primary IGF-1 deficiency pretreatment growth o Height standard deviation score less than or equal to −3 velocity o Basal IGF-1 standard deviation score less than or equal to −3 • 1 year if growth velocity o Normal or elevated growth hormone (GH) levels ≥ 2.5 cm/yr and o No evidence of secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, epiphyses are open hypothyroidism, or chronic treatment with pharmacologic doses of corticosteroids. Injectable Forteo, Prolia, Zoledronic Acid Osteoporosis See detailed document.

Last Update: 11/30/2017

Insulin Pens For patients with diabetes mellitus who meet the following: Initial Approval: • Request is for an insulin that is formulary preferred Indefinite Humulin N o Requests for NON-formulary insulins require T/F of 2 formulary insulins within the Humulin same class (i.e. rapid, regular, or basal) Age restrictions: 70/30 • In addition, for children: • Novolog: > 2 years Novolog o Patient is a school-aged child requiring multiple daily injections of insulin • Humalog: > 3 years Humalog • In addition, for adults must meet ONE of the following: • Apidra: > 4 years Apidra Toujeo o Patient is homeless; OR Tresiba o Patient does not have a caregiver who can administer insulin using vials and syringes Ryzodeg and is unable to effectively use insulin vials and syringes to self-administer insulin Lantus due to ANY of the following: Levemir • Patient has uncorrectable visual disturbances (e.g., macular degeneration, retinopathy, vision uncorrectable by prescription glasses) • Patient has a physical disability or dexterity problems due to stroke, peripheral neuropathy, trauma, or other physical condition

NOTE: Requests for Toujeo may be approved for patients who require >100 units per day of BASAL insulin (i.e., Lantus or Levemir). Since Toujeo is not available in vials, patient does NOT need to meet the other insulin pen criteria.

Integrin Receptor This guideline describes the criteria for use of Tysabri and Entyvio in inflammatory bowel Initial Approval: Antagonists for diseases. To see the criteria for use in of Tysabri in MS, refer to the section titled, “MS Agents.” 3 months Inflammatory Bowel Diseasesxxi General Criteria: First Renewal: • Prescribed by a gastroenterologist 3 months Tysabri Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Entyvio • 18 years of age or older Criteria for renewal: • Will be used as monotherapy and NOT in combination with antineoplastic, immunosuppressive, At least 20% symptom or immunomodulating agents (e.g., azathioprine, 6-mercaptopurine improvement cyclosporine, methotrexate, TNF-inhibitors) Additional Renewals: Additional Criteria for Inducing Remission in Crohn’s Disease: (Tysabri or 6 months (if patient is Entyvio) STEROID-DEPENDENT CROHN’S : responding) • Patient meets ONE of the following: o Relapse occurs within three months of stopping glucocorticoids NOTE: If member is unable to o Glucocorticoids cannot be tapered to <10 mg/day within three months without taper off of steroids in the first symptom recurrence 6-months, d/c Tysabri • Patient has failed a compliant, 3-month trial of ONE of the following: o 6-mercaptopurine(6-MP) or azathioprine (AZA) o Methotrexate (for patients with a contraindication to 6-MP and AZA) • Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF

STEROID-REFRACTORY CROHN’S: • Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV glucocorticoids for patients who are not responding to oral glucocorticoids) • Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF

Additional Criteria for Steroid-Dependent Ulcerative Colitis: (Entyvio) • Relapse occurs within three months of stopping glucocorticoids OR tapering prednisone to <10 mg/day • Patient has failed a compliant, 3-month trial of ONE of the following: o 6-mercaptopurine(6-MP) or azathioprine (AZA) o Sulfasalazine 4-6g per day, mesalamine 4.8g per day, or balsalazide 6.75g per day (if

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met patient has a contraindication to 6-MP and AZA) • Patient has failed a 3-month trial of ONE formulary anti-TNF

Additional Criteria for Steroid-Refractory Ulcerative Colitis: (Entyvio) • Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV glucocorticoids FIRST for patients who are not responding to oral glucocorticoids) • Patient meets ONE of the following: o Patient had a previous failure on 6-MP and AZA or a contraindication to both medications and is therefore not a candidate for treatment with these agents for current episode o Patient has symptoms after surgical intervention o Patient is not a surgical candidate or refuses surgery AND had an inadequate response to cyclosporine (NOTE: Switching to anti-TNF’s after cyclosporine failure is NOT recommended by clinical practice guidelines) o Patient has a contraindication to cyclosporine (NOTE: cyclosporine is used as a bridge therapy for patients who will be started on the slower acting 6-MP or AZA) • Patient has failed a 3-month trial of ONE formulary anti-TNF

Interferonsxxii Chronic Hepatitis B Infection: (Intron A, Pegasys) Initial Approval: • Patient has HBeAg-positive or HBeAg-negative chronic hepatitis B (HBsAg positive for α-Interferon more than six months) Hepatitis B: Intron A • Prescribed by, or in consultation with an infectious disease physician, • Intron A – 16 weeks Pegasys HIV specialist, gastroenterologist, hepatologist, or transplant physician • Pegasys – 48 weeks Sylatron • Patient has compensated liver disease (e.g., normal bilirubin, albumin within normal limits, Alferon N- no cytopenias) Osteopetrosis, CGD, Kaposi’s HPV • There is evidence of viral replication (HBeAg titer and/or HBV DNA levels >20,000 sarcoma: IU/mL for HBeAg-positive patients and >2000 IU/mL for HBeAg-negative patients) • 6 months • There is evidence of liver inflammation (e.g., elevated ALT, inflammation or fibrosis on liver

β-Interferon Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met See Multiple biopsy) Condylomata acuminate: Sclerosis Agents • Age restriction (Pegasys): Must be at least 18 years old • 3 weeks • Age restriction (Intron A): Must be at least 1 year old γ-Interferon All other indications: Actimmune AIDS-related Kaposi's sarcoma: (Intron A [powder for solution ONLY]) • 1 year • Prescribed by, or in consultation with an infectious disease physician or HIV specialist • Not being used for the treatment of visceral AIDS-related Kaposi's sarcoma Renewal: associated with rapidly progressive disease • Patient must be at least 18 years old Hepatitis B: • Intron A: additional 16 Chronic Granulomatous Disease: (Actimmune) weeks if still HBeAg- • Prescribed by, or in consultation with an immunologist or infectious disease specialist positive • Patient is also receiving antifungal and antibacterial prophylaxis (such as itraconazole • Intron A: up to 2 years for and trimethoprim/sulfamethoxazole) HBeAg-negative patients • Patient is at least 1 year old Osteopetrosis: Malignant Osteopetrosis: (Actimmune) • 1 year if no evidence of • Prescribed by, or in consultation with a hematologist/oncologist disease progression • Prescribed for the treatment of severe, malignant osteopetrosis • Patient is at least 1 year old CGD: • 1 year if number and/or Condylomata acuminata (genital or venereal warts): (Intron A, Alferon N-HPV) severity of infections has • Patient at least 18 years old decreased • For intralesional use • Lesions are small and limited in number Condylomata acuminate: • Trial and failure of topical treatments or surgical technique ( ie imiquimod cream, • 16 weeks Condylox, cryotherapy, laser surgery, electrodessication, surgical excision) Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met All other indications: This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia • 1 year for the determination of medically-accepted indications. Intravaginal For patients that meet the following: Initial Approval: Progesterone • Prescribed by, or in consultation with, a provider of obstetrical care Approve as requested until 37 Productsxxiii • Patient is not on Makena (17-hydroxyprogesterone) weeks gestation • Patient is pregnant with singleton gestation and meets either of the following: Crinone o History of spontaneous preterm birth (i.e. delivery of an infant < 37 weeks gestation) Begin progesterone use no Endometrin First- o Cervical length < 25 mm before 24 weeks of gestation earlier than 16 weeks, 0 progesterone days and no later than 23 suppositories weeks, 6 days

Intuniv/Kapvay For recipients 6 – 17 years old, these agents are part of the mental health formulary and should be Initial Approval: requested via the state’s pharmacy claims processor, Xerox (800-932-3918). For individuals not in Indefinite this age range, Intuniv ER and Kapvay ER continue to be part of the MCO pharmacy benefit and will be reviewed based on past failure of other agents used to treat ADHD. Invokanaxxiv May be authorized for patients at least 18 years old who meet all of the following criteria: Initial Approval: • Diagnosis of Type 2 diabetes Indefinite • Trial and failure of metformin in combination with Januvia or Byetta for at least 3 consecutive months OR • Trial and failure of Janumet for at least 3 consecutive months

Kineretxxv General Criteria for All Indications: Initial Approval: • Patient is NOT on another biological DMARD or other anti-TNF agent 4 months • Prescribed by, or consultation with, a rheumatologist • Patient is up to date with all recommended vaccinations Renewal:

Last Update: 11/30/2017

Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA): Requires: • Patient is at least 2 years old At least 20% symptom • Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy, improvement hepatomegaly, splenomegaly, or serositis) AND synovitis in at least 1 joint; OR • Patient does NOT have currently ACTIVE systemic features but has continued synovitis in >1 joint QLL: despite treatment for 3 months with MTX or leflunomide 30 syringes per 30 days

Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS) • Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation • Patient is at least 2 years old

Additional Criteria for Rheumatoid Arthritis (RA): • Patient is at least 18 years old • Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the following: o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) unless contraindicated) • Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF) • Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ, SSZ+HCQ o ONE formulary anti-TNF (Note: anti-TNF’s require PA)

Long-Acting Tudorza Pressair and Incruse Ellipta are the formulary preferred agents. Spiriva requires step Initial Approval: Muscarinic through either Tudorza or Incruse for COPD treatment. Prior Authorization will be required for Indefinite Antagonists prescriptions that do not process automatically at the pharmacy.

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met (LAMA) Criteria for the use of Spiriva Respimat for Asthma: Spiriva HandiHaler • Patient is at least 12 years old Spiriva Respimat • Patient is currently taking an inhaled corticosteroid (ICS) and will continue an ICS when Anoro Ellipta Spiriva is initiated Incruse Ellipta • Patient has had a trial and failure to at least 2 formulary agents: Tudorza Pressair o Inhaled corticosteroid o Inhaled corticosteroid with a long-acting beta-2 agonist o Montelukast or zafirlukast (zafirlukast requires ST)

NOTE: Spiriva HandiHaler, Tudorza, and Incruse are NOT FDA-approved for asthma Long Acting Note: Women of reproductive age should be counseled about opioid use during Initial Approval: Opioidsxxvi pregnancy and neonatal abstinence syndrome (NAS) 1 year Oxycontin STEP criteria for Oxymorphone ER: Renewal: Butrans Patch Exalgo • Treatment of chronic pain 1 year Oxymorphone • At least 18 years old ER Zohydro ER • Failed a minimum of 2 week trials of maximum tolerated doses of at least TWO formulary long- NOTE: QL’s may exist Xartemis XR acting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone) OR have contraindications Nucynta ER to all formulary agents.

Criteria for Oxycontin and Non-Formulary Long-Acting Opioids: • Treatment of malignant pain and pain due to sickle cell anemia (Oxycontin) OR • Treatment of chronic non-malignant pain: o At least 18 years old o Failed a minimum of 2 week trials of maximum tolerated doses of at least THREE

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met formulary long-acting agents (i.e., fentanyl patch, morphine sulfate ER, methadone, oxymorphone ER) one of which must be oxymorphone ER OR • Treatment of diabetic peripheral neuropathy (Nucynta ER only): o At least 18 years old o Failed an adequate trial (at least 4 weeks at maximum tolerated doses) of duloxetine and tramadol and at least ONE additional formulary medication (i.e., gabapentin, amitriptyline, nortriptyline, or topical capsaicin)

Makenaxxvii For members who meet the following criteria: Initial Approval: • Prescribed by, or in consultation with, a provider of obstetrical care Until 37 weeks gestation • Patient is currently pregnant with singleton gestation • Patient has a history of a spontaneous preterm singleton delivery (i.e. delivery of an Injections begin no earlier than infant < 37 weeks gestation) 16 weeks, 0 days and no later than 23 weeks, 6 days

Multaqxxviii Multaq will be authorized when prescribed by, or in consultation with a cardiologist. If Initial Approval: not prescribed by or in consultation with a cardiologist, the following must be met: Indefinite • Diagnosis is atrial fibrillation • Patient has tried and failed amiodarone • Age restriction: must be at least 18 years old. Multiple Sclerosis Avonex, Betaseron, Extavia, Rebif, Copaxone, Gilenya, Glatopa, Mitoxantrone, Agents Tecfidera, Aubagio, Tysabri

See Detailed document.

Last Update: 11/30/2017

Natroba, For patients that meet all of the following: Initial Approval: SkliceError! • Diagnosis of pediculosis capitis (head lice) x 1 time (30 days) Bookmark not • Failure of, or contraindication/intolerance to at least 2 formulary agents such defined. as malathion, permethrin, pyrethrins-piperonyl butoxide, or Ulesfia • Age restriction: must be at least 4 years old Non-Calcium For patients that meet all of the following: Initial Approval: Based • Treatment of hyperphosphatemia due to ESRD Indefinite Phosphate • Receiving dialysis Bindersxxix • At least 18 years old • Failed Renvela or Renagel (sevelamer) AND failed a calcium-based phosphate binder or has Fosrenol contraindications to both. (Note: Patients with elevated total serum calcium after Velphoro correcting for albumin should not receive a calcium-based product) Onychomycosis Luzu can be approved as non-formulary for members who meet the following: Initial Approval: xxx and Tinea • Topical treatment of tinea pedis, tinea cruris, and tinea corporis. Luzu: • At least 18 years old • 30 days Luzu • Failure of OR contraindication to terbinafine cream Jublia • Failure of at least 1 other formulary topical antifungal agents (i.e. clotrimazole, ciclopirox, Renewal: Kerydin econazole, ketoconazole, miconazole, etc.) OR contraindication to all formulary agents Luzu: • 30 days if responding to Jublia or Kerydin can be approved as non-formulary for members who meet the following: therapy • Treatment of onychomycosis of the toenails with ONE of the following comorbidities: o Diabetes Jublia or Kerydin: o HIV • 48 weeks o Immunosuppression (i.e. receiving chemotherapy, taking long term oral corticosteroids, taking anti-rejection medications) o Peripheral vascular disease

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met o Pain caused by the onychomycosis • At least 18 years old • Failure of 2 OR contraindication to all formulary antifungal agents indicated for (i.e. ciclopirox, griseofulvin, itraconazole and terbinafine tablets) Orencia[viii] General authorization criteria for all indications: Initial Approval: • Prescribed by a rheumatologist 4 months • Patient is NOT on another biological DMARD • Patient is up to date with all recommended vaccinations Renewals: • Patient has been screened for latent TB and hepatitis B Indefinite

In addition, May be authorized for Rheumatoid Arthritis (RA) when the following are met: Renewals require at least 20% • Patient is at least 18 years old symptom improvement • If patient has COPD, the prescriber confirms that the benefit of using Orencia outweighs the risk in the patient • Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the following: o 2 different oral DMARD regimens (1 of which must include methotrexate (MTX) unless contraindicated) • Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF) • Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ, SSZ+HCQ o ONE formulary anti-TNF (Note: anti-TNF’s require PA)

In addition, May be authorized for Juvenile Idiopathic Arthritis (JIA) when the following are met: • Patient is at least 6 years old • Request is for the IV formulation • For SEVERE Polyarticular JIA: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met o Patient has failed an adequate 3-month trial with ONE formulary anti-TNF • For MODERATE Polyarticular JIA: o Patient has failed an adequate 3-month trial of MTX AND one formulary anti-TNF • For Systemic JIA: o Patient does NOT have currently ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis) o Patient has continued synovitis in >1 joint despite treatment for 3 months with MTX or leflunomide and one formulary anti-TNF Otezlaxxxi Criteria for Psoriatic Arthritis (PsA): Initial Approval: • Patient is at least 18 years old 4 months • Prescribed by or in consultation with a rheumatologist • Patient is currently on an NSAID and will be continued when Otezla is initiated OR has a Renewal: contraindication to NSAID use 12 months • Patient has active PsA (>3 swollen/tender joints) despite a 3-month trial of adequate dose MTX (or leflunomide or sulfasalazine if MTX is contraindicated) Requires: • At least 20% symptom Criteria for Plaque Psoriasis: improvement • Patient is at least 18 years old • Patient is not experiencing • Prescribed by or in consultation with a dermatologist depression and/or suicidal • Symptoms are not controlled with topical therapy thoughts. • Disease has a significant impact on physical, psychological or social wellbeing • Patient’s BMI is >18.5 • Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true contraindication to both QLL (after initial 5 day • Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or titration): a PASI score of more than 10) 60 tablets per 30 days • Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is defined as greater than 50% of baseline disease severity within 3 months) Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met PCSK9’sxxxii Criteria for all patients and indications: Initial Approval: 3 months • Current lipid panel results within the past 90 days • Failed an adequate 60 day trial of 2 high intensity statins* ( e.g., atorvastatin ≥ 40 mg and Renewal: 6 months Repatha rosuvastatin ≥ 20 mg) at maximum tolerated doses and in combination with other lipid Praluent lowering therapies such as Zetia (ezetimibe), bile acid sequestrants or niacin Requires: • Will be used in combination with maximum tolerated dosed statin* and other lipid lowering • Current Lipid Panel within therapies such as Zetia (ezetimibe), bile acid sequestrants or niacin or LDL apheresis the past 3 months • Claims history to support Additional Criteria based on Indication: compliance or adherence • ASCVD (For Repatha or Praluent): • LDL reduction from o There is supporting evidence of high CVD risk (i.e., history of acute coronary syndrome, baseline history of MI, stable or unstable angina, coronary or other revascularization (PCI/CABG), stroke, TIA, Peripheral Arterial Disease (PAD) presumed to be of atherosclerotic origin) Age Restriction: o Lab results to support an LDL ≥ 70 mg/dL (treated) • Praluent: at least 18 years • Heterozygous Familial Hypercholesterolemia (HeFH) (For Repatha or Praluent): old o There is evidence of ONE of the following: • Repatha for HeFH or • LDL-C > 190 mg/dL (age ≥ 18 years) either pretreatment or highest on ASCVD: at least 18 years treatment and physical evidence of tendon xanthomas or evidence of these old signs in a 1st or 2nd degree relative • Repatha for HoFH: at least • DNA based evidence of an LDL receptor (LDLR) mutation, APO-B100, 13 years old or PCSK9 mutation or • Who/Dutch Lipid Network Criteria result with a score of > 8 points QLL: o Lab results to support a current LDL ≥ 70 mg/dL on treatment • Praluent: 2 syringes per 28 • Homozygous Familial Hypercholesterolemia (HoFH) (For Repatha only): days o Genetic confirmation of 2 mutant alleles at LDLR, APO-B100, • Repatha (for ASCVD or or PCSK9 OR HeFH): 2 syringes per 28 o History of untreated LDL at 500mg/dL or LDL 300mg/dL on maximum dosed days. May be increased to statin AND evidence of ONE of the following: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Presence of cutaneous xanthoma before the age of 10 3 (140mg) syringes • HeFH in both parents OR 1 (420mg) syringe o LDL reduction was <50% on current lipid lowering therapy (high intensity per 28 days if LDL is statin + another treatment) >70 after initial trial • Repatha (for HoFH): 3 * Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at (140mg) syringes OR least one trial being a moderate to high potency statin). Documentation will include chart notes 1 (420mg) syringe per supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued; 28 days and documentation the member has been rechallenged at a lower dose or with a different statin.

Pulmonary Adcirca, Adempas, epoprostenol, Letairis, Opsumit, Remodulin, Revatio (sildenafil), Hypertension Tracleer, Tyvaso, Ventavis, Uptravi Agents See Detailed Document:

Platelet Effient or Brilinta can be approved for patients who meet the following: Initial Approval: Inhibitorsxxxiii • Diagnosis of ACS (unstable angina, STEMI, NSTEMI) Effient and Brilinta: • Failure or contraindication/intolerance to clopidogrel, including patients identified • 12 months Effient as CYP2C19 poor metabolizers • Indefinite approval can Brilinta • No active pathological bleeding, history of intracranial hemorrhage, or planned CABG be given to patients Zontivity • In addition, for Effient: with a history of stent o Age <75 unless patient is considered high thromboembolic risk thrombosis/ restenosis o Taking concomitant 75-325mg/day aspirin o No history of TIA or stroke Zontivity: • In addition, for Brilinta: • Indefinite

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Requirements Duration of Approval if Guideline Requirements Are Met o Taking concomitant 75-100mg/day aspirin Renewals: o No severe hepatic impairment Effient and Brilinta: o No concomitant use with medications known to interact with Brilinta (i.e., • 12 months; requires potent CYP3A4 inhibitors/inducers and simvastatin or lovastatin in doses documentation from >40mg/day) without provider documentation that benefit outweighs the risk cardiologist that risk of thrombosis outweighs Zontivity can be approved for patients who meet the following: bleeding risk with long- • Prescribed for the secondary prevention of atherothrombosis in patients with PAD or term use of antiplatelets history of MI (drug NOT indicated for ACS) • Must be used with aspirin and/or clopidogrel according to the standard of care for the patient’s diagnosis • No evidence of contraindications: history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding Promactaxxxiv Chronic idiopathic thrombocytopenic purpura (ITP): Initial Approval: 4 weeks • Patient is at least 1 year old • Patient had insufficient response to corticosteroids, immunoglobulins, or splenectomy Renewal: • Promacta is being used to prevent major bleeding in a patient with a platelet count of • ITP (with PLT increase to <30,000/mm3 and NOT in an attempt to achieve platelet counts in the normal range >50,000): Indefinite at i.e., 150,000- 450,000/mm3 current dose. • ITP (without PLT increase Hepatitis C with thrombocytopenia: to >50,000): 4 additional • Patient is at least 18 years old weeks with dose • Patient has chronic hepatitis C with baseline thrombocytopenia (platelet count < 90,000/mm3) increase to 75mg. which prevents initiation of interferon-based therapy when interferon is required • HCV (with PLT increase to >90,000): Duration of Peg- Severe aplastic anemia: INF treatment • HCV (without PLT increase • Patient is at least 18 years old Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • Diagnosis of severe aplastic anemia is confirmed by ONE of the following: to >90,000): 4 additional o Bone marrow biopsy showing <25% of normal cellularity; OR weeks with a dose increase o Bone marrow biopsy showing <50% of normal cellularity AND at least TWO of of 25mg every 2 weeks until the following: platelets are >90,000 or to a • Absolute neutrophil count <500/mm3 maximum of 100mg. • Platelet count <20,000/mm3 • Aplastic anemia (with PLT • Absolute reticulocyte count <40,000/mm3 (value may be given as percent increase to >50,000): of RBCs) Indefinite at current dose. • Anemia is refractory to a previous first line treatment including hematopoietic cell • Aplastic Anemia (without transplantation or immunosuppressive therapy with a combination of cyclosporine A and PLT increase to >50,000): antithymocyte globulin (ATG) Every 4 weeks with a dose increase of 50mg every 2 When to Discontinue Promacta: weeks until PLT >50,000 or • Decrease dose if PLT >200,000 and stop if >400,000. to a maximum of 150mg. • ITP: If PLT is NOT >50,000 after 4 weeks of 75mg dose, discontinue treatment. • HCV: If PLT is NOT >90,000 after 8 weeks or on max dose of 100mg, discontinue treatment. • Aplastic Anemia: Discontinue if NONE of the following occur after 16 weeks; 1) platelet increase by 20,000 above baseline; 2) Stable platelet counts with transfusion independence for >8 weeks; 3) hemoglobin increase by >1.5 g/dL; 4) Decrease of >4 units of RBC transfusions for 8 consecutive weeks; 5) Doubling of baseline ANC or an increase >500.

Proton Pump Omeprazole OTC, lansoprazole OTC, and esomeprazole OTC are the formulary preferred agents. Initial Approval: Inhibitorsxxxv Pantoprazole requires step therapy through at least 2 of the formulary preferred agents. Once daily NF: • Indefinite Omeprazole Non-preferred PPI’s can be authorized when the following criteria are met: • High dose: 12 months Prilosec OTC • Trial and failure of at least TWO formulary PPI’s • Trial and failure of at least ONE formulary PPI at double-daily dose: Renewal:

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Lansoprazole o Prilosec OTC 40mg High dose: 12 months Prevacid OTC o Nexium OTC 40mg Prevacid Solutab o Prevacid OTC 60mg Requires: Response to therapy and Aciphex Sprinkle High Dose PPI’s can be authorized when the following criteria are met: rationale for continuing BID Rabeprazole Provider must submit rationale for high dose (e.g., patient has unsatisfactory or partial response dosing to once daily dosing, night-time symptoms, severe erosive esophagitis, stricture, Zollinger- Pantoprazole Ellison) Patient must have failed Prilosec OTC 40mg, Nexium OTC 40mg, and Prevacid OTC 60mg

Esomeprazole Nexium suspension Nexium OTC

Dexilant Ranexa[vii] For patients age 18 years of age or older who meet all of the following: Initial Approval: • Diagnosis of chronic angina Indefinite • Patient meets ONE of the following: o Ranexa is prescribed as ADD-on therapy after failure to achieve therapeutic benefit on at least 1 formulary agent from EACH of the following 3 drug classes: • Beta blockers: acebutolol, atenolol, carvedilol, metoprolol, nadolol, propranolol • Calcium channel blockers: amlodipine, diltiazem, felodipine, isradipine, nifedipine, nicardipine, verapamil • Long acting nitrates: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin patch o Has a documented contraindication or intolerance to beta blockers, calcium channel blockers, AND long-acting nitrates

Last Update: 11/30/2017

Stelaraxxxvii May be authorized for Plaque Psoriasis when the following criteria is met: Initial Approval: • Patient is at least 18 years old 6 months • Prescribed by a dermatologist • Symptoms are not controlled with topical therapy Renewal: • Disease has a significant impact on physical, psychological or social wellbeing 2 years, with clinical notes • Patient has failed a 3-month compliant trial with MTX or cyclosporine or has documenting an a true contraindication to both improvement (e.g., reduction • Psoriasis is severe and extensive (for example, more than 10% of body surface in PASI, decreased area affected or a PASI score of more than 10) swollen/painful joints) • Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse NOTE: Safety and efficacy of

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met is defined as greater than 50% of baseline disease severity within 3 months) ustekinumab have not been • Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF established beyond 2 years of use May be authorized for Psoriatic Arthritis when the following criteria is met: • Patient is at least 18 years old • Prescribed by a dermatologist or rheumatologist • Patient is currently on an NSAID which will be continued when Stelara is initiated OR has a contraindication to NSAID use • Patient meets ONE of the following: o Has active PsA despite a 3-month trial of adequate dose MTX (or leflunomide or sulfasalazine if MTX is contraindicated) o Patient has predominantly axial disease AND active PsA despite a 3-month trial of TWO different NSIADs at an adequate dose OR has a contraindication to NSAID use • Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF

Symlinxxxviii For patients that meet all of the following: Initial Approval: • Diagnosis of Type 1 or Type 2 DM Indefinite • Prescribed by, or in consultation with an endocrinologist • Patient is 18 years of age or older • Patient is currently on mealtime bolus insulin (e.g., Novolog, Humalog) • Patient failed to achieve desired glucose control with optimal insulin therapy • Patient does not have any of the following: o Hypoglycemia unawareness or recurrent episodes of hypoglycemia o Gastroparesis o Poorly controlled diabetes (e.g., A1c > 9%) o Poor adherence to current insulin regimen Synagisxxxix For patients in one of the following groups: 1 dose per month until infant Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met • 3 months of age, or younger, at the start of RSV season: reaches 3 months o Gestational Age (GA) 32 weeks 0 days to 34 weeks 6 days AND of age (maximum of 3 doses): o One of the following risk factors: • Infants with GA of 32 weeks 0 • the infant attends child care, defined as a home or facility in which care is days to 34 weeks 6 days with provided for any number of infants or toddlers; OR least 1 risk factor and born less • 1 or more siblings, or other children, younger than 5 years live permanently in the than 3 months before the same household onset, or during, RSV season. • 6 months of age, or younger, at the start of RSV season: o GA 29 weeks to 31 weeks 6 days 1 dose per month for a • 12 months of age, or younger, at the start of RSV season: maximum of 5 doses: o GA ≤ 28 weeks, OR • Infants <2 years of age with o Infants with significant congenital abnormalities of the airway, or a neuromuscular CLD requiring medical therapy condition that compromises handling of respiratory tract secretions. • Infants <2 years of age with • 2 years of age, or younger, at the start of RSV season with all of the following: CHD requiring medical therapy o A diagnosis of chronic lung disease of prematurity (CLD), [formerly known as • Premature infants born at GA bronchopulmonary dysplasia or BPD]) ≤31 weeks 6 days o Has required medical therapy with supplemental oxygen, bronchodilator, diuretic or chronic corticosteroid therapy for their CLD within 6 months prior to RSV season Certain infants with • 2 years of age, or younger, at the start of RSV season with all of the following: neuromuscular disease or o A diagnosis of hemodynamically significant* cyanotic or acyanotic congenital heart congenital abnormalities of the disease (CHD) airways o Is receiving medication to control congestive heart failure, has moderate-severe pulmonary hypertension, or cyanotic heart disease

AND No contraindications to therapy: A history of a severe prior reaction to Synagis or to other components of this product

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Testosterone The formulary preferred agents will be authorized using the following criteria based on the Initial Approval: agentsxl indication being treated. Requests for Branded agents must also meet the Brand Name Medication • 6 months for criteria for approval. hypogonadism and delayed Preferred: puberty Testosterone Criteria for the use in Hypogonadism: • Indefinite for other enanthate • Confirmation of diagnosis confirmed by two separate A.M. serum testosterone indications Testosterone measurements with results below normal range as evidenced by ONE of the following: cypionate o At least one low total testosterone level (below the normal range for the laboratory) Renewal: Testosterone gel WITH elevated FSH and/or LH; OR Delayed puberty: Testosterone o At least two total testosterone levels, both of which are less than normal based upon • 6 months packets the laboratory reference range WITH at least one low free testosterone level (below • Requires X-ray of the hand the normal range for the laboratory) and wrist every 6 months Branded Products • Patient presents with symptoms associated with hypogonadism, such as but not limited to to determine bone age Non-Preferred the following: and to assess the effect of Androderm o Breast discomfort/gynecomastia; OR treatment on the Androgel o Loss of body (axillary and pubic) hair, reduced shaving need; OR epiphyseal centers. Android o Very small (especially less than 5 mL) or shrinking testes; OR Hypogonadism: Androxy o Inability to father children or low/zero sperm count; OR • Indefinite Aveed o Height loss, low trauma fracture, low bone mineral density; OR • Requires testosterone Axiron o Hot flushes, sweats; OR within normal range and/or Fortesta o Other less specific signs and symptoms including decreased, energy, depressed improvement in symptoms Methitest mood/dysthymia, irritability, sleep disturbance, poor Natesto concentration/memory, diminished physical or work performance. Striant • Patient does not have: Testopel o Metastatic prostate cancer Testred o Breast cancer Vogelxo o Unevaluated prostate nodule or induration o PSA >4 ng/ml (>3 ng/ml in individuals at high risk for prostate cancer, such as African-

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Americans or men with first-degree relatives who have prostate cancer) o Hematocrit >50% o Uncontrolled or poorly controlled congestive heart failure o Severe lower urinary tract symptoms associated with benign prostatic hypertrophy as indicated by AUA/IPSS>19

Criteria for the use in Aids-Associated Wasting: • Must meet criteria noted above for hypogonadism regarding labs and symptoms. • There is documentation of adequate nutritional support/caloric intake • Note: Eugonadal men will be reviewed on case by case basis by the Medical Director based on clinical documentation to support Medical Necessity.

Criteria for the use in Delayed Puberty: • Patient is an adolescent male • Baseline x-ray of the hand and wrist was completed to determine bone age

Criteria for the use in palliative treatment of inoperable breast cancer in women : • Prescribed by oncologist Criteria for the use in Transexualism: • Patient must be 18 years of age or greater • Female to male gender change

Topical Elidel and tacrolimus are covered for patients between 2 and 10 years of age. Initial Approval: Calcineurin For other age groups, Elidel and tacrolimus require step therapy with topical corticosteroids. Indefinite Inhibitorsxli • If patient has filled 2 topical corticosteroids in the last 60 days, the prescription will automatically process at the pharmacy.

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Elidel • Prior Authorization will be required for prescriptions that do not process automatically at the Tacrolimus pharmacy. In those cases, Elidel and tacrolimus will be reviewed for the treatment of eczema or atopic dermatitis based upon the affected area being treated: o Body/extremities – authorized after trial and failure or intolerance to at least 2 different formulary topical corticosteroids. o Face – authorized after trial and failure of one formulary low- potency topical corticosteroid o Eyelid or other sensitive area – authorized without trial and failure of topical corticosteroids

NOTE: Can also be approved for vitiligo if other criteria is met Topical Hyaluronic When used for treatment of burns, dermal ulcers, wounds, radiation dermatitis: Initial Approval: Acid Agentsxlii • Prescriber must be a dermatologist Burns or dermatitis: • Patient must be at least 18 years old • 3 fills of generic agent Bionect HyGel When used for treatment of xerosis: Xerosis: Hylira • Prescriber must be a dermatologist • Up to 1,000 grams of XClair • Trial and failure of ammonium lactate or a topical corticosteroid equivalent generic • Patient must be at least 18 years old agent per 30 days for three months

Renewal: 3 months Topical NSAIDsxliii May be approved for adults, age 18 and older, who meet the following criteria: Initial Approval: • Diclofenac 1% Gel: Diagnosis of OA of knee or hand Flector Patch: Diclofenac 1% gel • Pennsaid: Diagnosis of OA of knee • 1 month Pennsaid • History of, or high risk for, adverse GI effects associated with oral NSAID use AND trial and Flector patch All others: Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met failure of celecoxib; OR • 1 year • High risk for other adverse effects associated with oral NSAID use (i.e., CHF, renal failure, concomitant use of lithium); OR Renewal: • Failure on TWO formulary NSAIDs Flector Patch: • 1 month Note: Flector patch is only FDA approved for acute pain. Requests for Flector patch for chronic pain should be denied. If patient meets all other criteria above, offer Diclofenac 1% Gel or Pennsaid as All others: an alternative. • 1 year

The risk factors that correlate strongly to adverse GI effects of oral NSAID use are: • History of GERD, GI bleed, or ulcer • Chronic oral steroid use • Current anticoagulant or antiplatelet use • Age 65 or greater Tranexamic acid Criteria for the treatment of cyclic heavy menstrual bleeding: Initial Approval: tabletsxliv • Trial and failure, intolerance or contraindication to oral NSAIDs • 90 days for menstrual • Trial and failure, intolerance or contraindication to ANY of the following: oral hormonal bleeding cycle control combinations, oral progesterone, Mirena, Depo Provera • Indefinite for hemophilia • Age restriction: 12 years of age or older Renewal: Tranexamic acid may also be authorized for the treatment of acute bleeding episodes in patients • Indefinite with hemophilia. QLL: • 30 tablets per 30 days for menstrual bleeding • 84 tablets per 30 days for hemophilia

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met Vancomycin NOTE: Because oral vancomycin is not absorbed systemically, it should not be used for the treatment Doses and Approval Durations: Oralxlv of systemic infection. • Standard adult dose: 125mg QID for 10 days Oral vancomycin can be approved for members who meet the following: • Pediatric dose: 40 • Treatment of culture confirmed, Enterocolitis caused by Staphylococcus aureus (MSSA or MRSA); mg/kg/day in 3 or 4 divided OR doses for 7 to 10 days. • Treatment of C.difficile infection (CDI) associated diarrhea: Total daily dosage should o For Mild-to-moderate CDI in patients who are: not exceed 2 g • Intolerant/allergic to metronidazole; OR • For severe, complicated • Still symptomatic after 7 days of metronidazole when CDI has been confirmed CDI with no significant by labs [e.g., toxin enzyme immunoassay (EIA), nucleic acid amplification abdominal distention: (NAAT)]; OR 125mg QID with IV • Pregnant or breastfeeding metronidazole. Approve for o For initial episode of severe CDI (WBC > 15,000 OR Scr > 1.5x Normal) duration requested by o For severe, complicated CDI with hypotension or shock, ileus, or megacolon provider o For first recurrence of CDI when previously treated with vancomycin if CDI has been • For severe, complicated confirmed by labs [e.g., toxin enzyme immunoassay (EIA), nucleic acid amplification CDI with ileus or toxic colon (NAAT)]; and/or significant o For first recurrence of severe, CDI regardless of previous agent used abdominal distention: o For second recurrence* of CDI that has been confirmed by labs [e.g., toxin enzyme 500mg oral QID with rectal immunoassay (EIA), nucleic acid amplification (NAAT)]; vancomycin and IV • Pulsed vancomycin regimen is recommended metronidazole. Approve for • Fecal microbiota transplant should be considered after failing pulsed duration requested by vancomyin regimen provider. • Staphylococcal enterocolitis: 500-2000mg per day in 3 or 4 divided doses for 7 to 10 days.

Last Update: 11/30/2017

Xeljanz[vii] May be authorized for Rheumatoid Arthritis (RA) when the following are met: Initial Approval: • Patient is at least 18 years old 3 months • Prescribed by a rheumatologist • Patient is NOT on a biological DMARD or azathioprine or cyclosporine Renewal: • Patient is up to date with all recommended vaccinations Indefinite • Patient has been screened for latent TB and hepatitis B • Patient has moderate or high disease activity despite an adequate 3-month trial of Renewals require at least 20% BOTH of the following: symptom improvement o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX) unless contraindicated) • Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF) • Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ, SSZ+HCQ o ONE formulary anti-TNF (Note: anti-TNF’s require PA) Xolair[x] For the treatment of moderate-severe persistent asthma: Initial Approval: • Prescribed by, or after consultation with a pulmonologist or allergist/immunologist Asthma: 6 months • 12 years of age or older • Baseline IgE levels between 30-700 IU/ml Chronic urticaria: 3 months • Weight is less than 150 kg (330 lbs.) • Allergic sensitization demonstrated by positive skin testing or in vitro testing for allergen-specific Renewal: IgE to an allergen that is present year round (a perennial allergen), such as dust mite, animal Asthma: 1 year

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met dander, cockroach, or molds Requires demonstration of • Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200-ml clinical improvement (e.g., .4' increase or 20% or greater improvement in PEF as a result of a short-acting bronchodilator use of rescue medications or challenge) systemic corticosteroids, ↑ in • Patient should be non-smoking or actively receiving smoking cessation treatment FEV1 from pre-treatment • Patient has tried and failed conventional immunotherapy or immunotherapy is not indicated. baseline, .4' in number of ED (Immunotherapy has demonstrated efficacy against dust mites, animal dander, and pollens but visits or hospitalizations) and not against molds and cockroach allergies). compliance with asthma • Asthma symptoms are not adequately controlled by high dose inhaled corticosteroids AND a long- controller medications, and acting beta agonist (LABA) for 6 months non-smoking status. o Inadequate control is defined as: • Requirement for systemic corticosteroids (oral, parenteral) to treat asthma Chronic urticaria: exacerbations; OR 6 months • Daily use of rescue medications (short-acting inhaled beta-2 agonists); OR Requires demonstration of • 2 ED visits or 1 hospitalization for asthma in the last 12 months; OR adequate symptom control • 2-3 unscheduled office visits with documentation of intensive care for (e.g., .4' itching) acute asthma exacerbation; OR • Nighttime symptoms occurring more than once a week

For the treatment of chronic urticaria: • Symptoms continuously or intermittently present for at least 6 weeks. • Prescribed by an allergist/immunologist or dermatologist • 12 years of age or older • Currently receiving H1 antihistamine therapy • Failure of a 4 week, compliant trial of at least two high dose H1 antihistamines AND • Failure of a 4-week, compliant trial of at least one of the following medications (used in addition

Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name PA Guideline Requirements Duration of Approval if Requirements Are Met to H1 antihistamine therapy): o Leukotriene inhibitor (montelukast or zafirlukast) o H2 antihistamine (ranitidine or cimetidine) o Doxepin AND • Failure of a 4 week, compliant trial of low dose cyclosporine (used in addition to H1 antihistamine therapy) or contraindication to cyclosporine.

• NOTE: Anti-inflammatory medications (dapsone, sulfasalazine, or hydroxychloroquine) may be useful in treating urticaria, however the evidence is limited

**Note: Off-label and not covered for diagnosis of Allergic Rhinitis or food allergy**

i Actemra References 1. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res. 2013;65(10):1551-1563. 2. Actemra (tocilizumab) [package insert]. South San Francisco, CA; Genetec, Inc; Revised November 2014. 3. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic- juvenile-idiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016. 4. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrin- associated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016. 5. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and ii biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. Ampyra References 1. Drug Facts and Comparisons on-line. (https://www.drugs.com/ppa/), Wolters Kluwer Health, St. Louis, MO. Updated periodically 2. National Multiple Sclerosis Society Disease Management Consensus Statement-Recommendations from the MS Information Sourcebook; 2007 Update. National Multiple Sclerosis Society. Available at: http://www.nationalmssociety.org/For-Professionals/Clinical-Care/Managing-MS. Accessed on Sept 2, 2014 iii Injectable Anticoagulants References Last Update: 11/30/2017

Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name

1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically 2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. 3. PL Detail-Document, Comparison of Injectable Anticoagulants. Pharmacist’s Letter/Prescriber’s Letter. August 2012,26(9):260902 4. Kahn SR., Lim W., Dunn AS., et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines), Chest 2012; 141 (Suppl 2): e195S-e226S 5. Gould MK., Garcia DA., Wren SM,, et al. Prevention of VTE in Nonorthopedic Surgical Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e227S-e277S 6. Falck-Ytter Y., Francis CW., Johanson NA,, et al. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e278S-e325S 7. Douketis JD., Spyropoulos AC., Spencer FA., et al. Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e326S-e350S 8. Kearon C., Akl EA., Comerota AJ., et al. Antithrombotic Therapy for VTE Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e419S-e494S. 9. You JJ., Singer DE., Howard PA., et al. Antithrombotic Therapy for Atrial Fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e531S-e575S 10. Lansberg MG., O’Donnell MJ., Khatri P., et al. Antithrombotic and Thrombolytic Therapy for Ischemic Stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e601S-e636S. 11. Bates SM., Greer IA., Middeldorp S., et al. VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e691S-e736S. iv Oral Anticoagulants References: 1. Product monograph for Eliquis. Bristol-Myers Squibb Canada. Montreal, QC H4S 0A4. May 2015. 2. Product information for Xarelto. Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. May 2015. 3. Product information for Pradaxa. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877. May 2015. 4. PL Detail-Document, Comparison of Oral Anticoagulants. Pharmacist’s Letter/Prescriber’s Letter. June 2014. Accessed May 2015. 5. Singer DE, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians evidence-based clinical practice guidelines (9th edition), Chest 2012; 141 (Suppl 2): e531S-e575S 6. Guyatt GH, Aki EA, Crowther M, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141(Suppl 2):7S-47S. 7. Walter A, Gallus A, et al. Oral Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (9th edition), Chest 2012 (Suppl 2): e44s-e88s. 8. You JJ, Singer DE, Howard PA, et al. Antithrombotic therapy for atrial fibrillation: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141(Suppl 2):e531S-75. v ARBs References 1. Gold Standard. (2010, April 9). Benicar. Tampa, Florida. Retrieved November 1, 2014, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=2750&sec=monindi&t=0

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2. Gold Standard. (2012, April 19). Tektuna. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=3555&sec=monindi&t=0 3. Gold Standard. (2014, May 29). Valsartan. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=2119&sec=monindi&t= 4. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427. vi Cambia References 1. Cambia [full prescribing information]. Newark, CA: Depomed Inc.; Revised 01/2014. 2. Marmura MJ, Silberstein SD, Schwedt TJ. The Acute Treatment of Migraines in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache. 2015;55:3-20. vii Cialis References 1. Gold Standard. (2014, March 7). Cialis. Tampa, Florida, USA. Retrieved November 3, 2014, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=2701&sec=monindi&t=0 2. Walters Kluwer Health Inc. (2014, June 1). Cialis. St Louis, Missouri, USA. Retrieved November 3, 2014, from http://online.factsandcomparisons.com/MonoDisp.aspx?monoID=fandc- hcp1415&quick=264475%7c5&search=264475%7c5&isstemmed=True&NDCmapping=-1&fromTop=true#firstMatch 3. Cunningham GR, Kadmon D. Medical treatment of benign prostatic hyperplasia. Waltham, MA: UptoDate; Last modified October 8, 2015. http://www.uptodate.com/contents/medical- treatment-of-benign-prostatic-hyperplasia?source=search_result&search=benign+prostatic+hypertrophy&selectedTitle=1%7E150#H186693674. Accessed March 22, 2016. viii Colony Stimulating Factors References 1. Infectious Disease Society of America: Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update by the Infectious Diseases Society of America. Available at: http://news.idsociety.org/idsa/issues/2011-01-01/17.html Accessed October 5, 2015. 2. Zarxio (filgrastim-sndz) [package insert]. Princeton, NJ: Sandoz Inc. December 2014. 3. Granix (tbo-filgrastim) [package insert]. North Wales, PA: Cephalon, Inc. July 2015. ix Cystic Fibrosis Medications References 1. Katkin, JP. Cystic fibrosis: Clinical manifestations and diagnosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.); 2. Simon, RH. Cystic fibrosis: Antibiotic therapy for lung disease. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.); 3. Tobi Podhaler [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2013; 4. Cayston [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2012; 5. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2010; 6. Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Truven Health Analytics, 2014. http://www.thomsonhc.com/. Accessed March 21, 2014; 7. Fakhoury, K; Kanu, A. Management of bronchiectasis in children without cystic fibrosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on March 21, 2014.). 8. Amorim, A. (2013). New advances in the therapy of non-cystic fibrosis bronchiectasis. Revista Portuguesa de Pneumologia, 19(6)(266), 266-275. Retrieved from http://www.elsevier.pt/en/revistas/revista-portuguesa-pneumologia-320/artigo/new-advances-in-the-therapy-of-non-cystic-fibrosis-90251782 9. Mogayzel P, Naureckas E, Robinson K, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013 Apr 1;187(7):680-9. 10. Pulmozyme [package insert]. San Francisco, CA: Genentech, Inc.; 2014;

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11. Kalydeco [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2015; 12. Tobi-tobramycin solution [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014; 13. Bethkis-tobramycin solution [package insert]. Cary, NC: Chiesi USA, Inc.; 2014; x Daliresp References 1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org xi Daraprim References 1. Gandhi RT. Toxoplasmosis in HIV-infected patients. Waltham, MA: UptoDate; Last modified September 21, 2015. http://www.uptodate.com/contents/toxoplasmosis- in-hiv-infected-patients?source=searchresult&search=daraprim&selectedTitle=6%7E47. Accessed September 25, 2015. 2. Thomas CF, Limper AH. Treatment and prevention of Pneumocystis pneumonia in non-HIV-infected patients. Waltham, MA: UptoDate; Last modified January 6, 2015. http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-pneumonia-in-non-hiv-infected- patients?source=searchresult&search=pneumocystis&selectedTitle=4%7E150. Accessed September 25, 2015. 3. Sax PE. Treatment and prevention of Pneumocystis infection in HIV-infected patients. Waltham, MA: UptoDate; Last modified August 27, 2015. http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-infection-in-hiv-infected- patients?source=searchresult&search=pneumocystis&selectedTitle=2%7E150#H2384560994. Accessed September 25, 2015. xii Direct Renin Inhibitors References 1. Gold Standard. (2011, January 14). Aliskiren; Amlodipine; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com 2. Gold Standard. (2012, February 1). Aliskiren; Amlodipine. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com 3. Gold Standard. (2010, February 12). Aliskiren; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com 4. Gold Standard. (2013, September 18). Aliskiren. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com 5. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427. xiii Duavee References 1. Duavee ® [package insert] 10/2013. Philadelphia, PA: Wyeth Pharmaceuticals Inc. 2. Gold Standard, Inc. (2014, September 29). Duavee. Clinical Pharmacology [database online]. Retrieved from http://www.clinicalpharmacology.com 3. Daily Med [Internet database]. NIH U.S. National Library of Medicine. Duavee. Bethesda, MD. Updated 26 Nov. 2012. 4. Cosman, F., de Beur, S.J., LeBoff, M.S., et al. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoprosis International. 24 Jun. 2014. xiv GnRH Agonists References 1. American College of Obstetricians and Gynecologists (ACOG). Management of endometriosis. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2010 Jul. (ACOG practice bulletin; no. 1114). Available at : http://www.guideline.gov/content.aspx?id=16327 2. Gold Standard, Inc. Eligard, Lupron, Synarel and Supprelin. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Accessed Jun 2013. 3. Gold Standard, Inc. Trelstar, Zoladex, and Vantas. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Jun 2013. 4. Kaplowitz, MD, PhD, Paul B. Precocious Puberty. emedicine [database online] Available at http://emedicine.medscape.com/article/924002-overview. Accessed April 6, 2010. 5. Lupron Depot [Prescribing Information]: AbbVie Inc., North Chicago, IL; Jan 2013. http://www.rxabbvie.com/pdf/lupron3month1125mg.pdf. and http://www.rxabbvie.com/pdf/lupron3_75mg.pdf. Accessed Jun 2013 6. Lupron Depot Ped [Prescribing Information]: AbbVie Inc., North Chicago, IL; April 2013. http://www.rxabbvie.com/pdf/lupronpediatric.pdf. Accessed Jun 2013

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7. Supprelin LA [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; April, 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/supprelinla.pdf. Accessed Jun 2013; 8. Synarel [Prescribing Information]: Pfizer; New York, NY; Jan 2012. http://www.accessdata.fda.gov/drugsatfdadocs/label/2012/019886s030lbl.pdf. Accessed June 2013 9. Eligard [Prescribing Information]: Bridgewater, NJ: Sanofi-Aventis US LLC; Feb 2013. http://products.sanofi.us/eligard/eligard.html. Accessed June 2013 10. Zoladex [Prescribing Information]: AstraZeneca Pharmaceuticals LP, Wilmington DE. 6/2013. http://www1.astrazeneca-us.com/pi/zoladex36.pdf. and http://www1.astrazeneca-us.com/pi/zoladex10_8.pdf; Accessed Jun 2013. 11. Vantas [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; Rev Apr 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/vantas.pdf. Accessed Jun 2013 12. Trelstar [Prescribing Information]: Watson Pharma, Inc., Parsippany, NJ: Mar 2013. http://pi.actavis.com/datastream.asp?productgroup=1684&p=pi&language=E. Accessed Jun 2013 13. ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis. http://www.aafp.org/afp/2011/0101/p84.html. accessed 8/23/12 14. National Guideline Clearing House Management of Endometriosis. Available http://guidelines.gov/content.aspx?id=16327; accessed 8/23/12 15. National Guideline Clearing House Alternatives to hysterectomy in the management of leiomyoma. http://guidelines.gov/content.aspx?id=13318; accessed 8/23/12 for fibroids 16. Schenken, RS: Treatment of endometriosis. In UpToDate, Barbieri, RL (Ed), UpToDate, Waltham, MA, Jan 2013. 17. Saenger, P: Treatment of precocious puberty. In UpToDate, Snyder, PJ (Ed), UpToDate, Waltham, MA, April 2013. 18. ESHRE Guideline for the Diagnosis and Treatment of Endometriosis. http://guidelines.endometriosis.org/concise-pain.html; Accessed 8/23/2012 19. Pain Management of Endometrosis. http://www.acog.org/About_ACOG/News_Room/News_Releases/2010/Pain_Management_of_Endometriosis. Accessed 8/23/2012 20. Dysfunctional Uterine Bleeding: http://emedicine.medscape.com/article/257007-medication#8. Accessed 9/7/2012 21. NCCN Prostate Cancer Treatment Guidelines for Patients: http://www.psa-rising.com/download/nccnguidelines.pdf. Accessed 9/7/12 xv Hetlioz References 1. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. 2. HetliozTM [package insert]. Washington, D.C.: Vanda Pharmaceuticals, Inc.; January 2014 3. Vanda Pharmaceuticals. Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 Mar 20]. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01163032 NLM Identifier: NCT01163032. xvi HP Acthar References 6. H.P. Acthar (corticotropin) [package insert]. Hazelwood, MO; Mallinckrodt ARD Inc; Revised January 2015. 7. Olek MJ. Treatment of acute exacerbations of multiple sclerosis in adults. Waltham, MA. UpToDate. Last modified. July 14, 2015. http://www.uptodate.com/contents/treatment- of-acute-exacerbations-of-multiple-sclerosis-in-adults?source=searchresult&search=multiple+sclerosis&selectedTitle=8%7E150. Accessed August 11, 2015 xvii Hyperlipidemia Medication References 1. Berglund L, et al. Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2012; 97(9): 2969–2989. 2. Cuchel M, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Concensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014; 3. Goldberg AC, et al. Familial Hypercholesterolemia: Screening, diagnosis and management of pediatric and adult patients Clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011;(5):S1-S8. 4. Jacobson TA, et al. National lipid association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary. J Clin Lipidol. 2014;8:473-488.

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5. Robinson JG. Management of familial hypercholesterolemia: a review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Manag Care Pharm. 2013;19(2):139-49. 6. Stone NJ, et al. 2013 ACC/AHA blood cholesterol guideline. Circulation. 2013; 7. Watts GF, et al. Integrated guidance on the care of familial hypercholesterolaemia from the International FH Foundation. Int J Cardiol. 2014; 8. Crestor® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised June 2015. 9. Epanova ® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised September 2014. 10. Juxtapid ® [package insert]. Cambridge, MA: Aegerion Pharmaceuticals, Inc.; Revised April 2015. 11. Kynamro ® [package insert]. Cambridge, MA: Genzyme Corporation; Revised April 2015. 12. Livalo® [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised August 2011. 13. Lovaza ® [package insert]. RTP, NC: GlaxoSmithKline; Revised September 2014. 14. Vascepa ® [package insert]. Bedminster, NJ: Amarin Pharmaceuticals; Revised May 2014. 15. Zetia ® [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; Revised September 2013. xviii Idiopathic Pulmonary Fibrosis Agents References 1. Esbriet [package insert]. Brisbane, CA: InterMune, Inc.; 2014. 2. National Clinical Guideline Centre. Idiopathic pulmonary fibrosis. The diagnosis and management of suspected idiopathic pulmonary fibrosis. London (UK): National Institute for Health and Care Excellence (NICE); 2013 Jun. 32 p. (Clinical guideline; no. 163). 3. National Institute for Health and Care Excellence (NICE). Pirfenidone for treating idiopathic pulmonary fibrosis. London (UK): National Institute for Health and Care Excellence (NICE); 2013 Apr. 66 p. 4. Raghu G, Collard HR, Egan JJ et al. for the ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med 2011; 183: 788-824. 5. Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; Revised October 2014. xix Ilaris References 8. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res. 2013;65(10):1551-1563. 9. Ilaris (canakinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised October 2014. 10. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic- juvenile-idiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016. 11. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrin- associated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016. xx IL-17 Antagonist References: 1. Cosentyx (secukinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; January 2015. 2. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-of- psoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.

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3. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153). xxi Integrin Receptor Antagonist References 1. Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT. American gastroenterological association institute guideline on the use of thiopurines, methotrexate, and anti–TNF-a biologic drugs for the induction and maintenance of remission in inflammatory crohn’s disease. Gastroenterol. 2013;145:1459–1463. 2. The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults. Am J Gastroenterol. 2010;105:501-523. 3. Farrell RJ, Peppercorn MA. Overview of the medical management of severe or refractory Crohn disease in adults. Waltham, MA: UpToDate; Last modified June 10, 2015. http://www.uptodate.com/contents/overview-of-the-medical-management-of-severe-or-refractory-crohn-disease-in- adults?source=searchresult&search=crohns&selectedTitle=2%7E150. Accessed October 1, 2015 4. Cohen RD., Stein AC. Approach to adults with steroid-refractory and steroid-dependent ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/approach-to-adults-with-steroid-refractory-and-steroid-dependent-ulcerative-colitis?source=seelink. Accessed August 11, 2015. 5. Peppercorn MA., Farrell RJ. Management of severe ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/management-of- severe-ulcerative-colitis?source=searchresult&search=ulcerative+colitis&selectedTitle=2%7E150. Accessed August 11, 2015 xxii Interferon References: 1. American Association for the Study of Liver Diseases. (2014, August 11). Recommendations for Testing, Managing, and Treating Hepatitis C. Retrieved September 13, 2014, from American Association for the Study of Liver Diseases and the Infectious Diseases Society of America: http://www.hcvguidelines.org/fullreport 0. 2. Gold Standard, Inc. (2013, October 13). Interferon Gamma-1b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com 3. Gold Standard, Inc. (2014, April 22). Interferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com 4. Gold Standard, Inc. (2014, April 22). Interferon Alfacon-1. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com 5. Gold Standard, Inc. (2014, August 18). Peginterferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com 6. Lok, A. S., & McMahon, B. J. (2009, September). Chronic Hepatitis B: Update 2009. Retrieved September 14, 2014, from American Association for the Study of Liver Diseases: www.aasld.org 7. Rosenzweig, S. D., & Holland, S. M. (2014, January 24). Chronic granulomatous disease: Treatment and prognosis. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com 8. Schering Corporation. (2014, August). Infergen. Whitehouse Station, NJ, USA. 9. Sosman, J. A. (2014, June 10). Adjuvant immunotherapy for melanoma. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com 10. Tallman, M. S. (2014, February 13). Treatment of hairy cell leukemia. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com 11. The NIH Osteoporosis and Related Bone Diseases ~ National Resource Center. (2012, December). Osteopetrosis Overview. Retrieved from http://www.niams.nih.gov/health_info/bone/ 12. Thomson Micromedex. (2014, August 08). DRUGDEX System. Retrieved September 1, 2015, from Interferon Gamma: http://www.thomsonhc.com 13. Aetna.com. Clinical Policy Bulletin: Interferon. Last reviewed 6/16/2015 Available at: http://www.aetna.com/cpb/medical/data/400499/0404.html. accessed August 29, 2015 14. Clinical Pharmacology Online. Tampa, FL. Gold Standard Inc. Updated periodically; accessed August 28, 2015. http://www.clinicalpharmacology-ip.com. 15. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Diseases Treatment Guidelines 2010. MMWR. 2010;59:1 xxiii Intravaginal Progesterone Products References 1. The American College of Obstetricians and Gynecologists. Committee on Practice Bulletins – Obstetrics, Practice Bulletin: Prediction and Prevention of Preterm Birth. Obstetrics & Gynecology. Oct 2012; 120;4: 964-973. Last Update: 11/30/2017

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2. National Institute for Health and Care Excellence. Preterm labour and birth (NG25): NICE guideline. 20 Nov. 2015. 3. O’brien, J.M., DeFranco, E.A., Adair, C.D., Lewis, D.F., Hall, D.R., How, H., Bsharat, M., and Creasy, G.W. Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2009; 34:653-659. 4. Coomarasamy, A., Williams, H., Truchanowicz, E., et al. A randomized trial of progesterone in women with recurrent miscarriages. N Engl .' Med. 2015;373:2141-8. xxiv Invokana 1. Gold Standard, Inc. Invokana. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed Mar 24, 2014. 2. InvokanaTM, canagliflozin. Jansen Pharmaceuticals, Inc., Titusville, NJ 08560. October, 2013.http://www.invokana.com/prescribing-information.pdf. Accessed March 24, 2014. 3. Facts & Comparisons eAnswers. Drug Facts and Comparisons. Indianapolis, IN: Wolters Kluwer Health; 2013. http://online.factsandcomparisons.com/. Accessed March 24, 2014 xxv Kineret References 12. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res. 2013;65(10):1551-1563. 13. Kineret (anakinra) [package insert]. Stockholm, Sweden; Swedish Orphan Biovitrum AB; Revised November 2013. 14. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic- juvenile-idiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016. 15. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrin- associated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016. 16. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. xxvi Long-Acting Opioid References 1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2013. 2. National Institute for Health and Care Excellence (NICE). Neuropathic pain - pharmacological management. The pharmacological management of neuropathic pain in xxvii adults in nonspecialist settings. London (UK): National Institute for Health and Care Excellence (NICE); 2013 Nov. 41 p. (Clinical guideline; no. 173). Makena References 1. Makena (17- hydroxyprogesterone caproate) [package insert]. St. Louis, MO: Ther-Rx Corporation; Feb 2011. 2. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl .' Med. 2003;348(24):2379-85. 3. Makena [Daily Med]. NIH, U.S. National Library of Medicine. Updated 28 Feb. 2015. Accessed 25 Feb. 2016. xxviii Multaq References 1. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. 2. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically 3. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing committee to revise the 2001 guidelines for the management of patients with atrial fibrillation). J Am Coll Cardiol 2006; 48:e14 4. MULTAQ Dronedarone tablets prescribing information products.sanofi.us/Multaq/Multaq.pdf. xxix Non-Cacium Based Phosphate Binder References

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1. Gold Standard. (2014, April 21). Velphoro. Tampa, Florida, USA. Retrieved 19 December, 2014, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=2575&sec=monindi&t=0 2. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease: Am J Kidney Dis. 2003 Oct;42(4):s1-s201 xxxOnychomycosis and Tinea References 1. El-Gohary M, van Zuuren EJ, Fedorowicz Z, Burgess H, Doney L, Stuart B, Moore M, Little P. Topical antifungal treatments for tinea cruris and tinea corporis. Cochrane Database of Systematic Reviews 2014, Issue 8. Art. No.: CD009992. DOI: 10.1002/14651858.CD009992.pub2. 2. Bell-Syer SEM, Khan SM, Torgerson DJ. Oral treatments for fungal infections of the skin of the foot. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD003584. DOI: 10.1002/14651858.CD003584.pub2. 3. Luzu [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; June 2014. 4. Jublia [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; February 2015 5. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672 6. Facts and Comparisons. (2014, September 1). St Lois, Missouri, USA. 7. Gold Standard, Inc. (2013, November 20). Luzu. Retrieved April 08, 2015, from http://www.clinicalpharmacology.com: http://www.clinicalpharmacology.com 8. Gold Standard, Inc. (2015, 01 27). Jublia. Retrieved April 08, 2015, from www.clinicalpharmacology.com: http://www.clinical [viii] Orencia References: 1. Orencia (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Revised June 2015. 2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. 3. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res. 2013;65(10):15511563. 4. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations and diagnosis. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis- treatment?source=searchresult&search=juvenile+arthritis&selectedTitle=8%7E150 Accessed October 5, 2015. xxxi Otezla References 17. Otezla (apremilast) [package insert]. Summit, NJ; Celgene Corporation; Revised December 2015. 18. Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012;71:4-12. 19. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153). 20. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment- of-psoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015. xxxii PCSK9 References 4. Repatha [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; Aug 2015 5. Praluent [Prescribing Information]. Bridgewater, NJ,: Regeneron and Sanofi Aventis LLC; Oct 2015

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6. Stone, NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; doi:10.1016/j.jacc.2013.11.002. 7. Mangement of familial hypercholesterolemia http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=16222 http://www.google.com/url?url=http://www.amcp.org/WorkArea/DownloadAsset.aspx%3Fid%3D16222&rct=j&frm=1&q=&esrc=s&sa=U&ei=RJSUVf2bDsuTyATgvoHwAw&ved=0CEAQFjA G&usg=AFQjCNEDp9VnIHhpJLov4D4lQgRPWNuQLQ 8. Cuchel M, Bruckert E, Ginsberg HN, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014 Aug 21;35(32):2146-57. doi: 10.1093/eurheartj/ehu274. Epub 2014 Jul 22. xxxiii Platelet Inhibitors References: 1. Gordon H. Guyatt, MD, FCCP, Elie A. Akl, MD, PhD, MPH, et al. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST Journal February 2012; 141(2_suppl) 2. Simons, Michael. "Antiplatelet agents in acute non-ST elevation acute coronary syndromes." UpToDate. http://www.uptodate.com (accessed March 24, 2014). 3. Cutlip, Donald. “Antithrombotic therapy for percutaneous coronary intervention: General Use.” UpToDate. http://www.uptodate.com (accessed March 24, 2014). 4. Lincolff, Michael A. “Antiplatelet agents in acute ST elevation myocardial infarction.” UpToDate. http://www.uptodate.com (accessed March 24, 2014). 5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically 6. Effient (prasugrel) package insert. Indianapolis, IN: Eli Lilly and Company 7. Brilinta (ticagrelor) package insert. Wilmington, DE:AstraZeneca LP 8. (O'Gara, Kushner, & Ascheim, 2013) 9. Amsterdam EA, et al. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation 10. Acute Coronary Syndromes: Executive Summary. J Am Coll Cardiol. 2014;64(24):e139-228. 11. Eikelboom JW, Hirsh J, Spencer FA, Baglin TP, Weitz JI. Antiplatelet drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl):e89S–e119S 12. Weitz JI, Eikelboom JW, Samama MM. New Antithrombotic Drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl) :e120S–e151S 13. Zontivity (vorapaxar) package insert. xxxiv Promacta References 1. Promacta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; Revised June 2015. 2. Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207. 3. Schrier SL. Aplastic anemia: Pathogesis; clinical manifestations; and diagnosis. Waltham, MA: UptoDate; Last modified November 11, 2015. http://www.uptodate.com/contents/aplastic- anemia-pathogenesis-clinical-manifestations-and-diagnosis?source=search_result&search=aplastic+anemia&selectedTitle=1%7E150#H21 Accessed March 30, 2016. 4. Judith C. W. Marsh, e. a. (2009). Guidelines for the diagnosis and management of aplastic. British Journal of Hematology. 5. Marsh, J. R. (2010). Aplastic Anemia: First-line Treatment by Immunosuppression and Sibling Marrow Transplantation. ASH Education Book. xxxv Proton Pump Inhibitors References:

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1. Katz P, Gerson L, Vela M. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol 2013; 108:308-328; doi:10.1038/ajg.2012.444; published online 19 February 2013 2. Fass R, Sontag SJ, Traxler B, Sostek M. Treatment of Patients With Persistent Heartburn Symptoms: A Double-Blind, Randomized Trial. Clin Gastroenterol Hepatol; 2006;4:50–56. 3. Fass R, Murthy U, Hayden CW, et al. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventional-dose lansoprazole therapy-a prospective, randomized, multi-centre study. Aliment Pharmacol Ther. 2000; 14: 1595-1603. 4. Fass, R. Approach to refractory gastroesophageal reflux disease in adults. In: UpToDate. Talley NJ, ed. UpToDate, Waltham, MA: UpToDate; 2015. Available at: http://www.uptodate.com/home. Accessed June 15, 2015. [vii] RaneXa References 1. Fihn SD, G. J. (December 2012). 2012 American College of Cardiology Foundation/American Heart Association/American College of Physicians/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society for Cardiovascular Angiography and Interventions/Socie. Journal of the American College of Cardiology, Volume 60 Issue 24. 2. Gold Standard, Inc. (2013, Decemember 25). Ranexa. Retrieved August 25, 2015, from ClinicalPharmacology: http://www.clinicalpharmacology.com 3. Kannam, J. e. (201, August 12). Stable ischemic heart disease: Overview of care . Retrieved August 25, 2015, from Up to Date: http://www.uptodate.com. 4. National Institute for Health and Care Excellence (NICE). Management of stable angina. NICE Clinical Guideline 126 (July 2011). From https://www.nice.org.uk/guidance/cg126/chapter/1- Guidance#anti-anginal-drug-treatment Accessed September 17, 2015. XXXvi Restasis References 1. Shtein, Roni M., Dry Eyes. In: UpToDate, Trobe, Jonathan (Ed), Park, Lee (Ed), UpToDate, Waltham, MA, May 13, 2015. xxxvii Stelara References: 4. Ustekinumab. (2015) In Clinical Pharmacology online. Retrieved from http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=3586&n=Stelara&t=0. 5. Stelara (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 2014 March.; 6. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-of- psoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015. 7. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153). xxxviii Symlin 1. Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Truven Health Analytics, 2014. http://www.thomsonhc.com/. Accessed February 24, 2014. 2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated December, 2009. 3. AACE Comprehensive Diabetes Management, Endocr Pract. 2013;19(Suppl 2) xxxix Synagis References 1. Aetna.com. 2014. Clinical Policy Bulletin: Synagis (Palivizumab). [online] Available at: http://www.aetna.com/cpb/medical/data/300_399/0318.html [Accessed: 28 Jul 2014]. 2. Perrin, MD, FAAP, J., Meissner, MD, FAAP, H. and Ralston, MD, FAAP, S. 2014. Updated AAP Guidance for Palivizumab Prophylaxis For Infants and Young Children at Increased Risk of RSV Hospitalization. [e-book] pp. 1-23. Available through: American Academy of Pediatrics http://www.aap.org/en-us/my-aap/Pages/rsv.aspx [Accessed: 28 Jul 2014]. 3. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection, COMMITTEE ON INFECTIOUS DISEASES AND BRONCHIOLITIS GUIDELINES COMMITTEE, Pediatrics 2014;134;415; originally published online July 28, 2014; DOI: 10.1542/peds.2014-1665, Accessed online on 8/13/2014 at http://pediatrics.aappublications.org/content/134/2/415.full.html Xl Testosterone References:

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1. Fernández-Balsells MM, Murad MH, Lane M, Lampropulos JF, et al. Clinical review 1: Adverse effects of testosterone therapy in adult men: a systematic review and meta- analysis. J Clin Endocrinol Metab. 2010;95(6):2560-75 2. Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59. 0. http://www.aetna.com/cpb/medical/data/300399/0345.html 3. Tang AM, Forrester J, Spiegelman D, et al. Weight loss and survival in HIV-positive patients in the era of HAART. J Acquir Immune Defic Syndr 2002:31:230-236. 4. Micromedex: Testosterone, http://www.micromedexsolutions.com accessed 12.30.15 xli Elidel/tacrolimus References 1. Gold Standard. (2013, September 26). Elidel. Tampa, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=2670&sec=monindi&t=0 2. Gold Standard. (2013, October 16). Tacrolimus. Tamp, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacology- ip.com/Forms/Monograph/monograph.aspx?cpnum=587&sec=monindi&t=0 xlii Viscosupplement References: 1. Synvisc One Prescribing Information, Genzyme. Sept, 2014. 2. Supartz Prescribing information, Smith & Nephew. Sept, 2014. 3. Hyalgan Prescribing information, Sanofi-Synthelabo. Sept, 2014. 4. Orthovisc Prescribing information, Depuy Mitek. Sept, 2014. 5. Euflexxa Prescribing information, Ferring Pharmaceuticals. Sept, 2014 6. American Academy of Orthopedic Surgeons. (Resource of the World Wide Web). http://www.aaos.org/research/guidelines/OAKSummaryofRecommendations.pdf. Accessed on Sept 2, 2014 7. www.uptodate.com. Accessed on Sept 2, 2014. 8. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically 9. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. xliii Topical NSAID References 1. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. 2000 Sep (revised 2012 Apr). 2. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of glenohumeral joint osteoarthritis. 2009 Dec 4 (reaffirmed 2014). 3. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis of the knee, 2nd edition. 1996 (revised 2013 May 18). 4. VA/DoD clinical practice guideline for the non-surgical management of hip and knee osteoarthritis. 2014. 10. Voltaren Gel (diclofenac sodium topical gel) package insert. Parsippany, NJ: Novartis Consumer Health; 2007 Oct. 11. Pennsaid (diclofenac sodium) topical solution package insert. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; 2013 Oct. 12. Flector (diclofenac epolamine) [prescribing information]. Bristol, TN: King Pharmaceuticals; August 2011. 13. Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med 1991;151:1825-32.

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9. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012;60:616-31. 10. Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation 2008;118:1894-909. 11. Masso Gonzalez EL, Patrignani P, Tacconelli S, Garcia Rodriguez LA. Variability among nonsteroidal antiinflammatory drugs in risk of upper gastrointestinal bleeding. Arthritis Rheum 2010;62:1592-601. 12. Lanza FL, Chan FK, Quigley EM, Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009;104:728-38. 13. Hernandez-Diaz S, Rodriguez LA. Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 2002;55:15763. 14. Roth SH, Fuller P. Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older. Clin Interv Aging 2012;7:12737. 15. Derry S, Moore RA, Rabbie R. Topical NSAIDs for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev 2012;(9):CD007400. 16. Altman RD. Safety advantages of topical versus oral nonsteroidal antiinflammatory drugs. J Rheumatol 2011;38:572. 17. Sprix (ketorolac tromethamine) Nasal Spray package insert. Shirley, NY: American Regent, Inc.; 2014 Apr. xliv Tranexamic acid References 1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically 2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. Product Information. Lysteda®, tranexamic acid. Ferring Pharmaceuticals, Inc., Bethesda, MD 20814. October, 2013. 3. American College of Obstetricians and Gynecologists. Committee on Gynecologic Practice: Management of Acute Abnormal and Uterine Bleeding in Nonpregnant Reproductive- Aged Women. Resources & Publications. Number 557. Apr 2013. Reaffirmed 2015. Accessed Feb 6. 2016. http://www.acog.org/Resources-And-Publications/Committee- Opinions/Committee-on-Gynecologic-Practice/Management-of-Acute-Abnormal-Uterine-Bleeding-in-Nonpregnant-Reproductive-Aged-Women 4. Lysteda ® [package insert] 10/2013. Parsippany, NJ. Ferring Pharmaceuticals, Inc. 5. Lukes, Andrea S, et al. Tranexamic Acid Treatment for Heavy Menstrual Bleeding. Obstetrics & Gynecology. 116(4) Oct 2010: 865-875. xlv Oral Vancomycin References 1. Cohen, Stuart H., Gerding, Dale N., Johnson, Stuart, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infection Control and Hospital Epidemiology. May 2010. 31;5:431-455. 2. Surawicz, Christina M., Brandt, Lawrence J., Binion, David G. et al. Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections. Am J Gastroenterol. Feb 2013. 108:478-498. 3. Gilbert, David N., Moellering Jr., Robert C., Eliopoulos, George M., Chambers, Henry F., Saag, Michael S. The Sanford Guide to Antimicrobial Therapy 2011: Forty-First Edition. Antimicrobial Therapy, Inc. Sperryville, VA. 2011. 4. Uptodate [database]. Clostridium difficile in adults: Treatment. Updated 2015 Nov 23. Accessed 2016. Feb 22. http://www-uptodate-com.libproxy1.usc.edu/contents/clostridium- difficile-in-adults-treatment?source=searchresult&search=clostridium+difficile+treatment&selectedTitle=1%7E150 5. Vancocin [Prescribing Information]. Exton, PA: ViroPharma Incorporated 2005. 6. Vancomycin. Facts and Comparisons. (2014, September 1). St Louis, Missouri, USA.

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Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name

[vii] Xeljanz References: 1. Xeljanz (tafacitinib citrate) [package insert]. NJ, NJ; Pfizer Labs; Revised November 2012. 2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents [x] in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. Xolair References 1. Barnes, P. J. (May 2015 ). Anti-IgE therapy. UpToDate. (B. S. Bochner, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from http://www.uptodate.com/contents/anti- ige-therapy?source=related_link#H7764932 2. DRUGDEX® Evaluations. (n.d.). Omalizumab. DRUGDEX System. Greenwood Village, CO. Retrieved June 16, 2015, from http://nv- ezproxy.roseman.edu:3305/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/E8C454/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/318DA6/ND_PG/e videncexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.Intermedi 3. Khan, D. A. (2013, September 19). education, Chronic urticaria: Standard management and patient. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved from http://www.uptodate.com/contents/chronic-urticaria-standard-management-and-patient-education?source=see_link 4. Khan, D. A. (May 2015 ). Chronic urticaria: Treatment of refractory symptoms. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from http://www.uptodate.com/contents/chronic-urticaria-treatment-of-refractory-symptoms?source=see_link#H1 5. National Heart, Blood, and Lung Institute Expert Panel Report 3 (EPR 3): Guidelines for the Diagnosis and Management of Asthma. NIH Publication no. 08-4051, 2007. 6. Gold Standard. (2015) Xolair. Retrieved http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=2633&n=Xolair&t=0. 7. Bernstein JA, Lang DM, Khan DA, et al. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133:1270-1277. 8. Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69:868–887.

Last Update: 11/30/2017