P & T: January 10, 2019

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PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Drug/PA Products Included in Exclusion Required Medical Age Prescriber Other Criteria Covered Uses Coverage Duration Group Group Criteria Documentation Restriction Restriction Requirements

HEADING

Drugs covered by the The maximum Indications for same TAR criteria. duration of TAR which PHC will Documents to be Trade names, approval before

For PHC consider prior Specified submitted with the strengths, dosage Prescriber renewal is Internal authorization based reasons for TAR for clinical Any age limit forms are for example specialty required, when all Other criteria use, used on the stated denial (if any), review. Absence or CCS only. requirement for criteria are met. and notations for criteria. Other uses other than not of these screening Criteria apply to the TAR Less than the not included grouping may require meeting documents will associated active ingredient entity, consideration, if maximum may be elsewhere. drugs with additional criteria result in delay or with the drug. DEFINITION unless separate criteria any. authorized when like criteria. documentation of requirements. denial of the exist for different additional clinical safety, efficacy & request. strengths/forms of same information is medical necessity. drug. required.

 This page is for general information only, to assist with interpretation of the TAR/PA criteria.  Please review the information above if you are unfamiliar with this criteria format.  New & revised criteria begin on the next page.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 1 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Generic substitution required when there is an FDA approved generic equivalent; additional criteria apply for brand name requests per PHC Policy MPRP4033.

Nusinersen Ombitasvir/Paritaprevir/ Deutetrabenazine Testosterone nasal gel Daclatasvir Testosterone 1% gel (Spinraza®) Riton/Dasab (Viekira (Austedo®) (Natesto ®) (Daklinza®) tube (Testim®) Pak®, Viekira XR®)

Ranibizumab Ombitasvir/Paritaprevir/ Rufinamide Testosterone 1.62% gel Pregabalin Scopolamine (Lucentis®) Ritonavir (Technivie®) (Banzel®) packet, pump(AndroGel®) (Lyrica CR®) (Transderm-Scōp®)

Bevacizuma Glecaprevir/Pibrentasvir Brimonidine Testosterone gel packets, Aflibercept Palifermin b (Avastin®) (Mavyret®) (Alphagan P®) pump 1% (AndroGel®, (Eylea®) (Kepivance®) Vogelxo®) Sofosbuvir Lesinurad/Allopurinol Elbasvir/Grazopr Testosterone Enanthate Cannabidiol Testosterone (Sovaldi®) (Duzallo®) evir (Zepatier®) (Delatestryl®) (Epidiolex ®) Undecanoate (Aveed®, Xyosted®) Lesinurad Sofosbuvir/ Testosterone Testosterone 2% gel Clobazam Testosterone (Zurampic®) Velpatasvir (Epclusa®) buccal (Striant®) pump actuation suspension Cypionate (Fortesta®) (Onfi®) (Depo-Testosterone®) Pegaptanib Ledipasvir/Sofosbuvir Testosterone Testosterone 2% solution Valbenazine Ribavirin (Copegus®, (Macugen®) (Harvoni®) patch pump (Axiron®) (Ingrezza®) Moderiba®, Rebetol®, (Androderm®) Ribasphere®)

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 2 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Brand/Trade names are shown for reference purposes only. Criteria apply to the generic product when a generic equivalent has been approved by the FDA. Additional criteria apply to brand name requests (when a generic is available), per PHC Policy #MPRP4033. Deutetrabenazine (Austedo®) 6mg, 9mg 12mg tablets – changes were made effective as of 11/17/2018 Drug Required Medical Age Coverage Group Covered Uses Exclusion Criteria Documentation Restrictions Prescriber Restrictions Duration VMAT2 (1) For the Taken with other (1) Unified Huntington’s Disease 18 years of age For chorea associated For Huntington’s Inhibitor treatment of VMAT2 inhibitors, Rating Scale (UHDRS) or with Huntington’s Chorea: Initial: 3 chorea associated such as Ingrezza equivalent (e.g., Total Maximal Disease (Huntington’s months. For TD: with Huntington’s (valbenazine) or Chorea (TMC) score) submitted Chorea): Prescribed by Initial 2 months. Disease currently using with chart notes documenting or in consultation with Renewal: Up to (Huntington’s monoamine chorea OR (2) Abnormal neurologist. For tardive 12 months. Chorea). (2) For oxidase inhibitor Involuntary Movement Scale dyskinesia: Prescribed by the treatment of (MAOI). (AIMS) test score or equivalent or in consultation with a tardive dyskinesia. test is submitted in chart notes psychiatrist or documenting tardive dyskinesia neurologist. (TD).

Other For Huntington’s Chorea: Must have chart document of a diagnosis of chorea associated with Huntington’s Disease (HD). For TD: Must meet all: (a) Diagnosis of moderate to severe tardive dyskinesia (TD) with current Abnormal Involuntary Movement Scale (AIMS). (b) Baseline evaluation of TD using Abnormal Involuntary Movement Scale (AIMS). (c) Chart notes confirming that member does not have risk for suicidal or violent behavior and has stable psychiatric symptoms.

Recommendation: If tardive dyskinesia is related to drug use, and if appropriate for patient, the causative drug must be discontinued or tried at a lower dose. Note: Austedo has a black box warning for suicidal ideation and depression and thus is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression). Renewal: Documentation of improvement in AIMS score from baseline and patient’s condition has stabilized/improved while on therapy. Dispensing Limits: Limited to dispensing to a 15 day supply per fill for the first 2-3 months of treatment. Dose consolidation required, meaning: using the smallest number of tablets to achieve desired dose by using increasing strengths when available, rather than “doubling” up tablets.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 3 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Covered Required Medical Age Prescriber Coverage Drug Group Uses Exclusion Criteria Documentation Restrictions Restrictions Duration VMAT2 Tardive Use is not recommended in severe renal Complete drug and problem 18 years and Neurology or Initial: 15 day Inhibitor dyskinesia impairment (CrCl less than 30mL/minute) lists, which include: (a) A older. Psychiatry supply per fill and concomitant administration with confirmed diagnosis of Tardive for the first 2- MAOI’s (isocarboxazid, phenelzine, Dyskinesia, (b) Abnormal 3 months. selegiline), a strong CYP3A4 inducer Involuntary Movement Scale Dose (carbamazepine, phenytoin, rifampin, St. (AIMS) consolidation Johns wort). is required.

Dual therapy with VMAT2 Inhibitor and Congenital long QT syndrome.

Other Limited to members with a documented diagnosis of Tardive Dyskinesia (TD) and for whom either a dose reduction or change in drug from the causative agent has been attempted or is not recommended.

Approvals are limited to 1 tablet per day dosing and dose consolidation is required: New start prescriptions should be written as 2 separate Rx’s (40mg & 80mg) for titration/initiation rather than doubling up the 40mm to yield an 80mg dose.

Recommendation: Discontinuation or reduction of causative agent such as anti-psychotic (neuroleptic) medication if clinically possible.

Renewal: Documentation of reduction in TD symptoms evidenced by a reduction in the AIMS score. Approve for 12 months with documentation of response to treatment.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 4 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Exclusion Age Prescriber Coverage Drug Group Covered Uses Criteria Required Medical Documentation Restrictions Restrictions Duration Antisense Treatment of SMA Type 4; (1) Documented diagnosis of spinal N/A Neurologist; Initial: 2 Oligonucleotide spinal muscular pediatric muscular atrophy (SMA) type 1, 2, or 3 pediatric months atrophy (SMA) patients with confirmed by molecular genetic testing of neurologist; or (loading doses type 0, 1, 2, or 3 advanced any of the following: SMN1 homozygous tertiary medical x 4 on D1, D15, in pediatric and disease; case gene deletion or mutation of the SMN1 center D29, and D59). adult patients. by case for age gene and number of copies of SMN2 gene; designated as a 21 years and AND nusinersen Renewal: 4 older. (2) Baseline laboratory tests within 30 days treatment month intervals prior to administration (including platelet center. count, prothrombin time; activated partial thromboplastin time, and quantitative spot urine protein testing; AND (3) Baseline (pre-treatment) motor function skills assessment using Hammersmith Functional Motor Scale-Expanded (HFMSE) score; AND (4) Respiratory function tests (e.g. FVC, etc).

Other

Initial request: all required medical documentation (1) through (4).

Renewal request: requires (1) nusinersen administration record to assess adherence to nusinersen treatment, and (2) clinical progress notes documenting clinical efficacy and absence of unacceptable toxicity (e.g. significant renal toxicity, thrombocytopenia, coagulation abnormalities, etc).

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 5 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Delayed puberty.  Severe lower urinary track symptoms.  Uncontrolled HF, MI or stroke within the last 6 months. Transgender hormonal therapy.  Thrombophilia. Required Medical Documentation Primary or secondary hypogonadism: (1) New to therapy: Lab reports documenting two total testosterone levels drawn prior to 9 am (fasting preferred) on separate days. In men with conditions which alter sex hormone-binding globulin (SHBG), or if initial total testosterone levels are at or near the lower limit of normal, additional laboratory levels may be required (free testosterone levels utilizing equilibrium dialysis, total testosterone, SHBG, albumin). Transgender hormonal therapy: (1) New to therapy: Evaluation by a mental health professional or other health care professionals who have the appropriate experience and training. Confirmation of the following: well-documented gender dysphoria/gender incongruence, ability to make a well-informed decision, and stability of relevant medical and mental health. Testosterone levels will not be required for initiation of therapy. (2) Renewal: Testosterone levels may be required if testosterone doses exceed the recommended dosing range. Levels should be drawn at the midpoint between injections, with a goal of maintaining serum concentrations approximately 400 to 800 ng/dL. For patients on testosterone injections, trough levels should be towards the lower end of this range, while peak levels should not exceed 1000 ng/dL. Routine monitoring schedule as recommended by the Endocrine Society: Evaluate the patient every three months in the first year corresponding to dose adjustment and then one to two times per year thereafter. Other Primary or secondary hypogonadism- New to therapy: Confirmation of diagnosis with documentation of symptoms consistent with testosterone deficiency AND two pretreatment total testosterone levels below the lower limit of the normal testosterone reference range of the individual laboratory used (fasting preferred). The levels should be taken on separate days before 9 am, within 90 days of the request.

Continuation of care from another plan: Pharmacy records or clinic notes documenting prior use of testosterone within the past 180 days.

Renewal: Testosterone levels may be required and should be in the mid-normal range between 450 to 600 ng/dL, drawn at the midpoint between injections.

MC☒ = Limited PHC Medi to -30Cal day supplyF = Formulary per fill. QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 6 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Brand/Trade names are shown for reference purposes only. Criteria apply to the generic product when a generic equivalent has been approved by the FDA. Additional criteria apply to brand name requests (when a generic is available), per PHC Policy #MPRP4033. Testosterone Undecanoate (Aveed®) 750 mg/3 ml injectable, Testosterone Enanthate (Xyosted®) 50mg/0.5ml, 75mg/0.5ml, 100mg/0.5ml solution, pre-filled syringe autoinjector (Non-preferred) Required Medical Age Prescriber Coverage Drug Group Covered Uses Exclusion Criteria Documentation Restrictions Restrictions Duration Testosterone Treatment for male  Males with prostate or breast cancer. Primary or secondary 18 years None 12 months injection members with  Palpable prostate nodule or PSA hypogonadism and and older confirmed diagnosis level > 4 ng/ml. transgender hormonal of primary or  Hematocrit > 48%. therapy: secondary Testosterone levels  Untreated severe obstructive sleep hypogonadism. confirming therapeutic apnea. failure to preferred Transgender  Severe lower urinary track testosterone products hormonal therapy. symptoms. following appropriate  Uncontrolled HF, MI or stroke within dosage adjustments. the last 6 months.  Thrombophilia. Other Primary or secondary hypogonadism: New to therapy or continuation of care from another plan: Prior trial and failure or intolerance to preferred formulary intramuscular testosterone cypionate or intramuscular testosterone enanthate. Confirmation of diagnosis with documentation of symptoms consistent with testosterone deficiency and two pretreatment total testosterone levels (fasting preferred) below the lower limit of the normal testosterone reference range of the individual laboratory used. Renewal: Testosterone levels may be required and should be checked at the end of the dosing interval just prior to the next injection with nadir levels in low-mid range (450 to 600 ng/dL).

Renewal: Testosterone levels may be required and should be drawn at the end of the dosing interval just prior to the next injection with nadir levels in low- mid range (400 to 800 ng/dL). For patients on testosterone injections, trough levels should be towards the lower end of this range, while peak levels should not exceed 1000 ng/dL. Routine monitoring schedule as recommended by the Endocrine Society: Evaluate the patient every three months in the first year corresponding to dose adjustment and then one to two times per year thereafter.

☒ LD/SP: • Testosterone Undecanoate (Aveed®) is limited to dispensing by Walgreens Specialty Pharmacy ☒ Limited to 30 day supply per fill

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 7 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Other Primary or secondary hypogonadism: New to therapy or continuation of care from another plan: Prior trial and failure or intolerance to preferred formulary intramuscular testosterone cypionate or intramuscular testosterone enanthate. Confirmation of diagnosis with documentation of symptoms consistent with testosterone deficiency and two pretreatment total testosterone levels (fasting preferred) below the lower limit of the normal testosterone reference range of the individual laboratory used.

Renewal: Testosterone levels may be required and should be in the mid-normal range between 450 to 600 ng/dL, drawn as per manufacture recommendations.

Renewal: Testosterone levels may be required and should be drawn as per manufacture recommendation with a goal of maintaining serum concentrations approximately 400 to 800 ng/dL. Routine monitoring schedule as recommended by the Endocrine Society: Evaluate the patient every three months in the first year corresponding to dose adjustment and then one to two times per year thereafter.

☒ Limited to 30 day supply per fill MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 8 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Brand/Trade names are shown for reference purposes only. Criteria apply to the generic product when a generic equivalent has been approved by the FDA. Additional criteria apply to brand name requests (when a generic is available), per PHC Policy #MPRP4033. Testosterone 1.62% gel packets 20.25 mg/1.25 g, 40.5 mg/2.5g (AndroGel®), Testosterone 1.62% gel pump 1.62%, 20.25 mg/actuation(AndroGel®), Testosterone 2% solution pump 30 mg/1.5 ml, 90 ml (Axiron®), Testosterone nasal gel (Natesto ®) 5.5 mg/actuation, 11 gm, Testosterone 30 mg buccal (Striant®), Testosterone 2% gel pump, 10 mg/ 0.5g actuation (Fortesta®) Required Medical Age Prescriber Coverage Drug Group Covered Uses Exclusion Criteria Documentation Restrictions Restrictions Duration Testosterone, Treatment for male  Males with prostate or breast cancer. Primary or secondary 18 years and None 12 months topical members with  Palpable prostate nodule or PSA level > 4 hypogonadism and older confirmed ng/ml. Transgender hormonal diagnosis of  Hematocrit > 48%. therapy: primary or  Untreated severe obstructive sleep Testosterone levels secondary apnea. confirming therapeutic hypogonadism.  Severe lower urinary track symptoms. failure to preferred  Uncontrolled HF, MI or stroke within the testosterone products Transgender last 6 months. following appropriate hormonal therapy.  Thrombophilia. dosage adjustments.

Other Primary or secondary hypogonadism: New to therapy or continuation of care from another plan: Prior trial and failure or intolerance to preferred formulary testosterone cypionate or intramuscular testosterone enanthate; followed by trial and failure to the following formulary testosterone products: transdermal patch (Androderm®), 1% gel packets (AndroGel®, Vogelxo®), 1% gel tube (Testim®), 1% gel pumps (AndroGel®, Vogelxo®). Confirmation of diagnosis may be requested with documentation of symptoms consistent with testosterone deficiency and two pretreatment total testosterone levels (fasting preferred) below the lower limit of the normal testosterone reference range of the individual laboratory used.

Renewal: Testosterone levels may be required and should be in the mid-normal range between 450 to 600 ng/dL, drawn as per manufacture recommendations.

Transgender hormonal therapy: New to therapy: Confirmation of diagnosis with evaluation from appropriate provider. Prior trial and failure or intolerance to preferred formulary intramuscular testosterone cypionate or intramuscular testosterone enanthate; followed by trial and failure to the following formulary testosterone products: transdermal patch (Androderm®), 1% gel packets (AndroGel®, Vogelxo®), 1% gel tube (Testim®), 1% gel pumps (AndroGel®, Vogelxo®). Labs will be required for initiating therapy for gender identity disorder if TAR states levels cannot be maintained on current regimen.

Renewal: Testosterone levels may be required and should be drawn as per manufacture recommendations with a goal of maintaining serum concentrations approximately 400 to 800 ng/dL. Routine monitoring schedule as recommended by the Endocrine Society: Evaluate the patient every three months in the first year corresponding to dose adjustment and then one to two times per year thereafter.

MC☒ = LimitedPHC Medi to- Cal30 day supplyF = Formulary per fill QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 9 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Other Prevention of motion sickness: Documented trial and failure or contraindication to formulary meclizine or diphenhydramine.

Prevention of post-operative nausea and vomiting: Approvable for a limited duration when (1) Rx is to be obtained from retail pharmacy prior to the procedure and (2) the prescriber has ruled out formulary oral treatment options such as ondansetron. Medications administered as inpatient are not a separately billable pharmacy benefit.

Off-label use: First-line therapies (those approved by the FDA for the indication requested) must be documented as tried and failed or that they are not medically appropriate for the member. TARs must contain documentation indicating why first-line treatments cannot be used. Pediatric use is considered to be off-label. Due to the risks of adverse reactions in the pediatric population, the provider’s documentation should include assessment of risk vs benefit or recommendation from a pediatric specialist.

☒ Limited to 6 day supply per fill (2 patches) unless documentation of need for extended treatment is indicated on the TAR.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 10 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Required Medical Documentation Specifics are listed on PHC HCV TAR supplemental form on PHC website.

A completed TAR Supplemental Form must be submitted to specialty pharmacy for initial TAR request. Most recent original data reports (including reference ranges) for the following: (1) HCV genotype & viral load. (2) Chemistry which includes AST, ALT, Total Bilirubin, Albumin. (3) CBC with Platelets. (4) If cirrhosis, include INR and CTP score. If applicable: (5) Request for Zepatier for genotype 1a, mixed 1a/b, or indeterminate 1 infection will require submission of HCV RNA Genotype 1 NS5A Drug Resistance Assay result. (6) Request for generic Epclusa for genotype 3 may require resistance-associated substitutions (RAS) testing for Y93H mutation (Genotype 3 NS5A resistance test). (7) Documentation of pregnancy prevention while on Ribavirin therapy. (8) Documentation of Interferon and/or Ribavirin intolerance or other ineligible rationale may be required. Other Must be dispensed through PHC’s contracted specialty pharmacy (Walgreen’s Specialty Pharmacy). 14-day dispensing limitation per fill.

In-Therapy HCV Viral Load (VL) testing require: (1) Baseline VL or start of treatment VL if baseline older than 12 months. (2) 4-wk for all regimen. (3) 6-wk if detectable at 4 wks for 12 wk regimen OR 12-wk if detectable at 4 wks for 16 wk regimen. (4) 12-wk if on regimen lasting beyond 16 weeks.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 11 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Brand/Trade names are shown for reference purposes only. Criteria apply to the generic product when a generic equivalent has been approved by the FDA. Additional criteria apply to brand name requests (when a generic is available), per PHC Policy #MPRP4033. Glecaprevir/Pibrentasvir (Mavyret®) 100mg/40mg tablets, Daclatasvir (Daklinza®) 30mg, 60mg, 90mg tablets, Ombitasvir/Paritaprevir/Ritonavir (Technivie®) 12.5mg/75mg/50mg tablets, Ribavirin (Copegus®, Moderiba®, Rebetol®, Ribasphere®) various, Ledipasvir/Sofosbuvir (Harvoni®) 90mg/400mg tablets, Sofosbuvir (Sovaldi®) 400mg tablets, Ombitasvir/Paritaprevir/Riton/Dasab (Viekira Pak®, Viekira XR®) 12.5mg/75mg/50mg/250mg, 8.33mg/50mg/33.33mg/200mg tabs Drug Covered Age Coverage Group Uses Exclusion Criteria Restrictions Prescriber Restrictions Duration Hepatitis C For Limited life expectancy (less than 12 months) Treatment Specialist in the area of Depending virus direct- treatment which cannot be remediated by HCV therapy, liver candidate must Gastroenterology, Hepatology, upon genotype, acting of chronic transplantation, or another directed therapy. be at least the Infectious Disease, HIV OR non- prior tx (if any), antivirals Hepatitis C minimum age specialist with documentation of cirrhosis Failure to comply with treatment regimen (e.g. Virus approved by the adequate training and status, regimen multiple missed doses), medication loss, missed (HCV). FDA for use of experience in the treatment of and response. appointments, missed lab data sets and/or non- the medication. HCV (e.g. Project ECHO). compliance with case management may result in revocation of treatment authorization. Required Medical Documentation Specifics are listed on PHC HCV TAR supplemental form on PHC website.

A completed TAR Supplemental Form must be submitted to specialty pharmacy for initial TAR request. Most recent original data reports (including reference ranges) for the following: (1) HCV genotype & viral load. (2) Chemistry which includes AST, ALT, Total Bilirubin, Albumin. (3) CBC with Platelets. (4) If cirrhosis, include INR and CTP score. If applicable: (5) Request for Zepatier for genotype 1a, mixed 1a/b, or indeterminate 1 infection will require submission of HCV RNA Genotype 1 NS5A Drug Resistance Assay result. (6) Request for generic Epclusa for genotype 3 may require resistance-associated substitutions (RAS) testing for Y93H mutation (Genotype 3 NS5A resistance test). (7) Documentation of pregnancy prevention while on Ribavirin therapy. (8) Documentation of Interferon and/or Ribavirin intolerance or other ineligible rationale. Other Must be dispensed through PHC’s contracted specialty pharmacy (Walgreen’s Specialty Pharmacy). 14-day dispensing limitation per fill.

Prescriber has considered patient readiness, transplant status, pregnancy risks, renal function, life expectancy, case management, patient responsibilities and prescriber’s experience (the latter required one-time for non-specialist prescribers) as indicated in the HCV TAR Supplement Form. In-Therapy HCV Viral Load (VL) testing require: (1) Baseline VL or start of treatment VL if baseline older than 12 months. (2) 4-wk for all regimen. (3) 6-wk if detectable at 4 wks for 12 wk regimen OR 12-wk if detectable at 4 wks for 16 wk regimen. (4) 12-wk if on regimen lasting beyond 16 weeks.

Requests for non-AASLD regimens: current medical literature supporting the regimen should be submitted. PHC Preferred Regimens: See HCV treatment matrix on PHC website for all preferred regimens for adults. Generic ribavirin 200mg capsules/tablets preferred - requests for other strengths, RibaPak, Moderiba dose pack, or other brand requests will not be covered per PHC brand policy and/or PHC Ribavirin criteria. MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 12 of 21

HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Brimonidine (Alphagan P®) 0.1%, 0.15% solution

Exclusion Required Medical Age Prescriber Coverage Drug Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Glaucoma, Reduction of None Clinical documentation with None Prescriber must 12 months Documentation to Alpha elevated confirmed diagnosis of be an indicate reason(s) Agonists intraocular open angle glaucoma, Ophthalmologist for failure, pressure (IOP) in ocular hypertension and or Optometrist contraindication or patients with documentation supporting intolerance to open-angle contraindication, or brimonidine 0.2%. glaucoma or intolerance, or failure to ocular formulary brimonidine hypertension. 0.2%.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 13 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Required Medical Documentation For ophthalmologic use, PHARMACY claims require: A documented diagnosis of DME, AMD, Diabetic Retinopathy with DME, ME following RVO; also mCNV if requesting Lucentis®).

Additional information may be requested prior to approval, such as: Clinic notes and/or documentation of low baseline visual acuity scores and/or ocular tests. Members with DME will be subject to a DUR performed of diabetic regimen to ensure members DM is being adequately treated. Labs may be requested (A1C, FBS) from member’s DM physician. This will not be a prerequisite for therapy with Anti-VEGF, but will be used as an opportunity to improve DM pharmacologic care in a member experiencing sequela from uncontrolled DM.

ClinicianOther Notification: Bevacizumab (Avastin®) billed as J9035 (bevacizumab injection, 10 mg) does not need a TAR for direct billing to PHC; limitedRenewal to will1 unit be billedbased for on single documentation date of service. of benefit from therapy (may be indicated on TAR unless clinic notes are specifically requested). Baseline and updated vision status may be requested with evidence of (1) improvement or stabilization compared to baseline or (2) decrease in rate of vision loss compared to baseline.

Initial approval: All drugs & indications-- 3 months. Exception: EYLEA may approve up to 5 mo depending on indication. Renewal is up to 6 months.

MUCAGEN: Maximum duration of therapy will be 2 (two) years (17 treatments given every 6 weeks). Ages 20 and younger: CCS review/referral required.

☒ LD/SP: Eylea®, Lucentis® and Macugen® are limited to dispensing by AllianceRx/Walgreen’s Prime when pharmacy dispensing is planned.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 14 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Exclusion Required Medical Age Prescriber Coverage Drug Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Anticonvulsant Treatment of None Initial: 2 years and Prescribed Initial: 3 Lennox-Gastaut syndrome – Cannabidiol seizures Neurologist clinic notes older by or in month. (LGS): A confirmed associated with which document: consultation diagnosis of LGS and Lennox-Gastaut Confirmed diagnosis of with a Renewal: 12 documentation of trial and syndrome (LGS) Lennox-Gastaut Neurologist months based failure or contraindication or Dravet syndrome or Dravet on to formulary clobazam syndrome (DS) syndrome along with documentatio (Onfi®) and in addition, any in patients ≥ 2 documentation of n of efficacy. one of: valproic acid, years of age current and prior divalproex sodium, therapies. topiramate or lamotrigine.

Renewal: Dravet syndrome: A Follow-up clinic notes diagnosis of Dravet with evaluation of syndrome and treatment response. documentation of trial and failure or contraindication to formulary clobazam (Onfi®) and in addition, any one of: valproic acid, divalproex sodium, topiramate or levetiracetam.

☒ LD/SP: Limited to dispensing by AllianceRx/Walgreen’s Prime

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 15 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case)

PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Exclusion Required Medical Age Prescriber Coverage Drug Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Anticonvulsant, Treatment of None Neurologist clinic notes 1 year or Prescribed by or 12 months A confirmed Triazole seizures which document: older in consultation diagnosis of LGS and Derivative associated with Confirmed diagnosis of with a documentation of trial Lennox-Gastaut Lennox-Gastaut Neurologist and failure or syndrome (LGS) syndrome along with contraindication to in ages ≥ 1 yr. documentation of formulary clobazam current and prior (Onfi®) and in therapies. addition, any one of: valproic acid, divalproex sodium, topiramate or lamotrigine.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 16 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Exclusion Required Medical Age Prescriber Coverage Drug Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Anticonvulsant, Treatment of None Clinical documentation 2 years and Prescribed by or 12 months A confirmed diagnosis of Benzodiazepine seizures of confirmed diagnosis older in consultation LGS and documentation associated with of Lennox-Gastaut with a of inability to use halved Lennox-Gastaut syndrome Neurologist &/or crushed clobazam syndrome (LGS) tablets in applesauce, in ages ≥ 2 yrs. and in addition any one of: valproic acid, divalproex sodium, topiramate or lamotrigine.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 17 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Drug Covered Exclusion Required Medical Age Prescriber Coverage Group Uses Criteria Documentation Restrictions Restrictions Duration Other GABA Diabetic None Clinic note confirming 18 years and None 12 months Either diagnosis: (1) limited to once Analogs Peripheral diagnosis and older daily dosing and (2) dose Neuropathy documentation of consolidation is required, using the and adequate trial and strength which results in the fewest Postherpetic failure to formulary number of tablets for the desired Neuralgia alternatives. dose.

Specific reason(s) Diabetic Peripheral Neuropathy: why immediate- Documentation of adequate trial and release capsules failure to formulary duloxetine, cannot be used. gabapentin, a tricyclic antidepressant, and non-formulary pregabalin immediate-release capsules. Maximum approved daily dose: 330 mg.

Postherpetic neuralgia: Documentation of adequate trial and failure to maximum tolerated dose of formulary gabapentin, a tricyclic antidepressant, non-formulary lidocaine 5% patch, and non- formulary pregabalin immediate- release capsules. Maximum approved daily dose: 660 mg.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 18 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Drug Exclusion Required Medical Age Prescriber Coverage Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Keratinocyte Per FDA Use in the For treatment None Hematology/ TBD, for duration Member must have an Growth indication: To setting of imitation, Oncology of risk period approved TAR for Factor reduce incidence allogenic hematology/oncology (through end of autologous stem cell (Palifermin) & duration of hematopoietic notes which myelotoxic transplant. severe mucositis stem cell document: treatment in members with support. (1) Hematologic regimen). Not to exceed the FDA hematologic malignancy approved dosing regimen malignancies, Not diagnosis. (60 mcg/kg/d, bolus receiving recommended(2) Expected treatment injection for 3 myelotoxic for use with duration consecutive days before treatment and melphalan (3) Frequency of and 3 consecutive days autologous 200 mg/m2 myelotoxic cycles after myelotoxic therapy hematopoietic (4) Member weight to total 6 doses). stem cell (5) Autologous stem cell support/transfer, support in regimens predicted to have WHO Grade 3 or greater mucositis.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 19 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Exclusion Required Medical Age Prescriber Coverage Drug Group Covered Uses Criteria Documentation Restrictions Restrictions Duration Other Uric Acid For the treatment Severe renal Documented 18 year old. None 12 months Require all of the following Transporter 1 of hyperuricemia impairment serum uric acid Safety and criteria: (URAT1) associated with (CrCl less than levels greater than efficacy of (1) Diagnosis of hyperuricemia Inhibitor; gout in patients 30 mL/min), 6.5 mg/dL lesinurad/allop associated with gout Xanthine who have not end stage renal urinol in (2) At least 3 months of therapy Oxidase achieved target disease patients <18 with allopurinol or Inhibitor serum uric acid (ESRD), kidney years have not febuxostat monotherapy at levels with a transplant been up to maximally tolerated medically recipients, established doses, unless appropriate daily patients on contraindicated or clinically dose of allopurinol dialysis or significant adverse effects alone. asymptomatic are experienced. hyperuricemia. Not indicated for Requests are approvable for asymptomatic no more than 1 tablet per hyperuricemia. day dosing.

Renewal: Documented response to therapy as defined by a reduction in occurrence of gout flares or serum uric acid levels maintained below 6 mg/dL.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 20 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case) PHC Medi-Cal P & T: January 10, 2019 Approved New & Revised PA Criteria : Effective 04/01/2019

Drug Required Medical Age Prescriber Coverage Group Covered Uses Exclusion Criteria Documentation Restrictions Restrictions Duration Other Uric Acid In combination Dual therapy with Documented serum 18 years old. None 12 months Require all of the following Transporter with a xanthine Duzallo uric acid levels Safety and criteria: 1 (URAT1) oxidase inhibitor greater than 6.5 efficacy of (1) Diagnosis of hyperuricemia Inhibitor for the treatment Severe renal mg/dL lesinurad associated with gout of hyperuricemia impairment (CrCl (Zurampic®) (2) At least 3 months of therapy associated with less than 30 in patients with allopurinol or gout in patients mL/min), end stage <18 years febuxostat monotherapy at who have not renal disease have not been up to maximally tolerated achieved target (ESRD), kidney established. doses, unless serum uric acid transplant contraindicated or clinically levels with a recipients, or significant adverse effects xanthine oxidase patients on dialysis are experienced inhibitor alone. (3) Must be used as Asymptomatic combination therapy with Not indicated for hyperuricemia allopurinol or febuxostat asymptomatic hyperuricemia. Requests are approvable for no more than 1 tablet per day dosing.

Renewal: Documented response to therapy as defined by a reduction in occurrence of gout flares or serum uric acid levels maintained below 6 mg/dL.

MC = PHC Medi-Cal F = Formulary QL = Quantity Limit NF = Non-formulary, TAR required (aka, PA Required) 21 of 21 HK = PHC Healthy Kids AL = Age Limit STE = Step therapy requirement in claim history TBD = To be determined (case-by-case)