CurrentCignaPolicy N/A

Antifungals - Cresemba (Oral) Prior Authorization Policy

Defines medical necessity and prior authorization requirements for coverage of Cresemba capsules under Cigna-administered health benefit plans for FDA-approved indications and other uses with supportive evidence.

Policy Summary

PayerCigna

PolicyAntifungals - Cresemba (Oral) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage updates (indication additions, wording revisions, duration increases)

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization for oral Cresemba capsules and document that the patient meets a listed indication with supporting clinical information.

SourceLink

POLICY UPDATE CHANGES

Fungal Infection (Systemic) in a Patient with Graft-versus-Host Disease - Prophylaxis was added as a condition of approval.

The wording for the neutropenia-related prophylaxis indication was changed to 'Fungal Infection (Systemic) in a Patient With Cancer and Neutropenia - Prophylaxis' and examples of cancers predisposing to neutropenia were added.

Approval durations for Aspergillus Infection and Mucormycosis treatments were changed to 6 months from a previous 3 months.

10distinct approved indications/conditions listed

6 moAspergillus & Mucormycosis approval

3 moOther listed uses approval

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.

12 moCryptococcal meningitis approval

Coverage Criteria for Cresemba (isavuconazonium sulfate) Capsules

Covered indications and durations

Cresemba capsules are covered as medically necessary when the member meets one of the following indication-specific criteria:

FDA-approved indications: 1. Aspergillus Infection - Treatment; Approve for 6 months. 2. Mucormycosis - Treatment; Approve for 6 months.

Other uses with supportive evidence: 3. Esophageal Candidiasis in a Patient with Human Immunodeficiency Virus Infection - Treatment; Approve for 3 months. 4. Fungal Infection (Systemic) in a Patient with Human Immunodeficiency Virus Infection - Treatment; Approve for 3 months. 5. Fungal Infection (Systemic) in a Patient With Cancer and Neutropenia - Prophylaxis; Approve for 6 months. Note: examples of cancers predisposing neutropenic patients to risk of fungal infections include myelodysplastic syndrome, acute myeloid leukemia, patients post-allogeneic hematopoietic cell transplant. 6. Fungal Infection (Systemic) in a Patient with Graft-versus-Host Disease - Prophylaxis; Approve for 6 months. 7. Coccidioidomycosis in a Patient with Human Immunodeficiency Virus Infection - Treatment; Approve for 6 months. 8. Cryptococcal Meningitis - Treatment; Approve for 12 months. 9. Fungal Infection (Systemic) That Is Susceptible to Cresemba - Treatment; Approve for 3 months. 10. Patient is Currently Receiving Cresemba; Approve for 3 months to complete the course of therapy.

Each listed condition is sufficient for approval for the specified duration.

Cresemba (isavuconazonium sulfate) capsules are considered not medically necessary for any use(s) other than the FDA‑approved indications and other uses specifically listed in this policy. Coverage is limited to the indications and approval durations described in the Coverage Criteria section; requests for uses not meeting those criteria may be denied.

Any use not explicitly listed in this policy is considered not medically necessary. The policy will be updated if new published data support additional indications.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cresemba (isavuconazonium sulfate capsules). Approvals are issued for the indication-specific durations shown in the policy (months counted as 30 days). Ensure PA is obtained before dispensing to avoid denial of coverage.

Approval durations align with FDA‑approved and supportive‑evidence uses (see policy for specific month approvals).
If member is currently receiving Cresemba, authorize for up to 3 months to complete the course.
When approval length is given in months, 1 month = 30 days.

Documentation Required

Required Documentation for Prior Authorization

Include relevant clinical documentation with the prior authorization request to support the requested indication and duration.

Diagnosis and supporting clinical findings (culture, histopathology, imaging) that establish invasive fungal infection or other indicated use.

Background on Cresemba

Cresemba (isavuconazonium sulfate) is an azole antifungal available in intravenous and oral capsule formulations and is indicated for invasive aspergillosis and mucormycosis in eligible patients. Clinical guidelines (including IDSA, global mucormycosis guidance, and NCCN) list Cresemba as a treatment option for these infections and for certain other settings such as prophylaxis in graft‑versus‑host disease and neutropenia. The oral and IV formulations are bioequivalent and patients are commonly transitioned from IV to oral; prior authorization is required for oral capsule coverage and approvals are granted for the durations specified per indication.

Definitions and Formulation Notes

inv-09: Bioequivalent formulations — oral and IV formulations are bioequivalent and switching rules

BioequivalenceOral and IV formulations of Cresemba are bioequivalent.

Switching guidanceSwitching between IV and oral formulations is acceptable and commonly performed when transitioning from inpatient to outpatient care.

Loading dose when switchingA loading dose is not required when switching between IV and oral formulations.

Typical transition practicePatients are typically started on IV Cresemba and then transitioned to oral formulation during hospitalization or at discharge.

Clinical study contextIn pivotal invasive aspergillosis trials, patients were initiated on IV Cresemba and then transitioned to oral therapy (mean treatment duration ~47 days; IV for ~8–9 days).

Policy Summary

PayerCigna

PolicyAntifungals - Cresemba (Oral) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage updates (indication additions, wording revisions, duration increases)

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization for oral Cresemba capsules and document that the patient meets a listed indication with supporting clinical information.

SourceLink

On This Page

Documentation of prior therapies and response or intolerance when Cresemba is requested for refractory disease or as an alternative to other agents (e.g., amphotericin B intolerance).

For prophylaxis indications, documentation of underlying condition (eg, neutropenia, graft‑versus‑host disease) and reason prophylaxis is indicated.

For HIV‑related indications, documentation of HIV status and relevant clinical findings (eg, esophageal candidiasis, coccidioidomycosis).

Current medication list and any drug interactions or contraindications considered.

Treatment plan including proposed dose, route (IV vs oral), and anticipated duration.

If switching formulations (IV to oral), note that no loading dose is required when switching and provide dates of formulation changes if applicable.

Step Therapy

Step Therapy / Alternatives

No formal step therapy sequencing is specified in this policy. Requests should be evaluated in the context of guideline recommendations and the clinical history submitted with the PA request.

When Cresemba is requested for refractory disease or intolerance, provide documentation of prior antifungal therapies and reasons for discontinuation (lack of efficacy, adverse effects, or contraindication).
Consider IDSA, NCCN, and other guideline context when reviewing requests (treatment durations and scenarios vary by indication).

Denial Risk

Not Covered Uses / Denial Risk

Requests for uses not listed in the policy are considered not medically necessary and will be denied unless new supporting evidence is provided.

The policy lists covered FDA‑approved indications and other uses with supportive evidence; any other use is considered not covered.
Coverage criteria will be updated as new published data become available.