In:
Pharmacia, Pensoft Publishers, Vol. 68, No. 2 ( 2021-05-12), p. 421-425
Abstract:
Despite the early access procedures for marketing authorization (MA) valid throughout the European Union still in the most of the Member states patient access to innovative medicines depends on cost-effectiveness, budget impact assessment and negotiations for price discount with the public payers. Retrospective analysis on the availability and time to market access of medicines authorized under the European medicines agency’s specific procedures for early access shows that despite the shortening of the time to market access after 2013, for most medicines still exceeds 365 days. This is due to the fact that requirements for pricing and reimbursement across EU is fixed to some degree and medicines with MA for early access are subject to the same legal requirements as the medicines with standard centralized marketing authorization. Some specific national legal requirements for pricing and reimbursement decisions, population of interest and manufactures intentions to enter certain markets should also be considered.
Type of Medium:
Online Resource
ISSN:
2603-557X
,
0428-0296
DOI:
10.3897/pharmacia.68.e64931
DOI:
10.3897/pharmacia.68.e64931.figure1
DOI:
10.3897/pharmacia.68.e64931.figure2
Language:
Unknown
Publisher:
Pensoft Publishers
Publication Date:
2021
detail.hit.zdb_id:
3010005-7
SSG:
15,3
