CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Isavuconazole (Cresemba) prior authorization and coverage criteria for invasive aspergillosis and mucormycosis

Policy governs prior authorization and coverage criteria for Cresemba (isavuconazole) capsules or injection for treatment of invasive aspergillosis or invasive mucormycosis for Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIsavuconazole (Cresemba) prior authorization and coverage criteria for invasive aspergillosis and mucormycosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization with clinical and laboratory documentation of the causative organism and evidence of infectious disease specialist oversight; approvals are for 3 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsauthorization duration

1 yr / 6 yrage limits (inj/cap)

5/daycapsule qty limit

medicaidscope

Coverage Criteria for Isavuconazole (Cresemba)

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Initial authorization criteria

Covered when ALL of the following are met:

Indication: Patient is being treated for either invasive aspergillosis or invasive mucormycosis

Microbiology documentation: Clinical & laboratory documentation of causative organism(s)

Age and formulation: Patient is 1 year and older if the request is for Cresemba injection OR patient is 6 years and older and weighing >= 6 kg if the request is for Cresemba capsules

Specialist care: Patient is under the care of an infectious disease specialist

Continuation of inpatient therapy: Patient is continuing Cresemba therapy that was initiated as an inpatient in a hospital setting

Prior antifungal failure: Patient has failed an adequate dose and duration of voriconazole due to inadequate outcome and/or intolerance

There are no explicit exclusions listed in this policy.

Requests may be unsupported when required documentation or clinical circumstances are not met. Specifically, the policy requires clinical and laboratory documentation of the causative organism(s), the patient to be under the care of an infectious disease specialist, and age/weight thresholds depending on formulation (Cresemba injection: ≥ 1 year; Cresemba capsules: ≥ 6 years and ≥ 6 kg). Additionally, approval generally requires that the patient has failed an adequate dose and duration of voriconazole for inadequate outcome or intolerance, so lack of prior voriconazole failure when step therapy applies may preclude approval.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cresemba. Approvals are issued for a 3-month duration when all clinical criteria are met.

Approval duration: 3 months
Affected therapy: Cresemba (isavuconazole)

Step Therapy

Step Therapy Requirement

Step therapy applies: the patient must have failed an adequate dose and duration of voriconazole due to inadequate outcome and/or intolerance before Cresemba will be approved.

Document prior trial of voriconazole with dose/duration and reason for failure/intolerance

Documentation Required

Required Documentation

Clinical and laboratory documentation of the causative organism(s) must be provided with the request. Requests should indicate the treated condition (e.g., invasive aspergillosis or invasive mucormycosis), patient age/weight relevant to the formulation, and that the patient is managed by an infectious disease specialist.

Specify organism(s) from culture, histopathology, or validated molecular testing
Indicate treated diagnosis: invasive aspergillosis or invasive mucormycosis
Provide patient age/weight and formulation requested (injection vs capsules)
Confirm infectious disease specialist is managing care

Denial Risk

Denial Triggers

Requests may be denied if documentation of the causative organism is missing, the request is not managed by an infectious disease specialist, or the patient does not meet age/weight criteria for the requested formulation.

Denial triggers: missing organism documentation
Denial triggers: not under care of an infectious disease specialist
Denial triggers: patient does not meet age/weight criteria for chosen formulation

Background and Indications

Isavuconazole (Cresemba) is indicated in this policy for treatment of invasive aspergillosis and invasive mucormycosis. The policy mandates involvement of an infectious disease specialist and requires clinical and laboratory documentation of the causative organism(s) to support use. Prior authorization is granted for a 3‑month duration when all clinical criteria are met.

Definitions

inv-12: Continuing inpatient-initiated therapy — definition for therapy started inpatient and continued outpatient

DefinitionCresemba therapy that was started during an inpatient hospital stay and is being continued as an outpatient.

Coverage implicationRequests for continuation of inpatient-initiated therapy are included among criteria for a 3-month authorization when all other criteria are met.

DocumentationClinical & laboratory documentation of causative organism(s) and infectious disease specialist oversight still required when continuing inpatient-initiated therapy.