H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

What we do

Operations

The Division for Health Technology Assessment carries out the critical appraisal of reimbursement submissions for pharmaceuticals, medical devices and other medical technologies utilized for preventive and/or therapeutical services (such as surgical or diagnostic procedures). Based on the critical appraisal process, an expert opinion is issued, synthesizing the clinical and socioeconomic aspects worth considering throughout the governmental reimbursement process in Hungary. Our expert employees present these assessments/expert opinions at the meetings of the Technology Assessment Committee.

What kind of tasks are included in the critical appraisal process?

Our exact tasks vary depending on whether the reimbursement submission concerns a pharmaceutical, a medical device, or any other medical technologies utilized for preventive and/or therapeutical services. For pharmaceuticals and medical technologies utilized for preventive and/or therapeutical services, we first evaluate the therapeutic’s role in healthcare delivery, assessing if it meets an unmet medical need, and we consider its added value compared to current alternatives. Also we carefully evaluate whether it justifies the proposed price, and its budgetary impacts. The exact considerations are somewhat different for medical devices, but this process is also focused on providing insights into unit costs and expected budgetary impacts in clinical settings.

How many assessments are performed by our Division?

The annual number of reimbursement submissions requiring a critical appraisal is between 150 and 200 (equalling one new submission per every other days). In general, these include a similar proportion of submissions for pharmaceuticals and medical devices, accompanied by a smaller portion of submissions for other medical technologies utilized for preventive and/or therapeutical services.

The annual breakdown of figures by type of technology is shown below.

What are the time frames of the assessments?

Current legislations that define the time-frames for the critical appraisal of reimbursement submissions provide 43 days for the critical assessment of pharmaceuticals, 15 days for medical devices and 30 days for any other medical technologies utilized for preventive and/or therapeutical services. These time-frames are relatively short compared to the practice of other member states of the European Union. Thus, it would be reasonable to increase the time period available for the critical appraisal process, especially if we consider the ever-increasing complexity of healthcare services.

Who prepares the assessments?

As the critical appraisal process requires interdisciplinary skills, our medical expert and health economist colleagues work jointly as a team during the assessments. Accordingly, the Division for Health Technology Assessment is sub-divided into two departments, i.e. the Medical Department and the Health Economics Department.

Last updated: 2018.12.19 15:19