Subject: Alinia Limit Policy 9-I 03-2021

Drug

ALINIA  (nitazoxanide)

Policy:

FDA-APPROVED INDICATIONS                 
Alinia for Oral Suspension (patients 1 year of age and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Alinia for Oral Suspension and Alinia Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Compendial Uses
Human fascioliasis (Fasciola hepatica)
Clostridium difficile colitis

Limit Criteria 
This drug is indicated for short-term acute use.

	1 Month Limit*	Age Edit
Alinia 100 mg/5 mL Oral Suspension  (nitazoxanide)	540 mL per 25 days	1 year of age and older
Alinia 500 mg Tablets  (nitazoxanide	20 tablets per 25 days	12 years of age and older

* These drugs are for short-term acute use; therefore, the mail limit will be the same as the retail limit. The intent is for prescriptions of the requested drug to be filled one month at a time, even if filled at mail order; there should be no 3 month supplies filled.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Alinia [package insert]. Tampa, FL: Romark Laboratories, L.C.; June 2019.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2021; Accessed February 1, 2021.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 1, 2021.
4. Centers for Disease Control. https://www.cdc.gov/parasites/fasciola/health_professionals/index.html#tx Accessed February 2021.
5. L Clifford McDonald, Dale N Gerding, Stuart Johnson, Johan S Bakken, Karen C Carroll, Susan E Coffin, Erik R Dubberke, Kevin W Garey, Carolyn V Gould, Ciaran Kelly, Vivian Loo, Julia Shaklee Sammons, Thomas J Sandora, Mark H Wilcox, Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA), Clinical Infectious Diseases, Volume 66, Issue 7, 1 April 2018, Pages e1–e48, https://doi.org/10.1093/cid/cix1085

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.

August 10, 2021