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ph-91110

Alinia Quantity Limit Program Summary

Policy Number: PH-91110

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, SourceRx-Performance, and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Alinia^® (nitazoxanide) Tablet* Suspension	Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum Limitations of Use: Alinia has not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients	* generic available	1

Agent(s)

FDA Indication(s)

Notes

Ref#

Alinia^®

(nitazoxanide)

Tablet*

Suspension

Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum

Limitations of Use:

Alinia has not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients

* generic available

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 (NTZ). Among the many protozoan parasites in the genus Cryptosporidium, the species C. hominis and C. parvum cause greater than 90% of human infections. NTZ is FDA labeled as a treatment of cryptosporidiosis in immunocompetent patients 1 year of age or older.(8)

Merative Micromedex lists the following non-FDA labeled uses with a Class IIa Strength of Recommendation (treatment is generally considered to be useful, and is indicated in most cases) or higher:(2)

Infection by Fasciola in adults and children (12 years or older)
- NTZ appeared to be well tolerated and effective when used in the treatment of human fascioliasis, in an open-label study. Patients received an oral regimen of NTZ 500 mg twice daily for 6 consecutive days.(3)
General intestinal parasitism in adults and pediatrics
- A 3-day course of NTZ 500 mg twice daily was a safe and effective treatment for diarrhea associated with infection by the intestinal parasites Giardia intestinalis, Entamoeba histolytica, or Entamoeba dispar.(4)
- Results of a large field study in Egypt indicate that NTZ is safe and effective for treating intestinal protozoan and helminthic infections. Patients took medication with food at 12-hour intervals over 3 days; those older than 12 years received 500 mg of NTZ, children aged 4 to 11 years received 200 mg of drug, and children aged 1 to 3 years received 5 mL of a 100 mg per 5-mL suspension.(5)
- NTZ and metronidazole have been similarly effective in treating symptomatic intestinal giardiasis in children.(6)

Number	Reference
1	Alinia prescribing information. Lupin Pharmaceuticals, Inc. July 2016.
2	Alinia Non-FDA uses. Merative Micromedex. Last Modified: November 12, 2024. https://www.micromedexsolutions.com
3	Kabil SM, Ashry EE, Ashraf NK. An open-label clinical study of nitazoxanide in the treatment of human fascioliasis. Current Therapeutic Research. 2000;61(6):339-345. doi:10.1016/s0011-393x(00)80003-x
4	Rossignol J, 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. The Journal of Infectious Diseases. 2001;184(3):381-384. doi:10.1086/322038
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. Current Therapeutic Research. 1998;59(2):116-121. doi:10.1016/s0011-393x(98)85006-6
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. Alimentary Pharmacology & Therapeutics. 2001;15(9):1409-1415. doi:10.1046/j.1365-2036.2001.01066.x
7	Shane AL, Mody RK, Crump JA, et al. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clinical Infectious Diseases. 2017;65(12):e45-e80. doi:10.1093/cid/cix669
8	Centers for Disease Control and Prevention (CDC) Yellow Book 2024: Health Information for International Travel. https://wwwnc.cdc.gov/travel/page/yellowbook-home

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 ; SourceRx-Performance
Alinia	Nitazoxanide Tab 500 MG	500 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

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: The patient has ONE of the following diagnoses: Diarrhea caused by Giardia lamblia or Cryptosporidium parvum OR Adult with Fasciola infection OR General intestinal parasitism AND ONE of the following: BOTH of the following: The patient has been re-infected AND requires an additional course of therapy AND ONE of the following: The requested quantity (dose) is less than or equal to the ONE of the following: For diarrhea caused by Giardia lamblia or Cryptosporidium parvum, 3000 mg over 3 days OR For adults with Fasciola infection, 6000 mg over 6 days OR For general intestinal parasitism, 3000 mg over 3 days OR There is support for therapy with a higher dose and/or duration for the requested indication OR BOTH of the following: The request is for a higher dose and/or duration of therapy for the same infection AND There is support for therapy with a higher dose and/or duration for the requested indication Length of Approval: up to 3 months

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when BOTH of the following are met:

The patient has ONE of the following diagnoses:
1. Diarrhea caused by Giardia lamblia or Cryptosporidium parvum OR
2. Adult with Fasciola infection OR
3. General intestinal parasitism AND
ONE of the following:
1. BOTH of the following:
  1. The patient has been re-infected AND requires an additional course of therapy AND
  2. ONE of the following:
    1. The requested quantity (dose) is less than or equal to the ONE of the following:
      1. For diarrhea caused by Giardia lamblia or Cryptosporidium parvum, 3000 mg over 3 days OR
      2. For adults with Fasciola infection, 6000 mg over 6 days OR
      3. For general intestinal parasitism, 3000 mg over 3 days OR
    2. There is support for therapy with a higher dose and/or duration for the requested indication OR
2. BOTH of the following:
  1. The request is for a higher dose and/or duration of therapy for the same infection AND
  2. There is support for therapy with a higher dose and/or duration for the requested indication

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.