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Alinia Quantity Limit Program Summary
Policy Number: PH-1110
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Alinia® (nitazoxanide) Tablet* Suspension |
Oral suspension (patients 1 year of age and older) and tablets (patients 12 years of age and older) indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum Limitations of Use:
|
* generic available |
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Infectious Diarrhea |
Persistent watery diarrhea generally should not be treated in the absence of an identified cause. When persistent diarrhea is caused by infection, the most common etiologic agents are protozoal (including parasites such as Giardia lamblia, Cryptosporidium species, Cyclospora cayetanensis, and Cystoisospora belli) and are best managed with pathogen-specific therapy (rather than empiric therapy before the infection is diagnosed).(7) Giardiasis is caused by the anaerobic protozoan parasite Giardia duodenalis (e.g., G. lamblia or G. intestinalis). Effective treatments include metronidazole, tinidazole, and nitazoxanide. Among the many protozoan parasites in the genus Cryptosporidium, the species C. hominis and C. parvum cause greater than 90% of human infections. Nitazoxanide is FDA approved as a treatment of cryptosporidiosis in immunocompetent patients.(8) IBM Micromedex lists the following non-FDA approved uses with a Class IIa Strength of Recommendation (treatment is generally considered to be useful, and is indicated in most cases) or higher:
Nitazoxanide and metronidazole have been similarly effective in treating symptomatic intestinal giardiasis in children.(6) |
Number |
Reference |
1 |
Alinia prescribing information. Romark, L.C. January 2022. |
2 |
IBM Micromedex. Alinia Non-FDA Uses. Last modified February 2024. |
3 |
Kabil SM, El Ashry E, Ashraf NK. An open-label clinical study of nitazoxanide in the treatment of human fascioliasis. Curr Ther Res 2000;61(6):339-345. |
4 |
Rossignol J-F, Ayoub A, Ayers MS. Treatment of Diarrhea caused by Giardia intestinalis and Entamoeba histolytica or E. dispar: A Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide. J Infect Dis. 2001;184(3):381-384. |
5 |
Abaza H, El-Zayadi AR, Kabil SM, Rizk H. Nitazoxanide in the treatment of patients with intestinal protozoan and helminthic infections: A report on 546 patients in Egypt. Curr Ther Res Clin Exp 1998;59(2):116-121. |
6 |
Ortiz JJ, Ayoub A, Gargala G, Chegne NL, Favennec L. Randomized Clinical Study of Nitazoxanide Compared to Metronidazole in the Treatment of Symptomatic Giardiasis in Children from Northern Peru. Aliment Pharm Ther. 2001;15(9):1409-15. |
7 |
2017 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infec Dis. 2017 Dec;65:e45-e80. |
8 |
2020 Centers for Disease Control and Prevention (CDC) Yellow Book: Health Information for International Travel. |
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Alinia |
Nitazoxanide For Susp 100 MG/5ML |
100 MG/5ML |
300 |
mLs |
90 |
DAYS |
|
|
|
Alinia |
Nitazoxanide Tab 500 MG |
500 MG |
12 |
Tablets |
90 |
DAYS |
|
|
|
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Alinia |
Nitazoxanide For Susp 100 MG/5ML |
100 MG/5ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Alinia |
Nitazoxanide Tab 500 MG |
500 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when BOTH of the following are met:
Length of Approval: up to 3 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Alinia__QL _ProgSum_ 10-01-2024
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