CurrentUnitedHealthcarePolicy N/A

Daraprim (pyrimethamine) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity requirements for outpatient Daraprim (pyrimethamine) pharmacy access, including indications, documentation, and duration of approval for affected members.

Policy Summary

PayerUnitedHealthcare

PolicyDaraprim (pyrimethamine) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for outpatient Daraprim and submit chart notes documenting the indication, relevant labs (e.g., CD4, Toxoplasma IgG), and prior TMP‑SMX intolerance or desensitization when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

8/1/2025effective date

Daraprim Directaccess program

<100CD4 threshold

Coverage Criteria for Daraprim (pyrimethamine)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered Indications and Criteria

Covered when any ONE of the following criteria is met and documented:

Indications for coverage: Treatment of severe acquired toxoplasmosis, including toxoplasmic encephalitis

Indications for coverage: Treatment of congenital toxoplasmosis

Indications for coverage: Secondary prophylaxis of toxoplasmic encephalitis

Indications for coverage

PCP prophylaxis requirements: Patient has experienced intolerance to prior prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX)
PCP prophylaxis requirements: Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate OR there is evidence of a moderately severe or life‑threatening reaction to TMP‑SMX (e.g., toxic epidermal necrolysis, Stevens‑Johnson syndrome) in the past

Indications for coverage

TE primary prophylaxis criterion: CD4 count < 100 cells/mm3 if initiating prophylaxis or CD4 count 100–200 cells/mm3 if reinstituting prophylaxis<100 cells/mm3 (initiation); 100–200 cells/mm3 (reinstitution)
TE primary prophylaxis criterion: Toxoplasma IgG positive
TE primary prophylaxis criterion: Will be used in combination with dapsone or atovaquone
TE primary prophylaxis criterion: One of the following: prior intolerance to TMP‑SMX; failed desensitization to TMP‑SMX; or prior moderately severe/life‑threatening reaction to TMP‑SMX (e.g., TEN, Stevens‑Johnson syndrome)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for outpatient access to Daraprim (pyrimethamine). Outpatient medication access is available exclusively through the Daraprim Direct program in partnership with Optime Care, Inc. Approvals may be issued for up to 12 months; supply limits may apply.

Outpatient access: Daraprim Direct (Optime Care, Inc.)
Authorization duration: up to 12 months

Step Therapy

TMP‑SMX Intolerance / Step Requirement

If the member has a history of intolerance to trimethoprim-sulfamethoxazole (TMP‑SMX), or has undergone TMP‑SMX desensitization and remains unable to tolerate it, document this in the chart. Applicable when Daraprim is requested for PCP or toxoplasmosis prophylaxis/therapy.

Documented intolerance to prior TMP‑SMX prophylaxis or therapy
Documented failure to tolerate TMP‑SMX after a desensitization protocol
Evidence of moderately severe or life‑threatening reaction to TMP‑SMX (e.g., TEN, Stevens‑Johnson syndrome)

Documentation Required

Required Documentation and Denial Risk

Chart notes must document the indication for Daraprim and supporting clinical details. Lack of documentation demonstrating the required indication or TMP‑SMX intolerance/rechallenge/desensitization will result in a documentation‑based denial.

Document the specific indication: severe acquired toxoplasmosis (including toxoplasmic encephalitis), congenital toxoplasmosis, secondary prophylaxis of toxoplasmic encephalitis, or primary prophylaxis criteria (see policy).
For primary prophylaxis, document CD4 count and Toxoplasma IgG status, and planned combination therapy (dapsone or atovaquone).
Document prior medication history including TMP‑SMX use, intolerance, desensitization attempt, or severe adverse reaction.
Include relevant chart notes, diagnostic codes, and any prior claim/medication history used for automated approval processes.

Definitions and Background

Primary prophylaxis of toxoplasmic encephalitis

Eligible populationToxoplasma IgG positive patients being considered for primary prophylaxis of toxoplasmic encephalitis

CD4 requirementCD4 count < 100 cells/mm3 for initiation (100–200 cells/mm3 when reinstituting)

Concomitant therapy requirementMust be used in combination with dapsone or atovaquone when TMP‑SMX intolerance exists

TMP‑SMX step/exception criteriaOne of: prior intolerance to TMP‑SMX; failed desensitization to TMP‑SMX; or prior moderately severe/life‑threatening reaction to TMP‑SMX (e.g., TEN, Stevens‑Johnson syndrome)

Drug class notePyrimethamine is indicated for toxoplasmosis only when used conjointly with a sulfonamide; outpatient access via Daraprim Direct program

Pyrimethamine (Daraprim) is indicated for the treatment of toxoplasmosis when used in combination with a sulfonamide because of documented synergism between the agents. Outpatient access to Daraprim is provided exclusively through the Daraprim Direct program in partnership with Optime Care, Inc. The product is no longer recommended for malaria treatment or prophylaxis according to CDC guidance; for malaria treatment consult the CDC Malaria Hotline as noted in the CDC guidance.