Sarclisa®
Drug - Sarclisa® (isatuximab-irfc) [Sanofi]
September 2020
Therapeutic Area - Oncology
Initial approval criteria
- Patient must be ≥ 18 years of age AND
- Patient must have a diagnosis of multiple myeloma AND
- Patient has received prior treatment with lenalidomide (Revlimid) AND a proteasome inhibitor (bortezomib [Velcade], carfilzomib [Kyprolis], OR ixazomib [Ninlaro]) AND
- Patient will be receiving concomitant therapy with pomalidomide (Pomalyst®) and dexamethasone AND
- Prior authorization requests for Pomalyst AND Sarclisa must be submitted concurrently AND
- Patient has NOT failed treatment with previous anti-CD38 therapy (e.g., daratumumab [Darzalex]) AND
- Patient does NOT have severe hypersensitivity to isatuximab-irfc or any other components AND
- In females of childbearing potential, pregnancy has been ruled out prior to treatment AND contraception will be used during treatment and for ≥ 5 months after treatment
- Initial approval is for 6 months
Renewal criteria
- Patient must continue to meet the above criteria AND
- Patient must have disease improvement and/or stabilization AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., severe infusion reactions including anaphylactic reactions, neutropenia, secondary primary malignancies)
- Renewal approval is for 6 months
Quantity limits
- Cycle 1: 10mg/kg on days 1, 8, 15 and 22 (weekly)
- Cycle 2 and beyond: 10mg/kg on days 1, 15 (every 2 weeks)
Billing for Sarclisa
Sarclisa must be billed as a medical claim.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411