https://journals.aboutscience.eu/index.php/grhta/issue/feed 2025-01-16T12:54:29+00:00 Lucia Steele lucia.steele@aboutscience.eu Open Journal Systems <p>Health technology assessment (HTA) is a discipline in which global policies and guidelines are applied at regional level. <strong>Global and Regional Health Technology Assessment (GRHTA)</strong> is an international, indexed, peer-reviewed, open access, online only journal, which aims to promote health technology assessment and economic evaluation globally and/or regionally, supporting the decision-making process among alternative therapeutical approaches and technologies with different clinical and economic outcomes.</p> <p>The journal focuses on the role of scientific and technological advancement in reaching higher healthcare standards and on the intrinsic limitations within each region in allocating resources in healthcare. These topics are of great relevance to the local academic communities and policymakers for their impact on healthcare governance in different countries.</p> <p>The journal publishes new articles continuously, as soon as they are ready for publication to guarantee rapid and efficient publication times and a content distribution to its indexing databases and then collects them in a yearly issue.</p> https://journals.aboutscience.eu/index.php/grhta/article/view/3259 2025-01-15T13:20:10+00:00 Raffaella Cocciolo raffaella.cocciolo@intexo.it Paola Turella paola.turella@intexo.it Daniela Pilunni daniela.pilunni@policlinicogemelli.it Pierluigi Navarra pierluigi.navarra@unicatt.it

<p class="abstract"><strong>Background:</strong> The duration of price&amp;reimbursement (P&amp;R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&amp;R negotiations in Italy in the period 2021-2023.</p> <p class="abstract"><strong>Methods:</strong> Data were retrieved from the Intexo database, which included all medicines with EC approval within the period 2021-2023. Biosimilars, generics, gene therapies, Sars-Cov-2 vaccines and medicines with no negotiated price at the datalock of December 2023 were excluded from the analysis. The ex-factory price of the most expensive package was taken as the price of each reimbursed medicine, whereas the time between the publication of EC decision in the European GU and the publication of P&amp;R AIFA decision in the Italian GU (gazette-to-gazette time) as well as the time between the submission of P&amp;R dossier and the publication of AIFA decision in the Italian GU (AIFA negotiation time) were taken as the procedure duration.</p> <p class="abstract"><strong>Results:</strong> Sixty-seven EC approved medicines completed the P&amp;R procedure in Italy within the study period, and had a reimbursed price. The median and mean gazette-to-gazette times were 395 and 442.6 days, respectively, whereas the mean and median AIFA negotiation times were 389.5 and 434.7 days, respectively. The mean price was 10,942 euros. The analysis of correlation between the duration of procedure and the negotiated price showed that there is no correlation whatsoever between the length of procedures and the price of medicines.</p> <p class="abstract"><strong>Conclusions:</strong> We can reasonably exclude that the price of medicines negatively affected the duration of P&amp;R negotiation procedures.</p>

2025-01-15T00:00:00+00:00 Copyright (c) 2025 The authors https://journals.aboutscience.eu/index.php/grhta/article/view/3354 2025-01-16T12:54:29+00:00 Oriol Solà-Morales osola@fhitt.org Iga Lipska iga.lipska@healthpolicy.institute Francois Meyer meyerfrancois@gmail.com Pier-Luigi Canonico pierluigi.canonico@uniupo.it Herbert Altmann Herbert.Altmann@pharmalex.com

<p class="abstract">There has been a lot of discussion on the technical aspects of the soon to be implemented European Union’s Health Technology Assessment (EU HTA) regulation. However, there has been limited discussion on the implementation aspects and the potential limitations from a policy perspective. In May 2024, a group of HTA experts with previous policy responsibilities met in Rome to propose some policy aspects to be considered.</p> <p class="abstract">As a result of the discussion, several proposals were made. Building mutual trust, improving collaboration and engaging all relevant stakeholders seems a must. Equally important are the communication aspects, and ensuring equal commitment by all parties, allocating the appropriate incentives at all levels. Finally, it is noted that the EU HTA regulation has to be seen from the perspective of a wider policy change within the large EU legal framework.</p>

2025-01-16T00:00:00+00:00 Copyright (c) 2025 The authors