CurrentCignaPolicy IP0683

Cosentyx Intravenous Prior Authorization Policy

Cigna coverage policy establishing prior authorization criteria, dosing, authorized durations, and exclusions for secukinumab intravenous (Cosentyx IV) for ankylosing spondylitis, non-radiographic axial spondyloarthritis, and psoriatic arthritis; includes dosing, prescribing specialist requirement, continuation criteria, not-covered uses, and J-code billing guidance.

Policy Summary

PayerCigna

PolicyCosentyx Intravenous Prior Authorization Policy

Policy CodePolicy IP0683

Change TypeNew; Clarification; Revision

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Cosentyx IV is prescribed by or in consultation with a specialist; document ≥6 months prior therapy and at least one objective measure of response for continuation.

POLICY UPDATE CHANGES

New policy created.

Updated Preferred Specialty Management Policy note.

Updated dosing for each indication and CPT coding changes.

3Covered FDA Indications

5+Not covered indications (examples)

J3247Primary HCPCS code

Coverage Summary

Policy IP0683 (status: CURRENT, effective 2025-02-01) is Cigna's prior authorization coverage policy for Cosentyx intravenous (secukinumab IV) that establishes prior authorization criteria for FDA-approved indications (ankylosing spondylitis, non-radiographic axial spondyloarthritis with objective signs of inflammation, and psoriatic arthritis), approved dosing regimens including an optional 6 mg/kg IV loading dose and maintenance 1.75 mg/kg IV every 4 weeks (maximum 300 mg per dose), authorized approval durations (initial approvals generally 6 months with continuation approvals up to 1 year for established therapy), continuation criteria tied to objective response measures, exclusions for experimental/unproven uses, and billing guidance to use HCPCS J3247 for secukinumab IV.

Initial Therapy Criteria

Ankylosing Spondylitis (FDA-Approved Indication)

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- The medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving Cosentyx Intravenous or Subcutaneous
- Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months≥ 6 months
- At least ONE of
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Cosentyx intravenous or subcutaneous)
    Examples of objective measures include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers (e.g., C-reactive protein, erythrocyte sedimentation rate).
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living)

Non-Radiographic Axial Spondyloarthritis (FDA-Approved Indication)

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- At least ONE of
  - C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory
  - Sacroiliitis reported on magnetic resonance imaging
- The medication is prescribed by or in consultation with a rheumatologist

Psoriatic Arthritis (FDA-Approved Indication)

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- The medication is prescribed by or in consultation with a rheumatologist or a dermatologist
B) Patient is Currently Receiving Cosentyx Intravenous or Subcutaneous
- Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months≥ 6 months
- At least ONE of

Continuation Therapy Criteria

Continuation Therapy (Established Patients)

Continuation criteria consolidated from the indications for patients currently receiving Cosentyx IV or SC:

Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months≥ 6 months
At least ONE of: when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples listed) OR patient-reported improvement in at least one symptom compared with baseline
Objective measures examples: ASDAS, BASDAI, BASFI, ASQoL, BAS-G, BASMI, DFI, HAQ-S, DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and/or serum markers such as CRP or ESR.

Approval durations and continuation criteria are aligned with objective response measures: initial therapy approvals are typically granted for 6 months where indicated and continuation approvals for established responders are granted for up to 1 year when the patient has been on therapy ≥ 6 months and demonstrates benefit by at least one objective measure or symptom improvement; extended approvals are allowed if the patient continues to meet the Criteria and Dosing. When approval is authorized in months, 1 month = 30 days.

Dosing (Approved regimens)

Approve the following dosing regimens (A or B):

A single 6 mg/kg intravenous loading dose followed by 1.75 mg/kg (up to a maximum of 300 mg per dose) given once every 4 weeks thereafter
B: 1.75 mg/kg (up to a maximum of 300 mg per dose) given intravenously once every 4 weeks

Billing Rule

Dosing documentation and quantity

Bill using J3247 (1 mg per unit); approved dosing regimens are a single 6 mg/kg intravenous loading dose followed by 1.75 mg/kg IV every 4 weeks (maximum 300 mg per dose) or 1.75 mg/kg IV every 4 weeks (maximum 300 mg per dose).

J3247 - 1 mg per unit
Single 6 mg/kg IV loading dose then 1.75 mg/kg IV q4w (max 300 mg per dose)
1.75 mg/kg IV q4w (max 300 mg per dose)

Provider Actions & Documentation

Prior Authorization

Prior authorization required

Prior Authorization is recommended for Cosentyx IV and initial approval requires the medication to be prescribed by or in consultation with a specialist (rheumatologist; dermatologist for psoriatic arthritis).

Affected code: J3247

Documentation Required

Documentation of response for continuation

For patients currently receiving Cosentyx IV or SC, document at least 6 months of prior therapy and at least one objective measure showing beneficial clinical response or patient-reported improvement compared with baseline.

Examples of objective measures: ASDAS, BASDAI, DAPSA, CRP/ESR

Step Therapy

Preferred product requirement under prescription benefit

When covered under the Prescription Drug Benefit, preferred product step requirements may apply per the referenced Preferred Specialty Management Policy (PSM009 or PSM016).

Operational notes: Prior Authorization is recommended for Cosentyx IV and initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist; dermatologist for PsA). Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist). When approval is authorized in months, 1 month = 30 days. Receipt of sample product does not satisfy any criteria requirements for coverage. If covered under the Prescription Drug Benefit, preferred product step requirements may apply per referenced Preferred Specialty Management Policies (PSM009 or PSM016).

Definitions

Objective signs of inflammation: Defined as elevated C-reactive protein beyond the upper limit of normal for the reporting laboratory and/or sacroiliitis reported on magnetic resonance imaging (MRI).

Background: Cosentyx IV (secukinumab) is an IL-17A antagonist indicated for adult ankylosing spondylitis, non-radiographic axial spondyloarthritis (with objective signs of inflammation), and psoriatic arthritis. The intravenous dosing options include an optional single 6 mg/kg loading dose and a maintenance regimen of 1.75 mg/kg IV every 4 weeks (maximum 300 mg per dose). The policy aligns approval duration and continuation criteria with objective response measures to document clinical benefit.

Policy Summary

PayerCigna

PolicyCosentyx Intravenous Prior Authorization Policy

Policy CodePolicy IP0683

Change TypeNew; Clarification; Revision

Effective DateFeb 1, 2025

Next Review Date

On This Page

Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months≥ 6 months
At least ONE of
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Cosentyx intravenous or subcutaneous)
  Examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers such as CRP or ESR.
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living)

C9399	Noted as removed from coding list
J3490	Noted as removed from coding list
J3590	Noted as removed from coding list

OpenPayer

Cosentyx Intravenous Prior Authorization Policy

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Dosing (Approved regimens)

Provider Actions & Documentation

Unproven / Exclusions

Applicable Codes

Clinical Evidence

Definitions

Revision History