FOLLOW-UP ANALYSIS OF VALIDITY OF BIA FOR DRUGS TEMPORARILY REIMBURSED IN MODE OF COVERAGE WITH EVIDENCE DEVELOPMENT
Author(s)
Zizalova J, Rrahmaniova D, Svorcikova J, Vrubel F
Ambruz & Dark Deloitte Legal, Prague 8, Czech Republic
Presentation Documents
OBJECTIVES: BIA is a mandatory requirement for setting the reimbursement for highly innovative drugs (HID) obtaining the coverage with evidence development (CED).Our previous analysis of HID which obtained CED in 2013 showed no match between the drug costs expected in BIA and the real costs.We analyzed whether the administrative procedures in 2014 constituted an improvement of the estimation. METHODS: Eleven HIDs obtaining CED in 2013 (scope of previous analysis) were re-analyzed.Real costs were extrapolated from data of General Health Insurance Company (VZP) which holds 60% of health insurance market.The real costs of second year of therapy were compared to the relevant figure in BIA included in first submission for CED.Due to temporary nature of CED, five new procedures were held and their actualized BIAs were analyzed. Furthermore, BIAs and real costs of five new HIDs obtaining CED in 2014 were examined.Potential improvement of difference between estimated and real drug costs was investigated. RESULTS: The estimation for second year of therapy costs was more accurate.However, the extent of differences between the estimation and real costs -86% to 272% was still observed. Only in one case the estimation for the relevant year of therapy in actualized BIA was less accurate than in the original BIA. Concerning CED from 2014, the estimated costs were dramatically exceeded in two cases (185% and 412%). In two cases real costs did not achieve the estimation (-61% and -68%).Nearly exact estimation was submitted once. CONCLUSIONS: The follow-up analysis confirmed the previous conclusion that no improvement of estimation can be expected while mandatory BIA undergoes no further review,however real world consumption data slightly improve the quality of estimation.Also the analysis of CED from 2014 showed no improvement of BIA validity caused by experience.It seems that as long as no practical impact of BIA is enforced (by payers), only formal requirement fulfilling BIAs will be produced.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP240
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
Multiple Diseases