OBJECTIVES

: In 2017, Oncology (93,7 B$), anti-rheumatics 53,3 B$), anti-viral (48,5 B$), anti-diabetes (43,6 B$) and bronchodilators (28,3 B$) had the highest global pharmaceutical sales. This research compare approval, reimbursement level, delays from EMA date and timing trends taken by EU5-countries for approval between 2014-2018 for top 5 pharmaceutical therapeutic areas, analysing their impact in HTA and reimbursement decisions.

METHODS

: Using the Prismaccess database we identified oncology, anti-rheumatics, anti-viral, anti-diabetes and bronchodilators indications approved by EMA between January 1, 2014 to Jun 5, 2018. For each EU5 country we review the process, the HTA and reimbursement decisions, the assessment timing since EMA approval, generating tables and figures to facilitate the compression. Delay trends by therapeutic areas were calculated for each country.

RESULTS

: The study included 171 HTA and reimbursement decisions across United Kingdom, France, Germany, Italy and Spain. HTA advise and reimbursement decisions vary between 70 to 367 days on average count on the country and therapeutic area evaluated since EMA authorization. The percentage of drugs evaluated, drugs reimbursed and timing varies considerably depending on the therapeutic area and the country.

CONCLUSIONS

: HTA and Reimbursement decisions varies substantially among the 5 European countries analysed, but not in the same measure for all the therapeutic areas. In addition, the time used by each agency to evaluate a new drug or indication varies considerably. The time used to evaluate the same new drug or new indication can be tripled depending on the country. The therapeutic area plays a key role in the agility of health technology assessment processes.