Favourable opinion for reimbursement only in the treatment of osteoporosis in postmenopausal women with either a history of at least one vertebral fracture or a history of at least two fractures.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Low
The Committee deems that the clinical benefit of ELADYNOS (abaloparatide) 80 micrograms subcutaneous injection is low only in the treatment of osteoporosis in postmenopausal women with either a history of at least one vertebral fracture or a history of at least two fractures.
Insufficient
The Committee deems that the clinical benefit of ELADYNOS (abaloparatide) 80 micrograms subcutaneous injection is insufficient to justify public funding in view of the available alternatives in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
evidence of the superiority of abaloparatide compared to placebo in women with postmenopausal osteoporosis for the incidence of new vertebral fractures at 18 months and for change in BMD at 18 months at the hip, femoral neck and lumbar spine,
a suggested maintenance of efficacy over time (data at 43 months) in women having switched to treatment with alendronate at 18 months for vertebral fractures,
but in view of:
the modest effect size observed for the primary endpoint of incidence of vertebral fractures,
the low clinical relevance of the ranked secondary endpoints of change in BMD at 18 months at the hip, femoral neck and lumbar spine,
the lack of evidence of a efficacy versus placebo for the endpoint of incidence of non-vertebral fractures, a relevant clinical endpoint in this disease,
the absence of useable comparative data versus teriparatide, given their exploratory nature in the ACTIVE study,
the medical need partially met by the existence of teriparatide, having demonstrated an efficacy on the incidence of vertebral and non-vertebral fractures.
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