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DrugOxbryta™ (voxelotor) [Global Blood Therapeutics, Inc.]

April 2020

Therapeutic area - Sickle Cell Disease

Initial approval criteria

  • Patients must be ≥ 12 years of age AND
  • Oxybryta will not to be used in combination with crizanlizumab (Adakveo) or L-glutamine (Endari) AND
  • Patient has a confirmed diagnosis of sickle-cell disease, of any genotype (e.g., HbSS, HbSC, HbS/beta0-thalassemia, HbS/beta+-thalassemia, and others) as determined by one of the following:
    • Identification of significant quantities of HbS with or without an additional abnormal β-globin chain variant by hemoglobin assay OR
    • Identification of biallelic HBB pathogenic variants where at least one allele is the p.Glu6Val pathogenic variant on molecular genetic testing AND
  • Patient had an insufficient response to a minimum 3-month trial of hydroxyurea (unless contraindicated or intolerant) AND
  • Patient will avoid concomitant use with, or use decreased doses of, CYP3A4 substrates, for which minimal concentration changes may lead to serious or life-threatening toxicities (e.g., clopidogrel, amitriptyline, cyclosporine, fentanyl, sorafenib, etc.) AND
  • Patient has symptomatic anemia with a baseline hemoglobin (Hb) level between ≥ 5.5 g/dL and ≤ 10.5 g/dL prior to start of therapy AND
  • Laboratory values are obtained within 30 days of the date of administration (unless otherwise indicated) AND
  • Other causes of anemia (e.g. hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out AND
  • Patient does not have known hypersensitivity to voxelotor
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the criteria for initial approval AND
  • Patient must be absent of unacceptable toxicity from the drug (e.g., hypersensitivity reactions) AND
  • Disease response as evidenced by an increase in hemoglobin (Hb) of >1 g/dL from baseline AND
  • Laboratory values are obtained within 30 days
  • Renewal approval is for 12 months

Quantity limits

  • 150 tablets every 30 days


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

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