Elapegademase-lvlr (Revcovi™)
OFFICE ADMINISTERED or SELF ADMINISTRATION
INTRAMUSCULAR INJECTION
Indications for Prior Authorization:
- Indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Must meet the following criteria for coverage:
- Chart note documentation is provided confirming the patient has a diagnosis of ADA-SCID confirmed by one of the following (1 OR 2):
- At baseline (i.e,; prior to initiating enzyme replacement therapy), the patient has had absent or very low (< 1% of normal) adenosine deaminase (ADA) catalytic activity; OR
- Patient has had molecular genetic testing confirming bi-allelic mutations in the ADA gene;
AND
- The medication has been prescribed by, or in consultation with, an immunologist, hematologist/oncologist, or a physician that specializes in ADA-SCID or related disorders.
Dosing:
- Recommended starting dosing:
- Patients transitioning from Adagen to Revcovi:
- If a patient’s weekly Adagen dose is unknown, or a patient’s weekly Adagen dose is at or lower than 30 U/kg, the recommended minimum starting dose of Revcovi is 0.2 mg/kg, intramuscularly, once a week.
- If a patient's weekly Adagen dose is above 30 U/kg, an equivalent weekly Revovi dose (mg/kg) should be calculated using the following conversion formula:
- Revcovi dose in mg/kg = (Adagen dose in U/kg) / 150
- Adagen-naive patients:
- The starting weekly dose of Revcovi is 0.4 mg/kg based on ideal body weight, divided into two doses (0.2 mg/kg twice a week), intramuscularly, for a minimum of 12 to 24 weeks until immune reconstitution is achieved.
- Patients transitioning from Adagen to Revcovi:
Approval:
- 1 year
Last review date: December 4, 2019