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DrugSarclisa® (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.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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