CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cosentyx 2017 A Sgm P2021

Defines prior authorization coverage criteria, documentation requirements, continuity/renewal criteria, TB screening and contraindications, dosing limits, and exclusions for Cosentyx (secukinumab) for FDA-approved indications (moderate-severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosentyx 2017 A Sgm P2021

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit chart notes/medical records documenting diagnosis, affected BSA (for psoriasis), prior medications tried and responses or clinical reasons to avoid (initial requests), and documentation of positive clinical response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material changes — policy remains unchanged for coverage criteria, documentation, safety prerequisites, and renewals.

4Covered FDA Indications

12Authorization length (months)

>=3%Psoriasis conditional BSA

>=10%Psoriasis direct BSA

Coverage stance: covered_with_criteria. Scope: This policy governs coverage of secukinumab (Cosentyx) for FDA-approved dermatologic and rheumatologic indications — specifically moderate to severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Non-FDA indications are considered experimental/investigational and not medically necessary.

Background: The policy requires prior authorization with submission of documentation including diagnosis, prior therapies and responses (or clinical reasons to avoid prior therapies), and evidence of positive clinical response for continuation. Safety screening prerequisites apply to all indications, notably tuberculosis (TB) screening requirements (documented negative TB test within 6 months prior to initiation for biologic‑naïve individuals and annual testing for those with TB risk factors continuing therapy). Approvals may be subject to dosing limits consistent with FDA labeling and guidelines.

Covered Indications (Overall)

The FDA-approved indications below are covered when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

Indication must be ONE of

Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
Adults with active psoriatic arthritis (PsA)
Adults with active ankylosing spondylitis (AS)
Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Safety Prerequisites and Screening

Crucial body areas: Examples include hands, feet, face, neck, scalp, genitals/groin, intertriginous areas (areas that when affected may justify coverage under psoriasis criteria).

Positive clinical response: Defined as measurable improvement from baseline such as reduction in body surface area (BSA) or improvement in signs and symptoms for psoriasis; for PsA, improvement in swollen/tender joint counts, dactylitis, enthesitis, or skin/nail involvement; for AS/axial SpA, improvement in functional status, total spinal pain, or inflammation (e.g., morning stiffness).

Provider Actions (Authorization & Documentation)

Prior Authorization

Prior authorization required with documentation

Submit chart notes or medical records that document the member’s diagnosis and relevant clinical details for the requested indication. For psoriasis initial requests include documentation of affected body surface area (BSA) and affected areas. Provide records of prior medications tried and responses, or a clinical reason to avoid those therapies for initial requests. For continuation requests supply documentation of positive clinical response (e.g., decreased BSA or improvement in symptoms). Include safety screening documentation such as TB testing per policy prior to initiation.

Diagnosis (specific FDA indication)
Affected BSA and areas (psoriasis)
Prior medications tried and responses or reasons to avoid
TB screening results and other safety testing

Documentation Required

Psoriasis baseline and follow-up documentation

For initial psoriasis requests provide chart notes or medical record documentation of the affected area(s) and percent body surface area (BSA) involved, plus prior therapies tried or clinical reasons to avoid them. For continuation requests provide chart notes or medical record documentation showing decreased BSA affected and/or improvement in signs and symptoms (for example, reduced itching, redness, flaking, scaling, burning, cracking, or pain).

Documentation Required

PsA/AS baseline and follow-up documentation

For PsA and AS/axial spondyloarthritis initial and continuation requests submit chart notes or claims history documenting prior medications tried (if applicable) and responses, or a clinical reason to avoid those therapies. For continuation requests provide documentation of positive clinical response from baseline — for PsA this may include improvement in swollen/tender joint counts, dactylitis, enthesitis, or skin/nail involvement; for AS/axial SpA this may include improved functional status, decreased spinal pain, or reduced inflammation (e.g., morning stiffness).

Documentation Required

TB testing requirement

Obtain and document TB screening prior to initiating therapy: a negative TB test (PPD, IGRA, or chest x‑ray) within 6 months before starting therapy is required for persons naïve to biologic or targeted synthetic DMARDs. If TB screening is positive, provide further testing to exclude active disease; do not start the requested medication if active TB is present. If latent TB is identified, document that TB treatment was started before initiation. For members continuing biologic therapy who have TB risk factors, repeat TB testing yearly.

Negative TB test (PPD, IGRA, or chest x-ray) within 6 months prior to initiation for biologic‑naïve persons
If positive: further testing to exclude active TB or documentation of latent TB treatment before starting therapy
Yearly testing for members with TB risk factors who are continuing biologics

Billing Rule

Dosing limits

Approvals may be subject to dosing limits consistent with FDA‑approved labeling, accepted compendia, and evidence‑based practice guidelines. Dosing and any applicable limits will be applied per the policy’s dosage and administration provisions.

Clinical Evidence & References

Evidence references include the Cosentyx package insert (June 2020) and multiple guideline citations (joint AAD-NPF, EULAR, ACR/ASAS and other society guidance) listed in the references.

Note: These references support the clinical use of secukinumab across the FDA‑approved indications described in this policy.

Background

This policy governs secukinumab (Cosentyx) across FDA‑approved dermatologic and rheumatologic indications and requires prior authorization. Required documentation includes chart notes/medical records of diagnosis, affected BSA for psoriasis, prior medications tried and responses (or clinical reasons to avoid), and evidence of positive clinical response for continuation requests.

Safety screening prerequisites apply to all indications — notably TB screening: a documented negative TB test (PPD, IGRA, or chest x‑ray) within 6 months prior to initiating therapy for biologic‑naïve persons; if screening is positive, further testing must exclude active disease and latent TB must be treated before initiation. For members continuing biologic therapy who have TB risk factors, TB testing must be repeated yearly.

Non‑FDA indications are considered experimental/investigational and not medically necessary under this policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosentyx 2017 A Sgm P2021

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Cosentyx 2017 A Sgm P2021

Coverage Summary

Initial Therapy Criteria

Continuation / Renewal Criteria

Exclusions / Not Covered

Safety Prerequisites and Screening

Provider Actions (Authorization & Documentation)

Applicable Codes

Clinical Evidence & References

Background

Revision History