ModifiedmhnPolicy CP.PMN.181

Calcipotriene/Betamethasone Dipropionate Foam (Enstilar)

This policy governs medical necessity criteria, prior authorization, and coverage for Enstilar topical foam for treatment of plaque psoriasis for members of the payer lines of business (Commercial, HIM, Medicaid). It applies to providers requesting coverage for patients meeting the policy criteria.

Policy Summary

Payermhn

PolicyCalcipotriene/Betamethasone Dipropionate Foam (Enstilar)

Policy CodePolicy CP.PMN.181

Change TypeStep therapy bypass added (IL HIM)

Effective DateDec 1, 2018

Next Review Date

Key ActionSubmit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Step therapy bypass for Illinois HIM requests per IL HB 5395 effective 1/1/2026 was added.

≥12minimum covered patient age

60 g / 4 daysmaximum dosing limit

7 cansequivalent monthly maximum

1 monthinitial approval length

Commercial, HIM, Medicaid

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Coverage and Medical Necessity Criteria

inv-01: Initial Therapy — Plaque Psoriasis — Covered when ALL of the following are met.

Covered when ALL of the following are met:

Plaque Psoriasis initial criteria: 1. Diagnosis of plaque psoriasis (PsO).; 2. Age ≥ 12 years.; 3. Failure of a medium to ultra-high potency topical corticosteroid (see Appendix B), unless contraindicated or clinically significant adverse effects are experienced. (Note: For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395).; 4. Failure of one of calcipotriene, calcitriol, or tazarotene, unless clinically significant adverse effects are experienced or all are contraindicated. (Note: For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395).; 5. Dose does not exceed 60 g every 4 days (equivalent to up to 7 cans per month).

Approval duration: 1 month

inv-02: Continued Therapy — Plaque Psoriasis — Continued coverage when ALL of the following are met.

Continued coverage when ALL of the following are met:

Plaque Psoriasis continuation criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations.; 2. Member is responding positively to therapy.; 3. If request is for a dose increase, new dose does not exceed 60 g every 4 days (equivalent to up to 7 cans per month).

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

inv-03: Other Diagnoses/Indications — For other indications or recent label changes.

For other indications or recent label changes:

Other uses: 1. If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy (e.g., new indication, age expansion, or dosing), follow the applicable formulary/non-formulary policy for the relevant line of business (see policies referenced in source).; 2. If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

See referenced policies for commercial, HIM/marketplace, and Medicaid implementations

Requests for Enstilar that are for non‑FDA approved indications not addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member's line of business.

Coverage determinations for Enstilar are made using this clinical policy as a medical‑necessity guide; however, final coverage and payment remain subject to the member's plan terms, conditions, exclusions, and limitations and to applicable state and federal law and Health Plan administrative policies.

Use of Enstilar for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized without appropriate off‑label justification and supporting clinical documentation per the Health Plan's off‑label use policies; such requests may be denied if required documentation is not provided.

Product Availability and Dosing Limits

Product sizesmixed

60 g	Can containing 0.005% calcipotriene / 0.064% betamethasone dipropionate foam - single can size.
120 g	Two-can pack (2 x 60 g) - total 120 g.

Dosing Limits

Maximum dose60 g every 4 days (equivalent to up to 7 cans per month)

Prior Authorization, Documentation, and Step Therapy

Documentation Required

Required documentation

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) supporting that the member has met all approval criteria. Requests without sufficient documentation that the member meets all approval criteria may be denied.

Documentation should include: diagnosis (plaque psoriasis), member age, prior topical therapy trials and dates, reason for discontinuation if applicable (inefficacy, contraindication, or adverse effects), and dosing requested.
Examples of acceptable documentation: office visit notes, medication history, pharmacy records, prior authorization or denial notices for prior agents, and relevant laboratory or diagnostic test results.
For prior authorization: include evidence of failure of a medium to ultra-high potency topical corticosteroid and failure of one of calcipotriene, calcitriol, or tazarotene unless contraindicated or clinically significant adverse effects are documented.

Step Therapy

Step therapy and operational requirements

Step therapy requirement: Approval for plaque psoriasis requires documented failure of a medium to ultra-high potency topical corticosteroid and failure of one of the following: calcipotriene, calcitriol, or tazarotene, unless clinically significant adverse effects are experienced or agents are contraindicated. Dose limits must be observed (does not exceed 60 g every 4 days / 7 cans per month).

Clinical Background

Enstilar is a fixed‑combination topical foam containing calcipotriene 0.005% and betamethasone dipropionate 0.064%. It is indicated for the topical treatment of plaque psoriasis in patients aged ≥ 12 years, applied once daily for up to 4 weeks with precautions regarding use on the face, groin, axillae, areas of skin atrophy, or under occlusion.

Terms and References

PsO — Abbreviation

AbbreviationPsO = plaque psoriasis

ContextUsed in criteria and Appendix A as the shorthand for plaque psoriasis

Minimum age linked to PsO criteriaPolicy requires age ≥ 12 years for PsO treatment with Enstilar

Enstilar Prescribing Information

Primary referenceEnstilar Prescribing Information (LEO Laboratories Ltd; April 2022)

Access informationAvailable at: https://www.enstilar.com (accessed July 10, 2025)

Role in policy