Subject: Aldara Limit 2959-H 08-2022

Drug

ALDARA  (imiquimod cream 5%)

Policy:

FDA-approved Indications          
Actinic Keratosis
Imiquimod cream 5% 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.

LIMIT CRITERIA
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.

 

 

RATIONALE
Imiquimod cream 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adults. 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. Imiquimod cream 5% is also indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older.^1-4

For the treatment of actinic keratosis, imiquimod cream 5% should be applied two times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm² (e.g., 5 cm x 5 cm) on the face (e.g., forehead or one cheek) or on the scalp. No more than one packet of imiquimod cream 5% should be applied to the contiguous treatment area at each application. Unused packets should be discarded; partially used packets should be discarded and not reused. Patients should be prescribed no more than 36 packets for the 16-week treatment period.¹

For the treatment of Superficial Basal Cell Carcinoma (sBCC), imiquimod cream 5% should be applied five times per week for a full six weeks to a biopsy-confirmed sBCC. The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Unused packets should be discarded; partially used packets should be discarded and not reused. Patients should be prescribed no more than 36 packets for the 6-week treatment period.¹

For treatment of external genital warts, imiquimod cream 5% should be applied three times per week to external genital/perianal warts. Imiquimod cream 5% treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Each single-use packet of imiquimod cream 5% contains sufficient cream to cover a wart area of up to 20 cm²; use of excessive amounts of cream should be avoided.¹

Imiquimod cream 5% is supplied in single-use packets, each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Imiquimod cream 5% is supplied in boxes of 12 or 24 packets each.^1-2

Therefore, the quantity limit is set to 24 packets per 4 weeks, which allows a quantity sufficient for all Food and Drug Administration (FDA) approved indications. If the patient is requesting more than the initial quantity limit, the claim will reject with a message indicating that quantity limits are exceeded.

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; April 2018.
2. Imiquimod Cream 5% [package insert]. Mahwah, NJ: Glenmark Pharmaceuticals Inc., USA; March 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed June 24, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed June 24, 2022.

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 10, 2022