CurrentNeighborhood Health Plan of Rhode IslandPolicy 1341-A

Daraprim (pyrimethamine) prior authorization for toxoplasmosis and related indications

Prior authorization criteria for Daraprim (pyrimethamine) as managed by CVS Caremark on behalf of Neighborhood Health Plan of Rhode Island; defines clinical indications, required clinical conditions (including CD4 thresholds) and durations of approval for treatment and prophylaxis of toxoplasmosis, Pneumocystis jirovecii pneumonia (PJP) prophylaxis, and cystoisosporiasis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaraprim (pyrimethamine) prior authorization for toxoplasmosis and related indications

Policy CodePolicy 1341-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProviders must obtain prior authorization for Daraprim and supply required clinical documentation, including documentation of intolerance/contraindication to TMP‑SMX when applicable and CD4 results within the specified lookback window.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CD4 <200Immunologic threshold used for multiple prophylaxis criteria

3Typical duration of approval for most indications

12Duration of approval for congenital toxoplasmosis (pediatric)

6Duration of approval for cystoisosporiasis

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Prior Authorization Criteria for Daraprim (pyrimethamine)

Treatment of Toxoplasmosis (including congenital)

Authorization may be granted when the requested drug is being prescribed for treatment of toxoplasmosis, with special provision for congenital disease in pediatrics:

ANY of the following

Daraprim is being prescribed for treatment of toxoplasmosis (used conjointly with a sulfonamide).
Congenital toxoplasmosis in a pediatric patient.
Authorization may be granted for congenital toxoplasmosis in a pediatric patient.

Cystoisosporiasis — treatment or secondary prophylaxis

Authorization may be granted when prescribed for treatment or secondary prophylaxis of cystoisosporiasis when ALL of the following are met:

ALL of the following

The patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim.

Pneumocystis jirovecii pneumonia (PJP) prophylaxis and Primary Prophylaxis of Toxoplasmosis

Authorization may be granted when the requested drug is being prescribed for PJP prophylaxis or primary prophylaxis of toxoplasmosis when ALL of the following criteria are met:

ALL of the following

The patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim.
The patient has had a CD4 cell count less than 200 cells/mm3 within the past 3 months.CD4 < 200 cells/mm3
CD4 must be measured within prior 3 months.

Secondary Prophylaxis of Cystoisosporiasis

Authorization may be granted for secondary prophylaxis of cystoisosporiasis when ALL of the following criteria are met:

ALL of the following

The patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim.
The patient has had a CD4 cell count less than 200 cells/mm3 within the past 6 months.CD4 < 200 cells/mm3
CD4 must be measured within prior 6 months for this indication.

Secondary Prophylaxis of Toxoplasmosis

Authorization may be granted when prescribed for secondary prophylaxis of toxoplasmosis when the following criterion is met:

ALL of the following

The patient has had a CD4 cell count of less than 200 cells/mm3 within the past 6 months.CD4 < 200 cells/mm3
CD4 must be measured within prior 6 months.

Document Identifiers and Codes

Document identifiersmixed

1341-A

Daraprim PA Policy identifier

Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Providers must obtain prior authorization for Daraprim (pyrimethamine) for the covered indications; approval is granted only when the clinical criteria (intolerance/contraindication to sulfamethoxazole/trimethoprim where required, and required CD4 thresholds/timeframe) are met.

Policy 1341-A

Documentation Required

Clinical documentation of intolerance/contraindication

When authorization is requested for prophylaxis or cystoisosporiasis indications that require intolerance/contraindication to sulfamethoxazole/trimethoprim, providers must document the intolerance or contraindication.

Documentation Required

Clinical Context

Pyrimethamine (Daraprim) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, reflecting the known synergistic effect of this combination.

In addition to therapy for active disease, pyrimethamine is supported by compendia for use in prophylaxis of toxoplasmosis and Pneumocystis jirovecii pneumonia (PJP), and for the treatment and secondary prophylaxis of cystoisosporiasis when clinically appropriate.

When used as prophylaxis or treatment for opportunistic infections, pyrimethamine may be considered for patients who are intolerant of or have a contraindication to first-line sulfamethoxazole/trimethoprim (TMP‑SMX); several indications in this policy require documentation of such intolerance or contraindication.

This policy references standard clinical compendia (e.g., Lexicomp, Micromedex) and the panel guidelines for prevention and treatment of opportunistic infections in both adults and children with HIV for recommended uses and monitoring parameters.

Defined Terms

Definitions

Primary prophylaxisPreventative therapy given to patients who have not yet had the disease but are at increased risk (e.g., CD4 < 200 cells/mm3 for toxoplasmosis/PJP).

Secondary prophylaxisMaintenance therapy to prevent recurrence of a previously treated infection.

Clinical Thresholds Used in Criteria

Immunologic thresholds

CD4 cell count for PJP/primary toxoplasmosis prophylaxis< 200 cells/mm3 within the past 3 months

CD4 cell count for secondary prophylaxis (toxoplasmosis and cystoisosporiasis)< 200 cells/mm3 within the past 6 months

Policy Review Dates

01-2024Last reviewLatest

Policy document (Daraprim PA Policy 1341-A) was last reviewed in January 2024.