CurrentCentenePolicy CP PMN.182

Betamethasone dipropionate 0.05% spray (Sernivo) for plaque psoriasis — coverage criteria

Policy governs prior authorization and coverage criteria for Sernivo (betamethasone dipropionate 0.05% spray) for treatment of mild to moderate plaque psoriasis in adults, and applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyBetamethasone dipropionate 0.05% spray (Sernivo) for plaque psoriasis — coverage criteria

Policy CodePolicy CP PMN.182

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2018

Next Review DateN/A

Key ActionSubmit documentation showing diagnosis of plaque psoriasis and prior failure of a medium to ultra‑high potency topical corticosteroid and one listed alternative unless contraindicated; do not exceed 120 mL per 4 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+FDA-indicated patient age (years)

0.05%Drug strength

120 mLMax dose /4w

1 monthInitial approval

Up to 1 monthContinued approval

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria

Diagnosis of plaque psoriasis (PsO).
Plaque psoriasis (must meet all disease-specific requirements).
Failure of a medium to ultra-high potency topical corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced.
Failure of one of the following topical alternatives unless clinically significant adverse effects are experienced or all are contraindicated: calcipotriene, calcitriol, tazarotene.
Dose does not exceed 120 mL every 4 weeks.<= 120 mL per 4 weeks
Approval duration: 1 month

Operational note: Prior authorization requires submission of documentation supporting diagnosis and prior therapy failures (e.g., office notes, treatment history).

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy Criteria

Member continuity criteria
- Member is currently receiving the medication via a Centene benefit or has previously met initial approval criteria.
- Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).
Member is responding positively to therapy.
If request is for a dose increase, the new dose does not exceed 120 mL every 4 weeks.<= 120 mL per 4 weeks

Requests for use of Sernivo (betamethasone dipropionate 0.05% spray) for non‑FDA approved indications are not covered under this policy unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP PMN.53 (Medicaid), or the member’s evidence of coverage documents support the use.

Coverage decisions and the administration of benefits for Sernivo are governed by the member’s coverage documents and applicable laws. All determinations are subject to the terms, conditions, exclusions, and limitations of the member’s plan (for example, evidence of coverage, certificate of coverage, policy or contract of insurance), state and federal requirements, and Health Plan‑level administrative policies and procedures. This clinical policy does not itself constitute a contract or guarantee of payment.

Coding and Quantity Limits

inv-05: Maximum product volume per 4 weeks — 120 mL every 4 weeks

Maximum volume120 mL every 4 weeks

Approval implicationDose must not exceed 120 mL per 4 weeks for initial or continued therapy

Dose increase requestsIf request is for a dose increase, the new dose must not exceed 120 mL every 4 weeks

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial coverage. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including a diagnosis of plaque psoriasis and previous treatment trials as specified below.

Initial approval requires documentation of diagnosis of plaque psoriasis.
Include supporting clinical documentation: office notes, prior therapy records, labs, or other relevant information.

Documentation Required

Provider Responsibility and Documentation

Providers must exercise professional medical judgment in treatment decisions and are responsible for maintaining and submitting documentation that supports medical necessity. Coverage decisions are made based on the documentation provided; insufficient documentation may result in denial.

Providers are responsible for documentation supporting medical necessity.

Background

Sernivo (betamethasone dipropionate 0.05% spray) is a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis (PsO) in adults 18 years of age and older. The recommended administration is topical spray applied to affected areas, generally twice daily for up to 4 weeks, with avoidance of intertriginous areas, face, and scalp. Prior therapy considerations and dosing guidance are described in the policy appendices and supporting clinical information.

Definitions

inv-15: Plaque Psoriasis (PsO) — Chronic inflammatory skin condition characterized by well‑demarcated plaques; Sernivo is indicated for mild to moderate plaque psoriasis ...

DefinitionChronic inflammatory skin condition characterized by well-demarcated plaques; Sernivo is indicated for mild to moderate plaque psoriasis in patients 18 years of age or older.

FDA indicationSernivo (betamethasone dipropionate 0.05% spray) indicated for treatment of mild to moderate plaque psoriasis in adults (>=18 years).

Typical regimenApply spray topically to affected areas twice daily (BID) for up to 4 weeks; avoid face, scalp, axilla/groin and other intertriginous areas.

inv-16: Medium to ultra‑high potency topical corticosteroid — Therapeutic classes listed in Appendix B that include medium, high, and ultra‑high potency topical corticosteroids (examples and dosing g...)

DefinitionTherapeutic classes in Appendix B include medium, high, and ultra-high potency topical corticosteroids with examples and dosing guidance provided in the appendices.

Policy Summary

PayerCentene

PolicyBetamethasone dipropionate 0.05% spray (Sernivo) for plaque psoriasis — coverage criteria

Policy CodePolicy CP PMN.182

Change TypeNo material clinical or coverage changes

Effective DateDec 1, 2018

Next Review DateN/A

SourceLink

On This Page

Approval duration: Up to 1 month (a single continuous course up to 4 weeks is recommended).

Operational note: Continuation requests should include documentation of clinical response and treatment history.

Requests lacking sufficient documentation to show criteria are met may be denied.

Step Therapy

Step Therapy Requirements

Step therapy requires failure of a medium to ultra‑high potency topical corticosteroid (see Appendix B for examples and dosing limits), unless contraindicated or clinically significant adverse effects occur. In addition, failure of one of the topical vitamin D analogs or tazarotene (calcipotriene, calcitriol, or tazarotene) is required unless contraindicated or not tolerated.

Failure of a medium to ultra‑high potency topical corticosteroid is required unless contraindicated.
Failure of one of: calcipotriene, calcitriol, or tazarotene, unless contraindicated or not tolerated.
Dose limit for product: does not exceed 120 mL every 4 weeks (as applicable).
Approval duration for initial authorization: 1 month.

Note

Step Therapy Not Specified — Provider Clinical Judgment

If no formal step therapy protocol is specified or a listed agent is contraindicated/intolerant, providers may use clinical judgment and must document the rationale and relevant adverse events or contraindications in the medical record.

When step therapy is not applicable or specifics are absent, document clinical rationale for therapy choice.
Document contraindications or clinically significant adverse effects that preclude required step agents.

Note

Medicaid Precedence May Affect Coverage

Medicaid members: when state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual and Medicaid-specific policies (e.g., CP PMN.53) for any differing coverage rules.

State Medicaid coverage provisions override this clinical policy when conflicts exist.
Refer to the state Medicaid manual for applicable coverage specifics.

Examples (medium to high potency)Betamethasone dipropionate 0.05% cream; desoximetasone 0.05%; fluocinolone acetonide 0.025%; fluticasone propionate 0.05%.

Usage guidanceAppendix entries note dosing regimens (typically BID) and maximum duration recommendations (many agents: should not be used for longer than 2 consecutive weeks).