The evaluation of new medicines in our country by the competent Human Medicines Evaluation and Reimbursement Committee (HTA) is progressing with ever-increasing speed.
In particular, over a period of 4 years (from 3/1/2020 to 23/4/2024) 1,289 applications were evaluated, of which 1,265 received a positive opinion. The applications submitted to the Commission in total were 1,216 plus 85 pending ones received from its previous composition.
Of these, 257 (about 20%) related to original substances, 68 to hybrid drugs, 54 to “orphans”, 33 to originals with a known active ingredient, 32 to biosimilars and 12 to vaccines.
During the same period, approximately 1,289 applications were evaluated, of which 270 (approximately 20%) related to original substances, 63 to hybrid drugs, 54 to “orphans”, 27 to originals with a known active substance, 35 to biosimilars and 11 in vaccines.
Out of all the applications, 39 were not accepted and 24 files received a negative opinion and were withdrawn. Today, 12 drug applications with complete dossiers are pending for evaluation.
The above information was presented by the president of the HTA Committee, professor of Pediatrics – Adolescent Medicine, Flora Bakopoulou from the stage of the 9th HTA Conference.
Medicines: “Gas” in procedures
According to the data, the productivity of the Commission is constantly increasing. It is noteworthy that 125 drugs were evaluated in 2020, 213 in 2021 and 219 in 2022. In 2023, 116 drugs were evaluated, however, this decrease reflects the decrease in applications submitted by the pharmaceutical industry. As for the current year, during the first two months 30 evaluations were carried out. The average evaluation days has been reduced drastically, from 160 days in 2020, to 31 days in 2023.
Regarding the Electronic Pre-Approval System (EPS), the Commission has received 14,970 requests in 3 years, of which 12,225 had a positive recommendation and 2,745 negative.
Central assessment from 2025
Health Technology Assessment (HTA) examines information about medical, economic, social and ethical issues related to the use of health technologies. In particular, it concerns the evaluation of new drugs and medical technology products.
In December 2021, the European Regulation on Health Technology Assessment was adopted, which concerns both of the above categories. The European Regulation provides for the clinical evaluation of new active substances and indications (evaluation of added clinical value of innovative drugs in relation to existing ones) at the European level.
As for the non-clinical evaluation (financial, ethical aspects) it will remain at the national level. Central assessments will be able to be used by Member States as a basis for their own further actions needed to make pricing and reimbursement decisions for new products.
Medicines: The schedule
The European Regulation is expected to come into force in January 2025, starting with medicines.
The first products to be evaluated will be oncology and advanced therapies (estimated not to exceed 10). From 2028, orphan drugs will be added to the evaluation and from 2030 it is expected that all pharmaceutical products (original active and new indications) will enter the central evaluation process.
From 2026, the first clinical evaluations for medical devices are expected and will concern high-risk medical devices and in vitro diagnostic medical devices, which are expected to have a very large impact on the health of patients as well as on health systems.
And in this case, the clinical assessment will be done centrally and the non-clinical assessment at the national level.
“In Greece we are a little behind. The first implementing act on joint clinical evaluations for medicines was expected to have already been issued. However, it is under consultation and it is expected to be issued next week”, said the president of the Commission.
As regards the implementing acts on the conflict of interest (Conflict of Interest), the exchange of information with the European Medicines Agency (EMA) and the methodology of joint scientific consultations on medicines are expected to be adopted around the summer, given that by January 2025 should have been issued and the member states should be able to implement them.
The same applies to implementing acts regarding the evaluation of medical devices.
Follow Reader.gr on Google News to always be up to date on all the news from Greece and the world.
