CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Noxafil (posaconazole) prior authorization

Prior authorization criteria for all dosage forms of Noxafil (posaconazole) covering treatment and prophylaxis indications; applies to prescribers and patients within the payer's covered population. Governs initial prior authorization requests processed by CVS Caremark.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNoxafil (posaconazole) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit an initial prior authorization request specifying the Noxafil formulation for the indication and provide documentation of prior treatment failure, intolerance, or contraindication when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indication groups

3Approval duration categories

3094-AInternal ID

Coverage Criteria for Noxafil (posaconazole)

Oropharyngeal Candidiasis

Authorization may be granted for treatment of moderate to severe oropharyngeal candidiasis when ALL of the following are met

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNoxafil (posaconazole) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Prevention of Invasive Aspergillus and Candida Infections

Authorization may be granted for prophylaxis when ALL of the following are met

Prophylaxis Criteria: The requested drug is being prescribed for the prevention of invasive Aspergillus and Candida infections in a patient who is at high risk of developing these infections due to being severely immunocompromised.

High-risk examples include HSCT recipients with graft-versus-host disease or patients with hematologic malignancies with prolonged neutropenia from chemotherapy (see definitions).

Treatment of Invasive Aspergillosis

Authorization may be granted for treatment of invasive aspergillosis when ALL of the following are met

Invasive Aspergillosis Treatment Criteria: The request is for Noxafil injection or Noxafil delayed-release tablets.

Use the formulation appropriate for the indication; delayed-release tablets and injection have formulation- and age-specific labeling per product information.

These criteria are formulation- and indication-specific. Use of a Noxafil formulation that is not specified for the requested indication is not supported by this policy. For example, Noxafil oral suspension (immediate‑release) is the formulation supported for treatment of moderate to severe oropharyngeal candidiasis, while Noxafil injection or Noxafil delayed‑release tablets are the formulations supported for treatment of invasive aspergillosis. Requests that propose a formulation‑indication mismatch (for example, oral suspension for invasive aspergillosis) may be denied unless adequate documentation justifying the non‑standard formulation is provided.

Prior authorization approvals are both indication‑specific and formulation‑specific. Providers must request the specific Noxafil dosage form appropriate to the clinical indication and include any required supporting documentation (such as prior intolerance or inadequate response to alternative agents where specified) to avoid denial for failing to meet the listed criteria.

Provider Requirements and Actions

Prior Authorization

Initial prior authorization required

Initial prior authorization is required for all Noxafil (posaconazole) dosage forms; approvals are specific to the requested indication and formulation and require meeting the policy's listed criteria.

Step Therapy

Step therapy for oropharyngeal candidiasis

For treatment of moderate to severe oropharyngeal candidiasis with Noxafil oral suspension, the patient must have had an inadequate response, intolerance, or a contraindication to both fluconazole and itraconazole oral solution before approval will be granted.

Documentation Required

Required request details and prior treatment documentation

Prescribers must request the Noxafil formulation appropriate for the indication (oral suspension for oropharyngeal candidiasis; injection or delayed‑release tablets for invasive aspergillosis) and include documentation of prior treatment failure, intolerance, or contraindication to required alternate azoles when applicable.

Denial Risk

Denial risk if indication‑specific criteria are not met

Requests that do not meet the specific indication and formulation criteria (for example, not requesting oral suspension for oropharyngeal candidiasis or not requesting injection/tablets for invasive aspergillosis) or that lack required documentation of prior inadequate response/intolerance may be denied.

Key Definitions

High risk for invasive fungal infection — definition and examples

DefinitionPatients who are severely immunocompromised and therefore at high risk for invasive Aspergillus and Candida infections.

Common examplesHematopoietic stem cell transplant (HSCT) recipients with graft‑versus‑host disease (GVHD).

Other examplePatients with hematologic malignancies who have prolonged neutropenia from chemotherapy.

Age/formulation notes (prophylaxis)Posaconazole formulations and age limits differ: injection and delayed‑release tablets — adults and pediatric patients 2 years and older; delayed‑release tablets — patients ≥2 years and >40 kg; oral suspension — patients ≥13 years; PowderMix — pediatric patients ≥2 years who weigh ≤40 kg.

Background

Posaconazole (Noxafil) is an azole antifungal available in multiple dosage forms including oral suspension (immediate‑release), delayed‑release tablets, and intravenous injection. It is indicated for several clinical uses addressed in this policy: treatment of invasive aspergillosis, prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, and treatment of moderate to severe oropharyngeal candidiasis (including cases refractory to other azoles).

Different product formulations are supported for different indications in the authorization criteria: the oral suspension is specified for oropharyngeal candidiasis treatment, while the injection and delayed‑release tablets are specified for invasive aspergillosis treatment. Providers should select the formulation consistent with the FDA‑approved uses and the coverage criteria when submitting prior authorization requests.