Commercial Utilization Management Policy
Version Date: July 2024
Restricted Product(s)
- secukinumab (Cosentyx®) intravenous infusion for administration by a healthcare professional
FDA Approved Use
- For the treatment of adults with active psoriatic arthritis
- For the treatment of adults with active ankylosing spondylitis
- For the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation
Criteria for Medical Necessity
The restricted product(s) may be considered medically necessary when the following criteria are met:
- The patient has a diagnosis of active psoriatic arthritis (PsA); AND
- The patient is 18 years of age or older; AND
- The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months [medical record documentation required]; OR
- The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA [medical record documentation required]; OR
- The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA [medical record documentation required]; OR
- The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) [medical record documentation required]; OR
- The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) [medical record documentation required]; OR
- The patient has a diagnosis of active ankylosing spondylitis (AS); AND
- The patient is 18 years of age or older; AND
- The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial [medical record documentation required]; OR
- The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of AS [medical record documentation required]; OR
- The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS [medical record documentation required]; OR
- The patient has a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA); AND
- The patient is 18 years of age or older; AND
- The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4- week total trial [medical record documentation required]; OR
- The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of nr-axSpA [medical record documentation required]; OR
- The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of nr-axSpA [medical record documentation required]; AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis; AND
- The patient will NOT be using secukinumab (Cosentyx® ) in combination with another biologic immunomodulator agent or Otezla® ; AND
- The patient does NOT have any FDA labeled contraindications to secukinumab (Cosentyx® ); AND
- The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
- The patient has a physical or cognitive limitation that makes the utilization of a self-administered formulation unsafe or otherwise not feasible, as demonstrated by BOTH of the following [medical record documentation required]:
- Inability to self-administer the medication; AND
- Lack of caregiver or support system for assistance with administration of self-administered products; AND
- The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
- For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
Duration of Approval: 365 days (1 year)
| Medication | Indication | Dosing | HCPCS | Maximum Units* |
|---|---|---|---|---|
secukinumab (Cosentyx®) intravenous (IV) infusion | PsA in patients ≥ 18 years old | IV:
| J3247 | 4,200 |
| AS in patients ≥ 18 years old | IV:
| |||
| nr-axSpA in patients ≥ 18 years old | IV:
|
*Maximum units allowed for duration of approval
*Site of Care Medical Necessity Criteria
- For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
- For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
- History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR
- Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR
- New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
- Re-initiation of therapy, defined as ONE of the following:
- First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
- First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
- Requirement of a change in the requested restricted product formulation; AND
- If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.
References
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.
July 2024: Coding change: Added HCPCS code J3247 to dosing reference table effective 7/1/2024; deleted C9166, J3490, and J3590 termed 6/30/2024.
July 2024: Criteria change: Added requirement for use of the self-administered product unless certain criteria are met. Policy notification given 5/1/2024 for effective date 7/1/2024.
April 2024: Coding change: Added HCPCS code C9166 to dosing reference table effective 4/1/2024; deleted C9399 termed 3/31/2024.
October 2023: Original medical policy criteria issued.
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