WHA
 

Daraprim (pyrimethamine)

Indications for Prior Authorization

Daraprim (pyrimethamine)
  • For diagnosis of Toxoplasmosis
    Indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Criteria

Brand Daraprim, generic pyrimethamine

Prior Authorization

Length of Approval: 12 Months [A, B]
For diagnosis of Toxoplasmosis

  • One of the following:
    • Patient is using pyrimethamine for one of the following: [2-6]
      • Active treatment of toxoplasmosis (e.g., toxoplasmic encephalitis, ocular toxoplasmosis)
      • Secondary prophylaxis/chronic maintenance of toxoplasmosis
      • Treatment of congenital toxoplasmosis
      OR
    • All of the following: [C, 8]
      • Patient is using pyrimethamine for primary prophylaxis of toxoplasmosis
        • AND
      • Patient has experienced intolerance to prior prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX)
        • AND
      • One of the following:
        • Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate
        • Evidence of life-threatening reaction to TMP-SMX in the past (e.g., toxic epidermal necrolysis [TEN], Stevens-Johnson syndrome)
    AND
  • Prescribed by or in consultation with an infectious disease specialist
Brand Daraprim, generic pyrimethamine

Prior Authorization


For diagnosis of Malaria (off-label)

  • Requests for coverage of any pyrimethamine products for the treatment and/or prophylaxis of malaria are not authorized and will not be approved. The use of pyrimethamine for the treatment and/or prophylaxis of malaria is not recommended by the Centers for Disease Control and Prevention (CDC) [7]

  • Guideline ID
    GL-603226

  • Formulary
    premium

  • Effective date
    Aug 1, 2026

  • P&T approval date
    Oct 13, 2015

P & T Revisions

2026-05-08, 2025-08-06, 2024-06-05, 2023-05-31, 2022-06-08, 2021-09-27, 2021-05-11, 2020-05-20, 2020-04-03

  1. Daraprim Prescribing Information. Vyera Pharmaceuticals, LLC. New York, NY. November 2021.
  2. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: Toxoplasma gondii encephalitis. Clinicalinfo.HIV.gov. Updated September 9, 2025. Reviewed March 16, 2026. Accessed May 8, 2026. Available from: https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/toxoplasmosis
  3. Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the prevention and treatment of opportunistic infections in children with and exposed to HIV: Toxoplasmosis. Clinicalinfo.HIV.gov. Updated December 22, 2025. Reviewed December 22, 2025. Accessed May 8, 2026. Available from: https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection/toxoplasmosis
  4. Maldonado YA, Read JS; Committee on Infectious Diseases. Diagnosis, treatment, and prevention of congenital toxoplasmosis in the United States. Pediatrics. 2017; 139(2):e20163860. Reaffirmed January 2022.
  5. Centers for Disease Control and Prevention (CDC). Clinical care of toxoplasmosis. CDC. Published January 22, 2024. Accessed May 8, 2026. Available from: https://www.cdc.gov/toxoplasmosis/hcp/clinical-care/index.html
  6. Gandhi RT, Sax PE, Mitty J. Toxoplasmosis in patients with HIV. Wolters Kluwer. Updated March 31, 2025. Literature review current through April 2026. Accessed May 8, 2026. Available with subscription from: https://www.uptodate.com
  7. Centers for Disease Control and Prevention (CDC). Clinical guidance: malaria diagnosis & treatment in the U.S. CDC. Published June 5, 2024. Accessed May 8, 2026. Available from: https://www.cdc.gov/malaria/hcp/clinical-guidance/index.html
  8. Montanaro A, Joshi S, Adkinson Jr NF, Feldweg AM. Sulfonamide hypersensitivity. Wolters Kluwer. Updated December 29, 2025. Literature review current through April 2026. Accessed May 8, 2026. Available with subscription from: https://www.uptodate.com
  1. Discontinuation of primary prophylaxis is indicated if adult/adolescent patient’s CD4 is greater than 200 cells/mm3 for more than 3 months with sustained HIV RNA below detectable limits after institution of combination antiretroviral therapy. Primary prophylaxis can be discontinued in children once the patient responds to antiretroviral therapy with a sustained rise (for more than 3 months) with CD4% greater than 22% (CD4 count greater than 500 cells/mm3) if between 1 to 5 years of age or CD4 greater than 200 cells/mm3 if 6 years of age or older. Prophylaxis should not be discontinued in patients less than 1 year of age. [2, 3]
  2. Discontinuation of secondary prophylaxis/chronic maintenance therapy is indicated in patients older than 1 year of age. For adult/adolescent patients, chronic maintenance can be discontinued once patient has successfully completed initial therapy, remains asymptomatic, and has CD4 count greater than 200 cells/mm3 for more than 6 months after institution of combination antiretroviral therapy. For children, secondary prophylaxis can be discontinued after completing treatment, with a concomitant and sustained rise to CD4% greater than 22% (CD4 greater than 500 cells/mm3) if 1 to 5 years of age or CD4 greater than 200 cells/mm3 if 6 years or older. [2, 3]
  3. For primary prophylaxis of toxoplasmosis in adults/adolescents with HIV, the preferred agent is TMP-SMX, which can be dosed at various frequencies and is also the preferred prophylaxis regimen for Pneumocystis jirovecii pneumonia (PCP), which all individuals at risk of toxoplamosis are also at risk of developing. If the patient is unable to tolerate TMP-SMX, pyrimethamine (in combination with leucovorin and dapsone/atovaquone) can be used as primary prophylaxis. Similarly, TMP-SMX is the preferred agent for primary prophylaxis of Toxoplasma encephalitis in children with HIV, with pyrimethamine (in combination with leucovorin and dapsone/atovaquone) as an alternative option for those who cannot tolerate TMP-SMX. [2, 3, 6]
  • 2026-05-08: Annual Review 2026 - Added "chronic maintenance" in addition to toxoplasma secondary prophylaxis criterion in line with treatment guideline definitions. Formatting update of toxoplasmosis criteria bucket with no change to clinical intent. Background updates.
  • 2025-08-06: 2025 Annual Review. No criteria changes, updated references
  • 2024-06-05: 2024 Annual Review. No criteria changes. Background updates.
  • 2023-05-31: Annual Review
  • 2022-06-08: Annual Review
  • 2021-09-27: Annual Review
  • 2021-05-11: Annual Review
  • 2020-05-20: 2020 UM Annual Review.
  • 2020-04-03: New generic available. Added generic pyrimethamine to guideline.