Time From Marketing Authorization to Reimbursement of Medicines in Greece After the Introduction of the Health Technology Assessment Process From July 2018 to April 2022

Objectives: This study aimed to quantify the median time from marketing authorization (MA) to the inclusion of medicines in the reimbursement list after the introduction of the health technology assessment process in Greece.

Methods: From July 2018 to April 2022, the Ministerial Decisions (MDs) and reimbursement lists, posted on the website of the Ministry of Health, were reviewed. The following information was collected for the medicines: the date that MDs and positive reimbursement lists were issued, the MA date, the date of the official price publication, and the type of the health technology assessment application. The time from MA to listing was calculated as the difference between the MA date and the date that the relevant reimbursement list was issued.

Results: During the study period, 93 MDs were issued, from which 79 (85%) were positive and 14 (15%) were negative. Focusing on medicines included in the positive list for the first time, the median time from MA to listing for the new molecules was found to be 34.8 (interquartile range 25.7-41.3) months. This time was statistically significantly shortened for fixed dose combinations (20.9 [15.3-45.4] months, P = .008), and biosimilars (23 [16.6-28.2] months, P = .001). For generics was 17.6 (interquartile range 10-30) months, statistically significantly lower than that of new molecules (P < .001).

Conclusions: The time from MA to the inclusion of medicines in the reimbursement list in Greece is significantly long, especially for innovative medicines. Thus, policy makers should consider this point to optimize and improve patients' subsidized access.