During the massive changes that were implemented in Greece in the health system during the period of 2010–2020 the requirement of the creation of ΗΤΑ body was always a prerequisite. The law for the establishment of an HTA committee was voted in January 2018  were the Ministerial Decisions describing the procedures and requirements were released in July and August 2018 [5, 6]. To the best of our knowledge, this is the first research work aiming to assess the efficiency of the HTA procedure in Greece after having the experience of 2.5 years of operation of the HTA committee. The outcome of the HTA process in Greece from its onset, back in July 2018, to January 2021, along with the median time from MA to listing new medicines during the study period were presented in this study.
After the establishment of the law the first MDs issued based in the new procedure were announced in July 2019 and for 22 medicines. This result was mainly driven by two reasons: a) inadequate staffing levels for the assessment and lack of assessors because of the strict rules set for the conflict of interest, b) HTA assessment of all medicines without exceptions including categories as generics, providing a huge burden in the two committees. Political changes in 2019 conclude in further delays as there was a reshuffle in the committee members.
During 2019 and 2020 there were done some legislative changes in the law to improve the productivity of the committees such the introduction of fast-track process for biosimilars and vaccines, exception of some categories from the HTA assessment and without negotiation if their price was low and subsequently, if they didn’t have a negative budget impact like generics, FDC etc [11–13]. All the above legislative changes led to an acceleration of the process as rationalizes the number of files that need full HTA assessment and reduce the burden of the committee. The result of this was to have 254 medicines included in the list for 2020 followed by another 42 medicines in January 2021 from which the 59% were Generics, 17% on patent medicines and 9% biosimilars.
Our analyses revealed that the median (IQR) time between MA to listing for new medicines (including on-patent, biosimilars and FDC) was 30 (22–39) months. For new generics, this time was estimated to be 22 (12.5–31) months, something that could be explained by the drastic legislative changes conducted during 2019 and 2020 exempting generics from the HTA process. Among the new medicines, on-patent drugs delayed significantly more to obtain access to the Greek market compared to new biosimilars, something that could be explained by the requirement of the external criterion obligation which affects mainly new active substances and innovative products and provoke further delay in the initiation of the assessment by the legislative changes, as well.
To the best of our knowledge, limited comparable data to those presented in this work are available from other European countries. A recently published study aiming to assess the access in Europe to newly registered cancer drugs, revealed that the average time between MA and first access, defined as the first sale in each country, in 28 European countries was 398 days (range 17-1187 days). In general, patients in Germany, the UK, and Austria had the most rapid potential access, with averages of 17, 22, and 31 days, respectively. Greece and many Eastern European countries were close to the upper limit . In the same study, it is mentioned that this delay in patient access to specific cancer drugs might be related with a significant loss of life years.
The time between MA to listing is affected by both the pricing and reimbursement system followed in each country. To assess the impact of reimbursement process in Greece, the time between price publication and listing was also calculated. It was found that almost 2 years were required to get a new medicine access to the Greek market from the date of price publication. Given that the HTA process should be completed within 6 months from submission of HTA application, based on the legislation, this delay could be explained from either the delayed submission after pricing due to external criterion required or delay in HTA process. Since, data on HTA submission date were not available we cannot conclude on which of these factors is responsible for delay. Moreover, it was found that ¼ of new medicines took at least 2 months from the time the MD was issued until the final inclusion in the reimbursement list. This indicates that actions should be taken by the decision policy makers so that the products to be included automatically in the reimbursement list directly after MD.
A recent report of OECD concluded that one of the key challenges is the often-significant uncertainty surrounding the degree of clinical benefit offered by a new medicine at the time of market entry. Especially in oncology, as new indications are frequently approved in earlier phases of development. This is often driven by the need to have a rapid access to promising therapies in areas of unmet medical need. The challenge of the HTA bodies is that the uncertainty of the value is higher. Recently a common approach for overcoming this obstacle is the use of managed entry agreements, mainly with the objective of managing financial risks. This key point could be addressed in Greece with the further evolution of the Negotiation Committee, setting concrete criteria for innovation and establishing a mechanism of horizon scanning to anticipate the challenges.