Cosentyx vial (125 mg/5 mL) — Blue Cross Blue Shield of Illinois

Preferred products

• Cosentyx Sensoready pen 150 mg/mL (1 or 2 pen dose)
• Cosentyx UnoReady pen 300 mg/2 mL
• Cosentyx prefilled syringe 75 mg/0.5 mL
• Cosentyx prefilled syringe 150 mg/mL (1 or 2 syringe dose)
• Cosentyx prefilled syringe 300 mg/2 mL

Initial criteria

• For AS: trial and inadequate response to TWO different NSAIDs used in treatment of AS after at least a 4-week total duration of therapy OR trial and inadequate response to ONE NSAID after at least a 4-week duration of therapy and intolerance or hypersensitivity to ONE additional NSAID OR intolerance or hypersensitivity to TWO different NSAIDs used in treatment of AS OR patient has FDA labeled contraindication to ALL NSAIDs used in treatment of AS OR patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for AS
• For nr-axSpA: trial and inadequate response to TWO different NSAIDs after at least a 4-week total duration of therapy OR trial and inadequate response to ONE NSAID after at least a 4-week duration and intolerance or hypersensitivity to ONE additional NSAID OR intolerance or hypersensitivity to TWO different NSAIDs OR patient has FDA labeled contraindication to ALL NSAIDs OR patient’s medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for nr-axSpA
• For PJIA: trial and inadequate response to ONE conventional agent (methotrexate, leflunomide) after at least a 3-month duration of therapy OR intolerance or hypersensitivity to ONE conventional agent OR FDA labeled contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator labeled or supported in compendia for PJIA
• For GCA: trial and inadequate response to ONE systemic corticosteroid (e.g., prednisone, methylprednisolone) after at least a 7-day duration of therapy OR intolerance or hypersensitivity to ONE systemic corticosteroid OR FDA labeled contraindication to ALL systemic corticosteroids OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for GCA
• For other FDA labeled or compendia-supported indications: either indication is FDA labeled or supported in compendia AND patient age is within labeling or supported for requested indication
• If request is for Cosentyx vial: one of the following – member is Fully Insured, HIM, or Non-ERISA ASO/self-insured municipalities/counties member; OR patient has tried a self-administered Cosentyx agent; OR patient is currently treated and stable on requested agent; OR inadequate response to ONE self-administered Cosentyx agent; OR discontinued ONE self-administered Cosentyx due to lack of efficacy or adverse event; OR intolerance or hypersensitivity to ONE self-administered Cosentyx agent not expected to occur with requested agent; OR FDA labeled contraindication to ALL self-administered Cosentyx agents; OR self-administered Cosentyx expected ineffective or causes adherence/comorbidity issues or harm; OR self-administered Cosentyx not in best interest based on medical necessity; OR patient had tried another prescription drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy or adverse event; OR support exists for use of requested provider-administered product over self-administered products
• Prescribing information TB testing requirements satisfied (tested and treated if positive, or not required by labeling)
• Prescriber is specialist or has consulted with specialist in appropriate field
• Requested use not in combination with another immunomodulatory agent unless labeling allows combination and evidence supports combination therapy
• Patient does not have any FDA labeled contraindications to requested agent
• For Ohio residents under Fully Insured or HIM Shop plans: no FDA contraindications to requested agent AND one of – FDA labeled indication, compendia-supported indication, or two supportive peer-reviewed journal articles provided

Reauthorization criteria

• Patient previously approved for requested agent through plan’s PA process (initial criteria applied for certain agents including tocilizumab for CRS, Omvoh for CD or UC, ustekinumab for CD or UC, Skyrizi for CD or UC, Tremfya for UC)
• Patient has had clinical benefit with requested agent
• Prescriber is specialist or has consulted with specialist in appropriate field
• Requested use not combined with another immunomodulatory agent unless labeling allows and there is evidence support for combination therapy

Approval duration

12 months (with exceptions: Tocilizumab for CRS up to 3 months; Entyvio, Omvoh, Skyrizi, Tremfya induction up to 12–14 weeks; Ustekinumab induction 3 months)