Daraprim (pyrimethamine) — United Healthcare
Secondary prophylaxis of toxoplasmic encephalitis
Initial criteria
- Submission of medical records (e.g., chart notes) documenting one of the following:
- 1. Treatment of severe acquired toxoplasmosis, including toxoplasmic encephalitis OR
- 2. Treatment of congenital toxoplasmosis OR
- 3. Secondary prophylaxis of toxoplasmic encephalitis OR
- 4. ALL of the following:
- a. Primary Pneumocystis pneumonia (PCP) prophylaxis in HIV-infected patients or as secondary prophylaxis in HIV-infected patients who have been treated for an acute episode of Pneumocystis pneumonia
- b. Patient has experienced intolerance to prior prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX)
- c. ONE of the following:
- (1) Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate
- (2) Evidence of moderately severe or life threatening reaction to TMP-SMX in the past (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome)
- OR
- 5. ALL of the following:
- a. Primary prophylaxis of toxoplasmic encephalitis
- b. Toxoplasma IgG positive
- c. CD4 count ≤ 100 cells/mm3 if initiating prophylaxis OR CD4 count < 100–200 cells/mm3 if reinstituting prophylaxis
- d. Will be used in combination with dapsone or atovaquone
- e. Patient has experienced intolerance to prior prophylaxis with TMP-SMX
- f. ONE of the following:
- (1) Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate
- (2) Evidence of moderately severe or life threatening reaction to TMP-SMX in the past (e.g., TEN, Stevens-Johnson syndrome)
Approval duration
12 months