As the implementation of the EU HTA Joint Clinical Assessment (JCA) regulation in 2025 draws nearer, our teams across Value and Access and Evidence Generation have been reflecting on the challenges and opportunities the JCA brings to our industry clients. We will be sharing our reflections each Wednesday over the month of July. First up, our Literature Reviews and Synthesis team has been considering what the new JCA regulation will mean for systematic literature reviews (SLRs), exploring the practical implications for the planning and implementation of SLRs, as well as the potential benefits for the wider scientific community. Read the full article here: https://lnkd.in/eB_WVxVu If you are interested in exploring how our teams could support you with projects in EU HTA, please contact Matthew Griffiths, Global Head of HTA, or Catherine Bunting, Head of Market Access.
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Interested on how the JCA methods and processes will influence your literature review strategies? Take a look at this blog post we've put together!
As the implementation of the EU HTA Joint Clinical Assessment (JCA) regulation in 2025 draws nearer, our teams across Value and Access and Evidence Generation have been reflecting on the challenges and opportunities the JCA brings to our industry clients. We will be sharing our reflections each Wednesday over the month of July. First up, our Literature Reviews and Synthesis team has been considering what the new JCA regulation will mean for systematic literature reviews (SLRs), exploring the practical implications for the planning and implementation of SLRs, as well as the potential benefits for the wider scientific community. Read the full article here: https://lnkd.in/eB_WVxVu If you are interested in exploring how our teams could support you with projects in EU HTA, please contact Matthew Griffiths, Global Head of HTA, or Catherine Bunting, Head of Market Access.
Better Together: The Impact of Joint Clinical Assessments on Systematic Literature Reviews
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Joint clinical assessment in Europe is approaching rapidly. As we move from an era of policy into practice, an evidence based, pragmatic approach to informing national questions and outlining Member State PICO requirements is critical. Furthermore, pulling these principles through, in a transparent manner, during EU consolidation will allow predictability for stakeholders and focus the JCA to where it can make most impact for patients. Currently proposed PICO guidance is limited and may create an unpredictable and challenging scope of work for developers and assessors. The proposals outlined in research by my co-authors and I, and highlighted by Greg Rossi below, can help ensure inclusivity of needs in a structured way, acceptability of the JCA scope and report and ultimately faster patient access and improved outcomes with new innovative technologies in Europe.
EU Health Technology Assessment Regulation (EU HTAR) is a unique opportunity to make a step change in the efficiency and speed of assessing new technologies and medicines across Europe. By reducing duplication of HTA processes, it has the potential to make patient access to new medicines and technologies faster and more equitable. This will lead to improved patient outcomes, which is also an important goal for us at AstraZeneca. I’d like to highlight the work of my colleague James Ryan who has collaborated with EFPIA - European Federation of Pharmaceutical Industries and Associations and IQVIA to develop this research manuscript in ISPOR—The Professional Society for Health Economics and Outcomes Research Value in Health journal: https://bit.ly/3z4xZ4Y This in press article illustrates some challenges of the proposed scoping model from EUnetHTA 21 for the EU HTAR, which risk jeopardising the Regulation’s aims in several ways: * The approach to defining and consolidating the populations, intervention, comparators and outcomes (PICOs), which is a critical component of the Joint Clinical Assessment (JCA), is currently unclear and demonstrates a potentially additive, instead of a harmonised, approach. * The impact of the proposed scoping process alongside the recent inclusion of many additional safety outcomes in the JCA method guidance will have assessors requesting thousands of analyses for each JCA – many of which are currently not required in Europe and not actually used by decision-makers. * The research, consistent with other studies, shows that the current proposal will result in PICOs in the double digits, creating extra and unnecessary work for both the Health Technology Developers and assessors, thus delaying review and ultimately access to patients. All stakeholders are aligned on the ambition of creating a transparent and evidence-based HTA across the EU, which has optimal impact for patients while being workable and efficient for assessors and health technology developers. This will also increase Europe's competitiveness as a life science region, driving and accelerating future innovation. But to successfully achieve the HTAR aims, we need the HTA Coordination Group and Member States, through their HTA bodies, to use evidence-based principles to inform national policy questions, as recommended by the World Health Organization. Reliable evidence and those representing the largest patient populations should be prioritised in evaluation of PICOs, with complementary analyses used where possible across Member States. I hope this research and other reviews will build consensus around the need to address these challenges, which will enable HTAR to achieve its goals. Megan Yuan Sandro Cesaro Shane Elder Christine Ney, R.Ph., Pharm.D. Daniel Widrig
The Impact of Additive PICOs in a European Joint Clinical Health Technology Assessment
valueinhealthjournal.com
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EU Health Technology Assessment Regulation (EU HTAR) is a unique opportunity to make a step change in the efficiency and speed of assessing new technologies and medicines across Europe. By reducing duplication of HTA processes, it has the potential to make patient access to new medicines and technologies faster and more equitable. This will lead to improved patient outcomes, which is also an important goal for us at AstraZeneca. I’d like to highlight the work of my colleague James Ryan who has collaborated with EFPIA - European Federation of Pharmaceutical Industries and Associations and IQVIA to develop this research manuscript in ISPOR—The Professional Society for Health Economics and Outcomes Research Value in Health journal: https://bit.ly/3z4xZ4Y This in press article illustrates some challenges of the proposed scoping model from EUnetHTA 21 for the EU HTAR, which risk jeopardising the Regulation’s aims in several ways: * The approach to defining and consolidating the populations, intervention, comparators and outcomes (PICOs), which is a critical component of the Joint Clinical Assessment (JCA), is currently unclear and demonstrates a potentially additive, instead of a harmonised, approach. * The impact of the proposed scoping process alongside the recent inclusion of many additional safety outcomes in the JCA method guidance will have assessors requesting thousands of analyses for each JCA – many of which are currently not required in Europe and not actually used by decision-makers. * The research, consistent with other studies, shows that the current proposal will result in PICOs in the double digits, creating extra and unnecessary work for both the Health Technology Developers and assessors, thus delaying review and ultimately access to patients. All stakeholders are aligned on the ambition of creating a transparent and evidence-based HTA across the EU, which has optimal impact for patients while being workable and efficient for assessors and health technology developers. This will also increase Europe's competitiveness as a life science region, driving and accelerating future innovation. But to successfully achieve the HTAR aims, we need the HTA Coordination Group and Member States, through their HTA bodies, to use evidence-based principles to inform national policy questions, as recommended by the World Health Organization. Reliable evidence and those representing the largest patient populations should be prioritised in evaluation of PICOs, with complementary analyses used where possible across Member States. I hope this research and other reviews will build consensus around the need to address these challenges, which will enable HTAR to achieve its goals. Megan Yuan Sandro Cesaro Shane Elder Christine Ney, R.Ph., Pharm.D. Daniel Widrig
The Impact of Additive PICOs in a European Joint Clinical Health Technology Assessment
valueinhealthjournal.com
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The EU Health Technology Assessment Regulation (EU HTAR) is indeed a significant opportunity to streamline the assessment of new technologies and medicines across Europe. However, as highlighted by this article, it's crucial to address the challenges in the current scoping model to ensure the regulation meets its goals. The potential for duplication and unnecessary complexity in the PICOs process could delay patient access to essential medicines. It's vital that the HTA Coordination Group and Member States prioritize evidence-based approaches and involve the relevant stakeholders to truly benefit patients, accelerate access and support innovation in the EU.
EU Health Technology Assessment Regulation (EU HTAR) is a unique opportunity to make a step change in the efficiency and speed of assessing new technologies and medicines across Europe. By reducing duplication of HTA processes, it has the potential to make patient access to new medicines and technologies faster and more equitable. This will lead to improved patient outcomes, which is also an important goal for us at AstraZeneca. I’d like to highlight the work of my colleague James Ryan who has collaborated with EFPIA - European Federation of Pharmaceutical Industries and Associations and IQVIA to develop this research manuscript in ISPOR—The Professional Society for Health Economics and Outcomes Research Value in Health journal: https://bit.ly/3z4xZ4Y This in press article illustrates some challenges of the proposed scoping model from EUnetHTA 21 for the EU HTAR, which risk jeopardising the Regulation’s aims in several ways: * The approach to defining and consolidating the populations, intervention, comparators and outcomes (PICOs), which is a critical component of the Joint Clinical Assessment (JCA), is currently unclear and demonstrates a potentially additive, instead of a harmonised, approach. * The impact of the proposed scoping process alongside the recent inclusion of many additional safety outcomes in the JCA method guidance will have assessors requesting thousands of analyses for each JCA – many of which are currently not required in Europe and not actually used by decision-makers. * The research, consistent with other studies, shows that the current proposal will result in PICOs in the double digits, creating extra and unnecessary work for both the Health Technology Developers and assessors, thus delaying review and ultimately access to patients. All stakeholders are aligned on the ambition of creating a transparent and evidence-based HTA across the EU, which has optimal impact for patients while being workable and efficient for assessors and health technology developers. This will also increase Europe's competitiveness as a life science region, driving and accelerating future innovation. But to successfully achieve the HTAR aims, we need the HTA Coordination Group and Member States, through their HTA bodies, to use evidence-based principles to inform national policy questions, as recommended by the World Health Organization. Reliable evidence and those representing the largest patient populations should be prioritised in evaluation of PICOs, with complementary analyses used where possible across Member States. I hope this research and other reviews will build consensus around the need to address these challenges, which will enable HTAR to achieve its goals. Megan Yuan Sandro Cesaro Shane Elder Christine Ney, R.Ph., Pharm.D. Daniel Widrig
The Impact of Additive PICOs in a European Joint Clinical Health Technology Assessment
valueinhealthjournal.com
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Update on the EU HTA - adopted guidance now available here - https://lnkd.in/eQmfgbw3 The 'Guidance on Validity of Clinical Studies' was adopted last week and the top line news is unlikely to be well received by rare disease (and also ATMP) companies who were hoping for some leniency for the different evidence challenges faced. It outlines how certainty (or uncertainty) should be assessed and described in JCA submissions. "𝗜𝘁 𝗶𝘀 𝗺𝗲𝘁𝗵𝗼𝗱𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹𝗹𝘆 𝗶𝗻𝗮𝗽𝗽𝗿𝗼𝗽𝗿𝗶𝗮𝘁𝗲, 𝗳𝗼𝗿 𝗲𝘅𝗮𝗺𝗽𝗹𝗲, 𝘁𝗼 𝘁𝗮𝗸𝗲 𝘁𝗵𝗲 𝗿𝗮𝗿𝗲𝗻𝗲𝘀𝘀 𝗼𝗳 𝗮 𝗱𝗶𝘀𝗲𝗮𝘀𝗲 𝗼𝗿 𝘁𝗵𝗲 𝗶𝗺𝗽𝗼𝘀𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗼𝗳 𝗯𝗹𝗶𝗻𝗱𝗶𝗻𝗴 𝗮𝘀 𝗮 𝗷𝘂𝘀𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗶𝗴𝗻𝗼𝗿𝗲 𝘁𝗵𝗲 𝗿𝗲𝘀𝘂𝗹𝘁𝗶𝗻𝗴 𝘂𝗻𝗰𝗲𝗿𝘁𝗮𝗶𝗻𝘁𝗶𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗲𝘃𝗶𝗱𝗲𝗻𝗰𝗲." As it's a catchy 44 pages long, here are my key insights: - 'Any effectiveness result in a JCA report must be accompanied by a description of its certainty'. Guidance cites the GRADE framework giving companies a steer on preference. - External validity should be used rather than applicability, transferability, directness etc. and can be described using qualitative descriptive methods. However any final judgement is left to member states - If the PICO can be addressed by higher grade evidence, it may be justified to not assess in detail any lower grade evidence provided. - To describe statistical precision, effect estimates should always be accompanied by the corresponding measures of variation, preferably CIs at a specified 1- α level of confidence, which is 0.95 (95%) in most cases. - RWE was defined and the strengths/weaknesses described, but no clear preference or level of acceptability was stated. - The clinical relevance of an effect size will be left to the member states to decide. - Risk of bias (RoB) assessment tools have been specified for most study types. Please get in touch if you'd like to discuss the implications of this new guidance or how we can help your team address JCA questions. #JCA #euHTA #HTA #
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Analysis of five HTAs of medical technologies in 2023 and strategic recommendations for evidence generation strategy in England. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 870+ market access and HEOR projects in Europe for more than 210 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Health technology assessment plays an important role in market access for medical technologies in England. National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to the assessment of medical technologies. One of the key med tech-related programs at NICE is the Interventional Procedures Program. The evidence requirements in the program are not entirely clear and depend on many factors (population, level of unmet need, level of invasiveness, safety profile, and many others). MTRC developed an analytical White Paper with review of five recent assessments by NICE to present the evidence requirements for medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. Request an analytical White Paper here: https://lnkd.in/eDfUCMnt
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Analysis of five HTAs of medical technologies in 2023 and strategic recommendations for evidence generation strategy in England. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 870+ market access and HEOR projects in Europe for more than 210 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Health technology assessment plays an important role in market access for medical technologies in England. National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to the assessment of medical technologies. One of the key med tech-related programs at NICE is the Interventional Procedures Program. The evidence requirements in the program are not entirely clear and depend on many factors (population, level of unmet need, level of invasiveness, safety profile, and many others). MTRC developed an analytical White Paper with review of five recent assessments by NICE to present the evidence requirements for medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. Request an analytical White Paper here: https://lnkd.in/eDfUCMnt
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Analysis of five HTAs of medical technologies in 2023 and strategic recommendations for evidence generation strategy in England. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 810+ market access and HEOR projects in Europe for more than 200 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Health technology assessment plays an important role in market access for medical technologies in England. National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to the assessment of medical technologies. One of the key med tech-related programs at NICE is the Interventional Procedures Program. The evidence requirements in the program are not entirely clear and depend on many factors (population, level of unmet need, level of invasiveness, safety profile, and many others). MTRC developed an analytical White Paper with review of five recent assessments by NICE to present the evidence requirements for medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. Request an analytical White Paper here: https://lnkd.in/ersEsFnq
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Analysis of five HTAs of medical technologies in 2023 and strategic recommendations for evidence generation strategy in England. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 810+ market access and HEOR projects in Europe for more than 200 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Health technology assessment plays an important role in market access for medical technologies in England. National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to the assessment of medical technologies. One of the key med tech-related programs at NICE is the Interventional Procedures Program. The evidence requirements in the program are not entirely clear and depend on many factors (population, level of unmet need, level of invasiveness, safety profile, and many others). MTRC developed an analytical White Paper with review of five recent assessments by NICE to present the evidence requirements for medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. Request an analytical White Paper here: https://lnkd.in/ersEsFnq
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Analysis of five HTAs of medical technologies in 2023 and strategic recommendations for evidence generation strategy in England. MTRC is the leading provider of reimbursement analysis in Europe. Since 2017 we have accomplished 810+ market access and HEOR projects in Europe for more than 200 companies. We specialize in multi-country assessments and have experience with analysis in 34 EU countries. Health technology assessment plays an important role in market access for medical technologies in England. National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to the assessment of medical technologies. One of the key med tech-related programs at NICE is the Interventional Procedures Program. The evidence requirements in the program are not entirely clear and depend on many factors (population, level of unmet need, level of invasiveness, safety profile, and many others). MTRC developed an analytical White Paper with review of five recent assessments by NICE to present the evidence requirements for medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. Request an analytical White Paper here: https://lnkd.in/ersEsFnq
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