Rezzayo (rezafungin)

REZZAYO (rezafungin)

Medical Administration –Reconstitution for intravenous injection

Diagnosis considered for coverage:

• Candidemia and invasive candidiasis: Indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for Rezzayo. Limitations of Use Rezzayo has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

Coverage Criteria:

For diagnosis of Candidemia and invasive candidiasis:

• Diagnosis of candidemia or invasive candidiasis with limited or no other options AND
• Patient is 18 years of age or older AND
• Trial and failure, contraindication or intolerance to one of the following: 
  • Generic caspofungin (echinocandins)
  • Generic micafungin (echinocandins)

Coverage Duration:

• Initial: 1 month
• Reauthorization: none

Dosing: 

• For diagnosis of Candidemia and invasive candidiasis:
  • 400 mg IV loading dose followed by 200 mg IV once weekly thereafter
  • If scheduled dose is missed (not taken the day assigned), administer the missed dose as soon as possible; if the missed dose is administered within 3 days of the assigned day, the next weekly dose may be given on schedule
  • If the missed dose is given more than 3 days after the assigned day, revise the dosing schedule to ensure at least 4 days before the next dose
  • If restarting after at least 2 weeks of missed dosing, restart again at the 400-mg loading dose
     

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information:

• Safety has not been established beyond 4 weekly doses
• Limitations: Rezafungin has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
• Orphan drug and a new molecular entity 
• Rezafungin is an echinocandin antifungal drug show to be active against Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis

Policy Updates:

• 3/1/2024 (policy effective date)- New Rezzayo Criteria (P&T 2/20/2024) (P&T meeting February)

References:

1.    Rezzayo Prescribing Information. Melinta Therapeutics LLC. Lincolnshire, IL. June 2023. 
2.    Rezzayo. IBM Micromedex Solution. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed November 18, 2023. http://www.micromedexsolutions.com.