CurrentCentenePolicy HIMPA.152

Clinical Policy: Nitazoxanide (Alinia)

Defines medical necessity and prior authorization criteria for nitazoxanide (Alinia) for treatment of Cryptosporidium parvum and Giardia lamblia diarrhea for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Nitazoxanide (Alinia)

Policy CodePolicy HIMPA.152

Change TypeClarified requirementsrevised HIV criterionadded age labeling

Effective Date12.01.20

Next Review Date

Key ActionObtain prior authorization and submit documentation showing the member meets diagnosis, age, dosing and other approval criteria.

SourceLink

POLICY UPDATE CHANGES

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

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

Added FDA label clarification limiting oral tablet use to ages ≥ 12 years.

2FDA-approved indications

3Max recommended duration (days)

500 mgTablet strength

100 mg/5 mLSuspension conc.

Coverage Criteria for Nitazoxanide (Alinia)

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Initial Therapy — Cryptosporidiosis

Covered when ALL of the following are met for Cryptosporidiosis (initial approval):

Cryptosporidiosis initial criteria: 1. Diagnosis of infectious diarrhea caused by Cryptosporidium parvum; 2. Member meets one of the following: a) member is not immunodeficient; OR b) if member has human immunodeficiency virus (HIV) infection, member is currently on antiretroviral therapy; 3. Age and formulation: for tablets, age ≥ 12 years; for oral suspension, age ≥ 1 year; 4. For members age ≥ 12 years, member must use generic nitazoxanide tablets unless contraindicated (e.g., contraindication to excipients), clinically significant adverse effects are experienced, or there is medical justification for inability to swallow tablets; 5. Dosing does not exceed age-based limits per dosing table (suspension: age 1-3 years 200 mg [10 mL] every 12 hours up to 3 days; age 4-11 years 400 mg [20 mL] every 12 hours up to 3 days; age ≥ 12 years 1,000 mg [50 mL] per day up to 3 days; tablets: 1,000 mg [2 tablets] per day up to 3 days); Approval duration: 1 month; re-authorization not permitted.

Dosing specifics: suspension and tablet regimens up to 3 days per dosing table (see Dosage and Administration).

Initial Therapy — Giardiasis

Covered when ALL of the following are met for Giardiasis (initial approval):

Giardiasis initial criteria: 1. Diagnosis of infectious diarrhea caused by Giardia lamblia; 2. Failure of a 5-day course of metronidazole for this episode unless contraindicated, clinically significant adverse effects are experienced, or culture/susceptibility testing demonstrates resistance to metronidazole; 3. Age and formulation: suspension allowed for age ≥ 1 year; tablets only for age ≥ 12 years; 4. For members age ≥ 12 years, member must use generic nitazoxanide tablets unless contraindicated (e.g., contraindication to excipients), clinically significant adverse effects are experienced, or medical justification supports inability to swallow tablets; 5. Dosing does not exceed age-based limits per dosing table (suspension: age 1-3 years 200 mg [10 mL] every 12 hours up to 3 days; age 4-11 years 400 mg [20 mL] every 12 hours up to 3 days; age ≥ 12 years 1,000 mg [50 mL] per day up to 3 days; tablets: 1,000 mg [2 tablets] per day up to 3 days); Approval duration: 1 month; re-authorization not permitted.

Step therapy requires prior metronidazole trial unless contraindicated.

Other Indications / Off-label

Other diagnoses/indications:

Other uses: 1. If the drug is on the formulary/PDL for the relevant line of business, follow the no coverage criteria policy (HIM.PA.33) for that line of business; 2. If the drug is NOT on the formulary/PDL for the relevant line of business, follow the non-formulary policy (HIM.PA.103); 3. If the requested use (diagnosis, age, or dosing regimen) is not specifically listed under diagnoses/indications for which coverage is NOT authorized and the scenario in criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (HIM.PA.154).

For recent label changes (within 6 months) not yet reflected in this policy, follow the referenced policies above.

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

Per the FDA‑approved labeling, nitazoxanide (Alinia) has not been shown to be effective for treatment of diarrhea caused by Cryptosporidium parvum in HIV‑infected or immunodeficient patients. Approval under this policy for such patients requires meeting the specific criteria outlined (for example, documented current antiretroviral therapy for HIV patients) to support likely benefit.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for nitazoxanide (Alinia) for the indications covered by this policy. Providers must obtain approval before dispensing to ensure the member meets the coverage criteria.

Applies to requests for tablets and oral suspension
Approval duration: 1 month

Documentation Required

Required Supporting Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, culture/sensitivity testing, medication history demonstrating prior therapy and response, and any notes explaining contraindications or intolerance to first-line therapies.

Documentation must support that the member meets all approval criteria for the specific indication (Cryptosporidiosis or Giardiasis)
For Giardiasis, include evidence of failure of a 5-day course of metronidazole unless contraindicated or poorly tolerated
For members with HIV, include current antiretroviral therapy status when applicable

Step Therapy

Step Therapy for Giardiasis

Step therapy applies for Giardiasis: nitazoxanide will be approved for Giardiasis only after failure of a 5-day course of metronidazole for the current episode, unless metronidazole is contraindicated, causes clinically significant adverse effects, or culture/sensitivity testing documents resistance.

Document prior metronidazole treatment (dose, duration, and outcome) or provide rationale for why metronidazole is not appropriate
Therapeutic alternative: metronidazole — typical regimen 5 days (see Appendix B)

Denial Risk

PROVIDER ACTIONS — Lack of documentation / denial risk

Lack of adequate documentation may result in denial of the prior authorization request. If clinical notes, lab results, or treatment history are missing or do not clearly demonstrate that approval criteria are met (including step-therapy failure when required), the request will be returned or denied.

Common reasons for denial: no evidence of diagnosis, no documentation of prior metronidazole failure for Giardiasis, missing HIV/antiretroviral therapy information when relevant, no dosing or age justification for formulation requested
If tablets are requested for members age ≥12 years, documentation should show tablets are appropriate or why suspension is required

OpenPayer

Clinical Policy: Nitazoxanide (Alinia)

Coverage Criteria for Nitazoxanide (Alinia)

Product and Formulation Coding / Age Limits

Prior Authorization, Documentation, and Step Therapy

Background and Clinical Context

Contraindications and Definitions