CurrentNeighborhood Health Plan of Rhode IslandPolicy 3094-A

Noxafil (posaconazole) prior authorization

Defines prior authorization criteria for Noxafil (all dosage forms) for treatment and prophylaxis of invasive Aspergillus and Candida infections and for oropharyngeal candidiasis; applies to prescriptions requiring CVS Caremark prior authorization for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNoxafil (posaconazole) prior authorization

Policy CodePolicy 3094-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation showing formulation-specific indication and, for oropharyngeal candidiasis, trial and inadequate response or intolerance to fluconazole and itraconazole oral solution.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved major indications listed

6 monthsProphylaxis duration

3 monthsInvasive aspergillosis duration

1 monthOropharyngeal candidiasis duration

Coverage Criteria for Noxafil (posaconazole)

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Oropharyngeal Candidiasis

Authorization may be granted when ALL of the following are met:

Oropharyngeal candidiasis criteria: The request is for Noxafil oral suspension (immediate-release)

From policy: chunk 4

Oropharyngeal candidiasis criteria: The patient has experienced an inadequate treatment response, intolerance, or has a contraindication to fluconazole AND itraconazole oral solution

From policy: chunk 4

Prevention (Prophylaxis)

Authorization may be granted 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

From policy: chunk 5

Treatment of Invasive Aspergillosis

Authorization may be granted when ALL of the following are met:

Invasive aspergillosis treatment criteria: The request is for Noxafil injection or Noxafil delayed-release tablets

From policy: chunk 6

Requests for formulations not specified in the criteria for a given indication are not supported. For example, Noxafil oral suspension is only authorized under the policy for moderate to severe oropharyngeal candidiasis after documented inadequate response, intolerance, or contraindication to both fluconazole and itraconazole oral solution; it is not an approved formulation for treatment of invasive aspergillosis under these criteria, which require the injection or delayed‑release tablet formulations.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted when the request matches FDA‑labeled indications and formulation-specific criteria.

Prior authorization required for Noxafil formulations per indication-specific criteria

Step Therapy

Step Therapy for Oropharyngeal Candidiasis

Step therapy: For oropharyngeal candidiasis, a trial with inadequate response, intolerance, or documented contraindication to both fluconazole and itraconazole oral solution is required before approval of Noxafil oral suspension (immediate‑release).

Applies only to Noxafil oral suspension (immediate‑release)
Documentation must show trial and inadequate response, intolerance, or contraindication to fluconazole AND itraconazole oral solution

Documentation Required

Required Documentation

Documentation must support the specific formulation requested and demonstrate prior intolerance, treatment failure, or contraindication to the required comparator agents for oropharyngeal candidiasis.

Specify formulation requested (e.g., Noxafil oral suspension immediate‑release, delayed‑release tablets, injection)
For oropharyngeal candidiasis requests for oral suspension, include clinical notes or test results showing inadequate response, adverse reaction, or contraindication to both fluconazole and itraconazole oral solution
For invasive aspergillosis treatment, indicate the requested formulation is Noxafil injection or delayed‑release tablets and provide supporting clinical documentation of diagnosis and severity
For prevention of invasive aspergillus and candida infections, provide documentation of severe immunocompromise and high risk for these infections

Denial Risk

Oropharyngeal Candidiasis Denial Trigger

Requests for Noxafil oral suspension for oropharyngeal candidiasis will be denied if documentation does not show inadequate response, intolerance, or contraindication to both fluconazole and itraconazole oral solution.

Denial trigger applies specifically to Noxafil oral suspension (immediate‑release) for oropharyngeal candidiasis

Definitions and Formulation Limits

High‑risk severely immunocompromised patient

DefinitionPatients at high risk due to severe immunocompromise — examples include hematopoietic stem cell transplant (HSCT) recipients with graft‑versus‑host disease (GVHD) and patients with hematologic malignancies with prolonged neutropenia from chemotherapy.

Clinical contextThese patients are the population for whom Noxafil prophylaxis against invasive Aspergillus and Candida infections is indicated.

Examples (non‑exclusive)HSCT recipients with GVHD; patients receiving chemotherapy for hematologic malignancies who develop prolonged neutropenia.

Formulation‑specific age and weight limits

Noxafil InjectionApproved for adults and pediatric patients 2 years of age and older.

Noxafil delayed‑release tabletsApproved for adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.

Noxafil oral suspensionApproved for adults and pediatric patients 13 years of age and older.

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

Background

Posaconazole (Noxafil) is included in this policy for multiple indications and formulations. The policy specifically recognizes oral suspension (immediate‑release) as the formulation indicated for moderate to severe oropharyngeal candidiasis, but only when the patient has had an inadequate response, intolerance, or contraindication to both fluconazole and itraconazole oral solution. Other indications (prophylaxis of invasive Aspergillus and Candida infections and treatment of invasive aspergillosis) are tied to formulation‑specific criteria elsewhere in the policy (e.g., injection or delayed‑release tablets for invasive aspergillosis).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNoxafil (posaconazole) prior authorization

Policy CodePolicy 3094-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

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