CurrentUnitedHealthcarePolicy CS2026D00132F

Cosentyx (secukinumab) — IV injection medical benefit

Defines UnitedHealthcare Community Plan medical benefit coverage and medical necessity criteria for Cosentyx (secukinumab) administered intravenously for adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis; excludes the subcutaneous formulation (pharmacy benefit).

Policy Summary

PayerUnitedHealthcare

PolicyCosentyx (secukinumab) — IV injection medical benefit

Policy CodePolicy CS2026D00132F

Change TypeTemplate updatestate-specific language removed

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization for IV Cosentyx (J3247) with medical records documenting justification for IV route and prior therapy history.

SourceLink

POLICY UPDATE CHANGES

Template updated and content/language pertaining to the state of Louisiana removed.

3Indicated conditions

J3247Relevant HCPCS

12 moAuth period

Some statesState-specific guidance

Coverage Criteria for IV Cosentyx (secukinumab)

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Psoriatic Arthritis — Initial and Continuation

Covered when ALL of the following are met for PsA

PsA Initial: Diagnosis of active psoriatic arthritis

Prior therapy for PsA: History of failure to a 3-month trial of methotrexate at the maximally indicated dose unless contraindicated or clinically significant adverse effects are experienced; OR patient previously treated with a targeted immunomodulator FDA‑approved for psoriatic arthritis (document drug, date, and duration).

Examples of prior targeted immunomodulators are provided in policy (e.g., certolizumab, adalimumab, golimumab, ustekinumab, guselkumab, tofacitinib, apremilast, risankizumab, upadacitinib, etanercept, bimekizumab).

Dosing and combination: Cosentyx is initiated and titrated according to U.S. FDA labeled dosing for PsA AND patient is not receiving Cosentyx in combination with another targeted immunomodulator.

Prescriber and duration: Prescribed by, or in consultation with, a rheumatologist or dermatologist; initial authorization will be issued for 12 months.

For continuation: documentation of positive clinical response, continued FDA‑labeled dosing, no concomitant targeted immunomodulator; authorization for 12 months.

Ankylosing Spondylitis / Non-radiographic Axial Spondyloarthritis — Initial and Continuation

Covered when ALL of the following are met for AS or nr-axSpA

AS/nr-axSpA Initial: Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis

Prior therapy for AS/nr-axSpA: History of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated or clinically significant adverse effects are experienced; OR patient previously treated with a targeted immunomodulator FDA‑approved for AS or nr‑axSpA (document drug, date, and duration).

Examples of prior targeted immunomodulators are provided in policy (e.g., adalimumab, golimumab, upadacitinib, tofacitinib, bimekizumab).

Dosing and combination: Cosentyx is initiated and titrated according to U.S. FDA labeled dosing for AS or nr‑axSpA AND patient is not receiving Cosentyx in combination with another targeted immunomodulator.

Prescriber and duration:

Cosentyx (secukinumab) for intravenous (IV) injection is considered unproven and not medically necessary when used to treat the following conditions: plaque psoriasis, enthesitis-related arthritis, and hidradenitis suppurativa. The policy distinguishes IV administration (medical benefit) from the self-administered subcutaneous formulation, which is obtained under the pharmacy benefit.

Requests for IV administration of Cosentyx for the conditions listed above are not supported by the policy and are therefore considered not medically necessary. Remember that Cosentyx for self-administered subcutaneous injection is covered under the pharmacy benefit, not under this IV medical benefit policy.

Coding — HCPCS and ICD-10

Applicable HCPCS CodesHCPCS

J3247

Injection, secukinumab, intravenous, 1 mg

Applicable ICD-10 CodesICD-10

L40.50	Arthropathic psoriasis, unspecified.
L40.51	Distal interphalangeal psoriatic arthropathy.
L40.52	Psoriatic arthritis mutilans.
L40.53	Psoriatic spondylitis.
L40.54	Psoriatic juvenile arthropathy.
L40.59	Other psoriatic arthropathy.
M08.1	Juvenile ankylosing spondylitis.
M45.0	Ankylosing spondylitis of multiple sites in spine.
M45.1	Ankylosing spondylitis of occipito-atlanto-axial region.
M45.2	Ankylosing spondylitis of cervical region.

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inv-07: NSAID trial requirement — Failure of two NSAIDs, each used for at least 4 weeks at maximally indicated doses

RequirementFailure of two NSAIDs (e.g., ibuprofen, naproxen) at the maximally indicated doses, each used for at least 4 weeks unless contraindicated or clinically significant adverse effects are experienced.

Where appliedInitial therapy for ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

DocumentationRecord drug names, dosing, start and stop dates, duration, and reason for discontinuation (e.g., lack of efficacy or adverse effects).

ExceptionsIf NSAIDs are contraindicated or cause clinically significant adverse effects, the requirement may be waived with documentation.

inv-08: Methotrexate trial requirement — 3-month trial at maximally indicated dose unless contraindicated

RequirementHistory of failure to a 3-month trial of methotrexate at the maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced.

Where appliedInitial therapy for psoriatic arthritis (PsA).

DocumentationProvide medical records showing methotrexate dose, start and stop dates, duration (3 months), and reason for discontinuation if applicable.

AlternativePrior treatment with an FDA‑approved targeted immunomodulator for PsA (document drug, date, duration) satisfies this requirement.

Provider Actions, Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for IV Cosentyx (J3247). Include the HCPCS code and indicate the initial authorization period will be 12 months. Ensure documentation supports continuation requests.

Affected code: J3247 (Cosentyx IV)
Initial authorization period: 12 months
Continuation authorization period: 12 months

Step Therapy

Step Therapy Requirement for Initial Authorization (PsA)

For initial authorization of Cosentyx for Psoriatic Arthritis (PsA), step therapy requirements must be met before approval: a 3-month trial of methotrexate at maximally indicated dose (unless contraindicated/intolerant) OR prior treatment with an FDA‑approved targeted immunomodulator for PsA documented by claims or medical records (include drug name, dates, and duration). Authorization for initial therapy is issued for 12 months.

Methotrexate trial: 3 months at maximally indicated dose, unless contraindicated or adverse effects
Acceptable alternative: prior targeted immunomodulator (e.g., adalimumab, ustekinumab, guselkumab, tofacitinib, apremilast, risankizumab, upadacitinib, etanercept, certolizumab, bimekizumab) — document drug, dates, duration

Documentation Required

Medical Records and Prior Therapy Documentation

Submit medical records documenting prior therapies and rationale for IV route. For prior therapy documentation, include specific drug names, start and stop dates, doses, and reason for discontinuation. For continuation requests, include documentation of positive clinical response.

Supply medical records or claims history documenting prior methotrexate trial or prior targeted immunomodulator (drug, date, duration)
For continuation: clinical response notes (symptom improvement, objective measures)

Denial Risk

IV Route Justification Required

All requests for IV Cosentyx must include a prescriber attestation that the patient or caregiver cannot be trained or are physically unable to self-administer Cosentyx per FDA labeling. Provide clinical justification why IV administration is medically necessary versus the FDA‑labeled self‑administered route to avoid denial.

Attestation that patient/caregiver cannot be trained or are physically unable to self-administer
Explain why IV route is necessary and why alternative routes are not feasible

Background

Cosentyx (secukinumab) is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits downstream proinflammatory cytokines and chemokines. The medical benefit policy addresses the intravenous (IV) formulation of secukinumab; effectiveness of IV dosing for adult psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis was extrapolated from the established effectiveness of the subcutaneous formulation based on pharmacokinetic exposure. Note that the self-administered subcutaneous product is managed under the pharmacy benefit.

Effectiveness Rationale and Definitions

inv-14: IV Cosentyx effectiveness rationale — extrapolation from subcutaneous formulation effectiveness for listed indications

RationaleEffectiveness of intravenous secukinumab (IV Cosentyx) for adult PsA, AS, and nr-axSpA was extrapolated from the established effectiveness of subcutaneous secukinumab based on pharmacokinetic exposure.

Evidence basisExtrapolation relies on pharmacokinetic exposure comparisons between IV and subcutaneous formulations rather than direct IV clinical trial outcomes in these indications.

ScopeApplies to adult patients with active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis as listed in the policy.

Clinical contextCosentyx is a human IgG1 monoclonal antibody that selectively binds IL-17A and inhibits downstream proinflammatory cytokines and chemokines, supporting mechanistic plausibility for efficacy across formulations.