CurrentCentenePolicy HIM.PA.152

Nitazoxanide (Alinia) coverage

Defines medical necessity and prior authorization criteria for nitazoxanide (Alinia) for treatment of cryptosporidiosis and giardiasis for members under Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyNitazoxanide (Alinia) coverage

Policy CodePolicy HIM.PA.152

Change TypeClarified/revised/added

Effective Date12.01.20

Next Review Date

Key ActionPrior authorization is required and approved when indication-specific criteria and dosing/age/formulation requirements are met.

SourceLink

POLICY UPDATE CHANGES

For all indications, clarified that member must use generic formulation if age ≥ 12 years.

For cryptosporidiosis, revised requirement that members with HIV infection must currently use antiretroviral therapy per HIV guidelines.

Step therapy bypass for Illinois HIM per IL HB 5395 was added for giardiasis.

2FDA-approved indications

3Max duration (days)

≥12Age threshold

On ARTHIV requirement

Coverage Criteria

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Initial Approval — Cryptosporidiosis

Covered when ALL of the following are met:

Cryptosporidiosis initial approval: 1) Diagnosis of infectious diarrhea caused by Cryptosporidium parvum; 2) Age: request for suspension and age ≥ 1 year OR request for tablets and age ≥ 12 years; 3) Immunologic status: member is not immunodeficient OR if HIV-infected, member is currently on antiretroviral therapy; 4) For members ≥ 12 years, use generic nitazoxanide tablets unless contraindicated, clinically significant adverse effects occur, or there is documented inability to swallow tablets; 5) Dose does not exceed age-specific dosing for up to 3 days: for suspension—age 1–3 years 200 mg/day (10 mL), age 4–11 years 400 mg/day (20 mL), age ≥ 12 years 1,000 mg/day (50 mL); for tablets—1,000 mg/day (2 tablets).duration <= 3 days

Approval duration: 1 month

Initial Approval — Giardiasis

Covered when ALL of the following are met:

Giardiasis initial approval: 1) Diagnosis of infectious diarrhea caused by Giardia lamblia; 2) Age: request for suspension and age ≥ 1 year OR request for tablets and age ≥ 12 years; 3) Failure of a 5-day course of metronidazole for this episode unless contraindicated, clinically significant adverse effects are experienced, or culture/sensitivity testing shows resistance (note: Illinois HIM requests bypass of this step therapy as of 1/1/2026 per IL HB 5395); 4) For members ≥ 12 years, use generic nitazoxanide tablets unless contraindicated, clinically significant adverse effects occur, or there is documented inability to swallow tablets; 5) Dose does not exceed age-specific dosing for up to 3 days: for suspension—age 1–3 years 200 mg/day (10 mL), age 4–11 years 400 mg/day (20 mL), age ≥ 12 years 1,000 mg/day (50 mL); for tablets—1,000 mg/day (2 tablets).duration <= 3 days

Approval duration: 1 month

Other Indications

Covered when ONE of the following is met:

Other uses: 1) If the drug has undergone a label change within the last 6 months not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the line of business (e.g., HIM.PA.33 or HIM.PA.103); 2) If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy HIM.PA.154 for the relevant line of business.

See related policies HIM.PA.33, HIM.PA.103, HIM.PA.154

Continued Therapy

Continuation is not permitted:

Continued therapy: Re-authorization is not permitted for cryptosporidiosis or giardiasis; members must meet the initial approval criteria for each episode.

Approval duration: Not applicable

Non‑FDA‑approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (see HIM.PA.154) or other applicable evidence of coverage documents.

Use of nitazoxanide for non‑FDA‑approved indications without sufficient supporting evidence is not authorized. The agent is FDA‑approved only for diarrhea caused by Giardia lamblia and Cryptosporidium parvum, and the product has not been shown effective for treatment of C. parvum diarrhea in HIV‑infected or immunodeficient patients unless criteria in this policy (for example, documented antiretroviral therapy) are met. For off‑label requests, submit documentation per HIM.PA.154.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved when the indication-specific criteria in the policy are met. Provider must submit supporting clinical documentation (such as office chart notes, lab results, or other pertinent clinical information) demonstrating that the member meets all approval criteria.

Prior authorization required for Alinia (nitazoxanide) for indicated infections per policy HIM.PA.152

Documentation Required

Documentation Requirement

Provider must submit documentation (such as office chart notes, laboratory results, culture/sensitivity testing, medication history, or other clinical information) that supports the member meets all approval criteria. Failure to provide requested documentation may result in a denial of the request.

Examples of acceptable documentation: symptom history, diagnostic test results identifying Cryptosporidium parvum or Giardia lamblia, prior medication trial records, and adverse reaction documentation.

Step Therapy

Step Therapy for Giardiasis

Step therapy: For giardiasis, member must have failed a 5-day course of metronidazole for the current episode before nitazoxanide will be approved, unless metronidazole is contraindicated, clinically not tolerated, or culture/sensitivity testing documents resistance. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 (effective 01/01/2026).

Step therapy: failure of metronidazole (5-day course) required unless contraindicated or resistance documented.
IL exception: IL HIM requests bypass step therapy requirement per IL HB 5395 effective 01/01/2026.

Revision History

07.25.24annual_review

4Q 2024 annual review: clarified that members ≥12 years must use generic formulation and revised cryptosporidiosis requirement that HIV‑infected members must currently be on antiretroviral therapy per HIV guidelines; references reviewed and updated.

11.24p_and_t_approval

P&T approval of 4Q 2024 annual review updates (generic formulation requirement and HIV/ART clarification for cryptosporidiosis).

07.09.25annual_review

4Q 2025 annual review: added step therapy bypass for Illinois HIM per IL HB 5395; references reviewed and updated.

11.25p_and_t_approvalLatest

P&T approval of 4Q 2025 annual review updates (added IL HIM step therapy bypass per IL HB 5395).

OpenPayer

Nitazoxanide (Alinia) coverage

Coverage Criteria

Coding and Duration

Provider Actions and Requirements

Background

Definitions

Revision History