medical mutual ohio Cosentyx prior auth Coverage

Recommended Authorization Criteria

Ankylosing Spondylitis (AS)

Approve when ONE of the following is met

AS - Initial or Continuation: A) Initial Therapy: Approve for 6 months if BOTH i and ii are met; i. Patient is >= 18 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Cosentyx); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

Examples of objective measures include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and serum markers (CRP/ESR).

Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Approve when ONE of the following is met

nr-axSpA - Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL i, ii, and iii are met; i. Patient is >= 18 years of age; AND ii. Patient has objective signs of inflammation, defined as at least ONE: (a) C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory; OR (b) sacroiliitis reported on magnetic resonance imaging; AND iii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: Approve if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR b) Compared with baseline, patient experienced improvement in at least one symptom.

Examples of objective measures include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and serum markers (CRP/ESR).

Plaque Psoriasis

Approve when ONE of the following is met

Plaque Psoriasis - Initial or Continuation: A) Initial Therapy: Approve for 3 months if ALL i, ii, and iii are met; i. Patient is >= 6 years of age; AND ii. Patient meets ONE: (a) tried at least one traditional systemic agent for >= 3 months unless intolerant; OR (b) prescriber documents a contraindication to methotrexate. Exception: prior biologic (other than Cosentyx), prior use of Otezla or Sotyktu, or prior intolerance to traditional systemic agents may exempt the traditional systemic requirement; AND iii. Medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous: Approve for 1 year if ALL i, ii, and iii are met; i. Patient has been established on therapy for at least 3 months; AND ii. Patient experienced a beneficial clinical response defined as improvement from baseline in at least one of estimated body surface area, erythema, induration/thickness, and/or scale; AND iii. Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, burning).

Dosing: adults 300 mg SC at weeks 0,1,2,3,4 then every 4 weeks; pediatric weight-based dosing specified.

Enthesitis-Related Arthritis (ERA)

Approve when ONE of the following is met

ERA - Initial or Continuation: A) Initial Therapy: Approve for 6 months if BOTH i and ii are met; i. Patient is >= 4 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: JADAS, MD global, PGA, PDA, cJADAS, JSpADA, CRP/ESR, reduced corticosteroid dose); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, decreased morning stiffness, improved function).

Pediatric dosing provided by weight (75 mg for patients >15 kg and <50 kg; 150 mg for patients >50 kg).

Psoriatic Arthritis (PsA)

Approve when ONE of the following is met

PsA - Initial or Continuation: A) Initial Therapy: Approve for 6 months if BOTH i and ii are met; i. Patient is >= 2 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: Approve for 1 year if BOTH i and ii are met; i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds dactylitis score, MDA, PsAID-12, CRP/ESR); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue, improved function, decreased soft tissue swelling).

Dosing: loading 150 mg weekly x5 then 150 mg every 4 weeks (or 150 mg every 4 weeks without loading); dose may be increased to 300 mg if active disease persists.

Hidradenitis Suppurativa (HS)

Approve when ONE of the following is met

HS - Initial or Continuation: A) Initial Therapy: Approve for 3 months if ALL i, ii, and iii are met; i. Patient is >= 18 years of age; AND ii. Patient has tried at least one other therapy (examples: intralesional or oral corticosteroids, systemic antibiotics, isotretinoin); AND iii. Medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous: Approve for 1 year if ALL i, ii, and iii are met; i. Patient has been established on therapy for at least 3 months; AND ii. When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index); AND iii. Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or drainage).

Dosing: 300 mg SC loading at weeks 0,1,2,3,4 then 300 mg every 4 weeks; may increase to 300 mg every 2 weeks if active disease persists.

Conditions Not Recommended for Approval

Conditions not recommended for approval (Cosentyx has not been shown effective or has safety concerns):

ConcurrentBiologicOrTargetedSynthetic: Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not recommended; conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are not excluded when used in combination.

Combination therapy is generally not recommended due to potentially higher adverse events and lack of controlled data; see Appendix for examples.

CrohnsDisease: Crohn's disease: Not recommended due to reports of exacerbations (including serious cases) in clinical trials; an IV formulation failed to meet endpoints in a Phase II trial and the study was terminated prematurely.

Safety concerns and lack of efficacy in trials cited.

RheumatoidArthritis: Rheumatoid arthritis: Not recommended due to limited or inferior efficacy versus current treatments in clinical trials; ACR response rates were variable and some doses did not perform significantly better than placebo in published studies.

Concurrent administration of Cosentyx with another biologic agent or with a targeted synthetic oral small molecule used to treat inflammatory conditions is not recommended. The policy explains that combination therapy is generally discouraged due to a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy. Conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) are not excluded and may be used in combination when clinically appropriate.

Coverage for Cosentyx is limited to the situations enumerated in the Recommended Authorization Criteria. Uses and patient populations not specifically listed in those criteria are not recommended for coverage under this policy; the criteria will be updated as new published evidence becomes available.

The Company may deny reimbursement when it determines the drug or services were not medically necessary, investigational, or experimental, or when the request is outside the scope of the member's benefits. Additional documentation supporting medical necessity (for example, patient records, test results, or provider credentials) must be provided upon request and the Company reserves the right to modify or interpret this policy in its coverage determinations.

Billing and Code References

Covered HCPCSHCPCS

J3590

HCPCS code reported in header

Prior authorization required HCPCSHCPCSCovered

J3590

Unclassified biologics (used when determined to be Cosentyx)

What Providers Must Do / Billing Rules

Billing Rule

Site of Care Restriction

Prior approval is required for some or all procedure codes listed in this Corporate Drug Policy. Initial and renewal requests for Cosentyx (HCPCS J3590 when unclassified biologic is Cosentyx) are subject to site-of-care management. When billed under the medical benefit, administration of the medication is restricted to a non-hospital facility-based location (e.g., home infusion provider, provider office, free-standing ambulatory infusion center) unless the member meets the site-of-care exception criteria. To view exception criteria and a list of medications subject to site-of-care management, follow payer resources.

HCPCS: J3590 (Unclassified biologics — when Cosentyx)
Site-of-care restriction: administration billed under medical benefit limited to non-hospital facility-based locations unless exception met

Denial Risk

Clinical Background

Secukinumab (Cosentyx) is an interleukin-17A (IL‑17A) antagonist available as a subcutaneous injection (and in some formulations as an intravenous preparation). It is indicated for multiple inflammatory conditions including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, enthesitis‑related arthritis, and hidradenitis suppurativa. Efficacy has been established in pivotal trials for psoriasis and in studies supporting its other labeled indications; objective signs of inflammation (for example, elevated CRP or sacroiliitis on MRI) were required in trial criteria for non‑radiographic axial spondyloarthritis.

Key Definitions and Terms

Objective signs of inflammation

DefinitionObjective signs of inflammation: elevated C-reactive protein (CRP) beyond the laboratory upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI).

Context of useRequired for enrollment in the pivotal non-radiographic axial spondyloarthritis (nr-axSpA) trial that supported Cosentyx use in nr-axSpA.

Age group referencedApplies to adult patients with non-radiographic axial spondyloarthritis (patients ≥ 18 years) in the trial criteria.

Examples of objective measures referenced elsewhere in policyOther objective measures used in policy examples include CRP/ESR and disease activity scores (e.g., ASDAS, BASDAI).

Cosentyx (secukinumab) — product description and indications

Generic name and class

OpenPayer

Cosentyx (secukinumab) subcutaneous — Prior Authorization and Coverage Criteria

Recommended Authorization Criteria

Billing and Code References

What Providers Must Do / Billing Rules

Clinical Background

Key Definitions and Terms