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