Nitazoxanide (Alinia) Form

Nitazoxanide (Alinia®) is a synthetic antiprotozoal agent. FDA Approved Indication(s) Alinia is indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitation(s) 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.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Alinia is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Cryptosporidiosis (must meet all):

1. Diagnosis of infectious diarrhea caused Cryptosporidium parvum;
   2. Member meets one of the following (a or b): a. Request for suspension: Age ≥ 1 year; b. Request for tablets: Age ≥ 12 years;
2. Member is not immunodeficient or infected with human immunodeficiency virus (HIV);
3. For members age ≥ 12 years, request is for generic nitazoxanide tablets, unless contraindicated (e.g., contraindications to excipients), clinically significant adverse effects are experienced, or medical justification supports inability to swallow tablets;

4. Dose does not exceed one of the following (a or b): a. Request for suspension and member meets one of the following (i, ii, or iii): i. Age ≥ 1 year and < 4 years: 200 mg (10 mL) per day for up to 3 days; ii. Age ≥ 4 years and < 12 years: 400 mg (20 mL) per day for up to 3 days; iii. Age ≥ 12 years: 1,000 mg (50 mL) per day for up to 3 days; b. Request for tablets: 1,000 mg (2 tablets) per day for up to 3 days. Approval duration: 1 month Page 1 of 5

   CLINICAL POLICY Nitazoxanide B. Giardiasis (must meet all):

5. Diagnosis of infectious diarrhea caused by Giardia lamblia;
   2. Member meets one of the following (a or b): a. Request for suspension: Age ≥ 1 year; b. Request for tablets: Age ≥ 12 years;
6. Failure of a 5-day course of metronidazole for this episode, unless contraindicated, clinically significant adverse effects are experienced, or culture/sensitivity testing showing antibiotic resistance to metronidazole;
7. For members age ≥ 12 years, request is for generic nitazoxanide tablets, unless contraindicated (e.g., contraindications to excipients), clinically significant adverse effects are experienced, or medical justification supports inability to swallow tablets;
8. Dose does not exceed one of the following (a or b): a. Request for suspension and member meets one of the following (i, ii, or iii): i. Age ≥ 1 year and < 4 years: 200 mg (10 mL) per day for up to 3 days; ii. Age ≥ 4 years and < 12 years: 400 mg (20 mL) per day for up to 3 days; iii. Age ≥ 12 years: 1,000 mg (50 mL) per day for up to 3 days; b. Request for tablets: 1,000 mg (2 tablets) per day for up to 3 days. Approval duration: 1 month C. Other diagnoses/indications (must meet 1 or 2):
9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
    II. Continued Therapy A. Cryptosporidiosis and Giardiasis
11. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):

12. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or Page 2 of 5

    CLINICAL POLICY Nitazoxanide b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

13. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace. III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies: HIM.PA.154 for health insurance marketplace or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HIV: human immunodeficiency virus
    Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Metronidazole (Flagyl®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Giardiasis
    250 mg orally 3 times daily Duration 5 days Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Hypersensitivity • Boxed warning(s): None reported V. Dosage and Administration
    Indication Cryptosporidiosis and Giardiasis Oral Suspension
    Cryptosporidiosis and Giardiasis Tablets
    Dosing Regimen • Age 1-3 years: 5 mL oral suspension (100 mg) every Duration 3 days 12 hours with food • Age 4-11 years: 10 mL oral suspension (200 mg) every 12 hours with food • Age ≥ 12 years: 25 mL oral suspension (500 mg) every 12 hours with food • 12 years and older: 1 tablet (500 mg) every 12 hours 3 days with food
    Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger Page 3 of 5

    CLINICAL POLICY Nitazoxanide VI. Product Availability
    • Tablets: 500 mg • Oral Suspension: 100 mg/5 mL VII.