Subject: Daraprim PA Policy 1341-A 01-2023

Drug

DARAPRIM  (pyrimethamine)

Policy:

FDA-approved Indications
Treatment of Toxoplasmosis
Daraprim is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Compendial Uses
Toxoplasmosis; Prophylaxis^2,3,4,5
Pneumocystis jirovecii pneumonia; Prophylaxis^2,3,4
Cystoisosporiasis; Treatment and secondary prophylaxis ^2,4,5

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed for the treatment of
          congenital toxoplasmosis in a pediatric patient
     OR
     •   The requested drug is being prescribed for the treatment of
          toxoplasmosis
     OR
     •   The requested drug is being prescribed for secondary prophylaxis
          of toxoplasmosis
          AND
          º   The patient has had a CD4 cell count of less than 200
               cells/mm3 within the past 6 months

     OR
     •   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: A)
          primary prophylaxis of toxoplasmosis, B) Pneumocystis jirovecii
          pneumonia prophylaxis
               AND
               º   The patient has had a CD4 cell count less than 200
                    cells/mm3 within the past 3 months
     OR
     •   The patient has experienced an intolerance or has a
          contraindication to sulfamethoxazole/trimethoprim AND the
          requested drug is being prescribed for the treatment of
          cystoisosporiasis
     OR
     •   The patient has experienced an intolerance or has a
          contraindication to sulfamethoxazole/trimethoprim AND the
          requested drug is being prescribed for secondary prophylaxis of
          cystoisosporiasis
               AND
               º   The patient has had a CD4 cell count less than 200
                    cells/mm3 within the past 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Daraprim [package insert]. New York, New York: Vyera Pharmaceuticals, LLC; August 2017.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 29, 2022.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. https://www.micromedexsolutions.com/. Accessed November 29, 2022.
4. Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association, and Infectious Diseases Society of America. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection. Accessed November 29, 2022.
5. Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection. Accessed November 29, 2022.
6. Treatment of Malaria: Guidelines for Clinicians (United States). Centers for Disease Control and Prevention. Available at https://www.cdc.gov/malaria/diagnosis_treatment/index.html. Accessed November 29, 2022.
7. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv. Accessed November 29, 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 15, 2023