CurrentMass General Brigham Health PlanPolicy N/A

Topical Vitamin D Analogues for Plaque Psoriasis

This policy governs prior authorization and quantity/step therapy rules for topical vitamin D analogues (calcipotriene products and calcipotriene/betamethasone combinations) for treatment of plaque psoriasis for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTopical Vitamin D Analogues for Plaque Psoriasis

Policy CodePolicy N/A

Change TypeRevised/Clarified

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of diagnosis, age, prior treatment history and for reauthorization, physician documentation of improvement.

SourceLink

POLICY UPDATE CHANGES

Removed calcitriol (moved to non-formulary) and removed Taclonex as a listed medication because the medication is available generic; combination products now require previous use of betamethasone and calcipotriene concurrently or as separate agents.

Sorilux requires trials of all calcipotriene formulations (cream, ointment, solution) prior to approval.

Approvals will be for 12 months and reauthorization requires physician documentation of improvement.

12 monthsApproval duration

Prior AuthorizationRequirement for listed products

>= 2 yrsMinimum patient age for products

Plaque psoriasis

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Coverage and Authorization Criteria

Initial Authorization — general and product-specific criteria

Covered when ANY of the following pathways are met:

Current therapy: Member is currently receiving treatment with a calcipotriene formulation, Enstilar, Sorilux, or Taclonex (excluding products obtained as samples or via manufacturer's patient assistance programs)

Documentation of current treatment required

Calcipotriene monotherapy: For calcipotriene cream, ointment, or solution: member is ≥ 2 years of age; diagnosed with plaque psoriasis; and has had inadequate response, intolerance, or contraindication to a generic topical corticosteroid.

Applies to calcipotriene monotherapy formulations

Sorilux-specific: For Sorilux: member is ≥ 2 years of age; diagnosed with plaque psoriasis; and has had inadequate response or intolerance to calcipotriene cream, ointment, and solution.

Requires trials of all calcipotriene formulations before Sorilux approval

Combination products (calcipotriene + betamethasone): For calcipotriene and betamethasone dipropionate combination products: member is ≥ 2 years of age; diagnosed with plaque psoriasis; and has had inadequate response, intolerance, or contraindication to a calcipotriene product and betamethasone dipropionate used concurrently as separate agents.

Applies to generic combination products and concurrent separate-agent trials

Enstilar-specific: For Enstilar: member is ≥ 2 years of age; diagnosed with plaque psoriasis; has had inadequate response, intolerance, or contraindication to a generic calcipotriene and betamethasone dipropionate combination product; and has had inadequate response, intolerance, or contraindication to a calcipotriene product and betamethasone dipropionate used concurrently as separate agents.

Enstilar requires prior trial of a generic combination product plus prior concurrent use trials

Continuation of Therapy

Reauthorization requires physician documentation of improvement in the member's condition.

Approvals will be for 12 months per policy limitations.

Products obtained as samples or through a manufacturer's patient assistance program are excluded from consideration for authorization. Requests for coverage should only be for dispensed prescriptions or pharmacy‑sourced supplies; documented receipt of samples or assistance‑program product does not satisfy the policy's requirement for current therapy or prior treatment history.

Provider Requirements, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — pharmacy benefit requirement for listed products. Prior authorization is required for calcipotriene, calcipotriene/betamethasone combination products (Enstilar, Taclonex) and Sorilux when billed under the pharmacy benefit.

Affected products: calcipotriene, calcipotriene/betamethasone (Enstilar, Taclonex), Sorilux
Benefit: Pharmacy Benefit
Contact: All Plans Pharmacy: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step therapy requirements

Step therapy requirements must be met before approval of combination or branded products. Members must have trialed and had an inadequate response, intolerance, or contraindication to required first-line products and formulations prior to coverage of the requested agent.

For calcipotriene cream, ointment, and solution: member must be ≥2 years of age and have plaque psoriasis and an inadequate response/intolerance/contraindication to a generic topical corticosteroid.

Listed Medications / Codes

Listed medicationsNDC

Enstilar	calcipotriene/betamethasone foam (listed product)
Taclonex	calcipotriene/betamethasone (listed product; note removed as brand available generic)
Sorilux	calcipotriene topical lotion (listed product)
Calcipotriene	Vitamin D analogue (multiple formulations: cream, ointment, solution)

Background and Context

Topical vitamin D analogues (calcipotriene) are indicated for the treatment of plaque psoriasis and are used either as monotherapy or in fixed‑dose combination with a topical corticosteroid (betamethasone dipropionate) to improve efficacy and tolerability. Combination products pair calcipotriene with betamethasone to provide additive benefit compared with single‑agent use. For purposes of authorization, the policy distinguishes monotherapy calcipotriene formulations (cream, ointment, solution), product‑specific approvals (for example, Sorilux), and combination products (calcipotriene + betamethasone), each with required prior treatment trials or documentation of current use.

Definitions

Plaque psoriasis definition and indication details

DefinitionPlaque psoriasis: a chronic inflammatory skin condition characterized by well-demarcated, scaly plaques; indication specified for topical vitamin D analogue therapies.

Age eligibilityMinimum age: >= 2 years for all listed calcipotriene monotherapy and combination products.

Calcipotriene monotherapy indicationCovered when member has plaque psoriasis and has had inadequate response, intolerance, or contraindication to a generic topical corticosteroid (applies to calcipotriene cream, ointment, or solution).

Sorilux-specific requirementFor Sorilux: member must have had inadequate response or intolerance to calcipotriene cream, ointment, and solution before approval.

Combination-product requirementFor calcipotriene + betamethasone combination products: member must have plaque psoriasis and had inadequate response, intolerance, or contraindication to calcipotriene and betamethasone dipropionate used concurrently as separate agents.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTopical Vitamin D Analogues for Plaque Psoriasis

Policy CodePolicy N/A

Change TypeRevised/Clarified

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of diagnosis, age, prior treatment history and for reauthorization, physician documentation of improvement.

SourceLink

On This Page

For Sorilux: member must have tried and had inadequate response or intolerance to calcipotriene cream, ointment, and solution.

For calcipotriene + betamethasone dipropionate combination products: member must be ≥2 years of age, have plaque psoriasis, and have had inadequate response/intolerance/contraindication to calcipotriene product AND to betamethasone dipropionate used concurrently as separate agents.

For Enstilar: member must be ≥2 years of age, have plaque psoriasis, and have had inadequate response/intolerance/contraindication to a generic calcipotriene + betamethasone dipropionate combination product; AND to calcipotriene product and betamethasone dipropionate used concurrently as separate agents.

Documentation Required

Required documentation

Required documentation must be submitted with the authorization request. Documentation should support diagnosis, member age, prior treatment history, and clinical response or intolerance to prior therapies.

Diagnosis and documentation that the member has plaque psoriasis.
Member age (must be ≥2 years where applicable).
Detailed prior treatment history including trials of generics, calcipotriene formulations, topical corticosteroids, and combination products as applicable, with clinical response or reasons for discontinuation (intolerance/contraindication).
For continuation/reauthorization: physician documentation of improvement in the member's condition.

Denial Risk

Denial risk for unsupported product source or missing criteria

Denial risk if the product was obtained as samples or via manufacturer's patient assistance programs, if required step therapy trials are not documented, or if supporting clinical documentation (diagnosis, age, prior therapy response/intolerance) is missing.

Authorization will not be granted when product is obtained as samples or through manufacturer's patient assistance programs.
Denial likely if required trials of generics, calcipotriene formulations, or concurrent separate-agent therapy are not documented.
Denial risk for missing documentation of diagnosis, member age, or clinical improvement on reauthorization requests.