Subject: Alinia Limit with Age Policy 9-I 03-2023
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.
Limitations of Use
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)2,3
Clostridium difficile colitis2,3
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LIMIT CRITERIA
Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength
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Drug
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1 Month Limit*
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3 Month Limit*
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Age Edit
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Alinia 100 mg/5 mL Oral
Suspension (nitazoxanide)
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540 mL per 25 days
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Does Not Apply*
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1 year of age
and older
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Alinia 500 mg Tablets
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20 tablets per 25 days
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Does Not Apply*
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12 years of age
and older
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* The duration of 25 days is used for a 30-day fill period to allow time for refill processing.
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* 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.
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Place of Service:
Outpatient
The above policy is based on the following references:
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- Alinia [package insert]. Tampa, FL: Romark Laboratories, L.C.; January 2022.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2023; Accessed February 3, 2023.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 3, 2023.
- Centers for Disease Control. https://www.cdc.gov/parasites/fasciola/health_professionals/index.html#tx. Accessed February 3, 2023.
- 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. Accessed February 3, 2023.
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 13, 2023
