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New HTA Decisions in France
December 2019
Drug name
VYNDAQEL® (tafamidis)
Company
Pfizer
Decision date
23/10/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Neurological conditions: general and other
Official notice date
04/11/2019
Reimbursement %
100
Decision (SMR)
Important
Decision (ASMR)
Minor improvement (IV)
Indication
VYNDAQEL® is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurological deficit.
Decision Type
Reassessment of SMR and ASMR
Summary
The committee considered the actual benefit of VYNDAQEL® to be 'important' in the indication of the Marketing Authorisation. Considering: - observational data with methodological limitations that suggest, with a decline of several years, a maintenance of effectiveness, although the effect size cannot be characterised; - the lack of comparative data versus ONPATTRO® (patisiran) or TEGSEDI® (inotersen); - the reassuring tolerance profile, with a decline over several years; - partially covered medical need in this rare disease; it was concluded that VYNDAQEL® provides a minor improvement in the medical service rendered (ASMR IV) in the therapeutic strategy which includes symptomatic management (excluding ONPATTRO® and TEGSEDI®). The committee proposed 100% reimbursement.