Oxbryta™

Drug - Oxbryta™ (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

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

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