ModifiedCignaPolicy N/A

Antifungals -Tolsura Prior Authorization with Step Therapy Policy

Defines prior authorization and step therapy requirements for Tolsura (super-bioavailable itraconazole capsules) for FDA-approved indications (aspergillosis, blastomycosis, histoplasmosis), approval durations, and non-covered indications (including onychomycosis). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAntifungals -Tolsura Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeDuration updates (aspergillosis, blastomycosis, histoplasmosis)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document either a prior trial of itraconazole capsules or oral solution or that the patient is currently receiving Tolsura for the requested FDA-approved indication.

SourceLink

POLICY UPDATE CHANGES

Duration of approval for Histoplasmosis changed to 6 months (previously 3 months).

Duration of approval for Aspergillosis changed to 6 months (previously 3 months).

Duration of approval for Blastomycosis changed to 12 months (previously 3 months).

Annual revisions noted with no criteria changes on some review dates.

3Covered Indications (FDA-approved)

1Not Covered Indication

3Approval durations listed

Coverage Summary

Tolsura (super-bioavailable itraconazole capsules) is covered with prior authorization and step therapy for FDA-approved indications: aspergillosis, blastomycosis, and histoplasmosis. Prior authorization requires documentation of a trial of a Step 1 product (itraconazole capsules or oral solution) or that the patient is currently receiving Tolsura. Approval durations are specified per indication (see policy). Tolsura is not indicated for onychomycosis and is considered not medically necessary for that use. Tolsura is not interchangeable with other itraconazole products due to differences in dosing and formulation properties.

Key Items

Covered Indications (FDA-approved)3

Explicitly Not Covered Indication1

Approval durations (months) listed2

Medical Necessity Criteria

Not Medically Necessary / Exclusions

Coding

Drug productNDCCovered

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Tolsura. The policy contains a step therapy requirement directing patients to try one Step 1 product (itraconazole capsules or oral solution) prior to Tolsura unless the patient is currently receiving Tolsura.

Step therapy: try itraconazole capsules or oral solution before Tolsura unless currently receiving Tolsura

Documentation Required

Document prior trial or current use

For approval, documentation must show either a prior trial of itraconazole capsules or itraconazole oral solution, or that the patient is currently receiving Tolsura for the requested FDA‑approved indication.

Background & Evidence

Tolsura is a super-bioavailable (SUBA) itraconazole capsule formulation indicated in adults for aspergillosis (pulmonary and extrapulmonary), blastomycosis (pulmonary and extrapulmonary), and histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal). It is referenced as a treatment option in IDSA guidance for histoplasmosis. The product is not indicated for onychomycosis (limitation of use). Tolsura is not interchangeable or substitutable with other itraconazole products because it contains itraconazole dispersed in a polymer matrix with improved absorption and has different dosing compared with conventional itraconazole formulations (capsules and oral solution).

Revision History

10/01/2025material_revisionLatest

Selected revision updated histoplasmosis approval duration: Duration of approval for Histoplasmosis changed to 6 months (previously 3 months).

07/31/2024material_revision

Annual revision updated aspergillosis and blastomycosis approval durations: Aspergillosis approval duration changed to 6 months (previously 3 months); Blastomycosis approval duration changed to 12 months (previously 3 months).

07/16/2025annual_revision

Annual revision noted (no criteria changes).