ModifiedmhnPolicy CP.PHAR.261

Secukinumab (Cosentyx) clinical coverage policy

Defines medical necessity criteria, dosing limits, prescriber requirements, prior authorization expectations, and continuation criteria for secukinumab (Cosentyx) for Medicaid members across FDA indications including psoriasis, psoriatic arthritis, axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa.

Policy Summary

Payermhn

PolicySecukinumab (Cosentyx) clinical coverage policy

Policy CodePolicy CP.PHAR.261

Change TypeCoding, pediatric indication, and authorization edits

Effective Date08.16

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing required prior therapy failures and indication-specific criteria (e.g., Hurley stage for HS).

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J3247 and removed code C9166 (06.03.24).

Added newly approved HS pediatric extension for ages > 12 years and clarified HS trial duration and bypass conditions.

2Q 2025 annual review added disclaimer that prior authorization may be required for Actemra for ERA and removed a continued therapy approval-duration clause.

2Q 2026 annual review: no significant changes; references reviewed and updated (03.30.26).

12 monthstypical approval duration

≥2 yrsmin age (PsA pediatric)

Fail ≥2 NSAIDsaxial spondyloarthritis requirement

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Hurley II/IIIHS requirement

J3247current HCPCS code

>12 yrsHS pediatric added

Coverage Criteria

Initial therapy - Axial Spondyloarthritis

Axial Spondyloarthritis (must meet all):

Axial Spondyloarthritis criteria: 1. Diagnosis of AS or non-radiographic axial spondyloarthritis (nr-axSpA).

2. Prescribed by or in consultation with a rheumatologist.

3. Age ≥ 18 years.

4. Failure of at least TWO non-steroidal anti-inflammatory drugs (NSAIDs) at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects occur or all are contraindicated, or prior biologic failure for AS or nr-axSpA.

5. For ankylosing spondylitis (AS) the member meets ALL of the following (each used ≥ 3 consecutive months unless adverse effects or contraindicated): a) failure of one adalimumab product (unless history of failure of two TNF blockers); b) failure of Taltz®; c) if not responsive or intolerant to one or more TNF blockers, failure of Xeljanz®/Xeljanz XR® unless cardiovascular risk outweighs benefit.

6. For nr-axSpA: failure of Taltz® used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects are experienced.

7. Member does not have combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi).

8. Dose does not exceed one of the following: a) SC: 150 mg at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks; OR b) IV: 6 mg/kg at week 0 followed by 1.75 mg/kg every 4 weeks. Approval duration: 12 months.

Initial therapy - Enthesitis-related Arthritis

Enthesitis-related Arthritis (must meet all):

ERA criteria: 1. Diagnosis of enthesitis-related arthritis (ERA).

2. Prescribed by or in consultation with a rheumatologist.

3. Age ≥ 4 years and < 18 years.

4. Failure of at least TWO NSAIDs at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects are experienced or all are contraindicated.

5. Member meets one of the following: a) failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses; OR b) intolerance/contraindication to MTX and failure of a ≥ 3 consecutive month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide) at up to maximally indicated doses.

Initial therapy - Plaque Psoriasis

Plaque Psoriasis (must meet all):

Plaque Psoriasis criteria: 1. Diagnosis of moderate-to-severe plaque psoriasis (PsO) evidenced by either ≥ 3% total body surface area (BSA) or involvement of hands, feet, scalp, face, or genital area.

2. Prescribed by or in consultation with a dermatologist or rheumatologist.

3. Age ≥ 6 years.

4. Member meets one of the following unless previously failed a biologic for PsO: a) failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; b) intolerance/contraindication to MTX and failure of a ≥ 3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses; c) intolerance/contraindication to MTX, cyclosporine, and acitretin and failure of phototherapy.

5. For adults (≥18 years) member meets ONE of: a) failure of a ≥ 3 consecutive month trial of one adalimumab product; OR b) history of failure of two TNF blockers.

Initial therapy - Psoriatic Arthritis

Psoriatic Arthritis (must meet all):

Psoriatic Arthritis criteria: 1. Diagnosis of psoriatic arthritis (PsA).

2. Prescribed by or in consultation with a dermatologist or rheumatologist.

3. Age ≥ 2 years.

4. For members ≥ 18 years: failure of ALL of the following, each used for ≥ 3 consecutive months unless adverse effects or contraindicated: a) one adalimumab product; b) Otezla®/Otezla XR®; c) Taltz®; d) one ustekinumab product; e) if not responsive/intolerant to one or more TNF blockers, failure of Xeljanz®/Xeljanz XR® unless cardiovascular risk outweighs benefit.

5. For members 6 to 17 years: failure of a ≥ 3 consecutive month trial of both Otezla/Otezla XR and one ustekinumab product unless adverse effects or contraindicated.

Initial therapy - Hidradenitis Suppurativa

Hidradenitis Suppurativa (must meet all):

Hidradenitis Suppurativa criteria: 1. Diagnosis of hidradenitis suppurativa (HS).

2. Prescribed by or in consultation with a dermatologist, rheumatologist, or gastroenterologist.

3. Age ≥ 12 years.

4. Documentation of Hurley stage II or III.

5. Failure of one adalimumab product used for ≥ 3 consecutive months unless history of failure of two TNF blockers, contraindicated, or clinically significant adverse effects are experienced.

6. Failure of at least TWO therapies from different classes (each tried ≥ 3 consecutive months) such as systemic antibiotics, oral retinoids, or hormonal treatments unless contraindicated or adverse effects are experienced.

Continued therapy

Continued Therapy (all indications):

Continued therapy criteria: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria OR continuity of care provisions apply.

2. Member meets one of: a) For HS: at least a 25% reduction in inflammatory nodules and abscesses; b) For all other indications: member is responding positively to therapy.

3. Member does not have combination use with bDMARDs or JAKi.

4. If request is for a dose increase, the new dose must not exceed the listed maximums per indication; specific provisions allow higher dosing for inadequate response in some indications (e.g., PsA or AS up to 300 mg; HS escalation to every 2 weeks if supported by documentation).

Dosing-based coverage criteria

Covered dosing and indications as described in dosing section

Psoriasis (adult): Adults: 300 mg SC at weeks 0,1,2,3,4 then 300 mg every 4 weeks; some patients may use 150 mg.max 300 mg q4w

For PsO with or without PsA; pediatric dosing separate

Psoriatic arthritis: SC regimens described; consider increasing to 300 mg if active disease persists; IV dosing options provided (6 mg/kg IV at week 0 then 1.75 mg/kg every 4 weeks or 1.75 mg/kg without loading).max 300 mg q4w

Both SC and IV regimens described

Ankylosing spondylitis / nr-axSpA: Standard SC maintenance 150 mg every 4 weeks (with loading weeks 0–4) with option to consider 300 mg for AS if inadequate response; IV regimens also available (6 mg/kg then 1.75 mg/kg q4w).max 300 mg q4w

Historical criteria modifications and policy-level coverage intent

Policy history documents applied criteria changes and redirections across indications (AS, PsA, PsO, HS, ERA, nr-axSpA) and step-therapy/bypass rules.

Pediatric HS extension: Added newly approved hidradenitis suppurativa (HS) pediatric extension for ages > 12 years and specified HS trial requirement of use for ≥ 3 consecutive months for the required adalimumab product with bypass if contraindicated or clinically significant adverse effects are experienced.age > 12 years; HS trial >= 3 months

RT4 update

Coding updates: Added HCPCS J3247 and removed prior HCPCS codes including C9166, C9399, and J3590; providers should bill using current HCPCS codes and follow updated coding guidance.

coding implications entries

Step therapy modifications: Multiple edits over time revised step-therapy and redirection rules: added requirement for one adalimumab product in several indications, removed some redirections (e.g., to Cimzia), applied pediatric redirection to Otezla for PsA, and clarified bypass of conventional therapies if a member has failed a biologic agent. Initial approval durations were extended to 12 months for chronic conditions.

Requests for concomitant administration of secukinumab with other biologic disease-modifying antirheumatic drugs (bDMARDs), Janus kinase inhibitors (JAKi), or other potent immunosuppressants are not authorized. This exclusion includes, but is not limited to, tumor necrosis factor (TNF) antagonists, interleukin-targeted agents, anti-CD20 therapies, selective co‑stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 inhibitors, and sphingosine 1‑phosphate receptor modulators due to the risk of additive immunosuppression and serious infections. Providers should not submit requests for combination use of secukinumab with these agents as such requests may be denied.

Uses of secukinumab that are not FDA‑approved and are not listed in this policy are not authorized unless supported per the applicable off‑label use policy. For Medicaid lines of business, refer to CP.PMN.53 for the process and evidentiary requirements to support off‑label prescribing. If a recent label change is not yet reflected in this policy, follow the directions in this policy to determine whether CP.PMN.255 or CP.PMN.16 applies before pursuing coverage for unlisted indications.

Secukinumab is contraindicated in individuals with a history of serious hypersensitivity to secukinumab or any of its excipients. Requests for therapy in the presence of such a hypersensitivity should be declined.

Codes listed in this policy are provided for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage. Providers must consult current professional coding guidance and the member's benefit documents when preparing claims.

This clinical policy provides guidance on medical necessity criteria for secukinumab but does not guarantee coverage or payment. Coverage determinations remain subject to the terms, conditions, exclusions, and limitations of the member's benefit documents and applicable state Medicaid provisions. The Health Plan may change, amend, or withdraw this policy and providers should confirm coverage with the member's specific plan prior to treatment.

Coding

HCPCS referenced codesHCPCSCovered

J3247

Injection, secukinumab, intravenous, 1 mg

Previously referenced/removed HCPCS codesHCPCS

C9166	Removed from policy (previous HCPCS code)
C9399	Removed from policy
J3590	Removed from policy

HS pediatric age

Pediatric age extension for HSPolicy added a hidradenitis suppurativa pediatric indication for ages > 12 years.

Minimum age in HS criteriaHS initial therapy criteria specify age ≥ 12 years for eligibility.

Required trial duration for required adalimumab productHS adalimumab trial must be used for ≥ 3 consecutive months unless contraindicated or clinically significant adverse effects occur.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required for Secukinumab (HCPCS J3247)

Prior authorization is expected for secukinumab when billed using HCPCS code J3247. Providers should obtain PA approval before administration to avoid claim denials or delays.

HCPCS: J3247 (secukinumab IV) may require prior authorization

Billing Rule

Coding Inclusion Is Not a Guarantee of Coverage

Inclusion of a drug or code in this policy is for informational purposes only and does not guarantee coverage. Providers are responsible for verifying coverage and following current coding guidance prior to claim submission.

Reference most up-to-date professional coding guidance before submitting claims

Background

Secukinumab (Cosentyx) is an interleukin‑17A (IL‑17A) antagonist indicated for multiple immune‑mediated conditions addressed in this policy, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis/axial spondyloarthritis, enthesitis‑related arthritis, and hidradenitis suppurativa. The policy frames use around specialty prescriber requirements, prior treatment failures, age‑ and weight‑based dosing regimens, and explicit exclusions such as combination therapy and hypersensitivity.

Definitions

AS definition

AbbreviationAS = ankylosing spondylitis

ContextListed in the policy abbreviation/acronym key used throughout clinical criteria and coverage sections.

Related indicationsReferenced in axial spondyloarthritis initial therapy criteria (AS and nr-axSpA).

ERA definition

AbbreviationERA = enthesitis-related arthritis

Classification referenceERA is discussed with reference to ILAR classification for juvenile idiopathic arthritis in Appendix D.

Age context

Policy Summary

Payermhn

PolicySecukinumab (Cosentyx) clinical coverage policy

Policy CodePolicy CP.PHAR.261

Change TypeCoding, pediatric indication, and authorization edits

Effective Date08.16

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing required prior therapy failures and indication-specific criteria (e.g., Hurley stage for HS).

SourceLink

On This Page

6. If disease is polyarticular (≥ 5 joints ever involved), failure of Actemra® used for ≥ 3 consecutive months unless adverse effects or contraindicated.

7. Member does not have combination use with bDMARDs or JAKi.

8. Dose does not exceed one of the following: a) Weight > 15 kg and < 50 kg: 75 mg at weeks 0,1,2,3,4 then 75 mg every 4 weeks; b) Weight ≥ 50 kg: 150 mg at weeks 0,1,2,3,4 then 150 mg every 4 weeks. Approval duration: 12 months.

6. Failure of a ≥ 3 consecutive month trial of Taltz® unless contraindicated or adverse effects occur.

7. Failure of a ≥ 3 consecutive month trial of one ustekinumab product unless contraindicated or adverse effects occur.

8. Member does not have combination use with bDMARDs or JAKi.

9. Dose limits: a) Age ≥ 18 years: 300 mg at weeks 0,1,2,3,4 then 300 mg every 4 weeks; b) Age 6–17 years & weight < 50 kg: 75 mg at weeks 0–4 then 75 mg every 4 weeks; c) Age 6–17 years & weight ≥ 50 kg: 150 mg at weeks 0–4 then 150 mg every 4 weeks.

6. Member does not have combination use with bDMARDs or JAKi.

7. Dose limits: a) PsA alone – Adults: SC 150 mg at weeks 0–4 then 150 mg every 4 weeks OR IV 6 mg/kg at week 0 then 1.75 mg/kg every 4 weeks; Pediatric weight-based SC dosing for age and weight as specified; b) PsA with concomitant PsO and ≥ 18 years: 300 mg at weeks 0–4 then 300 mg every 4 weeks.

7. Member does not have combination use with bDMARDs or JAKi.

8. Dose does not exceed: a) Adults: 300 mg at weeks 0,1,2,3,4 then 300 mg every 4 weeks; b) Pediatric: weight ≥ 30 kg and < 90 kg: 150 mg at weeks 0–4 then 150 mg every 4 weeks; weight ≥ 90 kg: 300 mg at weeks 0–4 then 300 mg every 4 weeks. Approval duration: 12 months.

nr-axSpA SC maintenance 150 mg q4w after loading

Enthesitis-related arthritis (ERA): Pediatric weight-based dosing: >15 kg & <50 kg: 75 mg loading weekly x5 then 75 mg q4w; ≥50 kg: 150 mg loading weekly x5 then 150 mg q4w.max 75 mg q4w if <50 kg; 150 mg q4w if ≥50 kg

Children age ranges provided

Hidradenitis suppurativa: Adults: 300 mg SC weekly for 5 weeks then 300 mg every 4 weeks; consider increasing to 300 mg every 2 weeks if inadequate response. Pediatric weight-based dosing for ≥12 years described (≥30 kg: 150 mg; ≥90 kg: 300 mg).adult max 300 mg q2w (if escalated)

Hurley staging referenced elsewhere for severity assessment

policy history entries 2023-2025

Documentation Required

Clinical Documentation Required

Provider must submit supporting clinical documentation with prior authorization requests. Acceptable documentation includes office chart notes, lab results, imaging, and other records demonstrating diagnosis, prior therapies tried, treatment duration, and response or intolerance.

Diagnosis and prescribing clinician specialty (e.g., rheumatologist, dermatologist, gastroenterologist)
Evidence of prior therapy trials and durations (e.g., NSAIDs, MTX/DMARDs, biologics) and reasons for failure/intolerance
Relevant labs or outcome measures (e.g., ESR/CRP, Hurley stage for HS, BSA for psoriasis)
Medication dosing and dates of administration

Prior Authorization

Cross-Agent Prior Authorization Note

Prior authorization may also be required for comparator or alternative agents referenced throughout the criteria. Check Appendix B for therapeutic alternatives and note that listed alternatives may themselves require PA.

Examples: adalimumab products, Taltz, Xeljanz/Xeljanz XR, Actemra, Otezla, ustekinumab products — PA may be required as noted in criteria
See Appendix B for full list of therapeutic alternatives and dosing

Step Therapy

Implied Step Therapy Expectations and Definition of Failure

Step-therapy sequencing is implied throughout the criteria: prescribers must document trials of specified conventional therapies (e.g., NSAIDs for axial disease; methotrexate or another DMARD where specified) and biologic or targeted agents as required prior to approval. Failure is defined by inadequate response after the stated trial duration or intolerance/contraindication.

Documented trials and duration (e.g., NSAIDs ≥ 4 weeks each; MTX or DMARDs ≥ 3 months unless contraindicated)
Failure defined as inadequate clinical response, intolerable adverse effects, or contraindication

Note

Step Therapy and Redirection History — Provider Awareness

Policy history includes multiple changes that instituted or updated step-therapy and redirection rules (e.g., additions of adalimumab product requirements, removal or modification of redirection to specific agents, and added bypasses when members previously failed biologics). Review the revision history for specifics that may affect prior authorization decisions.

Examples: added requirement for one adalimumab product for AS/PsO/PsA/HS; removed redirection to Cimzia for nr-axSpA; applied pediatric redirection for PsA to Otezla
Providers should confirm applicable step/redirection rules based on effective policy version and member-specific history

ERA initial therapy criteria apply to pediatric age groups (refer to coverage criteria for specific age ranges).

HS definition

AbbreviationHS = Hidradenitis suppurativa

Alternative namesPolicy notes HS may be referred to as acne inversa, apocrine acne, Verneuil's disease, among others.

Severity assessmentHurley staging is used to define disease severity for HS criteria (see Hurley stage II/III entry).

IL-17A definition

AbbreviationIL-17A = interleukin-17A

Mechanism contextSecukinumab is an IL-17A antagonist referenced in the policy background and indications.

Clinical relevanceIL-17A is the therapeutic target for secukinumab in multiple immune-mediated conditions included in the policy.

Hurley stage II/III

Hurley stage IIModerate HS: recurrent abscesses with sinus tracts and scarring; single or multiple widely separated lesions.

Hurley stage IIISevere HS: diffuse or near-diffuse involvement with multiple interconnected tracts and abscesses across an entire area.

Use in criteriaPolicy requires documentation of Hurley stage II or III to meet HS initial therapy severity requirement.

ERA / ILAR

ILAR referenceILAR classification divides juvenile idiopathic arthritis into 7 mutually exclusive categories based on joint count, extraarticular features, RF and HLA-B27 status.

Contemporary guideline focus2019 ACR guidance recommends focusing treatment on broad clinical phenotypes rather than strict ILAR categories.

Implication for ERAPolicy notes that while ILAR categories are useful for research, treatment decisions may be guided by broader clinical phenotype considerations.

Health Plan definition

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates.

Policy roleThe clinical policy provides guidance on medical necessity to assist in coverage decisions but does not guarantee payment or results.

Scope noteCoverage decisions remain subject to members' coverage documents, state/federal requirements, and Health Plan administrative policies and procedures.