CurrentNeighborhood Health Plan of Rhode IslandPolicy Daraprim PA Policy 1341-A 01-2022

Daraprim Pa Policy 1341 A 01 2022

Prior authorization criteria for Daraprim (pyrimethamine) covering treatment and prophylaxis indications (toxoplasmosis, Pneumocystis jirovecii pneumonia prophylaxis, cystoisosporiasis) when sulfamethoxazole/trimethoprim intolerance or contraindication exists and for certain CD4 thresholds; applies to initial prior authorization per CVS Caremark criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDaraprim Pa Policy 1341 A 01 2022

Policy CodePolicy Daraprim PA Policy 1341-A 01-2022

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrior authorization is required for Daraprim; document indication and intolerance/contraindication to sulfamethoxazole/trimethoprim when applicable and provide CD4 cell count within specified timeframe.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

3Primary covered indications listed

2Distinct CD4 threshold timeframes

Coverage Summary

Prior authorization is required. Daraprim (pyrimethamine) is covered with criteria for treatment and prophylaxis of toxoplasmosis (including congenital toxoplasmosis in pediatric patients and secondary prophylaxis), prophylaxis for Pneumocystis jirovecii pneumonia (PJP), and treatment/secondary prophylaxis of cystoisosporiasis. Compendial uses include prophylaxis for toxoplasmosis and PJP and treatment/secondary prophylaxis of cystoisosporiasis, and Daraprim is indicated for treatment of toxoplasmosis when used with a sulfonamide.

Primary Authorization Criteria (Initial Therapy)

Primary Authorization Criteria

The requested drug will be covered with prior authorization when the following criteria are met:

ANY of the following

ALL of the following
- The requested drug is being prescribed for the treatment of congenital toxoplasmosis in a pediatric patient
ALL of the following
- The requested drug is being prescribed for the treatment of toxoplasmosis
ALL of the following
- The requested drug is being prescribed for secondary prophylaxis of toxoplasmosis
- The patient has had a CD4 cell count of less than 200 cells/mm3 within the past 6 months< 200 cells/mm3 within the past 6 months
  CD4 lab required within past 6 months

ref

title

ref_orig_removed_placeholder

Alternative Indications when TMP‑SMX Not Tolerated or Contraindicated

Alternative Indications when TMP-SMX not tolerated or contraindicated

Covered when ALL of the following are met:

ALL of the following

The patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim
AND the requested drug is being prescribed for any of the following:
- Primary prophylaxis of toxoplasmosis
- Pneumocystis jirovecii pneumonia prophylaxis
The patient has had a CD4 cell count less than 200 cells/mm3 within the past 3 months< 200 cells/mm3 within the past 3 months
Applies to primary prophylaxis/PJP prophylaxis pathway

OR for cystoisosporiasis

The patient has experienced an intolerance or has a contraindication to sulfamethoxazole/trimethoprim
ANY of the following
- The requested drug is being prescribed for the treatment of cystoisosporiasis
- The requested drug is being prescribed for secondary prophylaxis of cystoisosporiasis
The patient has had a CD4 cell count less than 200 cells/mm3 within the past 6 months< 200 cells/mm3 within the past 6 months
Applies to cystoisosporiasis pathway

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Daraprim; initial prior authorization per CVS Caremark must document the indication for use. When applicable (e.g., for alternative indications or pathways that require it), the initial PA must also document intolerance or a contraindication to sulfamethoxazole/trimethoprim (TMP-SMX).

Documentation Required

CD4 count documentation

Provider must document a CD4 cell count that meets the specified threshold and timeframe for the indication. Specific thresholds: less than 200 cells/mm3 within the past 3 months for primary prophylaxis/Pneumocystis jirovecii pneumonia prophylaxis; less than 200 cells/mm3 within the past 6 months for toxoplasmosis secondary prophylaxis and cystoisosporiasis pathways.

Documentation Required

Documentation of TMP-SMX intolerance/contraindication

For alternative indications and the cystoisosporiasis pathway, the provider must document that the patient has experienced an intolerance to, or has a contraindication to, sulfamethoxazole/trimethoprim (TMP-SMX).

Background

Daraprim (pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide. Compendial uses include prophylaxis for toxoplasmosis and prophylaxis for Pneumocystis jirovecii pneumonia, and treatment and secondary prophylaxis of cystoisosporiasis.

TMP-SMX: Sulfamethoxazole/trimethoprim (TMP-SMX) — a combination antimicrobial commonly used for primary prophylaxis of toxoplasmosis and Pneumocystis jirovecii pneumonia; documentation of intolerance or contraindication to TMP-SMX is required for certain Daraprim indications.