Background

Cosentyx is a human interleukin (IL)-17A antagonist indicated in patients 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, patients 2 years of age and older with active psoriatic arthritis, adults with active ankylosing spondylitis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, active enthesitis-related arthritis in patients 4 years of age and older, and adults with moderate to severe hidradenitis suppurativa. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Cosentyx inhibits the release of pro-inflammatory cytokines and chemokines. Cosentyx is available in 150 mg dosages supplied as pens and prefilled syringes for subcutaneous injection as well as 300 mg dosages supplied as pens and prefilled syringes for subcutaneous injection. Cosentyx is also available as a 125 mg vial for intravenous infusion. Cosentyx for intravenous infusion may only be administered in adults with psoriatic arthritis, adults with ankylosing spondyloarthritis, and adults with non-radiographic axial spondyloarthritis. For pediatric patients, there is a 75 mg prefilled syringe available. Dosing information can be found in the package insert.

Policy (Criteria)

Coverage of these drugs is provided when the criteria below is met and for non-preferred products there has been a trial and failure of preferred therapy (if applicable).

Secukinumab intravenous may be considered MEDICALLY NECESSARY for the following condition(s):

Active psoriatic arthritis

1. Diagnosis of active psoriatic arthritis
2. One of the following:

• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement

3. Member meets FDA approved age requirement
4. Prescribed by or in consultation with one of the following:

• Dermatologist
• Rheumatologist

Authorization duration: 6 months

Continuation of Secukinumab may be considered MEDICALLY NECESSARY for the following condition(s) when all criteria is met:

Demonstrates positive clinical response to therapy as evidenced by at least one of the following:

• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
• Reduction in the BSA involvement from baseline

Authorization duration: 12 months

Ankylosing spondylitis

1. Diagnosis of active ankylosing spondylitis
2. Prescribed by or in consultation with a rheumatologist
3. Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of one month trial and failure, contraindication, or intolerance to two different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen) at maximally tolerated doses

Authorization duration: 6 months

Continuation of Secukinumab may be considered MEDICALLY NECESSARY for the following condition(s) when all criteria is met:

Demonstrates positive clinical response to therapy as evidenced by improvement from baseline for least one of the following:

• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count

Authorization duration: 12 months

Non-radiographic Axial Spondyloarthritis

1. Diagnosis of active non-radiographic axial spondyloarthritis
2. Member has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints.)
3. Prescribed by or in consultation with a rheumatologist
4. Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses

Authorization duration: 6 months

Continuation of Secukinumab may be considered MEDICALLY NECESSARY for the following condition(s) when all criteria is met:

Demonstrates positive clinical response to therapy as evidenced by improvement from baseline for least one of the following:

• Disease activity (e.g., pain, fatigue, inflammation, stiffness)
• Lab values (erythrocyte sedimentation rate, C-reactive protein level)
• Function
• Axial status (e.g., lumbar spine motion, chest expansion)
• Total active (swollen and tender) joint count

Authorization duration: 12 months

References

1. Cosentyx [package insert]. Novartis Pharmaceuticals. East Hanover, New Jersey. Updated November 2023.
2. Cosentyx Drug Evaluation. Express Scripts. January 2015 3.
3. UpToDate. “Hidradenitis suppurativa: Pathogenesis, clinical features, and diagnosis”. Accessed 3/2024. www.uptodate.com

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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