CurrentCignaPolicy N/A

Isotretinoin Step Therapy Policy

Defines a step therapy program for oral isotretinoin products administered by Cigna, designating Step 1 (preferred/generic and certain brands) and Step 2 (Absorica, Absorica LD) products and the criteria for coverage of Step 2 products. Approvals are for one year.

Policy Summary

PayerCigna

PolicyIsotretinoin Step Therapy Policy

Policy CodePolicy N/A

Change Typeclarified; revised

Effective DateN/A

Next Review DateN/A

Key ActionProviders must document that the patient has tried one Step 1 isotretinoin product before coverage of a Step 2 product will be approved; Absorica with DAW 9 counts as a Step 1 trial.

SourceLink

POLICY UPDATE CHANGES

Policy reiterates that Absorica with DAW 9 counts as a Step 1 product.

Annual revision performed with no criteria changes.

2Step 2 Products

7Step 1 Products Listed

Coverage Summary

Defines a step therapy program for oral isotretinoin products administered by Cigna, designating Step 1 (preferred/generic and certain brands) and Step 2 (Absorica, Absorica LD) products and the criteria for coverage of Step 2 products. Step 1 products are preferred first-line, and a trial of one Step 1 product is required before approval of a Step 2 product unless criteria are met. The policy notes that Absorica dispensed with DAW 9 counts as a Step 1 product. Approvals are provided for 1 year in duration.

Step Therapy Criteria (Initial)

Step Therapy Criteria

Isotretinoin Step Therapy policy product(s) is(are) covered as medically necessary when the following step therapy criteria is(are) met...

ALL of the following

Patient tried Step 1 Product: The patient has tried one Step 1 Product prior to the Step 2 Product; if this is met, approve a Step 2 Product.
Absorica dispensed with DAW 9 counts as a Step 1 Product.

Step 1 Products (examples)

Not Medically Necessary / Limitations

Requests that do not meet the specified step therapy criteria for isotretinoin (i.e., documentation of a trial of one Step 1 product prior to Step 2) are considered not medically necessary. All approvals are limited to a duration of 1 year, and no other exceptions to the step therapy requirements are described in the brief.

Applicable Products / Codes

Step 1 Products (preferred first-line for step therapy)mixedCovered

Accutane	isotretinoin capsules - JG Pharma, generic
Amnesteem	isotretinoin capsules - Mylan, generic
Claravis	isotretinoin capsules - Teva, generic
isotretinoin (generic)	all true generic isotretinoin products
Myorisan	isotretinoin capsules - Akorn (brand obsolete 02/23/2023)
Zenatane	isotretinoin capsules - Dr Reddy's, generic
Authorized generic to Absorica (from Sun Pharmaceuticals)	authorized generic

Step 2 Products (require Step 1 trial unless criteria met)mixed

Absorica	isotretinoin capsules - Sun
Absorica LD	isotretinoin capsules - Sun

Provider Actions & Authorization

Step Therapy

Step 1 trial required prior to Step 2 approval

Providers must document that the patient has tried one Step 1 isotretinoin product before coverage of a Step 2 product (Absorica or Absorica LD) will be approved; Absorica with DAW 9 counts as a Step 1 trial.

Documentation Required

Approval duration

All approvals are provided for 1 year in duration; documentation should support date of trial of Step 1 product.

Definitions & Background

Isotretinoin is indicated for severe recalcitrant nodular acne. The policy’s aim is to encourage use of Step 1 products before Step 2 branded formulations (i.e., require a Step 1 trial prior to coverage of Absorica or Absorica LD). Multiple branded and generic oral isotretinoin products and strengths are available across the listed products and formulations.

DAW 9: Dispense as written - substitution allowed by prescriber but plan requests brand; for this policy, Absorica with DAW 9 counts as a Step 1 product.

Revision History

01/17/2024revised

Annual revision performed with no criteria changes.

01/15/2025revised

Annual revision performed with no criteria changes.

01/14/2026revisedLatest

Annual revision performed with no criteria changes.

01/14/2026clarifiedLatest

DAW 9 notation will be accepted as evidence of Step 1 trial for step therapy purposes. Policy reiterates that Absorica with DAW 9 counts as a Step 1 product.

Policy Summary

PayerCigna

PolicyIsotretinoin Step Therapy Policy

Policy CodePolicy N/A

Change Typeclarified; revised

Effective DateN/A

Next Review DateN/A

Key ActionProviders must document that the patient has tried one Step 1 isotretinoin product before coverage of a Step 2 product will be approved; Absorica with DAW 9 counts as a Step 1 trial.

SourceLink

On This Page

OpenPayer

Isotretinoin Step Therapy Policy

Coverage Summary

Step Therapy Criteria (Initial)

Not Medically Necessary / Limitations

Applicable Products / Codes

Provider Actions & Authorization

Definitions & Background

Clinical Evidence

Revision History