CurrentCignaPolicy IP0361

Topical Vitamin D Analogs

Defines medical necessity and coverage criteria for non-preferred topical vitamin D analog products (various calcipotriene- and calcitriol-containing formulations) for treatment of plaque psoriasis across Cigna-administered health benefit plans, including employer group and individual/family plan-specific criteria, reauthorization, duration, and exclusions.

Policy Summary

PayerCigna

PolicyTopical Vitamin D Analogs

Policy CodePolicy IP0361

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review Date

Key ActionFormulary exceptions require documentation that product-specific coverage criteria are met, including age criteria, trials of generics, failures/intolerances, or documented allergy to inactive ingredients.

SourceLink

POLICY UPDATE CHANGES

No material changes

8Non-preferred products listed

12 monthsInitial authorization duration

12 monthsReauthorization duration

4Pediatric minimum age mentioned (≥4 years)

Coverage Summary

Topical Vitamin D Analogs — Key Stats

Non-preferred products listed8

Initial authorization duration12 months

Reauthorization duration12 months

Pediatric minimum age mentioned4

Medical Necessity Criteria

Employer Group Non-Preferred Products - Medical Necessity Criteria

Coverage criteria for listed non-preferred topical vitamin D products for treatment of plaque psoriasis; product-specific criteria follow.

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Employer Group Non-Preferred Products - Medical Necessity Criteria

Individual and Family Plan Non-Preferred Products - Medical Necessity Criteria

Product-specific criteria for individual/family plans when Calsodore coverage is requested.

ALL of the following

Calsodore (calcipotriene 0.005% cream) considered medically necessary when:
- Trial of calcipotriene 0.005% cream (generic for Dovonex)
- Cannot take that product due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction

Reauthorization / Continuation Criteria

Continuation of therapy requires ongoing benefit.

ALL of the following

Initial criteria are met
Beneficial response is demonstrated

Product List / Coding

Product list (no billing codes specified)mixed

calcipotriene 0.005% foam	authorized generic; non-preferred product referenced
Calsodore (calcipotriene 0.005% cream)	non-preferred product
Dovonex (calcipotriene 0.005% cream)	non-preferred product
Enstilar (calcipotriene 0.005%/betamethasone 0.064% foam)	non-preferred product
Sorilux (calcipotriene 0.005% foam)	non-preferred product
Taclonex (calcipotriene 0.005%/betamethasone 0.064% ointment)	non-preferred product
Vectical (calcitriol 3 mcg/gm ointment)	non-preferred product
Wynzora (calcipotriene/betamethasone dipropionate 0.005%/0.064% cream)	non-preferred product

Provider Actions

Prior Authorization

Medical necessity review for formulary exceptions

Formulary exceptions for non-preferred topical vitamin D analog products require documentation that product-specific coverage criteria are met (age criteria, trials of generics, failures/intolerances, or documented allergy to inactive ingredients).

Documentation Required

Trial and intolerance documentation

Providers must document trials of specified bioequivalent generic products and reason for inability to use them (formulation difference causing significant allergy or serious adverse reaction) or documentation of failures/intolerance to required prior therapies.

Billing Rule

Sample products not acceptable for coverage criteria

Receipt of sample product does not satisfy criteria requirements for coverage.

Prior Authorization

Authorization duration

Initial and reauthorization approvals are available for up to 12 months; reauthorization requires demonstrated benefit and that initial criteria remain met.

Background

Topical vitamin D analogs (calcipotriene and calcitriol formulations) are indicated for the treatment of plaque psoriasis, with product-specific age indications (for example, some products are indicated for adults only, Enstilar and Taclonex for patients ≥ 12 years, and calcipotriene foam and Sorilux for patients ≥ 4 years). This policy guides formulary exception medical necessity review for non-preferred topical vitamin D analog products and lists product-specific criteria (age criteria, trials of bioequivalent generics, documented failures/intolerances, or documented allergy to inactive ingredients).

Plan scope: This Coverage Policy applies to health benefit plans administered by Cigna Companies. Coverage for topical vitamin D products varies across plans; benefits are ultimately determined by the applicable customer benefit plan document and certain Cigna entities may provide utilization review services only. Receipt of sample product does not satisfy criteria requirements for coverage.

Formulation difference in inactive ingredient(s): An inactive ingredient variation that would result in a significant allergy or serious adverse reaction preventing use of the bioequivalent generic product.