CurrentCignaPolicy N/A

Infectious Disease - Pyrimethamine Prior Authorization Policy

This policy governs prior authorization requirements and medical necessity criteria for coverage of pyrimethamine tablets (Daraprim and generic) for Cigna-administered health benefit plans. It affects prescribers and payers managing prescription benefit coverage for patients considered for pyrimethamine therapy.

Policy Summary

PayerCigna

PolicyInfectious Disease - Pyrimethamine Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 11, 2024

Key ActionObtain prior authorization and document that pyrimethamine is prescribed with leucovorin and by or in consultation with an infectious diseases or HIV specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yeartypical approval duration

7covered indication groups

Yesspecialist prescribing required

Yesleucovorin co-prescription

Authorization Criteria

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Toxoplasmosis - Treatment (FDA‑approved)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Root: All of A, B, and C

A: The medication is prescribed in combination with leucovorin

B: Patient meets ONE of the following (i or ii):

B.i: The medication is prescribed in combination with sulfadiazine

B.ii: Patient meets BOTH of the following (a and b):

B.ii.a: Patient is unable to take sulfadiazine

B.ii.b: Patient meets ONE of the following (1 or 2):

B.ii.b.1: The medication is prescribed in combination with systemic clindamycin

B.ii.b.2: The medication is prescribed in combination with atovaquone

C: The medication is prescribed by or in consultation with an infectious diseases specialist or a physician specializing in the treatment of human immunodeficiency virus (HIV) infection

Cystoisosporiasis - Secondary Prophylaxis (Chronic Maintenance Treatment)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Root: All of A, B, and C

A: Patient has tried at least one other therapy for this condition (examples: trimethoprim-sulfamethoxazole, systemic ciprofloxacin)

B: The medication is prescribed in combination with leucovorin

C: The medication is prescribed by or in consultation with an infectious diseases specialist or a physician specializing in the treatment of human immunodeficiency virus (HIV) infection

Cystoisosporiasis - Treatment

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Root: All of A, B, and C

A: Patient has tried at least one other therapy for this condition (examples: trimethoprim-sulfamethoxazole, systemic ciprofloxacin)

B: The medication is prescribed in combination with leucovorin

C: The medication is prescribed by or in consultation with an infectious diseases specialist or a physician specializing in the treatment of human immunodeficiency virus (HIV) infection

Pneumocystis Pneumonia - Primary Prophylaxis

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Root: All of A, B, C, and D

A: Patient has tried at least one other therapy for this condition (examples: trimethoprim-sulfamethoxazole, systemic dapsone, aerosolized pentamidine, atovaquone)

B: The medication is prescribed in combination with leucovorin

C: Patient meets ONE of the following (i or ii):

C.i: The medication is prescribed in combination with systemic dapsone

Pneumocystis Pneumonia - Secondary Prophylaxis (Chronic Maintenance Therapy)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Root: All of A, B, C, and D

A: The medication is prescribed in combination with leucovorin

B: One of: medication with sulfadiazine OR (unable to take sulfadiazine AND one of clindamycin or atovaquone)

C: The medication is prescribed by or in consultation with an infectious diseases specialist or a physician specializing in the treatment of human immunodeficiency virus (HIV) infection

Toxoplasma gondii Encephalitis - Primary Prophylaxis

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Root: All of A, B, C, and D

A: Patient has tried at least one other therapy for this condition (examples: trimethoprim-sulfamethoxazole and atovaquone)

B: The medication is prescribed in combination with leucovorin

C: Patient meets ONE of the following (i or ii):

C.i: The medication is prescribed in combination with systemic dapsone

Toxoplasma gondii Encephalitis - Secondary Prophylaxis (Chronic Maintenance Therapy)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Root: All of A, B, and C

A: The medication is prescribed in combination with leucovorin

B: One of: medication with sulfadiazine OR (unable to take sulfadiazine AND one of clindamycin or atovaquone)

C: The medication is prescribed by or in consultation with an infectious diseases specialist or a physician specializing in the treatment of human immunodeficiency virus (HIV) infection

Requests for uses not listed in the policy's Recommended Authorization Criteria are considered experimental, investigational, or unproven and are not recommended for coverage. In particular, use of pyrimethamine for malaria chemoprophylaxis or treatment is excluded, because pyrimethamine is no longer indicated for acute malaria or malaria prevention.

Prescriber Requirements and Authorization Process

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for pyrimethamine tablets. Approvals are provided for the listed indications when the patient meets the criteria below. Because of the specialized skills required for evaluation, diagnosis, and monitoring, pyrimethamine tablets must be prescribed by or in consultation with a physician who specializes in the condition being treated (infectious diseases specialist or physician specializing in HIV treatment) where noted. Leucovorin must be prescribed in combination where required by the indication.

Prescriptions should document consultation or that the medication was prescribed by an infectious diseases or HIV specialist when required by the indication.
Document co-prescription of leucovorin for indications that require it (e.g., toxoplasmosis treatment, cystoisosporiasis treatment/maintenance, Pneumocystis prophylaxis, Toxoplasma encephalitis prophylaxis/maintenance).

Step Therapy

Required Prior Therapies

For several non‑primary indications and prophylaxis categories, patients must have tried at least one other appropriate therapy prior to approval. Examples of acceptable prior therapies are provided in the specific indication criteria and must be documented in the request.

Cystoisosporiasis (treatment and secondary prophylaxis): patient must have tried at least one other therapy (examples: trimethoprim‑sulfamethoxazole, systemic ciprofloxacin).
Pneumocystis pneumonia (primary and secondary prophylaxis): patient must have tried at least one other therapy (examples: trimethoprim‑sulfamethoxazole, systemic dapsone, aerosolized pentamidine via Respigard II nebulizer, atovaquone).
Toxoplasma gondii encephalitis (primary prophylaxis): patient must have tried at least one other therapy (examples: trimethoprim‑sulfamethoxazole, atovaquone).

Documentation Required

Prescribing and Co‑therapy Documentation

Prescribing and co‑therapy documentation requirements must be met for approval. Approval requires evidence the medication is being used with specified companion agents and that the prescriber is a specialist or consulted with one when indicated.

Prescribed in combination with leucovorin where required.
When indicated, pyrimethamine must be prescribed in combination with sulfadiazine, systemic clindamycin, atovaquone, systemic dapsone, or other specified agents per the indication; documentation of the specific concomitant agent must be provided.
Prescriptions must be by or in consultation with an infectious diseases specialist or a physician specializing in HIV treatment when the indication criteria require specialist involvement.

Denial Risk

Non‑Covered Uses / Denial Risk

Requests for uses not listed in the Recommended Authorization Criteria (including malaria chemoprophylaxis or treatment) are considered experimental/not covered. Coverage is not recommended for circumstances not listed in the criteria; criteria will be updated as new published data become available.

Malaria — chemoprophylaxis or treatment: not covered (pyrimethamine is no longer indicated).
Any use not explicitly listed in the authorization criteria: considered experimental, investigational, or unproven.

OpenPayer

Infectious Disease - Pyrimethamine Prior Authorization Policy

Authorization Criteria

Prescriber Requirements and Authorization Process

Clinical Background

Key Definitions