The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical natu...
18 November 2024
Many countries around the world use health technology assessment (HTA) to inform reimbursement and pricing decisions. HTA is often split into two steps, called assessment and appraisal. While the term HTA itself has been defined by international cons...
The European Health Technology Assessment (HTA) regulation (HTAR) came into effect in January 2025 and impacts the HTA process in all European Member States. Member States must give due consideration to the joint clinical assessment (JCA) report. Thi...
With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (...
14 March 2024
Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore...
4 June 2023
ABSTRACT Involvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process. A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA...
The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technolog...
Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated re...
23 December 2016
Background & objectives: Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for furthe...
Background: Lifestyle intervention programs have long been shown to be effective in preventing cardiometabolic risk factors (CMRFs) such as metabolic syndrome (MS), impaired fasting glycaemia (IFG), type II diabetes (T2DM), and hypertension (HTA). Ho...
Gene therapies that induce the body to produce therapeutic anti-vascular endothelial growth factor (anti-VEGF) proteins are an emerging topic related to neovascular age-related macular degeneration (nAMD). Continuous delivery of anti-VEGF protein dir...
13 November 2021
Background: Gene therapies can treat, prevent, or cure a disease by changing the expression of a person’s genes. They are an innovative strategy for treating genetic disorders; however, they are still emerging on the market access and in the healthca...
30 July 2019
Introduction: The appraisal of medicines is often a complex and iterative process. We compared the health technology assessment (HTA) process in England and France taking as a case study the example of ixazomib for multiple myeloma. Methods: We under...
6 October 2024
The Tunisian Health Technology Assessment (HTA) body, INEAS, conducted a cost-effectiveness analysis (CEA) of vemurafenib in the treatment of locally advanced or metastatic BRAF V600-mutated melanoma. The objective of this analysis was to enable the...
Public reimbursement systems face the challenge of balancing provision of needed treatments and the reality of limited resources. Canada has a complex system for drug approval and public reimbursement, with jurisdiction divided between the federal go...
The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonizing health technology assessments (HTAs) across EU member states. This article explores the implication...
20 May 2024
Background: Real-world evidence (RWE) can reinforce clinical trial evidence in health technology assessment (HTA). Objectives: Review HTA bodies’ (HTAbs) requirements for RWE, real uses, and acceptance across seven countries (Brazil, Canada, Fr...
Canada’s healthcare system, like others worldwide, is immersed in a process of evolution, attempting to adapt conventional frameworks of health technology assessment (HTA) and funding models to a new landscape of precision medicine in oncology....
Attitudes can be predictors of certain health-related behaviours. The attitudes of young females towards health and taste have not been yet fully examined and their associations with dietary behaviours remain unclear. The aim of the study was to inve...
Background/Objectives: This study determined the effects of 60 min or 30 min Pilates program on cervicothoracic alignment, muscular strength, and endurance in university students with upper-crossed syndrome (UCS). Methods: Twenty-six university stude...
15 March 2020
Background: Limited previous research and guidelines on the design of economic evaluation for biosimilars have led to unresolved methodological questions on how to assess biosimilars. Objectives: We want to raise awareness of and explore methodologic...
Electrical transport in 2D materials exhibits unique behaviors due to reduced dimensionality, broken symmetries, and quantum confinement. It serves as both a sensitive probe for the emergence of coherent electronic phases and a tool to actively manip...
Background: The aim of our study was to assess the influence of prepregnancy Body Mass Index (BMI) changes as well as excessive gestational weight gain (GWG) on maternal and fetal perinatal parameters. Furthermore, we aimed to analyze the influence o...
1 April 2022
The price of cancer drugs has skyrocketed, yet it is not clear whether their value is commensurate with their price. More cancer drugs are approved under expedited review, which considers less rigorous clinical evidence, yet only 20% of them show an...
Background and Objectives: This study aims to identify cardiovascular risk factors among 91 patients with multiple sclerosis in Bucharest, Romania, using data from medical records and a self-administered questionnaire. Materials and Methods: The rese...
As schools go digital, the use of tablet computers is increasing. Concerns are raised that the extensive use of tablets and the associated bent-over posture may negatively affect the individual’s health. In order to analyse the possible effects...
18 November 2015
Introduction and objective: Cell therapies can be classified into three main categories of products: advanced therapy medicinal products (ATMPs), ATMPs prepared on a non-routine basis (hospital exemptions), and minimally manipulated cells. Despite th...
11 October 2020
Objective: To provide recommendations for addressing previously identified key challenges in health economic evaluations of Gene Replacement Therapies (GRTs), including: 1) the assessment of clinical effectiveness; 2) the valuation of health outcomes...