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New HTA Decisions in France
December 2021
Drug name
BYLVAY® (odevixibat)
Company
Albireo AB
Decision date
27/10/2021
Therapeutic area
Diabetes and other endocrinal, nutritional and metabolic conditions
Therapeutic sub area
Endocrinal, nutritional and metabolic conditions: general and other
Official notice date
22/11/2021
Reimbursement %
65
Decision (SMR)
Important
Decision (ASMR)
Moderate improvement (III)
Indication
BYLVAY® is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) type 1 and 2 (with the exception of the BSEP3 subtype of PFIC 2) in patients 6 months of age and older.
Decision Type
New technology assessment
Summary
Considering the seriousness of the condition, the good benefit-risk profile of BYLVAY® established in PFIC types 1 and 2 in patients aged ≥6 months only, the alternatives available, and the potential impact of BYLVAY® on public health, the committee considered the actual benefit of BYLVAY® to be ‘important’ in PFIC types 1 and 2 (except BSEP3) in patients aged ≥6 months – proposing a reimbursement rate of 65% – and insufficient to justify reimbursement in other types of PFIC. Furthermore, given the quality of the clinical data supporting odevixibat in PFIC types 1 and 2, the superiority of odevixibat over placebo in terms of efficacy, a suggested improvement in quality of life, the medical need, lack of long-term data, and uncertainty in the need for surgery, BYLVAY® was considered to provide a moderate improvement in actual benefit (ASMR III) in PFIS types 1 and 2 (except BSEP3).