CurrentCignaPolicy IP0361

Topical Vitamin D Analog Products (Non‑Preferred) — Coverage Criteria for Plaque Psoriasis

Defines medical necessity, authorization, and coverage criteria for non-preferred topical vitamin D analog products (various calcipotriene and calcitriol formulations) for treatment of plaque psoriasis under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyTopical Vitamin D Analog Products (Non‑Preferred) — Coverage Criteria for Plaque Psoriasis

Policy CodePolicy IP0361

Change TypeNo material changes

Effective DateMar 15, 2024

Next Review DateMar 15, 2025

Key ActionObtain prior authorization and document trials of preferred/generic bioequivalent products, failure or intolerance, and any formulation-specific allergy or serious adverse reaction.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsinitial and reauthorization approval duration

8+products listed

4–18 yrspediatric age criteria vary

continuation requires benefitreauthorization condition

Coverage and Medical Necessity Criteria

Initial Therapy Criteria by Product

Coverage for listed non-preferred topical vitamin D analog products is considered medically necessary for plaque psoriasis when product-specific criteria below are met.

calcipotriene foam (Sorilux authorized generic, Sorilux): Covered when ANY of: (1) between the ages of 4 and 18 years; OR (2) failure or intolerance to calcipotriene cream, ointment, or solution.

[chunk 4]

Calsodore (calcipotriene 0.005% cream): Covered when ALL: trial of calcipotriene 0.005% cream (generic for Dovonex) AND cannot take due to a formulation difference in the inactive ingredient(s) resulting in a significant allergy or serious adverse reaction.

[chunk 4,6]

Dovonex (calcipotriene 0.005% cream): Covered when ALL: trial of calcipotriene cream (the bioequivalent generic product) AND cannot take due to a formulation difference in the inactive ingredient(s) resulting in a significant allergy or serious adverse reaction.

Policy Summary

PayerCigna

PolicyTopical Vitamin D Analog Products (Non‑Preferred) — Coverage Criteria for Plaque Psoriasis

Policy CodePolicy IP0361

Change TypeNo material changes

Effective DateMar 15, 2024

Next Review DateMar 15, 2025

Key ActionObtain prior authorization and document trials of preferred/generic bioequivalent products, failure or intolerance, and any formulation-specific allergy or serious adverse reaction.

SourceLink

On This Page

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Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred topical vitamin D analog products. Product-specific medical necessity criteria must be met for coverage.

Applies to listed non-preferred products (e.g., calcipotriene foams/creams/ointments, combination calcipotriene/betamethasone products, calcitriol ointment).
Receipt of sample product does not satisfy any criteria requirements for coverage.
Effective Date: 2024-03-15

Step Therapy

Step Therapy Expectations

Step therapy expectations apply. Approval for certain non-preferred products requires prior trials of preferred or generic bioequivalent calcipotriene (cream/ointment/solution) or combination products and/or multiple different generic topical corticosteroid agents as specified below.

Calcipotriene foam (Sorilux authorized generic / Sorilux): trial and failure/intolerance to calcipotriene cream, ointment, or solution required (unless age criterion met).
Calsodore / Dovonex cream: trial of generic calcipotriene cream required unless unable due to inactive ingredient allergy/serious adverse reaction.
Enstilar foam: trial failure/intolerance to BOTH (a) calcipotriene/betamethasone topical suspension or ointment AND (b) a calcipotriene-containing product in combination with FOUR different generic prescription-strength topical corticosteroids (unless age criterion met).
Taclonex ointment: trial of bioequivalent calcipotriene/betamethasone ointment (or inability due to inactive ingredient allergy/serious adverse reaction) AND a calcipotriene-containing product plus FOUR different generic prescription-strength topical corticosteroid products (or age criterion).
Wynzora cream: failure or intolerance to a calcipotriene-containing product in combination with FIVE different generic prescription-strength topical corticosteroid products.
Vectical (calcitriol ointment): trial of generic calcitriol ointment required unless unable due to inactive ingredient allergy/serious adverse reaction.

Documentation Required

Required Documentation

Required documentation must be provided with prior authorization requests to demonstrate trials and failures or documented intolerance/allergy to preferred or generic bioequivalent products, and to indicate applicable age-based exceptions.

Document prior trials: drug name, formulation, dose, dates of therapy, and reason for discontinuation (e.g., lack of efficacy, adverse reaction, intolerance).
If approval is requested based on formulation-related allergy/serious adverse reaction, provide clinical documentation describing the inactive ingredient sensitivity and why the preferred/generic agent cannot be used.
When relying on age-based criteria (e.g., calcipotriene foam or Sorilux for ages 4–18; Enstilar/Taclonex for ages 12–18), include patient age and supporting clinical rationale.
Dosage, frequency, duration, and site of care should be reasonable and supported by evidence-based literature and prior treatment history.

Denial Risk

Non-covered Uses

Any use of these products outside the specified, product-specific medically necessary criteria is considered experimental, investigational, or unproven and is not covered.

Conditions Not Covered: Any other use is considered experimental, investigational, or unproven.

Definitions

inv-09: Plaque psoriasis — definition and clinical context for the condition treated by topical vitamin D analogs

DefinitionPlaque psoriasis — a chronic inflammatory skin disease for which topical vitamin D analogs (eg, calcipotriene, calcitriol) and combination steroid–vitamin D formulations are indicated for topical treatment of lesions on the body and scalp.

Typical anatomic indicationsTopical vitamin D analogs are indicated for plaque psoriasis of the body and scalp (product-specific labeling varies).

Age-based product indicationsProduct approvals vary by age: calcipotriene cream/ointment/solution and Dovonex for adults; Enstilar and Taclonex for ≥12 years; calcipotriene foam (authorized generic) and Sorilux for ≥4 years; Wynzora for ≥18 years.

Pediatric use noteSeveral formulations have pediatric indications (calcipotriene foam authorized generic, generic calcipotriene–betamethasone ointment, Enstilar, Sorilux, and Taclonex are indicated for some patients <18 years).

Formulation relevanceClinical selection depends on formulation (cream, ointment, solution, foam, or combination with betamethasone) and patient age/location of lesions.

OpenPayer

Topical Vitamin D Analog Products (Non‑Preferred) — Coverage Criteria for Plaque Psoriasis

Coverage and Medical Necessity Criteria

Provider Requirements and Authorization

Background and Clinical Context

Definitions