Subject: Aldara Limit Policy 2959-H UDR 08-2023

Drug

ALDARA  (imiquimod cream 5%)

Policy:

FDA-APPROVED INDICATIONSActinic Keratosis
Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
Superficial Basal Cell Carcinoma
Imiquimod cream 5% is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of imiquimod cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.
External Genital Warts
Imiquimod cream 5% is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older.

Limitations of Use
Imiquimod cream 5% has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy.
Unevaluated Populations
The safety and efficacy of imiquimod cream 5% in immunosuppressed patients have not been established. Imiquimod cream 5% should be used with caution in patients with pre-existing autoimmune conditions. The efficacy and safety of imiquimod cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

 

INITIAL LIMIT QUANTITY
Limits should accumulate across all drugs and strengths up to highest quantity listed depending on      the order the claims are processed.
Drug	4 Week Limit*	12 Week Limit*
Aldara (imiquimod cream 5 percent)	24 packets / 21 days	72 packets / 63 days
*The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Aldara Cream 5% [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; June 2022.
2. Imiquimod Cream 5% [package insert]. Mahwah, NJ: Glenmark Pharmaceuticals Inc., USA; March 2021.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 17, 2023