Cosentyx (secukinumab) — Coverage Criteria and Prior Authorization
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Defines coverage, prior authorization requirements, required documentation, and clinical criteria for Cosentyx (subcutaneous and intravenous formulations) for multiple inflammatory dermatologic and rheumatologic indications for Wellmark Blue Cross and Blue Shield members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy Criteria
Covered when ALL indication-specific criteria are met as detailed below.
Psoriatic arthritis (initial)
Prior trial requirement
- Trials of preferred IV products: Documented inadequate response or intolerable adverse event with each of: Avsola, Inflectra, Simponi Aria, Skyrizi
- Avoid TNF plus Skyrizi trial: Documented clinical reason to avoid TNF inhibitors AND documented inadequate response or intolerable adverse event with Skyrizi
Self-administration limitation
- Reasons: The patient or caregiver is unable to perform subcutaneous injections with Cosentyx pen or prefilled syringe with proper technique OR the patient or caregiver is unable to adhere to the prescribed dosing regimen
Ankylosing spondylitis (initial)
Prior trial requirement
- Trials of preferred IV products: Documented inadequate response or intolerable adverse event with each of: Avsola, Inflectra, Simponi Aria
- Avoid TNF: Documented clinical reason to avoid TNF inhibitors
Self-administration limitation
- Reasons: The patient or caregiver is unable to perform subcutaneous injections with Cosentyx pen or prefilled syringe with proper technique OR the patient or caregiver is unable to adhere to the prescribed dosing regimen
Non-radiographic axial spondyloarthritis (initial)
- Self-administration limitation only: Member has a documented reason self-administration is not appropriate (unable to perform injections with proper technique OR unable to adhere to dosing)
Moderate to severe plaque psoriasis (initial)
Disease severity
- >=3% BSA pathway: >=3% BSA AND one of: inadequate response/intolerance to phototherapy (e.g., UVB, PUVA) OR inadequate response/intolerance to methotrexate, cyclosporine, or acitretin OR clinical reason to avoid those pharmacologic therapies
- Age requirement: Patient >=6 years of age
Enthesitis-related arthritis (initial)
- Disease demonstration: Active disease with three active joints involved and at least one site of active enthesitis at baseline or documented by history
- Prior therapy: Inadequate response or intolerance to NSAIDs, sulfasalazine, or methotrexate OR intolerance/contraindication to NSAIDs, sulfasalazine, and methotrexate
- Age requirement: Patient >=4 years of age
Hidradenitis suppurativa (initial)
- Prior therapy: Inadequate response to an oral antibiotic for HS for >=90 days OR intolerance/contraindication to oral antibiotics used for HS
- Age requirement: Patient >=12 years of age
- Previous biologic pathway: Authorization may be granted if member previously received a biologic indicated for HS
Continuation Therapy Criteria
Covered on continuation when improvement or low disease activity is documented.
Plaque psoriasis (continuation)
- Evidence of response: Reduction in body surface area (BSA) affected from baseline OR improvement in signs/symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain)
Psoriatic arthritis (continuation)
- Evidence of response: Improvement in any of: number of swollen joints; number of tender joints; dactylitis; enthesitis; axial disease; skin and/or nail involvement; functional status; or C-reactive protein (CRP)
AS and nr-axSpA (continuation)
- Evidence of response: Improvement in any of: functional status; total spinal pain; inflammation (e.g., morning stiffness)
Psoriatic arthritis (PsA) — renewal/continuation
Authorization of 12 months may be granted when ALL of the following are met
PsA 12-month authorization
- Supporting measures: Improvement in at least one of: number of swollen joints; number of tender joints; dactylitis; enthesitis; axial disease; skin and/or nail involvement; functional status; C-reactive protein (CRP)>=1 measure improved
Evidence must compare to baseline
Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) — renewal/continuation
Authorization of 12 months may be granted when ALL of the following are met
AS/nr-axSpA 12-month authorization
- Supporting measures: Improvement in at least one of: functional status; total spinal pain; inflammation (e.g., morning stiffness)>=1 measure improved
Evidence must compare to baseline
Enthesitis-Related Arthritis (ERA) — renewal/continuation (SC formulations only)
Authorization of 12 months (Cosentyx subcutaneous formulations only) may be granted when ALL of the following are met
ERA 12-month authorization
- Supporting measures: Improvement in at least one of: number of flares; number of joints with active arthritis; number of joints with limited movement; dactylitis; enthesitis>=1 measure improved
Evidence must compare to baseline
Moderate to severe hidradenitis suppurativa (HS) — renewal/continuation (SC formulations only)
Authorization of 12 months may be granted when ANY of the following is met demonstrating positive clinical response
Approvals may be subject to dosing limits per labeling/guidelines
This medical policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are made by the Federal Employee Program and may differ from the coverage described in this policy; verify individual member benefits and applicable contract language before authorizing therapy.
Do not administer the requested medication to members with active tuberculosis (TB) infection. For biologic- or targeted-synthetic–naïve persons, a documented negative TB test (tuberculin skin test [TST] or interferon‑gamma release assay [IGRA]) within 12 months prior to initiating therapy is required. If TB screening is positive, further evaluation to exclude active disease (for example, chest x‑ray) is required and latent TB must be treated prior to starting therapy. Additionally, concomitant use with any other biologic or targeted synthetic drug for the same indication is not allowed.
Cosentyx (secukinumab) is considered not medically necessary for members who do not meet the clinical criteria and documentation requirements set forth in this policy.
Actions Required by Providers
Prior authorization required for Cosentyx
Prior authorization is required for Cosentyx; initial and continuation requests must include the documentation specified in the policy and meet the indication-specific criteria (see Required Documentation and coverage criteria).
- Initial and continuation requests must meet the indication-specific criteria (e.g., prior trials, disease severity, age limits).
- Submit required documentation (chart notes, prior medication history, BSA when applicable) as detailed in the policy.
12-month approvals for responders (documentation required)
When positive clinical response or low disease activity is documented, prior authorization approvals may be granted for 12 months for multiple indications; documentation must compare response to baseline and cite specific improved measures per indication.
- 12-month authorizations may be granted for PsO, PsA, AS/nr-axSpA, ERA, and HS (subcutaneous formulations only for some indications) when criteria are met.
- Evidence of improvement must compare to baseline (e.g., swollen/tender joints, functional status, BSA, pain, abscess counts, CRP).
Step therapy / prior trials required
Step therapy is required for many indications: the member must have documented inadequate response or intolerance to specified preferred products or conventional therapies before Cosentyx is approved, unless there is a documented clinical reason to avoid those alternatives.
- Preferred IV alternatives (Avsola, Inflectra, Simponi Aria, Skyrizi) are required trials for certain IV requests.
- Conventional therapies (e.g., methotrexate, NSAIDs, sulfasalazine, oral antibiotics for HS) must be tried when indicated or a clinical reason to avoid must be documented.
Equitable treatment regardless of samples or assistance
Members receiving samples or manufacturer assistance must meet the same initial approval criteria as other members; providers must document that these criteria are met.
- Ensure members on samples/patient assistance have documentation of prior trials, disease severity, and other required criteria before submitting for authorization.
Required documentation for initial and continuation requests
Submit chart notes or medical record documentation for initial and continuation requests: affected areas and BSA (when applicable), prior medication trials and responses or reasons to avoid therapies for initial requests, and documentation of positive clinical response or decreased BSA for continuation requests.
- Initial requests: chart notes/records of affected area(s), BSA, prior medications tried and response, or clinical reason to avoid therapies.
- Continuation requests: chart notes documenting decreased BSA and/or clinical improvement compared with baseline.
Document evidence of clinical response vs baseline
Provide documentation of clinical response that compares to baseline and demonstrates improvement or low disease activity using disease-specific measures appropriate to the indication.
- PsA: improvement in swollen/tender joint counts, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.
- AS/nr-axSpA: improvement in functional status, total spinal pain, or inflammation (e.g., morning stiffness).
- ERA and HS: use the listed measures (e.g., number of flares, abscess/nodule counts, pain, quality of life) compared to baseline.
TB testing documentation required before initiation
Document a negative TB screen (TST or IGRA) within 12 months prior to initiating therapy for persons naïve to biologic or targeted synthetic drugs; if screening is positive, obtain further testing to exclude active disease and treat latent TB prior to initiation.
- If TB screening is positive, obtain confirmatory testing (e.g., chest x-ray) and do not start Cosentyx if active TB is present.
- If latent TB is identified, TB treatment must be started before initiating the requested medication.
Incomplete documentation may result in denial
Failure to submit required documentation (chart notes, BSA, prior medication history, or evidence of response) may prevent prior authorization review or lead to denial of initiation or continuation.
- Ensure all required chart notes, medication history, baseline measures, and response documentation are included with the authorization request to avoid denial.
Do not start therapy with active TB; positive screen requires follow-up
Do not administer Cosentyx to members with active TB infection; a positive TB screen requires further testing and treatment prior to initiation and active disease is a contraindication to therapy.
- If screening testing for TB is positive, obtain further testing (e.g., chest x-ray) to confirm no active disease before considering initiation.
Concomitant biologic/tsDMARD use not permitted
Concomitant use of Cosentyx with any other biologic or targeted synthetic drug for the same indication is not allowed and will result in a non-covered determination.
- Verify patient is not receiving another biologic or targeted synthetic drug for the same indication before approving or administering Cosentyx.
Definitions and Clinical Measures
Procedures and Billing Codes
| C9166 | Injection, secukinumab, intravenous, 1 mg (cancelled 7/1/2024) |
| J3247 | Injection, secukinumab, intravenous, 1 mg (effective 7/1/2024) |
| J3490 | Unclassified drugs (when specified as [Cosentyx] (secukinumab) (intravenous)) |
| J3590 | Unclassified biologics (when specified as [Cosentyx] (secukinumab) (intravenous)) |
Background
Cosentyx (secukinumab) is a targeted biologic indicated for inflammatory dermatologic and rheumatologic conditions. The policy aligns patient selection with product labeling and clinical guidance and addresses appropriate use across multiple indications, including requirements for TB screening and restrictions on concomitant biologic or targeted‑synthetic therapies.
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