How should health technology developers prepare for future market access activities in Europe?
Numerous discussions have already taken place in various forms and on various platforms around the upcoming implementation of the EU Joint Clinical Assessments (JCA); it’s a hot topic and keeps many of us in our industry occupied. Despite the European Commission’s active efforts in developing draft regulation and related materials to support the transition to JCA, to date, some questions remain unanswered. As the EU JCA aims to harmonize and accelerate evaluation processes in Europe, all stakeholders, including health technology developers, national health technology assessment (HTA) authorities, and EU JCA assessors and patients, are facing substantial changes with this new process on European-level HTA.
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Written by Grammati Sarri, David Smalbrugge, Andreas Freitag, and Evie Merinopoulou
The vision of a single, centralized system for the comparative joint clinical assessments (JCA) of health technologies in the European Union (EU) is now a reality, with corresponding guidance that supports EU member state cooperation and increases transparency in clinical assessments. However, oversight by the European Network for Health Technology Assessment (EUnetHTA) 21 will cease in September 2023, leaving stakeholders (pharmaceutical companies, local decision-makers) uncertain about next steps for the EU JCA guidance, particularly regarding the use and weight of real-world evidence (RWE) and its opportunities in decision-making.
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The draft Implementing Act of the EU Health Technology Assessment Regulation (HTAR) for Joint Clinical Assessments (JCA) of medicinal products — the first legal definition of the procedural and methodological details for the new EU HTAR JCA — was published by the European Commission on March 5, 2024, following some delay.1 The draft is currently open for public consultation until April 2, and feedback received will be considered before the European Commission finalizes the Implementation Act.
Here, we delve into the key elements of the Implementing Act and the implications for sponsors.
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Written by Marie Diamond and Maria Rizzo
Systematic literature reviews (SLR) are essential to informing healthcare decision-making and are pivotal for reimbursement submissions to health technology assessment (HTA) bodies. One limitation of SLRs, however, is that they quickly become outdated due to the continuous publication of new literature. The living systematic review (LSR) model can overcome this challenge by incorporating relevant new evidence as it is published. Read more »
Randomized control trials (RCTs) are the gold standard for estimating the efficacy of a treatment. They allow us to investigate treatment effects in a controlled setting designed to ensure reproducibility of the results, quality of data, and minimization of selection bias. In contrast, comparative effectiveness from real-world data (RWD) is traditionally regarded as inferior evidence, primarily due to its lack of randomization and limited availability of information on potentially relevant prognostic factors. As such, real-world evidence (RWE) has been mostly used to corroborate RCT results and for post-marketing monitoring.
Recently, the growing body of data from the real world, which accompanied the digitalization of health, has drawn increasing attention to RWD and its potential, leading to questions on whether comparative effectiveness evidence from RWD could support regulatory and HTA decisions.
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