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Cosentyx (secukinumab)(Subcutaneous)*IH*Document Number: IH-0229Last Review Date: 1/26/2016Date of Origin: 02/24/2015Dates Reviewed: 2/2015, 1/2016I.Length of AuthorizationCoverage will be provided for 6 months and may be renewedII.Dosing LimitsA. Quantity Limit (max daily dose) [Pharmacy Benefit]:Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasisLoading:Cosentyx 150 mg Sensoready Pen: 2 prefilled pens at weeks 0, 1, 2, 3, 4Cosentyx 150 mg prefilled syringe: 2 prefilled syringes at weeks 0, 1, 2, 3, 4Maintenance:Cosentyx 150 mg Sensoready Pen: 2 prefilled pens every 28 daysCosentyx 150 mg prefilled syringe: 2 prefilled syringes every 28 daysPsoriatic arthritis and ankylosing spondylitisLoading:Cosentyx 150 mg Sensoready Pen: 1 prefilled pen at weeks 0, 1, 2, 3, 4Cosentyx 150 mg prefilled syringe: 1 prefilled syringe at weeks 0, 1, 2, 3, 4Maintenance:Proprietary & Confidential 2016 Magellan Health Services, Inc.

Cosentyx 150 mg Sensoready Pen: 1 prefilled pen every 28 daysCosentyx 150 mg prefilled syringe: 1 prefilled syringe every 28 days(Note: for psoriatic arthritis with inadequate response to the 150 mg dosing, 300 mg may beconsidered)B. Max Units (per dose and over time) [Medical Benefit]:Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasisLoading:Cosentyx 150 mg single use vial: 2 single use vials at weeks 0, 1, 2, 3, 4Male:300 mg at weeks 0, 1, 2, 3, 4Female300 mg at weeks 0, 1, 2, 3, 4Maintenance:Cosentyx 150 mg single use vial: 2 single use vials every 28 daysMale:300 mg every 28 daysFemale:300 mg every 28 daysPsoriatic arthritis and ankylosing spondylitisLoading:Cosentyx 150 mg single use vial: 1 single use vial at weeks 0, 1, 2, 3, 4Male:150 mg at weeks 0, 1, 2, 3, 4Female150 mg at weeks 0, 1, 2, 3, 4Maintenance:Cosentyx 150 mg single use vial: 1 single use vials every 28 daysMale:150 mg every 28 daysFemale:150 mg every 28 days(Note: for psoriatic arthritis with inadequate response to the 150 mg dosing, 300 mg may beconsidered)III.Initial Approval CriteriaCoverage is provided in the following conditions: Adult patient (18 years or older); ANDCosentyx (secukinumab) Prior Auth CriteriaPage 2 Proprietary Information. Restricted Access – Do not disseminate or copywithout approval. 2016, Magellan Rx Management

Patient has been evaluated and screened for the presence of latent TB infection prior toinitiating treatment; AND Cosentyx will not be administered concurrently with live vaccines; AND Patient is free of any clinically important active infections; ANDPlaque Psoriasis †Patient has Moderate to severe plaque psoriasis for at least 6 months with at least 1 of thefollowing: oInvolvement of at least 10% of body surface area (BSA); ORoPsoriasis Area and Severity Index (PASI) score of 12 or greater; ORoIncapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia); AND Is not being treated with any other biological response modifier (ex. Humira, Amevive, andEnbrel); AND Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial totopical agents (i.e. Anthralin, Coal Tar preparations, corticosteroids, emollients,immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues);ANDooPatient did not respond adequately (or is not a candidate) to a 3 month minimumtrial of at least 1 systemic agents (i.e. immunosuppressives, retinoic acidderivatives, and/or methotrexate); ORPatient did not respond adequately (or is not a candidate) to a 3 month minimumtrial of phototherapy (i.e. Psoralens with UVA light (PUVA) OR UVB with coal taror dithranol)Client Specific InformationPatient has had an inadequate response to TWO preferred biologic therapies in theprevious 180 days. Current preferred biologics include – Enbrel (etanercept), Humira(adalimumab), Remicade (infliximab), or Stelara (ustekinumab). ooPatient has tried and failed therapy with, or has a contraindication to Remicade(infliximab), and Stelara (ustekinumab) when Cosentyx is physicianadministered; ORPatient has tried and failed therapy with, or has a contraindication to Enbrel(etanercept) and Humira (adalimumab) when Cosentyx is self-administered.Psoriatic Arthritis (PsA) †Documented moderate to severe active disease; AND oFor patients with predominantly axial disease OR active enthesitis and/or dactylitis, anadequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents(NSAIDs), unless use is contraindicated; ORCosentyx (secukinumab) Prior Auth CriteriaPage 3 Proprietary Information. Restricted Access – Do not disseminate or copywithout approval. 2016, Magellan Rx Management

oFor patients with peripheral arthritis, a trial and failure of at least a 3 month trial ofONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate,azathioprine, sulfasalazine, or hydroxychloroquine; ANDPatient must have experienced an inadequate response (e.g., have active psoriatic arthritis) toan adequate trial on the 150 mg dose before increasing to the 300 mg dose (unless they have coexistent plaque psoriasis) Client Specific Information Patient has had an inadequate response to TWO preferred biologic therapies in theprevious 180 days. Current preferred biologics include – Enbrel (etanercept), Humira(adalimumab), Remicade (infliximab), or Stelara (ustekinumab).ooPatient has tried and failed therapy with, or has a contraindication to Remicade(infliximab), and Stelara (ustekinumab) when Cosentyx is physicianadministered; ORPatient has tried and failed therapy with, or has a contraindication to Enbrel(etanercept) and Humira (adalimumab) when Cosentyx is self-administered.Ankylosing Spondylitis † Documented active disease; AND Patient had an adequate trial and failure of at least TWO (2) non-steroidal antiinflammatory agents (NSAIDs), unless use is contraindicatedClient Specific Information Patient has had an inadequate response to the following preferred biologic therapies inthe previous 180 days. Current preferred biologics include – Enbrel (etanercept), Humira(adalimumab), or Remicade (infliximab).ooPatient has tried and failed therapy with, or has a contraindication to Remicade(infliximab) when Cosentyx is physician administered; ORPatient has tried and failed therapy with, or has a contraindication to Enbrel(etanercept) and Humira (adalimumab) when Cosentyx is self-administered.†FDA Approved Indication(s)IV.Renewal CriteriaCoverage can be renewed based upon the following criteria: Patient continues to meet criteria identified in section III; AND Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity includethe following: severe exacerbations of Crohn’s disease, severe infections, and anaphylactic orother serious allergic reactions; ANDCosentyx (secukinumab) Prior Auth CriteriaPage 4 Proprietary Information. Restricted Access – Do not disseminate or copywithout approval. 2016, Magellan Rx Management

Ongoing monitoring for TB; AND Plaque PsoriasisDisease response as indicated by improvement in signs and symptoms compared to baselinesuch as redness, thickness, scaliness, and/or the amount of surface area involvement. Psoriatic ArthritisDisease response as indicated by improvement in signs and symptoms compared to baselinesuch as the number of tender and swollen joint counts Ankylosing SpondylitisDisease response as indicated by improvement in signs and symptoms compared to baselinesuch as total back pain, physical function, and/or morning stiffness. V.Dosage/AdministrationIndicationDosePlaque Psoriasis & 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300psoriatic arthritis mg every 4 weeks. Each 300 mg dose is given as 2 subcutaneous injections of150 mg. For some patients, a dosage of 150 mg may be acceptable.with co-existentplaque psoriasisWith loading dose:150 mg at weeks 0, 1, 2, 3, & 4 and every 4 weeks thereafterPsoriatic ArthritisWithout a loading dose:150 mg every 4 weeksNote: Cosentyx may be administered with or without a loading dose for thisindication. If the patient continues to have active psoriatic arthritis,increasing the dose to 300 mg may be consideredWith loading dose:150 mg at weeks 0, 1, 2, 3, & 4 and every 4 weeks thereafterAnkylosingspondylitisWithout a loading dose:150 mg every 4 weeksNote: Cosentyx may be administered with or without a loading dose for thisindication.VI.Billing Code/Availability InformationJcode: J3590 – Unclassified biologicNDC: Cosentyx 150 mg Sensoready Pen: 00078-0639-xx Cosentyx 150 mg prefilled syringe: 00078-0639-xxCosentyx (secukinumab) Prior Auth CriteriaPage 5 Proprietary Information. Restricted Access – Do not disseminate or copywithout approval. 2016, Magellan Rx Management

VII.Cosentyx 150 mg single use vial:00078-0657-61-xxReferences1. Cosentyx [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation;January 2016. Accessed January 2016.2. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis--results of twophase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258.Epub 2014 Jul 9.3. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaquepsoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.4. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasisand psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for thetreatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. doi:10.1016/j.jaad.2008.02.039.5. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS,Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for themanagement of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview andguidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol2008 May;58(5):851-64.6. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR)recommendations for the management of psoriatic arthritis with pharmacological therapies:2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi:10.1136/annrheumdis-2015-208337.7. Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/SpondylitisAssociation of America/Spondyloarthritis Research and Treatment Network 2015Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic AxialSpondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. doi: 10.1002/art.39298.Appendix 1 – Covered Diagnosis CodesICD-9 CodesDiagnosis696.0Psoriatic arthropathy696.1Other psoriasis720.0Ankylosing spondylitisICD-10 CodesDiagnosisL40.0Psoriasis vulgarisL40.50Arthropathic psoriasis, unspecifiedL40.51Distal interphalangeal psoriatic arthropathyCosentyx (secukinumab) Prior Auth CriteriaPage 6 Proprietary Information. Restricted Access – Do not disseminate or copywithout approval. 2016, Magellan Rx Management