Pharmacy Prior Authorization Criteria

Daraprim (pyrimethamine)

For diagnosis of Treatment of toxoplasmosis
Indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Prior Authorization

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

Active treatment of toxoplasmosis (e.g., toxoplasmic encephalitis, ocular toxoplasmosis)
Secondary prophylaxis of toxoplasmosis
Treatment of congenital toxoplasmosis

AND

Patient has experienced intolerance to prior prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX)

AND

Patient has been re-challenged with trimethoprim-sulfamethoxazole (TMP-SMX) using a desensitization protocol and is still unable to tolerate

Evidence of life-threatening reaction to trimethoprim-sulfamethoxazole (TMP-SMX) in the past (e.g., toxic epidermal necrolysis [TEN], Stevens-Johnson syndrome)

AND

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) [5]

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

Daraprim Prescribing Information. Vyera Pharmaceuticals. New York, NY. August 2017.
Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/treatment-hiv-associated. Accessed May 27, 2024.
Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-oi/tables-pediatric-oi.pdf. Accessed May 27, 2024.
Parasites - Toxoplasmosis (Toxoplasma infection). https://www.cdc.gov/parasites/toxoplasmosis/health_professionals/index.html#tx. Accessed May 5, 2023.
Centers for Disease Control and Prevention. CDC Yellow Book 2024: Health Information for International Travel. New York: Oxford University Press; 2024. https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/malaria. Accessed May 27, 2024.

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.