CurrentMass General Brigham Health PlanPolicy N/A

Noxafil (posaconazole) oral formulations prior authorization

Prior authorization requirements for Noxafil (posaconazole) oral suspension, packets, and tablets for commercial/exchange members age 13 and older under Mass General Brigham Health Plan pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNoxafil (posaconazole) oral formulations prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization for Noxafil oral formulations for commercial/exchange members age 13+ and provide documentation meeting the diagnosis-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/ExchangePlan applicability

≥13Minimum age

3 monthsStandard duration

6 monthsSpecialist duration

Coverage Criteria for Noxafil (posaconazole)

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Covered Indications

Authorization will be granted for members age 13 or older who meet ALL of the following diagnosis-specific criteria where applicable and documentation has been provided:

Indications list: Member has one of the following diagnoses: 1) Zygomycosis (mucormycosis); 2) Prevention of invasive aspergillus and candida fungal infection in patients with hematologic malignancy with neutropenia or graft-versus-host disease or who have undergone hematopoietic stem cell transplant; 3) Esophageal candidiasis; 4) Oropharyngeal candidiasis.

Esophageal candidiasis criteria

For esophageal candidiasis (when request is for oral suspension) the following ALL must be met:

Esophageal candidiasis - oral suspension: a) The request is for the oral suspension; AND b) The member has had an inadequate response, intolerance, or has a contraindication to all of the following: oral fluconazole; itraconazole; voriconazole.

Oropharyngeal candidiasis criteria

For oropharyngeal candidiasis (when request is for oral suspension) the following ALL must be met:

Oropharyngeal candidiasis - oral suspension: a) The request is for the oral suspension; AND b) The member has had an inadequate response, intolerance, or has a contraindication to both: oral fluconazole; itraconazole.

This policy applies to the Commercial/Exchange pharmacy benefit and does not apply to MassHealth UPPL (MassHealth UPPL is not selected for this document). Prior authorization is required under the pharmacy benefit for Noxafil (posaconazole) oral suspension, packets, and tablets for members meeting the eligibility criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Noxafil (posaconazole) oral formulations under the pharmacy benefit. Submit prior authorization requests to the pharmacy benefit contact listed on the plan header.

Applies to oral suspension, packets, and tablets
Pharmacy benefit only — not a medical benefit

Step Therapy

Required prior failures/intolerance — Esophageal candidiasis

For esophageal candidiasis, the request must be for the oral suspension and the member must have had inadequate response, intolerance, or a contraindication to all of the following systemic azoles: oral fluconazole, itraconazole, and voriconazole.

Required prior failures/intolerance: oral fluconazole; itraconazole; voriconazole
Policy applies to members aged ≥13 years

Step Therapy

Required prior failures/intolerance — Oropharyngeal candidiasis

For oropharyngeal candidiasis, the request must be for the oral suspension and the member must have had inadequate response, intolerance, or a contraindication to both oral fluconazole and itraconazole.

Required prior failures/intolerance: oral fluconazole and itraconazole
Policy applies to members aged ≥13 years

Documentation Required

Required clinical documentation and denial risk

Documentation must demonstrate the member is at least 13 years of age and include diagnosis-specific evidence supporting one of the covered indications (e.g., zygomycosis, prevention of invasive aspergillus/candida in high-risk hematologic patients, hematologic malignancy with neutropenia or graft‑versus‑host disease, hematopoietic stem cell transplant, esophageal or oropharyngeal candidiasis). Include prior treatment history, reasons for intolerance or contraindication, and specialist involvement when applicable. Requests that do not provide the required documentation or do not meet the listed criteria may be denied.

Minimum age: ≥13 years
Include diagnosis and clinical evidence for the requested indication
Document prior antifungal treatments and reasons for failure/intolerance/contraindication
Note: Approvals are for 3 months (up to 6 months if prescribed by ID or hematology/oncology specialist)

Definitions and Populations

Prophylaxis population — hematologic malignancy, neutropenia, GVHD, or HSCT

Population descriptionPatients with a hematologic malignancy who have neutropenia, or patients with graft‑versus‑host disease, or patients who have undergone hematopoietic stem cell transplant being considered for prevention of invasive Aspergillus and Candida infections.

Intended prevention targetsPrevention of invasive Aspergillus and Candida fungal infection in the above high‑risk populations.

Age requirementMember must be at least 13 years of age to qualify for prophylaxis under this policy.

Documentation neededClinical documentation must show the qualifying hematologic malignancy with neutropenia, graft‑versus‑host disease, or history of hematopoietic stem cell transplant.

Related coverage noteAuthorization for posaconazole (Noxafil) for prophylaxis is granted only when the above diagnosis‑specific criteria and documentation are provided.

Background

Posaconazole is a broad-spectrum triazole antifungal that inhibits fungal cytochrome P450 enzyme lanosterol-14α-demethylase, which decreases ergosterol synthesis and disrupts fungal cell membrane formation. It is used to treat invasive fungal infections such as zygomycosis (mucormycosis), for prophylaxis against invasive aspergillus and candida in high-risk hematologic patients (including those with neutropenia, graft-versus-host disease, or following hematopoietic stem cell transplant), and for treatment of oropharyngeal and esophageal candidiasis.