Currentculinary health fundPolicy N/A

Inflammatory Conditions - Cosentyx Intravenous UM Medical De-Identified

Defines prior authorization and medical necessity criteria, dosing, duration, and excluded indications for Cosentyx intravenous (secukinumab IV) for adult inflammatory conditions (ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriatic arthritis). Includes administration/dosing guidance, required prescriber specialty, and conditions not recommended for approval.

Policy Summary

Payerculinary health fund

PolicyInflammatory Conditions - Cosentyx Intravenous UM Medical De-Identified

Policy CodePolicy N/A

Change TypeRevisions; administrative review

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; initial approval requires prescription by or in consultation with a specialist (e.g., rheumatologist or dermatologist).

SourceLink

POLICY UPDATE CHANGES

Early Annual Revision added Hidradenitis suppurativa to Conditions Not Recommended for Approval and added Otezla XR to Appendix under Targeted Synthetic Oral Small Molecule drugs.

Selected Revision changed wording for Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug (replaced previous phrasing of oral small molecule drug as DMARD).

Annual Revision indicated 'No criteria changes.'

3Covered indications (FDA-approved, IV formulation addressed)

6Conditions Not Recommended for Approval (listed)

300 mgMax maintenance dose per infusion

18+Minimum age for approval (years)

Coverage Summary

Coverage stance: covered_with_criteria for Cosentyx intravenous (secukinumab IV) for adult ankylosing spondylitis, non-radiographic axial spondyloarthritis, and psoriatic arthritis. The policy defines prior authorization and medical necessity criteria, dosing, duration, prescriber specialty requirements, and conditions not recommended for approval, consistent with the scope summary.

Stats: 3 covered indications (FDA-approved, IV formulation addressed); 6 listed conditions not recommended for approval; operational dosing ceiling 300 mg maximum maintenance per infusion; minimum age requirement 18+.

Quick Facts & Thresholds

Maximum per infusion (maintenance)300 mg

Maximum per infusion (note)Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose.

Age requirement≥ 18 years

Covered indications (FDA-approved, IV formulation addressed)3

Conditions not recommended for approval (listed)6

Ankylosing Spondylitis — Approval Criteria

Ankylosing Spondylitis 6 Approval Criteria

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
- Medication is prescribed by or in consultation with a rheumatologist
B) Currently Receiving Cosentyx IV or SC
- Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months
- Response requirement

Non-Radiographic Axial Spondyloarthritis — Approval Criteria

Non-Radiographic Axial Spondyloarthritis 6 Approval Criteria

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
- Objective signs of inflammation (at least ONE)
  - C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory
  - Sacroiliitis reported on magnetic resonance imaging

Psoriatic Arthritis — Approval Criteria

Psoriatic Arthritis 6 Approval Criteria

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
- Medication is prescribed by or in consultation with a rheumatologist or a dermatologist
B) Currently Receiving Cosentyx IV or SC
- Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months
- Response requirement

Dosing Options & Administration Rules

Dosing Options

Approve ONE of the following dosing regimens:

ANY of the following

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
1.75 mg/kg (up to a maximum of 300 mg per dose) given intravenously once every 4 weeks

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Operational & Authorization Rules

General Authorization Rules

Operational coverage rules and prescriber requirement:

ALL of the following

Prior Authorization is recommended for medical benefit coverage
Initial approval requires Cosentyx intravenous to be prescribed by or in consultation with a physician who specializes in the condition being treated
Typically a rheumatologist or dermatologist as specified per indication
Extended approvals allowed if patient continues to meet Criteria and Dosing
Requests for doses outside of established dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist)

Exclusions — Conditions Not Recommended for Approval

Exclusions 6 Conditions Not Recommended for Approval

Coverage of Cosentyx intravenous is not recommended in the following situations:

ALL of the following

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition
Does not exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Appendix lists examples of biologics and targeted synthetic agents.
Crohn's disease (exacerbations occurred in trials; IV secukinumab did not reduce CDAI by ≥ 50 points vs placebo in Phase II and study terminated early)
Enthesitis-related arthritis
Cosentyx subcutaneous is indicated for this; IV coverage not recommended here

Applicable Codes

NDC / J-code / HCPCS / CPTmixed

No codes listed

Background & Clinical Evidence Notes

Background: Cosentyx intravenous is an interleukin (IL)-17A antagonist indicated for adult psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. IV formulation dosing summary: dosing options include an optional single 6 mg/kg IV loading dose followed by 1.75 mg/kg IV once every 4 weeks or 1.75 mg/kg IV Q4W without a loading dose, with total doses exceeding 300 mg per infusion not recommended for the 1.75 mg/kg maintenance regimen. The IV formulation is not addressed in most guidelines; guidelines reference IL-17 blockers and the subcutaneous formulation. In the pivotal nr-axSpA trial, patients were required to have objective signs of inflammation defined as elevated C-reactive protein and/or sacroiliitis on MRI.

Evidence: Prescribing information: Cosentyx [prescribing information], Novartis; August 2025. Crohn's disease trial finding: a Phase II IV secukinumab study did not reduce the Crohn's Disease Activity Index (CDAI) by ≥ 50 points versus placebo and was terminated early due to lack of efficacy and occurrences of exacerbations.

Definitions

Objective signs of inflammationDefined as at least ONE of: C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory; sacroiliitis reported on magnetic resonance imaging.

Established on therapyPatient has been receiving Cosentyx IV or SC for at least 6 months.

Revision History

09/11/2024Selected Revision

Selected Revision changed wording for Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug (replaced previous phrasing of oral small molecule drug as DMARD). (material)

11/13/2024Early Annual Revision

Early Annual Revision added Hidradenitis suppurativa to Conditions Not Recommended for Approval and added Otezla XR to Appendix under Targeted Synthetic Oral Small Molecule drugs. (material)

11/13/2024Annual Revision (administrative)

Annual Revision indicated 'No criteria changes.' (non-material)

Policy Summary

Payerculinary health fund

PolicyInflammatory Conditions - Cosentyx Intravenous UM Medical De-Identified

Policy CodePolicy N/A

Change TypeRevisions; administrative review

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; initial approval requires prescription by or in consultation with a specialist (e.g., rheumatologist or dermatologist).

SourceLink

On This Page

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, serum markers e.g., CRP, ESR)
Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living)

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title": "Ankylosing Spondylitis 6 Approval Criteria"}

Medication is prescribed by or in consultation with a rheumatologist

B) Currently Receiving Cosentyx IV or SC

Patient has been established on Cosentyx intravenous or subcutaneous for at least 6 months
Response requirement
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, serum markers e.g., CRP, ESR)
- Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living)

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title": "Non-Radiographic Axial Spondyloarthritis 6 Approval Criteria"}

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and/or serum markers e.g., CRP, ESR)
Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function or activities of daily living; decreased soft tissue swelling)

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title": "Psoriatic Arthritis 6 Approval Criteria"}

title": "Dosing Options"}

Operational dosing ceiling and administration notes: the maintenance regimen is 1.75 mg/kg IV once every 4 weeks with a recommended maximum of 300 mg per infusion for the 1.75 mg/kg maintenance dose; a single 6 mg/kg IV loading dose may be given prior to maintenance. Prior authorization is recommended for medical benefit coverage and initial approval requires prescription by or in consultation with a specialist in the condition being treated. Requests for doses outside of the established dosing documented in this policy will be considered case-by-case by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted and 1 month = 30 days when applicable.

All approvals are provided for the duration noted; when authorized in months, 1 month = 30 days

Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose

Operational dosing ceiling

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title": "General Authorization Rules"}

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage; initial approval requires prescription by or in consultation with a specialist in the treated condition (e.g., rheumatologist or dermatologist).

Specialists: rheumatologist, dermatologist

Billing Rule

Dosing ceiling

Ensure maintenance doses do not exceed 300 mg per infusion for the 1.75 mg/kg regimen; requests for dosing outside documented regimens require case-by-case clinical review.

300 mg maximum per infusion for 1.75 mg/kg regimen
Requests for doses outside established regimens will be reviewed case-by-case by a clinician

Documentation Required

Document objective measures and response

For continuation approvals, document that the patient has been established on Cosentyx IV or SC for at least 6 months and demonstrate benefit by at least one objective measure or improvement in clinical symptoms compared with baseline.

Examples of objective measures: ASDAS, BASDAI, DAPSA, CPDAI, PsA DAS, and/or serum markers (CRP, ESR)

Hidradenitis suppurativa

Cosentyx subcutaneous is indicated for this; IV coverage not recommended here

Plaque psoriasis

Cosentyx subcutaneous is indicated for this; IV coverage not recommended here

Rheumatoid arthritis (evidence shows less effectiveness vs current treatments in certain trials)

Circumstances not listed in the Recommended Authorization Criteria

Criteria will be updated as new published data are available

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title": "Exclusions 6 Conditions Not Recommended for Approval"}

Denial Risk

Excluded combinations and indications

Do not bill for Cosentyx IV in combination with another biologic or a targeted synthetic oral small molecule for inflammatory conditions; coverage is not recommended for listed excluded diagnoses.

Excluded diagnoses: Crohn's disease; Rheumatoid arthritis; Plaque psoriasis; Hidradenitis suppurativa; Enthesitis-related arthritis
Do not administer in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition

10/29/2025ReviewLatest

Policy review date updated to 10/29/2025 per history (most recent review).