CurrentNeighborhood Health Plan of Rhode IslandPolicy 351-C

Adapalene (topical) prior authorization and quantity limits

Policy governing prior authorization requirements and formulation-specific quantity limits for topical adapalene (brand and generic Differin) for treatment of acne vulgaris; applies to Neighborhood Health Plan of Rhode Island members under CVS Caremark benefit management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdapalene (topical) prior authorization and quantity limits

Policy CodePolicy 351-C

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and ensure requested quantity is within formulation-specific limits; for continuation, submit documentation of clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 moInitial DOA

12 moContinuation DOA

Formulation-specificQuantity limits

Acne vulgarisIndication required

Coverage Criteria

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Coverage Criteria (Initial and Continuation)

Covered when ALL of the following are met:

Indication: The requested drug is being prescribed for the topical treatment of acne vulgaris.

FDA-approved indication required for coverage

Therapy status

Initial therapy: The request is NOT for continuation of therapy.
If initial, approval duration: 4 months
Continuation of therapy: The request is for continuation of therapy.
If continuation, approval duration: 12 months

Clinical response for continuation: For continuation requests, the patient has achieved or maintained a positive clinical response (e.g., reduction in number of lesions).

Supporting documentation required for continuation approvals

Quantity limits: Requested quantity must be within the formulation-specific lower and upper limits for the applicable fill period (4‑week/21‑day and 12‑week/63‑day limits) as specified for each adapalene formulation (examples include solution: 120–240 mL/21 days and 360–720 mL/63 days; cream/gel 0.1%: 45–90 g/21 days and 135–270 g/63 days; swabs and other formulations have specified limits).

Pharmacy may adjust fill to package size within the stated limits; requests exceeding limits without justification based on treated body surface area may be denied

Relevant Codes and Quantity Limits

Relevant product codesNDC

NDC (various)

Document references branded/generic products; specific NDCs not listed in policy.

Quantity limits per fill period — formulation-specific

Gel / Cream (adapalene 0.1% and Differin cream 0.1%)4-week (21-day) limits: 45–90 grams; 12-week (63-day) limits: 135–270 grams.

Differin gel 0.3% (adapalene 0.3%)4-week (21-day) limits: 45–90 grams; 12-week (63-day) limits: 135–270 grams.

Lotion (Differin lotion 0.1%)4-week (21-day) limits: 59–118 mL; 12-week (63-day) limits: 177–354 mL.

Topical solution (adapalene solution)4-week (21-day) limits: 120–240 mL; 12-week (63-day) limits: 360–720 mL.

Topical solution (swab)4-week (21-day) limits: 28–56 swabs; 12-week (63-day) limits: 84–168 swabs.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of adapalene (topical retinoids). Approvals are granted when the medication is prescribed for the topical treatment of acne vulgaris and all PA criteria are met.

Applies to adapalene topical products when prescribed for acne vulgaris
Initial and continuation requests require review under PA criteria

Denial Risk

Quantity Limit — Potential Denial Risk

There are defined quantity limits for adapalene topical formulations. Requests that exceed the stated quantity limits, or additional quantities not justified by documented body surface area (BSA) or clinical need, may be denied.

Specified 4‑week and 12‑week quantity limits apply by formulation and strength (see policy quantity table)
Pharmacy may dispense per package size up to the quantity limit; day supply may be less than indicated
Requests > quantity limits require documentation of BSA or other clinical justification

Documentation Required

Clinical Response Documentation Required

Continuation approvals require documentation of a positive clinical response. The patient must have achieved or maintained improvement (for example, reduction in number of lesions) to support ongoing coverage.

Document objective clinical improvement for continuation requests (lesion counts, clinician assessment, photographs, or other notes)
Lack of documented positive response may result in denial of continued therapy

Step Therapy

No explicit step-therapy agents are listed in this policy; however, coverage is limited to the specified indication and PA criteria. Ensure the requested product meets indication and PA requirements before submission.

There are no stated step-therapy (fail-first) requirements in this policy document
Verify indication and PA criteria rather than trial of alternative agents unless otherwise directed

Denial Risk

Basis for Denial

Requests that do not meet the prior authorization and coverage criteria (for example, prescribed for a non-covered indication or lacking required documentation) will be denied.

Denial likely if medication is requested for indications other than topical acne vulgaris
Denial likely for continuation requests without documented positive clinical response
Denial likely for quantities exceeding limits without BSA/clinical justification

Definitions and Formulations

Adapalene formulations and concentrations

Differin Cream 0.1%Adapalene 0.1% — cream formulation indicated for topical treatment of acne vulgaris.

Adapalene Gel 0.1%Adapalene 0.1% — gel formulation indicated for topical treatment of acne vulgaris.

Differin Gel 0.3%Adapalene 0.3% — gel formulation indicated for topical treatment of acne vulgaris in patients ≥12 years.

Differin Lotion 0.1%Adapalene 0.1% — lotion formulation indicated for topical treatment of acne vulgaris in patients ≥12 years.

Adapalene Topical Solution 0.1% (including swab)Adapalene 0.1% — topical solution (and swab) indicated for topical treatment of acne vulgaris.

Background

Adapalene topical products (various gel, cream, lotion, and topical solution/swab formulations) are FDA-approved retinoid therapies for the topical treatment of acne vulgaris. Some formulations carry age indications— for example, Differin Gel 0.3% and Differin Lotion 0.1% are indicated for patients aged 12 years and older—while other 0.1% formulations are approved per their labeled indications. These products are intended for topical application to reduce acne lesions and are the basis for the prior authorization and quantity-limit framework in this policy.