Subject: Daraprim PA Policy 1341-A 01-2022

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: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed November 9, 2021.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. https://www.micromedexsolutions.com/. Accessed November 9, 2021.
4. Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Available athttps://clinicalinfo.hiv.gov/sites/default/files/inline-files/adult_oi.pdf. Accessed November 29, 2021.
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. Recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf.  Accessed November 29, 2021.
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 December 3, 2021.
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/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Accessed December 6, 2021.

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 12, 2022