Clinical Policy: Deucravacitinib (Sotyktu)
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Defines medical necessity and prior authorization criteria for coverage of deucravacitinib (Sotyktu) for adults with moderate-to-severe plaque psoriasis under Meridian Health Plan (Medicaid line of business). Applies to providers requesting coverage for members.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
Initial approval duration 6 months
inv-02: Continuation Therapy
Continued therapy is covered when ALL of the following are met:
Approval duration 12 months
Non‑FDA approved indications that are not specifically listed in Section III are not authorized for coverage under this policy unless there is sufficient supporting documentation of efficacy and safety in accordance with the Meridian off‑label use policy CP.PMN.53 (Medicaid) or other applicable evidence of coverage documents. Requests for such off‑label uses may be denied if this supporting documentation is not provided.
Initial Therapy (Plaque Psoriasis)
inv-14: Initial Therapy (Plaque Psoriasis)
Initial authorization requirements for use of deucravacitinib (Sotyktu) in plaque psoriasis
Initial approval duration 6 months
Continuation Criteria
inv-15: Continuation
Criteria for continued coverage of Sotyktu for plaque psoriasis
Approval duration 12 months
Provider Actions and Requirements
Prior authorization required for Sotyktu
Prior authorization is required for Sotyktu. The request must demonstrate that all initial approval criteria for plaque psoriasis are met, including diagnosis (moderate‑to‑severe PsO per policy), prescriber specialty (dermatologist or rheumatologist), patient age (≥ 18), required prior therapy trials or documented contraindications/intolerance, and dose limits (≤ 6 mg/day).
- Initial approval duration: 6 months (see Initial Therapy criteria).
- Dose limit: does not exceed 6 mg (1 tablet) per day.
Required prior therapy trials (step therapy)
Coverage requires documented trials of specified conventional systemic therapies and biologics with failure or intolerance as defined by the policy. At minimum, documentation must show failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses, or documented intolerance/contraindication plus failure of a ≥ 3 month trial of cyclosporine; phototherapy failure is required if applicable. Additionally, failure of a ≥ 3 month trial of an adalimumab product or history of failure of two TNF blockers is required unless contraindicated.
- Methotrexate trial: ≥ 3 consecutive months at up to maximally indicated doses.
- If MTX intolerant/contraindicated: ≥ 3 months cyclosporine trial at up to maximally indicated doses (unless adverse effects or contraindicated).
- If MTX and cyclosporine intolerant/contraindicated: failure of phototherapy (unless contraindicated).
- Biologic requirement: failure of ≥ 3 month trial of adalimumab product or history of failure of two TNF blockers.
Submit clinical documentation with prior authorization
Provider must submit supporting clinical documentation with the prior authorization request—examples include office chart notes, laboratory results, or other clinical information—that demonstrates the member meets all approval criteria.
- Include documentation that verifies diagnosis severity (BSA ≥ 3% or involvement of hands/feet/scalp/face/genital area), prescriber specialty, age, prior therapy trials, and current dosing.
- Supporting records may be needed to establish contraindications or intolerance to required therapies.
Provide detailed therapy trial documentation
Documentation must specifically detail prior therapy trials and the reason for discontinuation (failure, intolerance, or contraindication) for required agents such as methotrexate, cyclosporine, phototherapy, and specified biologics (e.g., adalimumab or two TNF blockers).
- Record start/stop dates, duration of each trial (e.g., ≥ 3 consecutive months for methotrexate/cyclosporine/adalimumab), doses used, and objective or clinical rationale for failure or discontinuation.
- If a therapy was not tried because of contraindication or intolerance, provide documentation supporting that contraindication/intolerance (see Appendix D as referenced in policy).
Non‑FDA indications may be denied without off‑label support
Requests for non‑FDA approved indications that are not specifically addressed in this policy may be denied unless supported by the off‑label use policy CP.PMN.53 or other evidence-of-coverage documentation demonstrating efficacy and safety.
- If seeking coverage for an off‑label indication, include evidence per CP.PMN.53 or evidence-of-coverage documents to justify use.
Do not exceed overdose limit of 6 mg/day
Requests that exceed the policy maximum dose may be denied; the policy specifies a maximum of 6 mg (one 6 mg tablet) per day for Sotyktu.
- Dose must not exceed 6 mg/day for initial approval and continuation criteria reference the same maximum.
Step Therapy Requirements
| Step | Required trial / condition | Minimum duration / notes |
|---|---|---|
| 1 | Failure of a ≥3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses, or documented intolerance/contraindication to MTX | ≥ 3 months (see Appendix D for definition of failure); MTX intolerance/contraindication described in Appendix D |
| 2 | If MTX is intolerant/contraindicated: failure of a ≥3 consecutive month trial of cyclosporine at up to maximally indicated doses, unless clinically significant adverse effects or contraindicated | ≥ 3 months; cyclosporine trial required only when MTX cannot be used |
| 3 | If intolerant/contraindicated to both MTX and cyclosporine: failure of phototherapy unless contraindicated or clinically significant adverse effects experienced | Phototherapy trial (duration per clinical judgment) unless contraindicated |
| 4 | Additionally, failure of a ≥3 consecutive month trial of an adalimumab product (including listed biosimilars) OR history of failure of two TNF blockers is required unless contraindicated | ≥ 3 months for adalimumab trial; two TNF blocker failures acceptable alternative (see Appendix D for TNF examples) |
| Notes | Documented trials, failures, or intolerance/contraindications must be provided. Prior authorization may be required for adalimumab products. | Dose limitation: therapy must not exceed 6 mg (1 tablet) per day. |
Coding and Clinical Thresholds
Quantity Limits
Site of Care
Oral administration — no site restrictions specified
Sotyktu is administered orally and the policy does not impose any site‑of‑care restrictions; therapy may be taken at home.
Definitions and Abbreviations
Background
Deucravacitinib (Sotyktu) is a selective TYK2 inhibitor indicated for adults with moderate‑to‑severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The policy applies to Meridian Health Plan (Medicaid) and defines medical necessity and prior authorization requirements for use in this population, including prescriber specialty, age ( ≥ 18 years ), required prior therapy trials, and dosing limits (maximum recommended daily dose 6 mg/day ).
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