Noxafil PowderMix (posaconazole)

Noxafil PowderMix (posaconazole)

Self-Administration – oral 

Diagnosis considered for coverage:

• Prophylaxis of Invasive Aspergillus and Candida Infections: Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: pediatric patients 2 years of age and older who weigh 40 kg or less.

Coverage Criteria:

• Used as prophylaxis of invasive fungal infections caused by one of the following: 
  • Aspergillus 
  • Candida, AND 
• Patient is 2 years of age and older, AND
• Patient weighs 40 kg or less, AND
• Patient is at high risk of infections due to severe immunosuppression from one of the following conditions:
  • Hematopoietic stem cell transplant (HSCT) with graft-versus-host disease (GVHD) 
  • Hematologic malignancies with prolonged neutropenia from chemotherapy, OR
• Patient has a prior fungal infection requiring secondary prophylaxis

Coverage Duration: 

• Initial: 6 months

Dosing:

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• Treatment of Invasive Aspergillosis 
• Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole

Additional Information: 

• The optimal duration of therapy for aspergillosis has not been defined. Most clinicians treat infections (pulmonary) until resolution or stabilization of clinical and radiographic manifestations. The IDSA recommends a minimal treatment period of 6 – 12 weeks in immunocompetent patients for invasive conditions. 
• According to the IDSA guidelines for aspergillosis, duration of therapy for most conditions for aspergillosis has not been optimally defined. Most experts attempt to treat pulmonary infection until resolution or stabilization of all clinical and radiographic manifestations. Other factors include site of infection (e.g., osteomyelitis), level of immunosuppression, and extent of disease. Reversal of immunosuppression, if feasible, is important for a favorable outcome for invasive aspergillosis.” 
• According to the IDSA guidelines for the treatment of aspergillosis, both Amphotericin B and itraconazole are listed as second line treatment options for the treatment of invasive disease. 
• NCCN recommends secondary prophylaxis with an appropriate antifungal agent in patients with prior chronic disseminated candidiasis or with invasive filamentous fungal infection during subsequent cycles of chemotherapy or HSCT. In patients with invasive aspergillosis before HSCT, antifungal therapy for more than a month and resolution of radiologic abnormalities correlate with a lower likelihood of post-transplant recurrence of infection. Secondary prophylaxis with a mold-active agent is advised for the entire period of immunosuppression. Secondary prophylaxis is generally administered for the duration of immunosuppression. Per recommendation from an infectious disease specialist, posaconazole is used for secondary prophylaxis of prior fungal infections. 

Policy Updates:

• 08/24/2023 – New policy approved by P&T.

References:

1. Wheat LJ, Freifeld AG, Kleiman MB, et al. Clinical practice guidelines for the management of patients with histoplasmosis: 2007 update by the Infectious Diseases Society of America. Clin Infect Dis. 2007;45:807-825. 
2. Per Clinical Consultation with an Infectious Disease Specialist. January 24, 2014.
3. Noxafil Prescribing Information. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. September 2022.