CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pyrimethamine (Daraprim) — Coverage Criteria for Toxoplasmosis, PCP Prophylaxis, and Cystoisosporiasis

Criteria and authorization guidance for use of pyrimethamine (Daraprim) for treatment and prophylaxis of toxoplasmosis, Pneumocystis jirovecii pneumonia prophylaxis, and cystoisosporiasis; affects prescribers and pharmacy prior authorization reviewers for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPyrimethamine (Daraprim) — Coverage Criteria for Toxoplasmosis, PCP Prophylaxis, and Cystoisosporiasis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document indication, intolerance/contraindication to sulfamethoxazole/trimethoprim when required, and recent CD4 counts as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDOA — congenital (peds)

3 monthsDOA — treatment/prophylaxis

6 monthsDOA — cystoisosporiasis prophylaxis

<200 cells/mm3CD4 threshold

Coverage Criteria for Pyrimethamine (Daraprim)

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Treatment of Toxoplasmosis

Authorization may be granted for treatment of toxoplasmosis when the following applies:

Toxoplasmosis treatment: Requested drug is being prescribed for treatment of toxoplasmosis

Daraprim is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide (synergism).

Pneumocystis jirovecii pneumonia prophylaxis / Primary prophylaxis of toxoplasmosis

Authorization may be granted when ALL of the following are met:

PCP or primary toxoplasmosis prophylaxis: Patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim

Immunologic threshold: Patient has had a CD4 cell count less than 200 cells/mm3 within the past 3 monthsCD4 < 200 cells/mm3 within 3 months

Secondary prophylaxis of cystoisosporiasis

Authorization may be granted when ALL of the following are met:

Cystoisosporiasis secondary prophylaxis: Patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim

Immunologic threshold: Patient has had a CD4 cell count less than 200 cells/mm3 within the past 6 monthsCD4 < 200 cells/mm3 within 6 months

Secondary prophylaxis of toxoplasmosis

Authorization may be granted when the following criterion is met:

Toxoplasmosis secondary prophylaxis: Patient has had a CD4 cell count of less than 200 cells/mm3 within the past 6 monthsCD4 < 200 cells/mm3 within 6 months

Congenital toxoplasmosis and cystoisosporiasis treatment

Authorization may be granted when the requested drug is being prescribed as follows:

Congenital toxoplasmosis (pediatric): Requested drug is prescribed for treatment of congenital toxoplasmosis in a pediatric patient

Duration of approval (DOA) specified separately

Cystoisosporiasis treatment: Requested drug is prescribed for treatment of cystoisosporiasis and the patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim

Use for cystoisosporiasis without documented intolerance or contraindication to sulfamethoxazole/trimethoprim is not authorized under the listed criteria.

Use of pyrimethamine for cystoisosporiasis is not authorized unless there is documented intolerance or contraindication to sulfamethoxazole/trimethoprim (TMP‑SMX). Requests that do not include evidence the patient cannot take TMP‑SMX should be denied under the policy criteria.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for pyrimethamine when prescribed for the listed indications. Requests lacking an approved prior authorization for these uses may be denied.

Indications covered when PA may be granted: treatment of toxoplasmosis and congenital toxoplasmosis, Pneumocystis jirovecii pneumonia prophylaxis, primary and secondary prophylaxis of toxoplasmosis, treatment and secondary prophylaxis of cystoisosporiasis.

Denial Risk

Denial Risk Conditions

Requests may be denied if the indication-specific authorization criteria are not met. Examples include absence of required clinical information or missing evidence of intolerance/contraindication to sulfamethoxazole/trimethoprim when that is a criterion.

Denial risk if CD4 documentation is not provided when required (e.g., CD4 <200 cells/mm3 within specified timeframe).
Denial risk if no documentation of intolerance/contraindication to TMP‑SMX where listed as a prerequisite.

Documentation Required

Documentation Checklist

Provide documentation supporting the clinical indication and relevant laboratory or clinical data, plus administration or receipt details for the requested therapy.

Document the specific indication (e.g., treatment of toxoplasmosis, congenital toxoplasmosis, cystoisosporiasis).
If applicable, provide CD4 cell count results with date to meet timing windows noted in the criteria (e.g., within past 3 or 6 months).
Include dates and details showing drug receipt or administration when requested.

Step Therapy

Requirement to Document Intolerance/Contraindication to TMP‑SMX

For cystoisosporiasis treatment or secondary prophylaxis, the request must include documentation that the patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim (TMP‑SMX).

Statement of intolerance or contraindication to TMP‑SMX in the medical record (e.g., allergic reaction, severe adverse event).
Clinical notes or allergy table entries and any relevant laboratory or consultant documentation supporting the contraindication.

Background

Pyrimethamine (Daraprim) is indicated for the treatment of toxoplasmosis when used in combination with a sulfonamide because of synergistic activity; compendial uses also include prophylaxis for toxoplasmosis and Pneumocystis jirovecii pneumonia, and treatment/secondary prophylaxis of cystoisosporiasis. This rationale underlies prior authorization requirements to ensure appropriate indication and that sulfonamide-based therapy is unsuitable where specified.

When pyrimethamine is requested for toxoplasmosis, reviewers should confirm the drug will be used in conjunction with a sulfonamide per its labeled and compendial use, and that documentation supports the clinical indication and any required contraindication or intolerance to alternative agents (for example, sulfamethoxazole/trimethoprim) where step requirements apply.