CurrentCignaPolicy N/A

Sotyktu (deucravacitinib) prior authorization for plaque psoriasis

Defines prior authorization requirements, coverage criteria, and conditions not recommended for approval for Sotyktu (deucravacitinib tablets) for treatment of plaque psoriasis in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySotyktu (deucravacitinib) prior authorization for plaque psoriasis

Policy CodePolicy N/A

Change TypeRevised guidance on established-on-therapy duration and combination therapy exclusions

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionObtain prior authorization and document age, a ≥3-month trial of a traditional systemic agent (or valid exception), and prescriber specialty to support initial approval.

SourceLink

POLICY UPDATE CHANGES

For a patient currently taking Sotyktu, the timeframe for 'established on therapy' was changed from 90 days to 3 months.

Conditions Not Covered: concurrent use with a biologic or with a targeted synthetic oral small molecule drug wording was updated from previous phrasing.

PUVA was removed from examples of traditional systemic therapies in the Note; a separate Note was added that a 3-month trial of PUVA counts as a traditional systemic therapy.

≥18min age

3 monthsinitial approval

1 yearcontinuation approval

3 monthsrequired trial/established threshold

Coverage Criteria for Sotyktu (deucravacitinib)

FDA-Approved Indication - Plaque Psoriasis

Covered when ONE of the following is met

Overall: Patient meets A (Initial Therapy) OR B (Currently Receiving Sotyktu)

A) Initial Therapy: Approve for 3 months if ALL of the following are met:

A.i: Patient is ≥ 18 years of age.

A.ii: Patient meets ONE of the following:

Policy Summary

PayerCigna

PolicySotyktu (deucravacitinib) prior authorization for plaque psoriasis

Policy CodePolicy N/A

Change TypeRevised guidance on established-on-therapy duration and combination therapy exclusions

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionObtain prior authorization and document age, a ≥3-month trial of a traditional systemic agent (or valid exception), and prescriber specialty to support initial approval.

SourceLink

On This Page

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A.ii.a: Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months, unless intolerant (examples include methotrexate, cyclosporine, or acitretin; a 3-month trial of PUVA also counts).≥ 3 months

A patient who has already had a 3-month trial or intolerance to at least one biologic (other than the requested biologic) may be exempted from the traditional systemic agent requirement; a biosimilar of the requested biologic does not count.

A.ii.b: Patient has a contraindication to methotrexate, as determined by the prescriber.

A.iii: Medication is prescribed by or in consultation with a dermatologist.

B) Patient Currently Receiving Sotyktu: Approve for 1 year if ALL of the following are met:

B.i: Patient has been established on therapy for at least 3 months.≥ 3 months

A patient who has received < 3 months of therapy or who is restarting therapy is reviewed under Initial Therapy (A).

B.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 of areas affected by psoriasis.

B.iii: Compared with baseline prior to initiating the requested drug, patient experienced improvement in at least one symptom such as decreased pain, itching, and/or burning.

Concurrent administration of Sotyktu with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition is not recommended and is considered a basis for denial. The policy states that Sotyktu "should not be administered in combination with another biologic or with a targeted synthetic oral small molecule drug" because combination therapy may increase adverse events and lacks controlled clinical data showing added benefit. The policy also clarifies that conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) are not excluded from use in combination with Sotyktu.

Concurrent use of Sotyktu with other potent immunosuppressants, including methotrexate, is specifically highlighted as not recommended due to the potential for additive immunosuppression and because such co‑administration has not been adequately evaluated.

Use of Sotyktu for any indication other than the FDA‑approved indication for plaque psoriasis is considered experimental, investigational, or unproven and is not recommended for approval. The policy explicitly states that Sotyktu "is(are) considered experimental, investigational or unproven for ANY other use(s)," and so requests for non‑FDA‑approved indications should be treated as not medically necessary under this policy.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for initial and continuing therapy. Initial approval requires documentation of age and prior-therapy criteria and that the prescriber is a dermatologist or the request is in consultation with a dermatologist. All approvals are for the duration noted in the policy (months counted as 30 days).

Sotyktu (deucravacitinib) requires prior authorization.
Initial prescribing must be by or in consultation with a dermatologist.

Step Therapy

Step Therapy / Prior Treatments

Trial of at least one traditional systemic agent is required for initial therapy unless the patient is intolerant or has previously tried a biologic (see note). Examples include methotrexate, cyclosporine, or acitretin; a 3-month PUVA trial also counts. An exception to the traditional systemic agent trial may be made if the patient has already had a 3-month trial or previous intolerance to at least one biologic other than the requested drug. A biosimilar does not count. Patients already on a biologic are not required to step back to a traditional systemic agent.

Required trial: ≥1 traditional systemic agent (e.g., methotrexate, cyclosporine, acitretin) for ≥3 months, unless intolerant.
3-month PUVA trial counts as a traditional systemic agent trial.
Exception: prior 3-month trial or intolerance to ≥1 biologic (not a biosimilar) may substitute.

Denial Risk

Combination Therapy Exclusion

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug is considered experimental and is not recommended. This does not exclude the use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) with this medication. Co-administration with other potent immunosuppressants has not been evaluated and is not recommended.

Combination therapy with another biologic or targeted synthetic oral small molecule drug: not covered / experimental.
Conventional synthetic DMARDs may be used in combination and are not excluded.
Concurrent use with other potent immunosuppressants (including methotrexate in some contexts) is not recommended due to added immunosuppression risk.

Drug Definitions

Sotyktu (deucravacitinib) — drug description and indication key facts

Generic namedeucravacitinib

Brand nameSotyktu

Drug class / mechanismOral tyrosine kinase 2 (TYK2) inhibitor

FDA‑approved indication (policy)Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Limitation of useNot recommended in combination with potent immunosuppressants

FormulationOral tablets

Background

Sotyktu (deucravacitinib) is an oral tyrosine kinase 2 (TYK2) inhibitor approved for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Because it modulates TYK2‑dependent cytokine signaling pathways, Sotyktu affects immune responses relevant to psoriasis. The policy emphasizes that Sotyktu is not recommended in combination with other biologics or targeted synthetic oral small molecule immunomodulators due to limited data on combined efficacy and a potentially higher rate of adverse events; co‑administration with other potent immunosuppressants has not been evaluated and may increase the risk of additive immunosuppression.