CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Posaconazole (Noxafil) prior authorization

Defines prior authorization requirements for all Noxafil (posaconazole) dosage forms for treatment and prophylaxis of invasive Aspergillus/Candida infections and for oropharyngeal candidiasis for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPosaconazole (Noxafil) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document inadequate response, intolerance, or contraindication to both fluconazole AND itraconazole oral solution.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3indications enumerated

4formulations/age notes

2alternative azoles referenced

Posaconazole (Noxafil) Coverage Criteria

Coverage Criteria

Covered when ONE of the following indication-based conditions is met AND step-therapy criteria are met:

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Indication: (A) Prophylaxis: prescribed for prevention of invasive Aspergillus and Candida infections in a patient who is at high risk due to severe immunocompromise (e.g., HSCT with GVHD or hematologic malignancy with prolonged neutropenia)

Formulation-specific age/weight requirements apply as per product labeling

Indication: (B) Treatment: Noxafil injection or Noxafil delayed-release tablets for treatment of invasive aspergillosis (adults and pediatric patients ≥13 years)

Refer to product-specific age indications for injection/delayed-release tablets

Indication: (C) Treatment: Noxafil oral suspension for moderate to severe oropharyngeal candidiasis (including cases refractory to itraconazole and/or fluconazole) in adults and pediatric patients ≥13 years

Oral suspension indicated for oropharyngeal candidiasis refractory to itraconazole/fluconazole

Step therapy/Prerequisite: Patient has experienced inadequate treatment response, intolerance, or has a contraindication to fluconazole AND itraconazole oral solution

Both agents (fluconazole and itraconazole oral solution) must be documented as failed, intolerant, or contraindicated

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Coverage requires prior authorization. The requested drug will be covered only when prior authorization is obtained and the medication is prescribed for an approved indication (e.g., prophylaxis of invasive Aspergillus and Candida in patients who are severely immunocompromised, treatment of invasive aspergillosis with injection or delayed‑release tablets, or treatment of moderate to severe oropharyngeal candidiasis with oral suspension).

Prior authorization required for all requests.
Covered only for listed indications in high‑risk, severely immunocompromised patients or specified treatment uses.

Step Therapy

Step Therapy Requirement

Step therapy requirement: a trial with inadequate response, intolerance, or documented contraindication to BOTH fluconazole and itraconazole (oral solution) is required before Noxafil will be approved for the covered indications.

Documented trial and inadequate response, intolerance, or contraindication to fluconazole
AND documented trial and inadequate response, intolerance, or contraindication to itraconazole oral solution

Documentation Required

Required Documentation

Required documentation: include clinical rationale and supporting medical records demonstrating the indication and patient risk status, patient age and weight when relevant to formulation selection, prior antifungal therapy trials (dates, doses, and reason for failure/intolerance), and any contraindications.

Indication for use (prophylaxis vs treatment) and supporting clinical details
Evidence the patient is severely immunocompromised/high‑risk (e.g., HSCT with GVHD, hematologic malignancy with prolonged neutropenia)
Patient age and weight when relevant to formulation (e.g., tablet vs suspension)
Documentation of trials with fluconazole and itraconazole oral solution including dates, doses, and reason for discontinuation or failure

Denial Risk

Denial Triggers

Denial triggers: requests may be denied if the drug is not prescribed for an approved prophylactic or treatment indication in a high‑risk, severely immunocompromised patient, if required step‑therapy has not been met, or if the submission lacks the required supporting documentation.

Not prescribed for prophylaxis in a severely immunocompromised high‑risk patient or not for the specified treatment uses
No documentation of trial/failure/intolerance/contraindication to both fluconazole and itraconazole oral solution
Missing key clinical documentation (patient risk status, age/weight when required, prior therapy details)

Clinical Background

Posaconazole (Noxafil) is an antifungal agent indicated for: (1) prophylaxis of invasive Aspergillus and Candida infections in patients at high risk because they are severely immunocompromised (for example, hematopoietic stem cell transplant recipients with graft‑versus‑host disease or patients with hematologic malignancies and prolonged neutropenia); (2) treatment of invasive aspergillosis with Noxafil injection or delayed‑release tablets; and (3) treatment of moderate to severe oropharyngeal candidiasis with Noxafil oral suspension. Formulation‑specific age and weight requirements apply per product labeling.

Key Definitions and Formulation Notes

High‑risk severely immunocompromised patient

Example patient groupsHematopoietic stem cell transplant (HSCT) recipients with graft‑versus‑host disease (GVHD)

Example patient groupsPatients with hematologic malignancies with prolonged neutropenia from chemotherapy

Risk contextPatients who are severely immunocompromised and therefore at high risk for invasive Aspergillus and Candida infections

Formulation age/weight notes

Noxafil injection (prophylaxis)Adults and pediatric patients 2 years of age and older

Noxafil delayed‑release tabletsAdults and pediatric patients 2 years of age and older who weigh greater than 40 kg

Noxafil oral suspensionAdults and pediatric patients 13 years of age and older (treatment of oropharyngeal candidiasis and prophylaxis in certain formulations)

Noxafil PowderMix for delayed‑release oral suspensionPediatric patients 2 years of age and older who weigh 40 kg or less

OpenPayer

Posaconazole (Noxafil) prior authorization

Posaconazole (Noxafil) Coverage Criteria

Drug Identifiers and Codes

Prior Authorization, Documentation, and Step Therapy

Clinical Background

Key Definitions and Formulation Notes