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Drug - Revcovi™ (elapegademase-lvlr) [Leadiant Biosciences, Inc.]

September 2019

Therapeutic area - Adenosine deaminase severe combined immunodeficiency disease (ADA-SCID)

Initial approval criteria

  • Patient has a diagnosis of severe combined immunodeficiency disease (SCID) with a definitive diagnosis of adenosine deaminase deficiency (ADA) as determined by one of the following:
    • ADA catalytic activity (< 1% of normal) in hemolysates (in untransfused individuals) or in extracts of other cells (e.g., blood mononuclear cells, fibroblasts) OR
    • Detection of pathogenic mutations in the ADA gene by molecular genetic testing AND
  • Patient has a marked elevation of the metabolite deoxyadenosine triphosphate (dATP) or total dAdo nucleotides (the sum of dAMP, dADP, and dATP) in erythrocytes AND
  • Patient is not a candidate for or has failed bone marrow transplantation (BMT) AND
  • Patient does not have severe thrombocytopenia (< 50,000/microL) AND
  • Baseline values for plasma ADA activity, red blood cell deoxyadenosine triphosphate (dATP), trough deoxyadenosine nucleotide (dAXP) levels, and/or total lymphocyte counts have been obtained

Renewal criteria

  • Patient continues to meet above criteria AND
  • Patient does not have unacceptable toxicity (e.g., severe injection site reactions/bleeding, severe thrombocytopenia) AND
  • Patient has adequate disease stability and/or response as indicated by 1 of the following:
    • Increase in plasma ADA activity (target trough level ≥ 15 mmol/hour/L) OR
    • Red blood cell dATP level decreased (target ≤ 0.005 to 0.015 mmol/L) OR
    • Improvement in red blood cell dAXP levels (target trough level ≤ 0.02 mmol/L) OR
    • Improvement in immune function with diminished frequency/complications of infection as evidenced in improvement in the ability to produce antibodies

Quantity limits

  • 20 vials/7 days (maximum dose: 23 mg twice weekly)


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

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