Secukinumab (Cosentyx) — Coverage Criteria
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Medical policy governing prior authorization, coverage criteria, and documentation requirements for secukinumab (Cosentyx) for FDA‑approved indications and compendial uses for Blue Cross Blue Shield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage and Clinical Criteria
Initial Therapy - Plaque psoriasis (PsO)
Covered when ANY of the following are met for members 6 years and older
Authorization of 12 months may be granted.
Authorization of 12 months may be granted.
Authorization of 12 months may be granted; see Appendix for clinical reasons to avoid therapies.
Initial Therapy - Psoriatic arthritis (PsA)
Covered when ONE of the following is met for members 2 years and older
Authorization of 12 months may be granted; prior biologic or targeted synthetic drug use noted as applicable.
Authorization of 12 months may be granted; prior biologic or targeted synthetic drug use noted as applicable.
Initial Therapy — Top-level initial authorization rules by indication and age (grouping of initial therapy criteria)
Initial authorization rules by indication and age
Providers must supply documentation of prior therapies tried or reasons to avoid them where applicable.
Providers must supply documentation of prior therapies tried or reasons to avoid them where applicable.
Prior biologic or targeted synthetic drug use may be required.
See Appendix for examples of contraindications.
Examples of antibiotics include clindamycin, metronidazole, moxifloxacin, rifampin, tetracyclines.
Initial therapy criteria — Initial authorization criteria that vary by indication and may require prior therapy failure or intolerance
Initial authorization criteria that vary by indication and may require prior therapy failure or intolerance
Authorization of 12 months may be granted for adult members.
Authorization of 12 months may be granted for members >=4 years; see Appendix for contraindication examples.
Authorization of 12 months may be granted for members >=12 years.
Initial therapy (IV) — Initial intravenous dosing for adults
Initial intravenous dosing for adults.
Weight‑based IV loading dose; prior authorization required to ensure dosing matches medication quantity limits.
inv-03: Plaque psoriasis — Continuation Therapy
Authorization of 12 months may be granted for members 6 years or older
Typical authorization length is 12 months.
Authorization of 12 months may be granted when improvement demonstrated.
Authorization of 12 months may be granted when reduction demonstrated.
inv-04: Psoriatic arthritis — Continuation Therapy
Authorization of 12 months may be granted for members 2 years or older
Authorization of 12 months may be granted when improvement demonstrated.
Authorization of 12 months may be granted when improvement demonstrated.
Authorization of 12 months may be granted when improvement demonstrated.
Typical authorization length is 12 months.
inv-05: Ankylosing spondylitis and nr-axSpA — Continuation Therapy
Authorization of 12 months may be granted for adult members
Chart notes documenting improvement are required for continuation approvals; typical authorization length is 12 months.
inv-06: Enthesitis-related arthritis — Continuation Therapy
Authorization of 12 months may be granted for members 4 years or older
Chart notes documenting improvement are required for continuation approvals; typical authorization length is 12 months.
inv-07: Hidradenitis suppurativa — Continuation Therapy
Authorization of 12 months may be granted for members 12 years or older
Chart notes documenting improvement are required for continuation approvals; typical authorization length is 12 months.
inv-37: Continuation Therapy — Continuation (renewal) requirements
Continuation (renewal) requirements
Typical approval duration is 12 months.
Provide supporting documentation with renewal requests.
inv-38: Continuation therapy criteria — Continuation approvals (typically 12 months) are granted when the member demonstrates improvement or low disease activity by indication-specific measures
Continuation approvals (typically 12 months) are granted when the member demonstrates improvement or low disease activity by indication-specific measures
Authorization typically granted for 12 months when documented.
Authorization typically granted for 12 months when documented.
Authorization typically granted for 12 months when documented.
Authorization typically granted for 12 months when documented.
Authorization typically granted for 12 months when documented.
Applicable to adult IV continuation dosing; requests exceeding maximum may be denied.
All indications not specifically listed as FDA‑approved indications or recognized compendial uses in this policy are considered experimental/investigational and are not medically necessary for Blue Cross Blue Shield of Tennessee members.
Secukinumab should not be administered to members with active tuberculosis infection. Prior to initiating therapy, document a negative TB test (TST or IGRA) within 12 months for biologic- or targeted‑synthetic–naïve persons; if TB screening is positive, perform further evaluation (e.g., chest x‑ray) to exclude active disease and treat latent TB before starting secukinumab.
Intravenous dosing that exceeds the stated maximum maintenance dose is outside the medication quantity limits. The policy specifies a maximum maintenance dose of 300 mg per infusion for the IV regimen (maintenance: 1.75 mg/kg every 4 weeks, with initial IV dose 6 mg/kg at week 0), and requests exceeding this per‑infusion maximum may be denied.
Use of secukinumab for indications other than those listed as FDA‑approved indications or accepted compendial uses in this policy is considered not medically necessary and may be denied.
Key Definitions and Thresholds
Codes and Coding Notes
| N/A | No specific CPT/HCPCS/ICD-10/NDC codes listed in this section of the document. |
Provider Requirements and Documentation
Prior authorization required
Prior authorization is required for secukinumab (Cosentyx) for the listed indications; when coverage criteria are met, authorization of up to 12 months may be granted.
Authorization duration — typically 12 months
Approvals are typically granted for 12 months when the clinical criteria for the requested indication are met; continuation approvals are also generally granted for 12 months when positive clinical response or low disease activity is documented.
Prior authorization required for Cosentyx IV dosing
Prior authorization is required for intravenous Cosentyx to confirm the request matches the specified IV regimens and medication quantity limits (initial IV loading and maintenance dosing, and maximum maintenance dose).
- Initial IV: 6 mg/kg on week 0
- Maintenance IV: 1.75 mg/kg every 4 weeks
- Maximum maintenance dose: 300 mg per infusion
Step therapy requirement — follow external guide
Step therapy per the referenced 'Step Therapy Requirements for Provider Administered Specialty Medications' document must be followed; providers should follow that external guide when submitting requests.
- See: Step Therapy Requirements for Provider Administered Specialty Medications (BCBST step therapy guide).
Required prior therapies or documented intolerance
For several indications, prior trials or documented intolerance/contraindication to specified therapies are required before approval (e.g., NSAIDs for AS/nr‑axSpA; NSAIDs, sulfasalazine, or methotrexate for ERA; oral antibiotics for HS).
- AS/nr‑axSpA: inadequate response to or intolerance/contraindication to at least two NSAIDs.
- ERA: inadequate response to NSAIDs, sulfasalazine, or methotrexate, or intolerance/contraindication to these agents.
- HS: inadequate response to an oral antibiotic for ≥90 days or intolerance/contraindication to oral antibiotics.
Required documentation for prior authorization
Initial prior authorization requests must include chart notes, medical record documentation, or claims history supporting prior medications tried and the member’s response; continuation requests require chart notes documenting clinical improvement or positive clinical response.
- For plaque psoriasis include documentation of affected areas and body surface area (BSA) when applicable.
- If a therapy is not advisable, include documentation of the clinical reason to avoid it.
TB screening and documentation required
Documented negative tuberculosis (TB) testing (TST or IGRA) within 12 months prior to initiating therapy is required for persons naïve to biologic or targeted synthetic drugs; if TB screening is positive, further evaluation must exclude active disease and latent TB must be treated prior to therapy.
- Do not administer secukinumab to members with active TB infection.
- If TB test positive, obtain confirmatory testing (e.g., chest x‑ray) and initiate latent TB treatment before starting secukinumab.
Reference compendia for dosing and safety guidance
Refer to standard reference compendia for dosing regimens, contraindications, precautions, warnings, and monitoring information when preparing prior authorization requests or managing therapy.
- Examples: NCCN Guidelines, Drugdex (Micromedex), AHFS Drug Information.
Non‑covered indications — may be denied
Requests for indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary; such requests may be denied.
Concurrent biologic or targeted synthetic therapy prohibits approval
The requested medication cannot be used concomitantly with any other biologic drug or targeted synthetic drug for the same indication; concurrent use will preclude approval.
Dose limit exceedance — may result in denial
Requests that exceed the stated maximum maintenance dose (300 mg per infusion) or that do not follow the specified IV regimen may be denied for exceeding quantity limits.
- Maximum maintenance dose: 300 mg per infusion.
- Maintenance IV regimen: 1.75 mg/kg every 4 weeks (adult).
Operational: confirm IV dosing and quantity limits
Operational: see medication quantity limits and IV regimen details in the policy to confirm coding and dosing when submitting requests.
Step Therapy Requirements
| Requirement | Details |
|---|---|
| Step therapy must be followed per the external 'Step Therapy Requirements for Provider Administered Specialty Medications' guide. | |
| Refer to the Step Therapy Requirements for Provider Administered Specialty Medications document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf |
| Indication | Required prior trial or documented intolerance/contraindication |
|---|---|
| Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) | |
| Intolerance/contraindication to two or more NSAIDs or inadequate response to at least two NSAIDs; prior biologic or targeted synthetic drug use may also be acceptable. | |
| Enthesitis-related arthritis (ERA) | |
| Inadequate response to NSAIDs, sulfasalazine, or methotrexate, or intolerance/contraindication to NSAIDs, sulfasalazine, and methotrexate; prior biologic use for active ERA is an alternative pathway. | |
| Hidradenitis suppurativa (HS) | |
| Intolerance or contraindication to oral antibiotics used for HS, or inadequate response to an oral antibiotic for at least 90 days (e.g., clindamycin, metronidazole, moxifloxacin, rifampin, tetracyclines); prior biologic use is an alternative. |
| Statement | Notes |
|---|---|
| No specific step therapy sequence is listed within the IV dosing and medication quantity limit sections of this document. | |
| Step therapy requirements are referenced elsewhere (see Step Therapy Requirements guide); the policy does not enumerate a step-by-step sequence in these chunks. |
Dosing and Quantity Limits
Site of Care and Administration
Subject to step therapy; no site restriction stated
Subject to the external Step Therapy Requirements for Provider Administered Specialty Medications; the policy does not impose an explicit site‑of‑care restriction for provider‑administered specialty medications.
IV route specified; setting not explicitly restricted
The intravenous regimens specified in the policy identify intravenous administration for adults; the policy does not explicitly restrict the setting (e.g., infusion center) where IV administration must occur.
- IV route: initial 6 mg/kg (week 0) and maintenance 1.75 mg/kg every 4 weeks.
Background
Secukinumab (Cosentyx) is an interleukin‑17A biologic indicated for multiple immune‑mediated inflammatory conditions including moderate to severe plaque psoriasis (≥6 years), psoriatic arthritis (≥2 years), ankylosing spondylitis and non‑radiographic axial spondyloarthritis in adults, enthesitis‑related arthritis (≥4 years), and hidradenitis suppurativa (≥12 years). Coverage under this policy is limited to those FDA‑approved indications and compendial uses when the specific clinical criteria are met.
Revision History
Policy implementation effective date established for this Secukinumab (Cosentyx) coverage policy (EFFECTIVE DATE 9/1/2026).
IV maintenance dosing and maximum maintenance dose specified for Cosentyx: maintenance 1.75 mg/kg every 4 weeks with a maximum maintenance dose of 300 mg per infusion (not to be implemented until 9/1/26).
Initial intravenous dosing for adults defined as 6 mg/kg on week 0 for specified indications (Ankylosing Spondylitis and Psoriatic Arthritis).
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