Pharmacy Prior Authorization Criteria

Daraprim (pyrimethamine)

Indications for Prior Authorization

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.

Criteria

Brand Daraprim, generic pyrimethamine

Prior Authorization

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

• Both of the following:
• One of the following:
• Patient is using pyrimethamine for one of the following: [2, 3]
• Active treatment of toxoplasmosis (e.g., toxoplasmic encephalitis, ocular toxoplasmosis)
• Secondary prophylaxis of toxoplasmosis
• Treatment of congenital toxoplasmosis
OR
• All of the following: [2]
• 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 trimethoprim-sulfamethoxazole (TMP-SMX) using a desensitization protocol and is still unable to tolerate
OR
• Evidence of life-threatening reaction to trimethoprim-sulfamethoxazole (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) [5]

P & T Revisions

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

References

1. Daraprim Prescribing Information. Vyera Pharmaceuticals. New York, NY. August 2017.
2. 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.
3. 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.
4. Parasites - Toxoplasmosis (Toxoplasma infection). https://www.cdc.gov/parasites/toxoplasmosis/health_professionals/index.html#tx. Accessed May 5, 2023.
5. 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.

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End Notes

1. Prescriber should consider discontinuation of primary prophylaxis if CD4 is greater than 200 cells/mm3 for more than 3 months after institution of combination antiretroviral therapy. [2]
2. Prescriber should consider discontinuation of secondary prophylaxis if CD4 is greater than 200 cells/mm3 for more than 6 months after institution of combination antiretroviral therapy. [2]

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Revision History

• 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.

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