Prior Auth Protocol

Prior Authorization Protocol

CRESEMBA (isavuconazonium)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

FDA Approved Indications:
For patients 18 years of age and older for the treatment of:
- Invasive aspergillosis
- Invasive mucormycosis
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of Invasive Fungal Disease (IFD), such as invasive aspergillosis or invasive mucormycosis
Coverage is Not Authorized For:
- Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
General Information:
- Use in patients with familial short QT syndrome should be avoided
- Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with Cresemba is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole.
- Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. Johns wort, or long acting barbiturates with Cresemba is also contraindicated

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Fungizone (amphotericin B)	aspergillosis/mucormycosis IV: 1-1.5 mg/kg/day	1.5 mg/kg/day
Vfend (voriconazole)	aspergillosis IV: initial: 6 mg/kg Q12H for 2 doses Maintenance dose: 4 mg/kg Q12H	≥ 40kg: 12 mg/kg/day IV; 800 mg/day PO < 40kg:12 mg/kg/day IV; 400 mg/day PO

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit
Cresemba
372 mg IV or PO
Q8H for 6 doses & then 1 dose QD
Length of benefit
Product Availability:

Capsule: 186 mg
Vial: 372 mg
References:

1. Cresemba [package insert]. Northbrook, IL: Astellas, Inc.; March 2015.

Drug	Dosing Regimen	Authorization Limit
Cresemba	372 mg IV or PO Q8H for 6 doses & then 1 dose QD	Length of benefit

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.