Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

Drug FDA Approved Indications Quantity limit per PI Criteria for Approval Actemra® (tocilizumab) • (RA) SUBCUTANEOUS • Routine PDL AND (1.1) • Weight <100kg: Two • Tried and failed Methotrexate; OR requested medication will be Adult patients with moderately syringes per 28 days. Max used in conjunction with ; OR patient has a to severely active rheumatoid dose is 4 syringes per 28 contraindication to Methotrexate (e.g., alcohol abuse, cirrhosis, arthritis who have had an days chronic liver disease, or another contraindication); AND inadequate response to one or • Weight >100kg: Four • Patient has tried and failed another DMARD (other than more DMARDs. syringes per 28 days Methotrexate), such as , d-, INTRAVENOUS cyclophosphamide, cyclosporine, salts, , • 4 to 8mg/kg every 28 , , or tacrolimus; days • Polyarticular Juvenile INTRAVENOUS • Routine PDL AND Idiopathic Arthritis (PJIA) • Weight <30kg: 10mg/kg • Tried and failed Methotrexate; OR requested medication will be (1.2) every 28 days used in conjunction with Methotrexate; OR patient has a Patients 2 years of age and • Weight >30kg: 8mg/kg contraindication to Methotrexate (e.g., alcohol abuse, cirrhosis, older with active polyarticular every 28 days chronic liver disease, or another contraindication); AND juvenile idiopathic arthritis. • Patient has tried and failed another DMARD (other than Methotrexate), such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, , hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus; • Systemic Juvenile Idiopathic INTRAVENOUS • Routine PDL AND Arthritis (SJIA) (1.3) • Weight <30kg: 12mg/kg • Tried and failed Methotrexate; OR requested medication will be Patients 2 years of age and every 14 days used in conjunction with Methotrexate; OR patient has a older with active systemic • Weight >30kg: 8mg/kg contraindication to Methotrexate (e.g., alcohol abuse, cirrhosis, juvenile idiopathic arthritis. every 14 days chronic liver disease, or another contraindication); AND • Patient has tried and failed another DMARD (other than Methotrexate), such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, gold salts, hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus; • Cytokine Release Syndrome INTRAVENOUS • Routine PDL AND • 30 kg or more: 8 mg/kg for one dose, up to 3 additional doses if no clinical improvement (max dose 800 mg) • Less than 30 kg: 12 mg/kg for one dose, up to 3 additional doses If no clinical improvement (max dose 800 mg) 1

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

Arcalyst® (rilonacept) • Cryopyrin-Associated Adults 18 years and older: • Routine PDL AND Periodic Syndromes (CAPS), •Loading dose: 320 mg, including Familial Cold delivered as two 160 mg (2 Auto-inflammatory mL) injections. Syndrome (FCAS) and •Maintenance dose -160 mg (2 Muckle-Wells Syndrome mL) injection once weekly (MWS) in adults and children ≥ 12 years old. Pediatrics 12 years to 17 years: •Loading dose: 4.4 mg/kg, up to a maximum of 320 mg, delivered as 1 or 2 injections (up to 2 mL/injection). • Maintenance dose: 2.2 mg/kg, up to a maximum of 160 mg (2 mL) injection once weekly • Maintenance of remission of • DIRA Adults and pediatric • Routine PDL AND deficiency of interleukin-1 patients weighing at least 10 receptor antagonist (DIRA) in kg is 4.4mg/kg up to a adults and pediatric patients maximum of 320 mg weighing ≥ 10 kg delivered as 1 or 2 subcutaneous injections once weekly Remicade® • Crohn’s Disease: 5mg/kg at week 0, 2 and 6, • Routine PDL (infliximabe) then every 8 weeks thereafter. Max dose 10mg/kg every 8 Biosimilar to weeks Remicade® • Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, • Routine PDL then every 8 weeks. • (≥ 6 years) Avsola™ • Ulcerative Colitis: reducing • 5mg/kg at week 0, 2 and 6, • Routine PDL (infliximab-axxq) signs and symptoms, inducing, then every 8 weeks Amgen and maintaining clinical thereafter.

• Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, • Routine PDL ® Inflectra then every 8 weeks. • (≥ 6 years) (infliximab-dyybe) • Rheumatoid Arthritis in 3mg/kg at week 0, 2 and 6, • Routine PDL Pfizer combination with then every 8 weeks thereafter. methotrexate: Max dose 10mg/kg every 8 weeks or 3mg/kg every 4 ® Renflexis weeks

2

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

(infliximab-abdae) • Ankylosing Spondylitis: 5mg/kg at week 0, 2 and 6, • Routine PDL Merck then every 6 weeks thereafter

• Psoriatic Arthritis: 5mg/kg at week 0, 2 and 6, • Routine PDL then every 8 weeks thereafter. • Plaque Psoriasis: 5mg/kg at week 0, 2 and 6, • Routine PDL then every 8 weeks thereafter

Cimzia® (certolizumab) • Reducing signs and symptoms • Six syringes/vials allowed • Routine PDL AND of Crohn’s disease and in the initial 54 days • Trial and failure of a compliant regimen of oral corticosteroids maintaining clinical response Two syringes/vials per 28 days (moderate to severe CD) unless contraindicated or intravenous in adult patients with after induction period corticosteroids (severe and fulminant CD or failure to respond to oral moderately to severely active corticosteroids), AND disease who have had an • Trial and failure of a compliant regimen of azathioprine or inadequate response to mercaptopurine for three consecutive months, AND conventional therapy • Trial and failure of a compliant regimen of parenteral methotrexate for three consecutive months • Moderately to severely active • Six syringes/vials allowed • Routine PDL AND RA in combination with in the initial 54 days • Trial and failure of, contraindication, or adverse reaction to methotrexate Two syringes/vials per 28 days methotrexate and at least one other DMARD (sulfasalazine, after induction period hydroxychloroquine, minocycline) • Psoriatic arthritis • Six syringes/vials allowed • Routine PDL in the initial 54 days • Trial and failure of Methotrexate; OR requested medication will be • Two syringes/vials per 28 used in conjunction with Methotrexate; OR patient has a days after induction contraindication to Methotrexate (e.g., alcohol abuse, cirrhosis, period chronic liver disease, or another contraindication) • Ankylosing spondylitis • Six syringes/vials allowed • Routine PDL in the initial 54 days • Trial and failure of failed an adequate trial of at least two NSAIDs; • Two syringes/vials per 28 OR use of NSAIDs is contraindicated in patient days after induction period • Active Non-radiographic Axial • Six syringes/vials allowed • Active Non-radiographic Axial Spondylarthritis (nr-axSpA) Spondylarthritis (nr-axSpA) in the initial 54 days • Cosentyx® • Adult Moderate to severe • Ten syringes/pens in the • Routine PDL (secukinumab) Plaque Psoriasis in adult initial 28 days • Must have a previous failure on a topical psoriasis agent patients who are candidates for • Two syringes/pens per 28 systemic therapy or days after induction phototherapy. period

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• • Adult patients with active • Five syringes/pens in the • Routine PDL psoriatic arthritis initial 28 days One syringe/pen per 28 days after induction period • Adult patients with active • Five syringes/pens in the • Routine PDL ankylosing spondylitis initial 28 days • One syringe/pen per 28 days after induction period • If patient continues to be symptomatic on above may increase to two syringe/pen per 28 days • Adults with active non- • Four syringes/pens in the • Adults with active non-radiographic axial spondyloarthritis (nr- radiographic axial initial 28 days axSpA) with objective signs of inflammation spondyloarthritis (nr-axSpA) with objective signs of inflammation Dupixent • Asthma • Routine PDL • Four (200 mg injections) • ≥ 12 years of age; AND syringes/pens in the initial • Diagnosis Moderate to severe Asthma with 28 days o eosinophilic phenotype; OR • Two (200 mg injections) o Oral corticosteroid dependent; AND syringes/pens per 28 days • Prescribing provider is a pulmonologist or after induction period • An allergy/asthma specialist; AND Or • Have a diagnosis of step 5 or higher (moderate to severe) asthma; AND • Four (300 mg injections) • Inadequately controlled asthma despite treatment with high dose syringes/pens in the initial inhaled or oral corticosteroid daily for at least 3 consecutive 28 days months; AND • Two (300 mg injections) • Along-acting beta agonist (unless is not a candidate) daily for at syringes/pens per 28 days least 3 consecutive months; AND after induction period • Is Add to current maintenance treatment; AND • • Is not pregnant • Atopic Dermatitis Adults • ≥ 6 years of age; AND • Three (300 mg injections) • Diagnosis of moderate to severe atopic dermatitis; AND syringes/pens in the initial • Prior documented trial and failure (or contraindication) of 1 topical 28 days corticosteroid of medium to high potency (e.g., mometasone,

4

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Two (300 mg injections) fluocinolone) and 1 topical calcineurin inhibitors (tacrolimus or syringes/pens per 28 days pimecrolimus); AND after induction period • Inadequate response to a 3-month minimum trial of at least 1 Pediatric patients 6 to 17 based immunosuppressive systemic agent (e.g., cyclosporine, on weight azathioprine, methotrexate, mycophenolate mofetil, etc.); AND • 15 to < 30 kg receiving an • Inadequate response (or is not a candidate) to a 3-month minimum initial dose of 600 mg (two trial of phototherapy (e.g., psoralens with UVA light [PUVA], 300 mg injections), UVB, etc) provided member has reasonable access to photo followed by subsequent treatment; AND doses of 300 mg every 4 • Is not pregnant; AND weeks; • • patients 30 to < 60 kg, initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week; and patients ≥ 60 kg, receiving an initial 600 mg (two 300 mg injections) dose, followed by 300 mg every other week. • For pediatric patients 6 to 11 years of age, the pre- filled syringe should be administered by a caregiver Chronic Rhinosinusitis with Nasal Two (300 mg injections) • ≥ 18 years of age; AND Polyposis syringes/pens per 28 • Diagnosis of In adequately controlled Chronic Rhinosinusitis with days. Nasal Polyposis (CRSwNP) • Is Add to current maintenance treatment Enbrel® (etanercept) • Rheumatoid Arthritis (RA) • Four 50mg syringes, OR • Preferred eight 25mg syringes per 28 days Juvenile Idiopathic Arthritis Four 50mg syringes, OR eight • Preferred (JIA) in members 2 years and 25mg syringes per 28 days older Psoriatic Arthritis (PsA) • Eight, 50mg syringes per Preferred 28 days for the initial 3 months

5

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Four 50mg syringes, per 28 days Ankylosing spondylitis • Four 50mg syringes, OR • Preferred eight 25mg syringes per 28 days • Plaque Psoriasis (PsO) in • Eight, 50mg syringes per • Preferred patients 4 years or older 28 days for the initial 3 months • Four, 50mg syringes per 28 days after induction period • Enspryng™ • Three 120 mg loading • Patient has a confirmed diagnosis based on the following: (satralizumab- • Neuromyelitis optica doses, administered at − Patient was found to be seropositive for aquaporin-4 (AQP4) mwge) spectrum disorder (NMOSD) weeks 0, 2, and 4, with IgG antibodies; AND in adult patients who are anti- subsequent maintenance − Patient has ≥ 1 core clinical characteristic (e.g., optic neuritis, aquaporin-4 (AQP4) antibody doses of 120 mg given every acute myelitis, area postrema syndrome, acute brainstem positive (NMOSD) 4 weeks. syndrome, symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions, symptomatic cerebral syndrome with NMOSD-typical brain lesions); AND • − Alternative diagnoses have been excluded (e.g., multiple sclerosis, sarcoidosis, cancer, chronic infection); • Entyvio® Adult Crohn’s Disease (CD): with • 300 mg at weeks 0, 2 and • Routine PDL AND (vedolizumab) moderately to severely active CD 6 for induction (3 vials/6 • Trial and failure of a compliant regimen of oral corticosteroids who have had an inadequate weeks), then 300 mg (1 (moderate to severe CD) unless contraindicated or intravenous response with, lost response to, or vial) every 8 weeks after corticosteroids (severe and fulminant CD or failure to respond to oral were intolerant to a TNF blocker the induction period corticosteroids), AND or immunomodulator; or had an • Trial and failure of a compliant regimen of azathioprine or inadequate response with, were mercaptopurine for three consecutive months, AND intolerant to, or demonstrated • Trial and failure of a compliant regimen of parenteral methotrexate for three consecutive months dependence on corticosteroids:

• achieving clinical response • achieving clinical remission • achieving corticosteroid-free remission Adult patients with moderately to • 300 mg at weeks 0, 2 and • Routine PDL AND severely active UC who have had 6 for induction (3 vials/6 6

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

an inadequate response with, lost weeks), then 300 mg (1 • Trial and failure of a compliant regimen of oral corticosteroids response to, or were intolerant to vial) every 8 weeks after (moderate to severe CD) unless contraindicated or intravenous a tumor necrosis factor (TNF) the induction period corticosteroids (severe and fulminant CD or failure to respond to oral blocker or immunomodulator; or corticosteroids), AND had an inadequate response with, • Trial and failure of a compliant regimen of azathioprine or were intolerant to, or mercaptopurine for three consecutive months, AND demonstrated dependence on • Trial and failure of a compliant regimen of parenteral methotrexate corticosteroids: for three consecutive months

• inducing and maintaining clinical response • inducing and maintaining clinical remission • improving endoscopic appearance of the mucosa • achieving corticosteroid-free remission • Rheumatoid Arthritis (RA) • Two syringes/pens per 28 • Preferred Humira® (adalimumab) • Adults days • Juvenile Idiopathic Arthritis • Two syringes/pens per 28 Preferred (JIA): days • Psoriatic Arthritis (PsA): • Two syringes/pens per 28 • Preferred days

• Ankylosing Spondylitis • Two syringes/pens per 28 • Preferred

(AS): days

Adult Crohn’s Disease (CD): • Six syringes/pens in the • Preferred

initial 28 days

• Two syringes/pens per 28 days after induction period

• Pediatric Crohn’s Disease: 37 lbs. to < 88 lbs.: • Preferred • Initial month One syringes/pen 80 mg One syringes/pen 40 mg One syringes/pen 20 mg • Maintenance Two syringes/pens 20 mg per 28 days ≥ 88 lbs.: 7

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Initial month One syringes/pen 160 mg One syringes/pen 80 mg One syringes/pen 40 mg • Begin a maintenance dose of Two syringes/pens 40 every 28 days. • Ulcerative Colitis (UC): • Six syringes/pens in the • Preferred initial 28 days • Two syringes/pens per 28 days after induction period • Plaque Psoriasis (Ps): • Four syringes/pens in the • Preferred initial 28 days • Two syringes/pens per 28 days after induction period • Hidradenitis Suppurativa (HS): • 160 mg day 1, followed • Preferred Adults by 80 mg day 15 (6 syringes/28 days) for induction period, thereafter 40 mg once a week starting day 29 (4 syringes/28 days) • Hidradenitis Suppurativa (HS): • >60 kg or more: 160 mg • Children 12-17 years old: day 1, followed by 80 mg • day 15(6 syringes/28 days) for induction period, thereafter 40 mg once a week starting day 29 (4 syringes/28 days) • 30-59 kg: 80 mg on day 1, then maintenance treatment of 40 mg once every other week starting on day • Uveitis (UV): • Adults: (Four syringes in • Preferred the initial 28 days), then Two syringes/ pens per

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

28 days after induction period. • Children 2-17 years old: • 30 kg or more: 40 mg every other week • 15-29 kg: 20 mg every other week • 10-14 kg: 10 mg every other week • Ilaris® Periodic Fever Syndromes: CAPS patients • Approvable with confirmation of this diagnosis. (canakinumabl) • 150 mg for body weight • Cryopyrin-Associated greater than 40 kg. Periodic Syndromes (CAPS), • body weight greater than or in adults and children 4 years equal to 15 kg and less than of age and older including: or equal to 40 kg, the o Familial Cold recommended dose is 2 Autoinflammatory mg/kg. Syndrome (FCAS) • For children 15 to 40 kg • Muckle-Wells Syndrome with an inadequate (MWS) (1.1) response, the dose can be increased to 3 mg/kg • Tumor Necrosis Factor • body weight less than or • Approvable with confirmation of this diagnosis. Receptor Associated Periodic equal to 40 kg, the Syndrome (TRAPS) in adult recommended dose is 2 and pediatric patients. mg/kg administered every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. Hyperimmunoglobulin D • body weight less than or • Approvable with confirmation of this diagnosis. Syndrome (HIDS)/Mevalonate equal to 40 kg, the Kinase Deficiency (MKD) in recommended dose is 2 adult and pediatric patients. mg/kg administered every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate.

9

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Familial Mediterranean Fever • body weight less than or • Approvable with confirmation of this diagnosis. (FMF) in adult and pediatric equal to 40 kg, the patients. recommended dose is 2 mg/kg administered every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. • Active Systemic Juvenile • 4mg/kg (max 300mg) • Routine PDL Idiopathic Arthritis (SJIA) in every 4 weeks Patients aged 2 years and older patients aged 2 years and older • QLL for doses <180mg: One vial per 28 days • QLL for doses >180mg: Two vials per 28 days Ilumya™ • Moderate-to severe plaque • For Plaque Psoriasis: 100 • Routine PDL AND (tildrakizumab-asmn) psoriasis (PSO) mg (two syringes) per 28 • Have moderate to severe plaque psoriasis for at least 6 months days for the induction with at least 1 of the following: period; then 100 mg (one • Involvement of at least 10% of body surface area (BSA); OR syringe) every 12 weeks • Psoriasis Area and Severity Index (PASI) score of 10 or greater; after the induction period. OR • Incapacitation due to plaque location (e.g., head and neck, palms, soles or genitalia); AND • Have not responded adequately (or is not a candidate) to a 3 month minimum trial of topical agents (e.g., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues); AND • Have not responded adequately (or is not a candidate) to a 3- month minimum trial of at least 1 systemic agent (e.g. Immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND Have not responded adequately (or is not a candidate) to a 3-month minimum trial of phototherapy (e.g. Psoralens with UVA light (PUVA) OR UVB with coal tar or dithranol) Kevzara® • Adult patients with moderately • Rheumatoid Arthritis: • Routine PDL AND (sarilumab) to severely active rheumatoid 200mg SC every 2 weeks, Initial Review Criteria: (Length of Authorization: 12 months) arthritis (RA) who have had an qty two syringes per 28 days • Patient age ≥ 18 years old; AND inadequate response or • Diagnosis of moderately to severely active rheumatoid arthritis intolerance to one or more (RA) -AND 10

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

disease-modifying anti- • Prescribed by or in consultation with a rheumatologist -AND rheumatic drugs (DMARDs). • History of failure, contraindication, or intolerance to one non- biologic disease modifying anti-rheumatic drug (DMARD) [e.g., Rheumatrex /Trexall (methotrexate), Arava (leflunomide), Azulfidine (sulfasalazine)] -AND • For continuation of prior Kevzara therapy o Patient is not receiving Kevzara in combination with any of the following: o Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] o Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] o Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] Renew Criteria: (Length of Authorization: 12 months) Documentation of positive clinical response to Kevzara therapy- AND Kineret® (anakinra) • Moderately to severely active • One syringe per day • Routine PDL AND RA • (qty 30/30 days) Trial and failure of, contraindication, or adverse reaction to • • methotrexate and at least one other DMARD (sulfasalazine, hydroxychloroquine, minocycline) • Juvenile Idiopathic Arthritis • One syringe per day • Routine PDL AND • • Cryopyrin-Associated Periodic • One syringe per day • Approvable with confirmation of this diagnosis. Syndromes (CAPS) (qty 30/30 days) • Treatment of Neonatal-Onset Multisystem Inflammatory Disease Olumiant (baricitinib) Adult patients with moderately to • One tablet (2mg) daily • Routine PDL AND severely active rheumatoid • (qty 30/30 days) • Patient age ≥ 18 years old; AND arthritis (RA) who have had an • • Use in combination with other JAK inhibitors, biologic disease- inadequate response to one or modifying antirheumatic drugs (DMARDs), or with potent more tumor necrosis factor (TNF) immunosuppressants, such as azathioprine and cyclosporine, is antagonist therapies not recommended Moderately to severely active SUBCUTANEOUS • Routine PDL AND Orencia® (abatacept) RA • 125 mg once a week (4 • Trial and failure of, contraindication, or adverse reaction to syringe/28 days) methotrexate and at least one other DMARD (sulfasalazine, INTRAVENOUS hydroxychloroquine, minocycline) • Weight <60kg: Two vials per 28 days • Weight 60-100kg: Three vials per 28 days

11

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

Weight >100kg: Four vials per 28 days • Juvenile Idiopathic Arthritis SUBCUTANEOUS • Routine PDL (JIA) in members 2 years and • weighing greater 50 kg: older 125 mg subcutaneously once a week (4 syringe/ 28 days) • weighing 25 kg to less than 50 kg: 87.5 mg (Four syringes of 87/5mg/28days) subcutaneously once a week • weighing 10kg to 25 kg: 50 mg subcutaneously once a week (Four syringes of 50mg mg/28days) INTRAVENOUS • Weight <75kg: 10mg/kg every 28 days (3 vial) • Weight >75kg: Follow adult Rheumatoid Arthritis dosing above Otezla® • Adult patients with active • Titrate to recommended • Routine PDL (apremilast) psoriatic arthritis dose of 30 mg twice daily. 60 tablets every 30 days • Patients with moderate to Titrate to recommended dose of • Routine PDL AND severe plaque psoriasis who 30 mg twice daily. 60 tablets • Must have a previous failure on a topical psoriasis agent and be a are candidates for every 30 days candidate for phototherapy or systemic therapy phototherapy or systemic therapy Otrexup® • Management of severe, active Quantity Limit = 4 auto- Length of Authorization: 6 months, then renew for 1 year for RA, if (methotrexate) rheumatoid arthritis (RA) injectors per month compliant and appropriate monitoring occurs. Approve for 6 months for psoriasis. • Polyarticular juvenile • idiopathic arthritis (pJIA), who Diagnosis of active rheumatoid arthritis (RA) are intolerant of or had an • inadequate response to first- Has had therapeutic failure to two preferred DMARD agents; AND • line therapy. Must have allergy or contraindication to benzoyl alcohol or other 12

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

preservative contained in generic injectable methotrexate • Symptomatic control of severe, recalcitrant, disabling Diagnosis of polyarticular juvenile idiopathic arthritis (pJIA) psoriasis in adults who are not • adequately responsive to other Has had therapeutic failure to two preferred NSAIDS agents; AND • forms of therapy. Must have allergy or contraindication to benzoyl alcohol or other preservative contained in generic injectable methotrexate • Diagnosis of Psoriasis • A therapeutic trial and failure on topical therapies such as topical emollients and/or topical corticosteroids, topical retinoids, topical vitamin D analogs, and topical tacrolimus AND pimecrolimus: AND • Must have allergy or contraindication to benzoyl alcohol or other preservative contained in generic injectable methotrexate RasuvoTM • Management of severe, active Quantity Limit = 4 auto- • Length of Authorization: 6 months, then renew for 1 year for RA, if (methotrexate) rheumatoid arthritis (RA) injectors per month compliant and appropriate monitoring occurs. Approve for 6 months for psoriasis. • Polyarticular juvenile • Diagnosis of active rheumatoid arthritis (RA) idiopathic arthritis (pJIA), who are intolerant of or had an • Has had therapeutic failure to two preferred DMARD agents; AND inadequate response to first- • Must have allergy or contraindication to benzoyl alcohol or other line therapy. preservative contained in generic injectable methotrexate

• Symptomatic control of Diagnosis of polyarticular juvenile idiopathic arthritis (pJIA) severe, recalcitrant, disabling psoriasis in adults who are not • Has had therapeutic failure to two preferred NSAIDS agents; AND adequately responsive to other • Must have allergy or contraindication to benzoyl alcohol or other forms of therapy. preservative contained in generic injectable methotrexate Diagnosis of Psoriasis • A therapeutic trial and failure on topical therapies such as topical emollients and/or topical corticosteroids, topical retinoids, topical vitamin D analogs, and topical tacrolimus AND pipecuroniums: AND • Must have allergy or contraindication to benzoyl alcohol or other preservative contained in generic injectable methotrexate

• For renewal, patient must be followed by a physician for monitoring of renal and hepatic function and complete blood counts with differential and platelet count.

13

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

Rinvoq (upadacitinib) • Adults with moderately to • 15 mg once daily • Routine PDL severely active rheumatoid • Use in combination with other JAK inhibitors, biologic DMARDs, arthritis or potent immunosuppressants such as azathioprine or cyclosporine is not recommended Siliq® (brodalumab) • Indicated for the treatment of • 210 mg of SILIQ by • Routine PDL AND moderate to severe plaque subcutaneous injection at Initial Review Criteria: (Length of Authorization: 12 months) psoriasis in adult patients who Weeks 0, 1, and 2 • Diagnosis of chronic moderate to severe plaque psoriasis -AND- are candidates for systemic followed by 210 mg • Greater than or equal to 5% body surface area involvement, therapy or phototherapy and every 2 weeks. palmoplantar, facial, or genital involvement, or severe scalp have failed to respond or have Quantity Limit = psoriasis -AND- lost response to other systemic • 3 single-dose prefilled • History of failure, contraindication, or intolerance to both of the therapies. syringes first fill (month) following conventional therapies: then 2 syringes monthly. • Topical therapy with one of the following: o Corticosteroids (e.g., betamethasone, clobetasol, desonide) o Vitamin D analogs (e.g., calcitriol, calcipotriene) o Tazarotene o Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) o Anthralin o Coal tar -AND- • Systemic therapy of at least 3 months duration with methotrexate -AND- • History of failure, contraindication, or intolerance to both of the following preferred biologic products (document drug, date, and duration of trial): o Humira (adalimumab) o Enbrel (etanercept) -AND- • Patient is not receiving Siliq in combination with any of the following: o Biologic DMARD [e.g., Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab), Cosentyx (secukinumab), Orencia (abatacept)] o Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] o Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] -OR- • Both of the following: o Patient is currently on Siliq therapy -AND- 14

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

o Diagnosis of chronic moderate to severe plaque psoriasis -AND- o Patient is not receiving Siliq in combination with any of the following: . Biologic DMARD [e.g., Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab), Cosentyx (secukinumab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)]

Renew Criteria: (Length of Authorization: 12 months) • Documentation of positive clinical response to Siliq therapy -AND- • Patient is not receiving Siliq in combination with any of the following: • Biologic DMARD [e.g., Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab), Cosentyx (secukinumab), Orencia (abatacept)] • Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] • Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] Simponi ® • Moderately to severely active • Quantity Limit = One, 50mg • Routine PDL AND (golimumab) Rheumatoid Arthritis (RA) in syringe per 28 days • Trial and failure of, contraindication, or adverse reaction to adults, combination with methotrexate alone and at least one other DMARD (sulfasalazine, methotrexate hydroxychloroquine, minocycline). • Must be in combination with methotrexate. • Active Psoriatic Arthritis • Quantity Limit = One, 50mg • Routine PDL (PsA) in adults, alone or in syringe per 28 days combination with methotrexate • Active Ankylosing Spondylitis • Quantity Limit = One, • Routine PDL in adults (AS) 50mg syringe per 28 days • Moderately to severely active • Quantity Limit = Three, • Trial and failure of a compliant regimen of oral or rectal Ulcerative Colitis 100mg syringes allowed in aminosalicylates (i.e., sulfasalazine or mesalamine) for two the initial 54 days consecutive months, AND • One, 100mg syringe per 28 • Trial and failure of a compliant regimen of oral corticosteroids (for days after induction period moderate to severe CD) unless contraindicated, or intravenous corticosteroids (for severe and fulminant CD or failure to respond to oral corticosteroids), AND 15

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Trial and failure of a compliant regimen of azathioprine or mercaptopurine for three consecutive months Skyrizi™ • Moderate-to-severe plaque Dosage 150mg Pen or Syringe • Routine PDL; AND (risankizumab-rzaa) psoriasis (PSO)in adults who (one injection) administered by • Patient is ≥ 18 years; AND are candidates for systemic subcutaneous injection at Week • Diagnosis of moderate to severe plaque psoriasis for ≥ 6 months therapy or phototherapy 0, Week 4 and every 12 weeks with ≥ 1 of the following:−Affected body surface area (BSA) of ≥ thereafter. 10%; OR−Psoriasis Area and Severity Index (PASI) score ≥ 10; OR−Incapacitation due to plaque location (e.g., head and neck, Quantity Limit: palms, soles or genitalia); AND • Two, 150 mg syringes or • Patient did not respond adequately (or is not a candidate) to a 3 pen allowed in the initial month minimum trial of topical agents (e.g., anthralin, coal tar 54 days. preparations, corticosteroids, emollients, immunosuppressives, • One, 150mg pen/ syringe keratolytics, retinoic acid derivatives, and/or Vitamin D analogues); per 84 days after AND induction period. • Patient did not respond adequately (or is not a candidate) to a 3 Dosage 150 mg (2, 75mg month minimum trial of ≥ 1systemic agent (e.g. injections) administered by Immunosuppressives, retinoic acid derivatives, and/or methotrexate); subcutaneous injection at AND Week 0, Week 4 and every 12 • Patient did not respond adequately (or is not a candidate) to a 3 weeks thereafter. month minimum trial of phototherapy (e.g., psoralens with UVA light (PUVA) or UVB with coal tar or dithranol); AND Quantity Limit = • Patient is not receiving risankizumab-rzaa in combination with • Four, 75 mg syringes another biologic agent for psoriasis or non-biologic allowed in the initial 54 immunomodulator (e.g., apremilast, tofacitinib, baricitinib) days. • Two, 75mg syringe per 84 days after induction period. Stelara® (ustekinumab) • Moderate to severe plaque Weight • Routine PDL psoriasis for Adult patients who are candidates for • less than or = 100 kg phototherapy or systemic Initial (two 45mg therapy prefilled syringe/28 days) then continue with one 45mg prefilled syringe/84 days • Greater than 100 kg Two 90 mg administered prefilled syringe/28 days then, then one 90 mg administered prefilled syringe/84 days

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Adult patients with Active • two 45mg prefilled • Routine PDL psoriatic arthritis, alone or in syringe/28 days; then combination with methotrexate continue with one 45mg prefilled syringe/84 days • Adult patients with Moderately • A single intravenous • Routine PDL to severely active Crohn’s infusion using weight- disease in patients who have based dosing failed or were intolerant to • up to 55 kg 260 mg (2 treatment with vials) immunomodulators or • greater than 55 kg to 85 corticosteroids, patients who kg 390 mg (3 vials) have failed or were intolerant • greater than 85 kg 520 mg to treatment with 2 preferred. (4 vials) • Adult patients with moderately • intravenous dose, then • Routine PDL to severely active ulcerative every 8 weeks thereafter colitis (1 vial per 56 days) • A subcutaneous 90 mg dose 8 weeks after the initial (90mg prefilled syringe/ 56 days) • Adolescent patients (6 years or 6 years and older SQ • Routine PDL older) with: moderate to severe < 60 kg (0.75 mg/kg); plaque psoriasis, who are dosing down to 15 kg candidates for phototherapy or 60 to 100 kg = systemic therapy • Initial (two 45mg prefilled syringe/28 days) then continue with one 45mg prefilled syringe/84 days Greater than 100 kg • Two 90 mg administered prefilled syringe/28 days then, then one 90 mg Taltz (ixekizumab) • Adults with moderate-to- • four 80 mg injections • Routine PDL severe plaque psoriasis who initially for 28 days, • Patient has tried and failed at least 2 topical treatments, such as are candidates for systemic • then Two 80 mg injection corticosteroids, calcipotriene, coal tar, tazarotene, or anthralin; therapy or phototherapy. lasting until week 10 • then one 80mg injection every 28 days

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Children ≥ 6 years with In pediatrics weight • Routine PDL moderate-to-severe plaque based. Initial from 40 mg • Patient has tried and failed at least 2 topical treatments, such as psoriasis who are candidates to 160 mg one time, and corticosteroids, calcipotriene, coal tar, tazarotene, or anthralin; for systemic therapy or every 4 week dosing phototherapy thereafter ranges from 20 mg to 80 mg • Adults with active psoriatic • Two 80 mg injection • Routine PDL arthritis. initially then one 80 mg injection every 4 weeks • Ankylosing Spondylitis • Two 80 mg injection • Routine PDL initially then one 80 mg injection every 4 weeks • Adults with active non- • One 80 mg injection SC • Routine PDL radiographic axial every 4 weeks spondyloarthritis (nr-axSpA) with objective signs of inflammation Tremfya™ • Adults with moderate-to- • 100 mg administered by • Routine PDL; AND (guselkumab) severe plaque psoriasis who subcutaneous injection at • Patient is ≥ 18 years; AND are candidates for systemic Week 0, Week 4 and • Diagnosis of moderate to severe plaque psoriasis for ≥ 6 months therapy or phototherapy. every with ≥ 1 of the following:−Affected body surface area (BSA) of ≥ • 8 weeks thereafter 10%; OR−Psoriasis Area and Severity Index (PASI) score ≥ 10; OR−Incapacitation due to plaque location (e.g., head and neck, palms, soles or genitalia);AND • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of topical agents (e.g., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues);AND • Patient did not respond adequately (or is not a candidate) to a 3- month minimum trial of ≥ 1systemic agent (e.g. Immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND • Patient did not respond adequately (or is not a candidate) to a 3- month minimum trial of phototherapy (e.g., psoralens with UVA light (PUVA) or UVB with coal tar or dithranol); AND • Patient is not receiving risankizumab-rzaa in combination with another biologic agent for psoriasis or non-biologic immunomodulator (e.g., apremilast, tofacitinib, baricitinib)

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

• Adults with psoriatic arthritis • 100 mg SC at week 0, 4, • Routine PDL; AND then every 8 weeks • Trexall® (methotrexate) • Neoplastic Diseases • • Routine PDL tablets • Psoriasis • Rheumatoid Arthritis including Polyarticular- Course Juvenile Rheumatoid Arthritis Xatmep™ oral solution • Treatment of pediatric • ALL: 20 mg/m2 one time • Patient is ≤12 years old; AND (methotrexate) patients with acute weekly (2.2) • Dosing will not allow the use of preferred methotrexate tablets; lymphoblastic leukemia • pJIA: Starting dose of 10 OR (ALL) as a component of a mg/m2 one time weekly • Patient is unable to swallow methotrexate tablets combination chemotherapy maintenance regimen

• Management of pediatric patients with active polyarticular juvenile • idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy Xeljanz® (tofacitinib) • Moderate to severe active RA • Xeljanz 5 mg twice daily • Routine PDL in adult members who are or • Trial and failure of, contraindication, or adverse reaction to Xeljanz® XR intolerant or not a candidate to • Xeljanz XR 11 mg once methotrexate and at least one other DMARD (sulfasalazine, (tofacitinib) methotrexate or in daily hydroxychloroquine, minocycline). combination with methotrexate • Patients with moderate and severe renal impairment or moderate hepatic impairment is XELJANZ 5 mg once daily • Juvenile Idiopathic Arthritis • • (JIA) (≥ 2 years) • Psoriatic Arthritis in Adults (in • Xeljanz 5 mg twice daily • Routine PDL combination with nonbiologic or Xeljanz XR 11 mg once • Trial and failure of, contraindication, or adverse reaction to DMARDs daily. methotrexate and at least one other DMARD (sulfasalazine, Patients with moderate hydroxychloroquine, minocycline). and severe renal impairment or moderate 19

Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

hepatic impairment is Xeljanz 5 mg once daily • Ulcerative Colitis • Induction: Xeljanz 10 mg • Routine PDL • Adult patients with moderately twice daily (qty 60/30days) Trial and failure or inadequate response or intolerant to TNF to severely active ulcerative or Xeljanz XR 22 (qty blockers. colitis (UC) 30/30days) mg once daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue Xeljanz 10 mg twice daily (qty 60/30days) or Xeljanz XR 22 mg (qty 30/30days) once daily for a maximum of 16 weeks. Discontinue Xeljanz 10 mg twice daily or Xeljanz XR 22 mg once daily (qty 30/30days) after 16 weeks if adequate therapeutic response is not achieved.

• Maintenance: Xeljanz 5 mg twice daily qty 60/30days) or Xeljanz XR 11 mg once daily (qty 30/30days). For patients with loss of response during maintenance treatment, Xeljanz 10 mg twice daily or Xeljanz XR 22 mg once daily (qty 30/30days) may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective

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Cytokine & CAM Antagonist Appendix A Revised 5.24.2021

dose needed to maintain response. Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

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