CurrentMass General Brigham Health PlanPolicy N/A

Targeted Immunomodulators — Cosentyx (secukinumab) IV vial prior authorization

Defines medical-benefit prior authorization, coverage criteria, and limits for IV Cosentyx (secukinumab) vials for Mass General Brigham Health Plan members; applies to medical/specialty benefit requests for listed rheumatologic and related indications.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTargeted Immunomodulators — Cosentyx (secukinumab) IV vial prior authorization

Policy CodePolicy N/A

Change TypeStep therapy updatedsite-of-care placement clarified

Effective DateJan 6, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis and documentation of required prior therapies per indication (including specified biologics and anti‑TNF trials).

SourceLink

POLICY UPDATE CHANGES

Intravenous formulation will be available through the medical benefit only.

Added another step-through with Skyrizi for diagnosis of psoriatic arthritis.

Ankylosing spondylitis; PsA; SAPHO; axial SpAIndications listed

3 or 6 moInitial auth duration

12 moReauth duration

Medical onlyBenefit placement

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Coverage Criteria for IV Cosentyx (secukinumab)

Ankylosing spondylitis or Non-radiographic axial spondyloarthritis (Initial Therapy)

Covered when ALL of the following are met:

Diagnosis of ankylosing spondylitis OR non-radiographic axial spondyloarthritis

NSAID trial: Inadequate response or adverse reaction to TWO or contraindication to ALL NSAIDs (a documented NSAID trial may be bypassed if member has tried biologic therapy)2 NSAIDs

Trial may be bypassed if prior biologic used

Anti-TNF trial: Inadequate response or adverse reaction to ONE or contraindication to ALL anti-TNF agents that are FDA-approved for ankylosing spondylitis1 anti-TNF

Taltz trial: Inadequate response, adverse reaction, or contraindication to Taltz1 biologic

Dosing: Appropriate dosing documented

Psoriatic arthritis (Initial Therapy)

Covered when ALL of the following are met:

Diagnosis of psoriatic arthritis

Prior biologics: Inadequate response, adverse reaction, or contraindication to ALL of the following: Stelara, Skyrizi, Taltzall listed biologics

Skyrizi was recently added to the step-through sequence

Anti-TNF trial: Inadequate response or adverse reaction to ONE or contraindication to ALL anti-TNF agents that are FDA-approved for psoriatic arthritis1 anti-TNF

Dosing: Appropriate dosing documented

SAPHO syndrome (Initial Therapy)

Covered when ALL of the following are met:

Diagnosis of SAPHO syndrome (synovitis-acne-pustulosis-hyperostosis-osteitis)

NSAID trial: Inadequate response or adverse reaction to ONE or contraindication to ALL NSAIDs1 NSAID

Systemic corticosteroid trial: Inadequate response or adverse reaction to ONE or contraindication to ALL systemic corticosteroids1 systemic corticosteroid

Requests for more frequent or higher doses (Initial approval conditions)

May be approved when ALL of the following are documented:

Severity: Severe disease documented

Prior biologic trial: Inadequate response or adverse reaction to ONE or contraindication to ALL other injectable biologics which are FDA-approved for the requested indication1 injectable biologic

Partial response to FDA-approved dosing of current biologic therapy

Specialist involvement: Prescriber is a specialist or consult notes from a specialist are provided

Continuation of Therapy / Reauthorization

Covered when the following are met:

Resubmission implies benefit: For ankylosing spondylitis, non-radiographic axial spondyloarthritis, or psoriatic arthritis: resubmission by prescriber will infer a positive response to therapy

No additional objective response documentation specified for these indications

SAPHO and dose increases: For SAPHO or requests for increased frequency/higher doses, prescriber must provide documentation of a positive response to therapy

Authorization duration: Initial approvals: SAPHO and more frequent/higher dose requests = 3 months; all other indications = 6 months; Reauthorizations = 12 months

The Cosentyx (secukinumab) auto-injection prefilled syringe is covered under the pharmacy benefit. The intravenous (IV) vial formulation is available and prior authorization is handled through the medical/specialty benefit only. Providers should submit medical benefit prior authorization requests for the IV vial formulation per the plan’s medical/specialty medication processes and contact the Medical and Specialty Medications line if needed.

Requests that do not document the required prior-therapy steps or that lack necessary diagnosis or dosing information will be considered not medically necessary. Examples include missing documentation of inadequate response, adverse reaction, or contraindication to required prior agents (for example, NSAID and anti-TNF trials for axial SpA/ankylosing spondylitis or specified prior biologics for psoriatic arthritis). Ensure the prescriber provides the diagnosis, treatment history, and dosing to avoid denial.

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for IV Cosentyx (secukinumab) when billed under the medical/specialty benefit. Ensure prior auth is requested for the IV vial formulation.

Medical benefit (IV formulation) — prior authorization required
Pharmacy benefit — see outpatient/SC policies as applicable

Step Therapy

Step Therapy Requirements

Step therapy requirements must be met before authorization. For each indication, document the required prior agents and the criteria used to demonstrate failure, intolerance, or contraindication.

Ankylosing spondylitis or non-radiographic axial spondyloarthritis: inadequate response or adverse reaction to TWO NSAIDs (trial may be bypassed if prior biologic documented) AND inadequate response or adverse reaction to ONE or contraindication to ALL FDA‑approved anti‑TNF agents for AS
Psoriatic arthritis: inadequate response, adverse reaction, or contraindication to ALL of the following: Stelara (ustekinumab), Skyrizi (risankizumab), Taltz (ixekizumab) as applicable; AND inadequate response or adverse reaction to ONE or contraindication to ALL FDA‑approved anti‑TNF agents for PsA

Billing and Coding References

Codes referencedmixed

NDC/CPT/HCPCS not specified

The document does not list explicit billing or NDC/CPT/HCPCS codes for the IV vial formulation; contact provided for medical/specialty medication claims.

Background and Clinical Context

Secukinumab (Cosentyx) is an interleukin-17A (IL-17A) antagonist. The IV vial formulation is an intravenous infusion option used for certain adult rheumatologic indications and is considered alongside FDA-approved indications such as active psoriatic arthritis and active ankylosing spondylitis (including non-radiographic axial spondyloarthritis). Coverage of the IV formulation is managed under the medical benefit and is contingent on meeting the indication-specific criteria and step-therapy requirements.

Definitions

Cosentyx (secukinumab) — key facts (definition)

Drug classInterleukin-17A (IL-17A) antagonist

Brand and generic nameCosentyx (secukinumab)

IV formulation availabilityAvailable as an intravenous infusion (IV vial) for specified adult rheumatologic indications

FDA-approved indications (IV noted)FDA approved for active psoriatic arthritis in adults and active ankylosing spondylitis in adults, including non-radiographic axial spondyloarthritis

Benefit placementIntravenous formulation administered under the medical benefit only

Documentation Required

Documentation Requirements

Required documentation must be submitted with the prior authorization request. Include diagnosis, prior treatment history (agents, dates, doses, reasons for discontinuation), and documentation of inadequate response, adverse reaction, or contraindication. For continuation requests (ankylosing spondylitis, non‑radiographic axial spondyloarthritis, psoriatic arthritis), prescriber resubmission will infer a positive response. For SAPHO and requests for increased frequency or higher doses, provide objective documentation of positive response, severity of disease, partial response to FDA‑approved dosing of current biologic, and specialist involvement or consult notes.

Diagnosis (specify indication: AS, non‑radiographic axial spondyloarthritis, PsA, SAPHO)
Prior treatment history with dates and outcomes (NSAIDs, anti‑TNF agents, ustekinumab/risankizumab/ixekizumab where applicable, systemic corticosteroids, other biologics)
Reason for discontinuation (inadequate response, adverse reaction, or contraindication)
For dose increase or increased frequency: documentation of severe disease, partial response to FDA‑approved dosing of current biologic, and evidence that ONE other injectable biologic (FDA‑approved for the indication) was ineffective/intolerable/contraindicated
For continuation: documentation or prescriber attestation of continued clinical benefit (required for SAPHO and dose‑change requests)
Specialist documentation: prescriber is a specialist or include specialist consult notes for the requested indication