Daraprim (pyrimethamine) — Prior Authorization and Medical Necessity
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Defines prior authorization and medical necessity criteria for outpatient coverage of Daraprim (pyrimethamine) for Colorado Rocky Mountain Health Plans members, including indications, documentation, and duration of authorization.
No material clinical or coverage changes in this revision.
Coverage and Indications
Covered indications and conditional prophylaxis requirements
Daraprim will be approved based on submission of medical records documenting ONE of the following:
PCP prophylaxis (conditional)
- Indication: Primary PCP prophylaxis in HIV-infected patients or secondary prophylaxis after treatment of an acute episode of Pneumocystis pneumonia
- TMP-SMX intolerance: Patient has experienced intolerance to prior prophylaxis with trimethoprim–sulfamethoxazole (TMP-SMX)
Re-challenge or severe reaction
- Desensitization attempted: Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate
- Severe prior reaction: Evidence of a moderately severe or life‑threatening prior reaction to TMP-SMX (e.g., toxic epidermal necrolysis [TEN], Stevens–Johnson syndrome)
Primary toxoplasmic encephalitis prophylaxis (conditional)
- Indication: Primary prophylaxis of toxoplasmic encephalitis
- Serology: Toxoplasma IgG positive
- CD4 count ≤ 100 cells/mm3 if initiating prophylaxis or CD4 count <100–200 cells/mm3 if reinstituting prophylaxis≤ 100 cells/mm3 if initiating; <100–200 cells/mm3 if reinstituting
- Combination therapy: Will be used in combination with dapsone or atovaquone
- TMP-SMX intolerance: Patient has experienced intolerance to prior prophylaxis with trimethoprim–sulfamethoxazole (TMP-SMX)
Re-challenge or severe reaction
- Desensitization attempted: Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate
- Severe prior reaction: Evidence of a moderately severe or life‑threatening prior reaction to TMP-SMX (e.g., toxic epidermal necrolysis [TEN], Stevens–Johnson syndrome)
The CDC no longer recommends use of pyrimethamine for the treatment or prophylaxis of malaria; therefore pyrimethamine (Daraprim) will not be approved for malaria indications. For malaria treatment guidance, providers should contact the CDC Malaria Hotline as listed in the CDC guidance.
Clinical Thresholds and Codes
Prior Authorization, Documentation, and Steps
Prior authorization and access pathway
Prior authorization is required for outpatient Daraprim. Approval is granted when submitted records (e.g., chart notes) document one of the policy’s specified indications. Outpatient access is available exclusively through the Daraprim Direct program and authorizations are issued for 12 months.
- Authorization duration: 12 months
- Outpatient access pathway: Daraprim Direct (exclusive program)
Step‑therapy / TMP‑SMX intolerance requirement
For use as primary or secondary PCP prophylaxis, or for primary toxoplasmic encephalitis prophylaxis, the patient must have experienced intolerance to prior TMP‑SMX and either have failed re‑challenge with TMP‑SMX via a desensitization protocol or have documented a prior moderately severe or life‑threatening reaction to TMP‑SMX (e.g., TEN, Stevens‑Johnson syndrome).
- PCP prophylaxis criteria: intolerance to TMP‑SMX plus either unsuccessful desensitization or evidence of severe prior reaction
- Primary toxoplasmic encephalitis prophylaxis: intolerance to TMP‑SMX plus either unsuccessful desensitization or evidence of severe prior reaction (listed as one required condition among others)
Submit medical records and clinical data
Submit medical records (for example, chart notes) that document one of the policy’s approved indications and relevant clinical details to support approval (e.g., toxoplasma IgG, CD4 counts, prior therapies and attempts at TMP‑SMX desensitization).
- Include documentation of the specific indication being requested (treatment of severe acquired toxoplasmosis, congenital toxoplasmosis, secondary prophylaxis, or the conditional prophylaxis branches).
- For prophylaxis requests include toxoplasma IgG and CD4 count per policy thresholds when applicable, and records of prior TMP‑SMX intolerance or desensitization attempts.
Documentation of indication required — denial risk
Requests lacking medical records or chart notes that document one of the policy’s listed approved indications (e.g., treatment of severe acquired toxoplasmosis, congenital toxoplasmosis, secondary prophylaxis, or the PCP/toxoplasmic prophylaxis conditional criteria) may be denied.
- Absence of documentation of TMP‑SMX intolerance or desensitization attempts for conditional prophylaxis criteria is a common denial risk.
- Failure to provide CD4 counts or toxoplasma IgG where required for prophylaxis may lead to denial.
Key Terms
Clinical Background
Daraprim (pyrimethamine) is indicated for treatment of toxoplasmosis when used in combination with a sulfonamide because of documented synergism between the two agents. This combination is the standard clinical indication supported in the policy background.
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