CurrentUnitedHealthcarePolicy N/A

Daraprim (pyrimethamine) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for outpatient Daraprim (pyrimethamine) access through the Daraprim Direct program for covered 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 and submit medical records documenting a covered indication for outpatient Daraprim via the Daraprim Direct program.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration when approved

≤100CD4 threshold initiating prophylaxis

2025 P 2071-10program identifier

Daraprim Directdistribution channel

8/1/2025effective date

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Covered indications and conditional prophylaxis criteria

Covered when ONE of the following is documented:

Primary covered indications: 1. Treatment of severe acquired toxoplasmosis, including toxoplasmic encephalitis OR 2. Treatment of congenital toxoplasmosis OR 3. Secondary prophylaxis of toxoplasmic encephalitis

Requires medical records documenting indication

PCP prophylaxis exception: 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: (1) Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate, OR (2) Evidence of a moderately severe or life‑threatening reaction to TMP-SMX in the past (e.g., toxic epidermal necrolysis [TEN], Stevens‑Johnson syndrome)

Applies when TMP-SMX alternatives not tolerated

Primary toxoplasmic encephalitis prophylaxis: 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 trimethoprim-sulfamethoxazole (TMP-SMX); f) One of: (1) Patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate, OR (2) Evidence of a moderately severe or life‑threatening reaction to TMP-SMX in the past (e.g., toxic epidermal necrolysis [TEN], Stevens‑Johnson syndrome)CD4 thresholds as specified

Authorization issued for 12 months; consider discontinuation if CD4 > 200 cells/mm3 for >3 months after antiretroviral therapy

Use of pyrimethamine (Daraprim) for the treatment or prophylaxis of malaria is not supported by this policy. The CDC Guidelines for the Treatment of Malaria in the United States no longer recommend pyrimethamine for malaria; management of malaria should follow CDC guidance and providers may contact the CDC Malaria Hotline for assistance.

This policy reiterates that pyrimethamine is not recommended for malaria treatment or prophylaxis per current CDC guidance. Outpatient access to Daraprim must follow the coverage criteria in this policy and the Daraprim Direct distribution program; malaria cases should be managed according to CDC recommendations rather than through this policy.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for outpatient Daraprim

Prior authorization is required for outpatient Daraprim (pyrimethamine); approval is granted only when medical records (e.g., chart notes) document one of the enumerated indications. Outpatient access is available exclusively through the Daraprim Direct program.

Medication: Daraprim (pyrimethamine) — outpatient access via Daraprim Direct
Approval contingent on submission of medical records documenting one of the listed indications (see coverage criteria)

Step Therapy

TMP‑SMX intolerance and failed desensitization required

For PCP or toxoplasma prophylaxis, patients must have documented intolerance to TMP-SMX and either a failed re-challenge using a desensitization protocol or prior evidence of a moderately severe or life‑threatening TMP-SMX reaction (e.g., TEN, Stevens‑Johnson syndrome) before pyrimethamine will be approved.

Must document intolerance to prior TMP-SMX prophylaxis
Either: (1) failed desensitization re-challenge with TMP-SMX, or (2) history of severe/life‑threatening reaction to TMP-SMX (e.g., TEN, Stevens‑Johnson syndrome)

Documentation Required

Required clinical documentation to support approval

Submit medical records (e.g., chart notes) that document the specific covered indication and relevant clinical data; prior claim/medication history, diagnosis codes (ICD-10) and claim logic may also be used for approval or reauthorization.

Documentation of the covered indication (treatment of severe acquired toxoplasmosis, congenital toxoplasmosis, secondary prophylaxis, or prophylaxis criteria)
Relevant labs/clinical history such as toxoplasma IgG and CD4 counts when applicable
Prior medication/claim history or ICD-10 codes may be sufficient for initial approval or reauthorization per program rules

Denial Risk

Denial risk for insufficient documentation of indication

Lack of medical records documenting one of the listed covered indications may lead to denial of the prior authorization request.

Covered indications include: treatment of severe acquired toxoplasmosis (including toxoplasmic encephalitis), congenital toxoplasmosis, secondary prophylaxis of toxoplasmic encephalitis, or met criteria for PCP/primary toxoplasmic encephalitis prophylaxis
Insufficient documentation of intolerance/desensitization or missing required labs (e.g., toxoplasma IgG, CD4) risks denial

Definitions and Background

Daraprim Direct (program definition)

Program definitionExclusive outpatient medication access program for Daraprim (pyrimethamine) distributed in partnership with Optime Care, Inc.

Access requirementOutpatient access to Daraprim is available only through the Daraprim Direct program

Related limitationMembers must meet the policy's coverage criteria for approval of outpatient Daraprim via Daraprim Direct

Pyrimethamine (Daraprim) is indicated for the treatment of toxoplasmosis when used in combination with a sulfonamide because of synergistic activity. The policy notes that outpatient access to Daraprim is available exclusively through the Daraprim Direct program in partnership with Optime Care, Inc., and members must meet the documented coverage criteria for authorization.

OpenPayer

Daraprim (pyrimethamine) prior authorization and medical necessity

Coverage Criteria — When Daraprim (pyrimethamine) Is Covered

Coding and Clinical Thresholds

Provider Requirements, Prior Authorization, and Documentation

Definitions and Background