CurrentHealth NetPolicy CP PMN.180

Halobetasol Propionate (Bryhali, Lexette, Ultravate)

Medical necessity policy governing coverage and prior authorization criteria for halobetasol propionate topical products for plaque psoriasis across Commercial, HIM, and Medicaid lines of business for Health Net/Centene-affiliated plans.

Policy Summary

PayerHealth Net

PolicyHalobetasol Propionate (Bryhali, Lexette, Ultravate)

Policy CodePolicy CP PMN.180

Change TypeNo material change

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Plaque psoriasisindication covered

12 monthsapproval duration

50 g/weekmax dose

Commercial/HIM/Medicaidapplicability

Coverage Criteria

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Initial Approval - General: 1) Diagnosis of plaque psoriasis (PsO). 2) Plaque psoriasis clinical requirement met. 3) Age requirements: for Lexette or Ultravate age >= 12 years; for Bryhali age >= 18 years. 4) Member must use generic topical halobetasol propionate (foam, ointment, cream) unless contraindicated or clinically significant adverse effects are experienced. 5) Failure of generic clobetasol propionate is required unless contraindicated or clinically significant adverse effects are experienced. 6) Dose does not exceed product-specific limits: Bryhali — one tube per 2 weeks (maximum 50 g/week per PI); Lexette — one canister per week or 100 g per 2 weeks (equivalently 50 g/week); Ultravate — one bottle (60 mL) per week or 50 g/week.see text

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Continuation Therapy

Covered when ALL of the following are met for continuation

Continued Therapy: 1) Member is currently receiving the medication via Centene benefit or previously met initial approval criteria (or is enrolled in continuity of care per state/product addendum). 2) Member is responding positively to therapy. 3) Medical justification supports treatment beyond the recommended duration in the prescribing information. 4) If request is for a dose increase, the new dose does not exceed product-specific maximums: Bryhali — one tube per 2 weeks (100 g per 2 weeks listed inconsistently in document; operational maximum 50 g/week per dosing table); Lexette — one canister per week or 50 g/week (100 g per 2 weeks referenced); Ultravate — one bottle (60 mL) per week or 50 g/week.Approval duration: 12 months

Approval duration for continued therapy is 12 months; provider must supply documentation of positive response and justification for continued use.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation supporting safety and efficacy in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for Commercial and HIM lines and CP.PMN.53 for Medicaid).

This clinical policy is the property of the Health Plan. Unauthorized copying, use, modification, distribution, or display of this clinical policy or any information contained herein is strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed within this policy by contract or by providing services and/or submitting claims for payment.

Coding and Quantity Limits

Maximum topical halobetasol quantity

Bryhali (halobetasol lotion 0.01%)Maximum: 50 g per week (apply thin layer QD up to 2 weeks per PI)

Lexette (halobetasol 0.05% foam)Maximum: 50 g per week or one canister per week as applicable (apply thin layer BID up to 2 weeks)

Ultravate (halobetasol 0.05% lotion/foam/ointment)Maximum: 50 g per week or one bottle (60 mL) per week as applicable (apply thin layer BID up to 2 weeks)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization requires documentation that the member has plaque psoriasis and meets the product-specific age and quantity limits; continuation requirements as applicable.

Products referenced: Bryhali, Lexette, Ultravate
Age and quantity limits vary by product; see criteria for specific limits

Note

Medicaid Precedence

Medicaid precedence — When state Medicaid coverage provisions conflict with this clinical policy for Medicaid members, state Medicaid provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage provisions.

Step Therapy

Step Therapy / Formulary Sequencing

Step therapy / formulary sequencing — Member must use generic topical halobetasol propionate (foam, ointment, cream) unless contraindicated or clinically significant adverse effects are experienced; documentation of trial and failure or intolerance is required.

Preferred alternative: halobetasol propionate 0.05% foam/cream/ointment (Ultravate)
Failure of generic clobetasol propionate may also be required unless contraindicated

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Include documentation of diagnosis, age, prior topical trials, dosing, and response to therapy

Denial Risk

Off‑Label / Non‑Covered Indications

Requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the plan's off‑label use policies.

Off‑label requests must reference supporting literature or clinical rationale per plan requirements

Note

Provider Adherence and Policy Proprietary Restrictions

Providers are bound to the terms and conditions expressed herein through the terms of their contracts; unauthorized copying or distribution of this clinical policy is prohibited.

Providers submitting claims agree to be bound by the policy terms
Unauthorized use of this policy may lead to restrictions

Background

Halobetasol propionate is a potent topical corticosteroid indicated for the treatment of plaque psoriasis. Brand formulations referenced in this policy include Bryhali (lotion 0.01%), Lexette (foam 0.05%), and Ultravate (lotion/foam 0.05%); each product has specific age indications and short, product‑label recommended treatment durations. Providers must follow product labeling for dosing limits and document clinical need when requesting coverage beyond labeled durations or quantities.

Policy Summary

PayerHealth Net

PolicyHalobetasol Propionate (Bryhali, Lexette, Ultravate)

Policy CodePolicy CP PMN.180

Change TypeNo material change

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

SourceLink

On This Page

OpenPayer

Halobetasol Propionate (Bryhali, Lexette, Ultravate)

Coverage Criteria

Coding and Quantity Limits

Provider Actions and Requirements

Background

Definitions