Betamethasone Dipropionate Spray Medical Necessity Criteria

Coverage Summary

Scope: Defines medical necessity and limits for betamethasone dipropionate 0.05% spray (Sernivo) for plaque psoriasis. Coverage stance: covered_with_criteria when initial and continued therapy criteria are met. Key thresholds: maximum dispensing of 120 mL every 4 weeks and dosing per label of Apply BID for up to 4 weeks. FDA-approved indication: treatment of mild to moderate plaque psoriasis in adults ≥18 years.

Key policy quick facts

Covered indication (FDA-approved)Treatment of mild to moderate plaque psoriasis in patients 18 years and older

Maximum dispense threshold120 mL every 4 weeks

Initial approval duration1 month

Continuation approval durationUp to 1 month (single continuous course up to 4 weeks recommended)

Initial Therapy Criteria

Initial Approval Criteria

Sernivo is medically necessary when ALL of the following are met:

Diagnosis of PsO (plaque psoriasis)
Plaque psoriasis (must meet all subcriteria)
- Topical corticosteroid failure: Failure of a medium to ultra-high potency topical corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced
  Refer to Appendix B for potency classifications
- Adjunct topical agent failure: Failure of one of the following agents, unless clinically significant adverse effects are experienced or all are contraindicated: calcipotriene, calcitriol, tazarotene

Other Diagnoses / Initial Requests

Other diagnoses/indications (Initial)

For diagnoses/indications not covered under the formulary/PDL or not listed:

On-formulary/PDL: If drug is on formulary/PDL: follow no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for HIM, CP PMN.255 for Medicaid)
Not on formulary/PDL: If drug is NOT on formulary/PDL: follow non-formulary policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for HIM, CP PMN.16 for Medicaid)
Off-label use: If the requested use (diagnosis, age, dosing) is not specifically listed under section III and prior conditions do not apply: refer to off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP PMN.53 for Medicaid)

References / Policy Cross-Referencesmixed

CP.CPA.190	No coverage criteria policy (commercial)
HIM.PA.33	No coverage criteria policy (health insurance marketplace)
CP PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (health insurance marketplace)
CP PMN.16	Non-formulary policy (Medicaid)
CP.CPA.09	Off-label use policy (commercial)
HIM.PA.154	Off-label use policy (health insurance marketplace)
CP PMN.53	Off-label use policy (Medicaid)

Continuation Therapy Criteria

Continued Therapy Criteria

Coverage for continuation is allowed when ONE of the following is met and dose limits are observed:

{

"operator":"any",

"children":[

{"text":"Member has previously met initial approval criteria for betamethasone dipropionate spray (prior authorization granted)", "note":"Prior authorization required per criteria"},

Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (continuity of care applies)

Unapproved / Excluded Indications

Diagnoses/Indications Not Authorized

Diagnoses/Indications Not Authorized: Non-FDA approved indications are not covered unless there is sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Refer to off-label policies CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP PMN.53 (Medicaid)

Denial Risk

Off‑Label Use Requirements

Non‑FDA (off‑label) indications require sufficient documentation of efficacy and safety per the applicable off‑label use policies and may be processed under the referenced off‑label policy codes for the member's line of business.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization requires documentation of prior failures of a medium‑ to ultra‑high potency topical corticosteroid and failure of one of calcipotriene, calcitriol, or tazarotene (unless contraindicated or not tolerated); initial approval duration is 1 month.

Medium to ultra‑high potency topical corticosteroid (see Appendix B)
One of: calcipotriene, calcitriol, or tazarotene

Documentation Required

Submit Supporting Documentation

Submit office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria (diagnosis, prior therapies, dosing limits, and clinical response).

Applicable Codes & Cross‑References

References / Policy Cross-Referencesmixed

CP.CPA.190	No coverage criteria policy (commercial)
HIM.PA.33	No coverage criteria policy (health insurance marketplace)
CP PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (health insurance marketplace)
CP PMN.16	Non-formulary policy (Medicaid)
CP.CPA.09	Off-label use policy (commercial)
HIM.PA.154	Off-label use policy (health insurance marketplace)
CP PMN.53	Off-label use policy (Medicaid)

Clinical Evidence & Guidance

Evidence: FDA approved indication — Sernivo Prescribing Information, April 2021 (indicated for treatment of mild to moderate plaque psoriasis in patients 18 years and older). Guideline reference — Joint AAD‑NPF Guidelines for management/treatment of psoriasis with topical therapy (J Am Acad Dermatol 2021). Therapeutic alternatives and potency‑based topical corticosteroid classes are listed in Appendix B (e.g., ultra‑high, high, medium potency topical corticosteroids and specific agents such as augmented betamethasone dipropionate, clobetasol, diflorasone, halobetasol, desoximetasone, fluocinonide, triamcinolone, mometasone), as referenced in the policy appendix.

Evidence / Label references

FDA indication (source)Sernivo is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older (Sernivo Prescribing Information, April 2021)

Guideline reference (source)Joint AAD-NPF Guidelines for management/treatment of psoriasis with topical therapy (J Am Acad Dermatol 2021)

Background

Background: Sernivo is betamethasone dipropionate 0.05% spray, a topical corticosteroid FDA‑approved for treatment of mild to moderate plaque psoriasis in adults 18 years and older. Per the prescribing information, the spray is applied topically to affected areas BID for up to 4 weeks, avoiding face, scalp, axilla/groin, or other intertriginous areas. Product availability is a 0.05% spray. Appendix B in the policy lists therapeutic alternatives and groups topical corticosteroids by potency for treatment considerations.

Thresholds & dosing

Maximum dispensing threshold120 mL every 4 weeks

Recommended treatment course (label)Apply spray topically to affected areas BID for up to 4 weeks

Revision History

4Q 2024 (P&T Approval Date = 11.24)annual_reviewLatest

4Q 2024 annual review: product availability section updated strength per prescriber information; references reviewed and updated.

4Q 2022 (Date = 07.20.22)annual_review

4Q 2022 annual review: template changes to other diagnoses/indications and continued therapy sections applied; references reviewed and updated.

4Q 2020 (P&T Approval Date = 11.20)annual_review

4Q 2020 annual review: HIM line of business added; references reviewed and updated.