CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

nitazoxanide (Alinia) coverage and limits

This document governs coverage, FDA indications, age edits, quantity/duration limits, and compendial uses for nitazoxanide (Alinia) products for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policynitazoxanide (Alinia) coverage and limits

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization when requested quantities exceed the stated 1-month limits or when fill durations other than monthly supplies are requested.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Giardia & CryptosporidiumFDA-approved indications listed

Not effective in immunodeficient patientsCryptosporidium limitation

>=1 yrSuspension age edit

>=12 yrTablet age edit

25-day supplyProcessing supply rule

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Standard coverage criteria

Covered when ALL of the following are met

FDA indication and product match: Prescription is for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum and the formulation matches product age requirements (oral suspension for patients >= 1 year; tablets for patients >= 12 years).

Refer to product-specific age edits.

Quantity and duration limits: Requested quantity does not exceed the 1-month limits: 540 mL per 25 days for Alinia 100 mg/5 mL oral suspension; 20 tablets per 25 days for Alinia 500 mg tablets. Fills are for one month at a time and the 25-day duration is used for processing.

Limits do not accumulate across strengths; 3-month supplies do not apply.

Immunodeficiency consideration: Provider acknowledges that Alinia (oral suspension or tablets) has not been shown to be effective for treatment of Cryptosporidium parvum diarrhea in HIV-infected or immunodeficient patients.

Document clinical rationale when used in immunodeficient patients; lack of demonstrated effectiveness is a limitation of use.

Treatment of diarrhea caused by Cryptosporidium parvum in patients who are HIV-infected or otherwise immunodeficient is a recognized limitation of use for Alinia products. The labeling states that Alinia (oral suspension and tablets) has not been shown to be effective in these populations; providers should document acknowledgement of this limitation when requesting therapy for immunodeficient patients and consider that effectiveness may be limited or unproven in these cases.

Coding, Age & Quantity Limits

Drug identifiersNDC|mixed

nitazoxanide

Alinia (generic name listed in products table)

inv-04: Oral suspension monthly limit

Oral suspension 1-month limit540 mL per 25 days for Alinia 100 mg/5 mL oral suspension

3-month limitDoes Not Apply for oral suspension

Fill frequencyOne-month fills only; 25-day duration used for 30-day processing

inv-05: Tablet monthly limit

Tablet 1-month limit20 tablets (500 mg) per 25 days for Alinia 500 mg tablets

3-month limitDoes Not Apply for tablets

Fill frequencyOne-month fills only; 25-day duration used for 30-day processing

inv-06: Age edits

Oral suspension age editApproved for patients 1 year of age and older (Alinia 100 mg/5 mL)

Tablet age editApproved for patients 12 years of age and older (Alinia 500 mg tablets)

Age verificationPrescribed formulation must match patient age per product labeling

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests that exceed standard one-month quantities or that request non-standard durations (e.g., multi-month fills or durations other than 25 days). Submit prior authorization documentation when the requested quantity or treatment duration is outside the limits below.

Applies when requested quantity exceeds the per‑month limits listed under "Limit Criteria".
Includes requests for multi-month supplies or durations other than the standard 25‑day (1 month) processing period.

Documentation Required

Required Clinical Documentation

Provide clinical documentation that supports the FDA‑indicated diagnosis and that the patient meets the age and product requirements (e.g., diagnosis of diarrhea caused by Giardia lamblia or Cryptosporidium parvum, age ≥1 year for oral suspension, age ≥12 years for tablets). Documentation should also address any contraindications or reasons therapy is appropriate despite limitations of use (such as immunodeficiency exclusions).

Confirm diagnosis consistent with FDA‑approved indication.
Confirm patient age matches product age edit: suspension ≥1 year; tablets ≥12 years.
If treating Cryptosporidium parvum in an immunocompromised patient, include supporting rationale and relevant specialist consultation notes.

Denial Risk

Quantity Limit Exceedance

Requests that exceed the program quantity limits will require additional review and will generally be denied or routed to prior authorization. Examples of quantity limit exceedance include >540 mL suspension per 25 days or >20 tablets per 25 days.

Exceeding per‑month limits (suspension >540 mL/25 days; tablets >20 tablets/25 days) triggers denial risk or prior authorization review.
3‑month limits do not apply; multi‑month supplies are not intended and will require justification.

Background

Nitazoxanide (Alinia) is an antiparasitic/antiprotozoal agent approved for treatment of diarrhea caused by Giardia lamblia and Cryptosporidium parvum in the indicated age groups. The product labeling for both the oral suspension and tablets includes a specific limitation of use: Alinia has not been shown to be effective for treatment of Cryptosporidium diarrhea in patients who are HIV-infected or otherwise immunodeficient.