[PHP40] Has Access To Innovative Therapies In Poland Improved Following The 2012 Reimbursement Act?

[PHP40] Has Access To Innovative Therapies In Poland Improved Following The 2012 Reimbursement Act?

2016 Value in Health

Jaros, P. | Kapuśniak, A. | Kornfeld, Å | Volume: 19, Issue: 7, Pages: A446,

OBJECTIVES: One of the goals of the Polish Reimbursement Act introduced in January 2012 was to increase overall access to medicines, and to innovative therapies in particular. The objective of this study was to analyze how the new law impacted access to innovative drugs in Poland. METHODS: We analysed changes in the Polish Reimbursement List from January 2014 to May 2016. RESULTS: Over one thousand new medicinal products, corresponding to 219 individual molecules or individual combinations, were added to the Polish Reimbursement List in the analysed period. Among them, 52 were entirely new molecules (or new combinations), admitted to the reimbursement for the first time. This group, however, included original (39 new molecules or new combinations) as well as generic products for which originators have never been included in the Reimbursement List (13 new molecules or new combinations). Among newly reimbursed original drugs, 20 obtained marketing approval relatively recently, i.e. between 2010 and 2014. Remaining drugs were older, approved between 1995 and 2009. Median time from marketing approval to inclusion in the Reimbursement List for all non generics was approximately 4 years. The longest, almost 19 years, patients had to wait for follitropin-alfa – in vitro fertilisation drug – approved in October 1995 and admitted to reimbursement in July 2014; the shortest, 7 months, for lipegfilgrastim – anti neutropenia drug used in cancer – approved in July 2013 and admitted to reimbursement in March 2014. Other innovative and relatively quickly (below 2 years) reimbursed drugs included: daclatasvir, simeprevir, sofosbuvir, ledipasvir/sofosbuvir, afatinib, riociguat, axitinib, simoctocog alfa, macitentan and glycopyrronium bromide. Remaining changes in the Polish Reimbursement List included expansion of covered indications and inclusion of new pharmaceutical formulations for already reimbursed drugs. CONCLUSION: Access to innovative therapies in Poland is improving following legislative changes, however it is still limited and delayed compared with marketing approval.

https://www.doi.org/10.1016/j.jval.2016.09.578