Antiprotozoals Prior Authorization — Georgia Medicaid FFS
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Rules for prior authorization (PA), coverage criteria, preferred and non-preferred antiprotozoal drugs for Georgia Medicaid Fee-for-Service members; affects prescribers and pharmacists submitting PA requests.
No material clinical or coverage changes in this revision.
Coverage Criteria for Antiprotozoals
Benznidazole (Chagas disease)
Benznidazole generic approvable when ALL of the following are met:
Lampit (nifurtimox) for pediatric Chagas
Lampit (nifurtimox) approvable when ALL of the following are met:
Daraprim (pyrimethamine) indications and prophylaxis
Daraprim (pyrimethamine) approvable when ANY applicable scenario applies:
Non-preferred metronidazole (375 mg)
Flagyl 375 mg and metronidazole 375 mg (non-preferred) approvable when ALL of the following are met:
Letter of medical necessity must explain why preferred products are inappropriate; PA requests may be initiated per DCH guidance.
Nitazoxanide approvals
Nitazoxanide generic approvable when ALL of the following are met:
Toxoplasmosis prophylaxis criteria
Toxoplasmosis prophylaxis notes (Daraprim and other agents):
CDC does not recommend pyrimethamine for malaria treatment or prophylaxis; a written letter of medical necessity is required for malaria use.
The Centers for Disease Control and Prevention (CDC) does not recommend the use of pyrimethamine (Daraprim) for the treatment or prophylaxis of malaria. If pyrimethamine is requested for malaria treatment or prophylaxis, the prescriber must submit a written letter of medical necessity explaining why all other antimalarial agents are not appropriate for the member.
Non-preferred products including Flagyl 375 mg and generic metronidazole 375 mg require prior authorization and supporting documentation. The prescriber must submit a written letter of medical necessity that explains why preferred metronidazole products (250 mg or 500 mg) are not appropriate for the member; if generic metronidazole 375 mg is approved, authorization will be issued for the brand Flagyl 375 mg as well.
Coding and Clinical Limits
| NDC/HCPCS not listed | Document lists drug names and strengths but includes no billing codes. |
Provider Authorization, Documentation, and Step Therapy Requirements
Prior authorization required for selected antiprotozoals
Certain antiprotozoals listed as preferred still require prior authorization. The PA request must demonstrate that the specific clinical criteria for the agent are met (for example, diagnostic confirmation for Chagas, specialist prescribing/consultation, age/weight limits, or prior intolerance/ineffectiveness of alternatives) as detailed for each drug.
- Benznidazole, Daraprim (pyrimethamine), and Lampit (nifurtimox) are preferred but require prior authorization.
- PA documentation must include evidence required for the specific agent (e.g., confirmed diagnosis by listed tests for Chagas; infectious disease specialist prescribing or consultation; age/weight criteria; prior intolerance or contraindication to first-line therapy).
Step therapy / sequencing enforced for select agents
Therapy sequencing is enforced for some indications: Lampit (nifurtimox) is reserved for pediatric members (≤17 years and ≥2.5 kg) only after ineffectiveness, allergy, contraindication, interaction or intolerable side effect to benznidazole; nitazoxanide for Giardia is approvable after ineffectiveness or intolerance to metronidazole and tinidazole.
- Lampit: member aged 2–17 must have experienced ineffectiveness, allergy, contraindication, drug-drug interaction or intolerable side effect to benznidazole.
- Nitazoxanide: approvable for Giardia in members ≥12 years after ineffectiveness, allergies, contraindications, interactions or intolerable side effects to metronidazole and tinidazole.
Letter of medical necessity required for non‑preferred metronidazole 375 mg
When requesting non-preferred metronidazole 375 mg (or brand Flagyl 375 mg), the prescriber must submit a written letter of medical necessity explaining why the preferred metronidazole products (250 mg or 500 mg) are not appropriate for the member.
- If generic metronidazole 375 mg is approved, the PA will be issued for brand Flagyl 375 mg.
- Letter must state reasons preferred products are not appropriate.
Exceptions considered via PA; risk of denial without PA
Exceptions to coverage may be considered through the prior authorization process; failure to obtain a required PA may result in denial of coverage.
- Exceptions are considered via the PA process; to initiate PA call OptumRx at 1-866-525-5827 or use the online PA Request Process Guide.
- Failure to obtain prior authorization for PA-required agents may lead to denial.
Background
This policy governs prior authorization and coverage of antiprotozoal agents for Georgia Medicaid Fee‑for‑Service members and applies to prescribers and pharmacists who submit PA requests. It specifies agents covered with criteria (including benznidazole, nifurtimox/Lampit, pyrimethamine/Daraprim, metronidazole formulations, and nitazoxanide), required diagnostic confirmation for certain indications, specialist involvement where noted, age and weight limits for pediatric use, and documentation requirements such as letters of medical necessity when requesting non‑preferred products or when an agent (e.g., pyrimethamine) is sought for an indication not recommended by the CDC. Failure to obtain required prior authorization may result in denial of coverage.
Diagnostic and Clinical Confirmation Definitions
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