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Secukinumab (Cosentyx) — intravenous (Medicare Advantage)
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Medicare Advantage medical policy governing coverage criteria for intravenous secukinumab (Cosentyx) for adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis for members of the Health Plan.
No material clinical or coverage changes in this revision.
Coverage Criteria for Intravenous Secukinumab (Cosentyx)
Initial Therapy — Psoriatic Arthritis
Covered when ALL of the following are met
From policy initial criteria for psoriatic arthritis
Continuation Therapy — Psoriatic Arthritis
Covered when ALL of the following are met
Continuation criteria for psoriatic arthritis
Initial Therapy — Ankylosing Spondylitis
Covered when ALL of the following are met
Initial criteria for ankylosing spondylitis
Continuation Therapy — Ankylosing Spondylitis
Covered when ALL of the following are met
Continuation criteria for ankylosing spondylitis
Initial Therapy — Non-radiographic Axial Spondyloarthritis
Covered when ALL of the following are met
Initial criteria for non-radiographic axial spondyloarthritis
Continuation Therapy — Non-radiographic Axial Spondyloarthritis
Covered when ALL of the following are met
Continuation criteria for non-radiographic axial spondyloarthritis
Coverage criteria for IV secukinumab (adult indications)
Covered when ALL of the following are met for FDA-indicated adult uses of the intravenous formulation:
IV formulation may only be administered in adults for these indications
Step therapy expectations described in background and disease sections
All codes listed require prior authorization
Use of secukinumab (Cosentyx) for indications other than the adult rheumatologic conditions listed in this policy (psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis) is considered investigational and is not covered by the Health Plan.
When the specific patient selection criteria in this policy are not met, use of secukinumab (Cosentyx) is considered investigational and may be denied. Exceptions explicitly noted as not medically necessary elsewhere in the policy remain subject to those determinations.
Use of secukinumab is considered not medically necessary when required patient selection criteria for the specific disease are not fulfilled. Examples include failure to meet step-therapy requirements (e.g., for psoriatic arthritis: failure of one or more traditional DMARDs), insufficient duration of prior therapy or inadequate documentation for continuation (e.g., less than 6 months of prior Cosentyx therapy), or lack of documented clinical benefit (for example, no objective improvement on measures such as DAPSA, ASDAS, BASDAI, or no reduction in pain, stiffness, or functional impairment).
Investigational use determinations may trigger denials when patient-selection criteria are unmet or when the requested indication is outside those listed in this policy. Prior authorization is required for all requests; continuation approvals additionally require documentation of prior authorization or prior-plan authorization and evidence of benefit after at least 6 months of therapy. Uses explicitly designated as not medically necessary (see examples above) remain subject to those policies and are not eligible for investigational exceptions.
Coding
| J3247 | Secukinumab injection, intravenous (as listed in policy) |
| All Related Diagnoses | ICD-10 diagnosis codes related to indications |
| No CPT codes listed | Policy notes CPT codes are used generally; no specific CPT codes provided in this section |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for initial and continuation therapy
Initial and continuation use of intravenous Cosentyx (secukinumab) require prior authorization. Continuation requests must include either an initial authorization from this plan or documentation of an active course authorization from a previous health plan and evidence of benefit after at least 6 months of therapy.
- Continuation requires documentation of prior authorization from this plan OR documentation of authorization for an active course of treatment from a previous health plan.
- Continuation requires at least 6 months of therapy and demonstration of clinical benefit per continuation criteria.
Prior authorization required for associated codes (e.g., J3247)
All codes listed on this medical policy require prior authorization; for the intravenous formulation this includes HCPCS J3247 (secukinumab injection, intravenous).
- NOTICE: All codes listed on the Medical Policy require prior authorization.
- Applicable HCPCS code: J3247 for secukinumab intravenous.
Step therapy requirements and exceptions
Step therapy is required before IV Cosentyx in the specified diseases: psoriatic arthritis requires failure of one or more traditional DMARDs (e.g., methotrexate) unless contraindicated; ankylosing spondylitis and non‑radiographic axial spondyloarthritis require failure of appropriate NSAID therapy as specified.
- Psoriatic arthritis: failed treatment with one or more traditional DMARDs unless clinical evidence/history contraindicates their use.
- Ankylosing spondylitis: failed treatment with NSAIDs or documented contraindication to NSAIDs.
- Non‑radiographic axial spondyloarthritis: failed at least two months of continuous therapy with at least two different oral NSAIDs at prescription strength unless contraindicated.
Require conventional therapy (DMARDs/NSAIDs) before biologic
Conventional therapy must be tried before biologic IV Cosentyx for these indications: DMARDs (e.g., methotrexate) for psoriatic arthritis and NSAIDs for ankylosing spondylitis and non‑radiographic axial spondyloarthritis per the policy's prior‑therapy expectations.
- Psoriatic arthritis: traditional DMARDs are typical first‑line treatments prior to biologics.
- Axial spondyloarthritis (including non‑radiographic): oral NSAIDs are standard first‑line therapy; multiple NSAIDs may need to be tried because response varies.
Documentation required for continuation (authorization and clinical benefit)
For continuation authorization, provide documentation of the initial authorization or proof of a prior plan's authorization for an active course of treatment, plus objective or clinical evidence of a beneficial response after at least 6 months of therapy.
- Evidence of benefit may include improvement on objective measures (e.g., DAPSA, CPDAI, PsA DAS, ASDAS, BASDAI), decreased pain/stiffness, improved function/ADLs, decreased morning stiffness or fatigue, or decreased soft tissue swelling.
- Requested maintenance dose must be 1.75 mg/kg every 4 weeks not exceeding 300 mg per infusion.
Provide prior‑plan authorization documentation for transitions
If a member has an existing authorization from another health plan, supply documentation of that prior authorization to receive a 90‑day transition; the services must otherwise be covered under this plan.
- Documentation of the previous plan's authorization must be provided by the member or their provider to qualify for the transition period.
- All codes listed on the Medical Policy still require prior authorization under this plan.
Triggers for denial — unmet selection criteria and insufficient documentation
Denials commonly result when patient selection criteria are not met — for example, failure to document required prior therapies, insufficient duration of therapy for continuation (less than 6 months), or lack of documented clinical benefit on continuation requests.
- Psoriatic arthritis denials: no evidence of prior DMARD failure or <6 months of therapy or no documented clinical benefit.
- Axial spondyloarthritis denials: no evidence of prior NSAID failure or <6 months of therapy or no documented clinical benefit.
Investigational use outside listed indications is denied
Use of secukinumab (Cosentyx) for indications not listed in this policy or when patient selection criteria are not met is considered investigational and will be denied.
- Investigational determinations apply when patient selection criteria are not met or for any indication other than the FDA‑approved adult indications listed (psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis).
Background
Cosentyx (secukinumab) is a human interleukin-17A antagonist available in subcutaneous pens/syringes (75 mg, 150 mg, 300 mg) and an intravenous formulation supplied as a 125 mg vial. The intravenous formulation is intended for administration in adults and, per this policy, may only be used for the specified adult rheumatologic indications. Dosing regimens for the IV formulation include an optional loading dose of 6 mg/kg at Week 0 followed by maintenance dosing of 1.75 mg/kg every 4 weeks (maximum 300 mg per infusion), or maintenance dosing without a loading dose at the same weight-based rate and maximum.
Definitions
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