Cosentyx (secukinumab) drug policy
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Defines coverage, prior authorization requirements, documentation, prescriber specialties, and clinical criteria for Cosentyx (subcutaneous and intravenous formulations) for Wellmark/Blue Cross Blue Shield members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cosentyx (secukinumab)
Initial approval — Plaque psoriasis (PsO)
Authorization of 12 months may be granted for members 6 years and older when ANY of the following are met:
From policy: chunk 13.
Initial approval — Psoriatic arthritis (PsA)
Authorization of 12 months may be granted for members 2 years and older when ONE of the following is met:
From policy: chunks 14 and 8.
Initial approval — Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)
Authorization of 12 months may be granted for adult members when ALL of the following are met (options within):
From policy: chunks 15, 9, 10.
Initial approval — Enthesitis-related arthritis (ERA)
Authorization of 12 months (for subcutaneous formulations) may be granted for members 4 years and older when ALL of the following are met:
From policy: chunk 16.
Initial approval — Moderate to severe hidradenitis suppurativa (HS)
Authorization of 12 months (subcutaneous formulations) may be granted for adult members when ONE of the following is met:
From policy: chunk 17.
Self-administration exceptions / IV formulation
For IV Cosentyx and certain approvals, the member must have a documented reason that self-administration is inappropriate:
From policy: chunks 9, 8, 10.
Continuation of therapy
Authorization of 12 months may be granted for members already using Cosentyx who demonstrate positive clinical response:
From policy: chunks 18-19.
Plaque psoriasis continuation
Plaque psoriasis (PsO) continuation — Authorization of 12 months may be granted when ALL of the following are met
Response examples include reduction in BSA affected from baseline and improvement in signs/symptoms (chunk 19).
Psoriatic arthritis continuation
Psoriatic arthritis (PsA) continuation — Authorization of 12 months may be granted when ANY of the following show improvement from baseline
Measures include number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin and/or nail involvement, functional status, and C-reactive protein (CRP).
Ankylosing spondylitis / axial spondyloarthritis continuation
Ankylosing spondylitis (AS) / axial spondyloarthritis (axSpA) continuation — Authorization of 12 months may be granted when ANY of the following show improvement from baseline
Measures include functional status, total spinal pain, and inflammation (e.g., morning stiffness).
Enthesitis-related arthritis continuation
Enthesitis-related arthritis (ERA) continuation — Authorization of 12 months may be granted when ANY of the following show improvement from baseline
Measures include number of flares, number of joints with active arthritis, number of joints with limited movement, dactylitis, and enthesitis.
Hidradenitis suppurativa continuation
Hidradenitis suppurativa (HS) continuation — Authorization of 12 months may be granted when ANY of the following are met
Measures include reduction in abscess and inflammatory nodule count, reduced formation of new sinus tracts and scarring, decreased frequency of inflammatory lesions, reduction in pain, reduction in suppuration, improvement in relapse frequency, improvement in quality of life, or improvement on a disease severity assessment tool from baseline.
Benefits and coverage under this policy are determined by the member's contract and the applicable benefit language in effect at the time services are rendered. Benefit determinations, exclusions, limitations, or exceptions may apply, and the policy may not apply to Federal Employee Program (FEP) members; FEP benefits are determined separately by that program.
Prior to initiating Cosentyx, document a negative tuberculosis (TB) test (TST or IGRA) within 12 months for biologic/targeted-synthetic–naive persons. If TB screening is positive, obtain further testing to exclude active disease (e.g., chest X‑ray) and do not administer therapy to members with active TB infection. Additionally, the requested medication must not be used concomitantly with any other biologic or targeted synthetic drug for the same indication.
Cosentyx (secukinumab) is considered not medically necessary for members who do not meet the clinical criteria and documentation requirements specified in this policy.
Procedures, Codes, and Key Clinical Values
Provider Requirements, Documentation, and Step Therapy
Prior authorization required; include required documentation; 12‑month durations
Prior authorization is required for Cosentyx. Both initial and continuation requests must include the documentation elements listed under Required Documentation (e.g., chart notes/medical records showing affected areas and BSA for psoriasis; prior medications tried and responses or clinical reasons to avoid those therapies). Authorization durations for Cosentyx subcutaneous formulations are typically 12 months.
- Include chart notes/medical record documentation of affected area(s) and body surface area (BSA) when applicable (psoriasis).
- For initial requests, provide chart notes/medical record documentation or claims history of prior medications tried and responses, or documentation of clinical reasons to avoid therapy.
- For continuation requests, provide documentation of decreased BSA and/or improvement in signs and symptoms or other measures of positive clinical response.
- Typical authorization duration: 12 months for subcutaneous formulations.
Continuation authorization — 12 months for responders
Continuation authorization may be granted for 12 months for members using Cosentyx subcutaneous formulations who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms.
- Plaque psoriasis: reduction in BSA affected or improvement in signs/symptoms (e.g., itching, redness, scaling).
- Psoriatic arthritis: improvement in swollen/tender joint counts, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.
Step therapy — document inadequate response/intolerance to preferred agents
Many indications require documented inadequate response or intolerable adverse events to preferred or first‑line agents (examples include Avsola, Inflectra, Simponi Aria, Skyrizi, TNF inhibitors, conventional systemic agents, NSAIDs, or antibiotics depending on indication) prior to approval of Cosentyx.
- Psoriatic arthritis and ankylosing spondylitis initial approvals: documented inadequate response or intolerable adverse event to specified preferred agents (Avsola, Inflectra, Simponi Aria, Skyrizi) or documented clinical reason to avoid TNF inhibitors plus inadequate response to Skyrizi.
- Hidradenitis suppurativa: inadequate response to an oral antibiotic for at least 90 days or intolerance/contraindication to oral antibiotics; prior biologic for HS may also satisfy initial approval.
- Intravenous Cosentyx requests default to preferred IV products (Avsola, Inflectra, Skyrizi, Simponi Aria) unless a clinical exception is documented.
Documented clinical reasons to avoid comparator agents (see appendices)
Clinical reasons listed in the appendices may justify avoiding certain agents and inform selection of Cosentyx (e.g., reasons to avoid TNF‑inhibitors or reasons to avoid methotrexate/cyclosporine/acitretin/leflunomide).
- Appendix A examples to avoid TNF inhibitors: history of congestive heart failure, demyelinating disorder, hepatitis B infection, risk of lymphoma, autoantibody formation/lupus‑like syndrome.
- Appendix B examples to avoid methotrexate/cyclosporine/acitretin/leflunomide: pregnancy or planning pregnancy, breastfeeding, chronic liver disease or alcohol use disorder, drug interactions, significant comorbidity, history of intolerance or hypersensitivity.
Required documentation — chart notes, BSA, prior meds and responses
Submit chart notes or medical records that document the condition and prior treatment history: affected areas and BSA for psoriasis, prior medications tried and responses (or clinical reasons to avoid those therapies), and supporting notes for continuation requests showing clinical benefit.
- Initial requests: chart notes/claims history of prior medications tried and response; if a therapy is not advisable, include clinical reason to avoid that therapy.
- Plaque psoriasis initial: documentation of affected areas and BSA (when applicable).
- Continuation requests: documentation of decreased BSA and/or improvement in signs and symptoms or other condition‑specific response measures.
Document clinical response — baseline and follow‑up measures required
Document baseline and follow‑up measures that demonstrate improvement or low disease activity appropriate to the indication (e.g., BSA for plaque psoriasis; joint counts, dactylitis, enthesitis, axial findings, skin/nail involvement, functional status, or CRP for psoriatic arthritis).
- Plaque psoriasis: reduction in BSA and improvement in signs/symptoms (itching, redness, flaking, scaling, burning, cracking, pain).
- Psoriatic arthritis: improvement in number of swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.
- ERA, AS/axSpA, HS: use the indication‑specific measures listed in the policy (e.g., flares, joint counts, spinal pain, abscess/nodule counts, frequency of lesions, pain, QoL or disease severity tools).
TB test documentation — negative TST or IGRA within 12 months for biologic/ts‑naive persons
Provide a documented negative tuberculosis test (TST or IGRA) within 12 months prior to initiating therapy for persons naive to biologic or targeted synthetic therapies.
- A positive TB screening requires further testing (e.g., chest X‑ray) to exclude active disease before initiating therapy.
- Do not administer Cosentyx to members with active TB; latent TB must be treated prior to starting therapy.
Missing documentation may lead to PA denial
Failure to submit the required documentation (e.g., chart notes, BSA, prior medication history, documentation of response) may result in denial of the prior authorization request.
- Ensure initial requests include prior medication history or clinical reasons to avoid therapies; ensure continuation requests include objective measures of response.
TB screening and concomitant therapy — do not start if active TB; follow-up testing/treatment required
Do not administer Cosentyx to members with active tuberculosis. If TB screening is positive, perform further testing to exclude active disease (e.g., chest X‑ray) and initiate TB treatment for latent infection before starting the medication. Members may not use Cosentyx concomitantly with another biologic or targeted synthetic drug for the same indication.
- Positive TB screen → further testing to confirm no active disease; treat latent TB prior to initiation.
- Concomitant use with other biologic or targeted synthetic drugs for the same indication is prohibited.
Not medically necessary if criteria unmet
Cosentyx is considered not medically necessary for members who do not meet the policy criteria; ensure all applicable criteria and documentation are met to avoid a not‑medically‑necessary determination.
- Members receiving samples or patient assistance must still meet initial approval criteria when seeking coverage.
Background on Cosentyx
Cosentyx (secukinumab) is a monoclonal antibody approved for several inflammatory dermatologic and rheumatologic conditions including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, enthesitis‑related arthritis, and hidradenitis suppurativa. The policy distinguishes between subcutaneous pen/prefilled syringe formulations and the intravenous (IV) formulation, applies prior authorization requirements, and aligns coverage to preferred products with documented clinical exceptions. Typical authorization durations for Cosentyx subcutaneous formulations are 12 months, with continuation approvals contingent on documented clinical response and required supporting documentation.
Definitions and Clinical Measures
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