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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:

  • Nitazoxanide 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

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:

  • Infection by Fasciola in adults (IIa)(2)
    • Nitazoxanide appeared to be well tolerated and effective when used in the treatment of human fascioliasis, in an open-label study. Adult patients received an oral regimen of nitazoxanide 500 mg twice daily for 6 consecutive days.(3)
  • General intestinal parasitism in adults and pediatrics (IIa)(2)
    • A 3-day course of nitazoxanide (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 nitazoxanide 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 nitazoxanide, 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)

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:

  1. 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
  2. ONE of the following:
    1. The patient has been re-infected AND requires an additional course of therapy AND ONE of the following:
      1. The requested quantity (dose) is less than or equal to 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. The patient is seeking 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

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