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NEED is a 3-year research project aiming to identify and measure unmet health-related needs for a more needs-driven healthcare policy and innovation. |
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We are delighted to share with you some updates regarding the NEED (Needs Examination, Evaluation, and Dissemination) project. The past few months have been bustling with activity for our project.
We are pleased to announce that we have released four reports on the assessment of unmet health-related needs of patients and society. We invite you to read these reports, as they represent a significant milestone in our journey towards a more needs-driven health system.
Furthermore, the findings of our reports were presented at several conferences, including the high-level conference on “Health-related needs as drivers for healthcare policy and innovation”, held as part of the Belgian Presidency of the Council of the EU.
In this newsletter, you will also find interesting upcoming events and insightful publications.
Happy reading!
The NEED team
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NEED updates and recent events
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- Four scientific reports, along with two fact sheets and one synthesis, were published on 28th March 2024. These materials are accessible on the KCE website. In these publications, the NEED team developed a framework for evaluating health-related unmet needs and applied and tested it on two health conditions: Crohn’s disease and malignant melanoma. Additionally, a separate study was conducted to assess the feasibility of using the NEED framework and assessment procedures for rare diseases.
- The NEED team participated in the DIA Europe 2024 conference held in Brussels from March 12th to 14th. The conference featured discussions led by various speakers on defining and assessing unmet health-related needs, as well as strategies for incorporating this concept into regulatory frameworks under the new pharmaceutical legislation.
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- Within the context of the Belgian Presidency of the Council of the EU, we presented the results of our recent reports at the 43rd Strategic Review and Learning Meeting of the Committee on Orphan Medicinal Products and the Strategic Review and Learning Meeting jointly convened by the Paediatric Committee and the Committee for Advanced Therapies of the European Medicines Agency (27th March and 17th May, Leuven).
- The NEED reports were presented at a high-level conference hosted by the Belgian EU Presidency under the theme 'Health-related Needs: Drivers for Healthcare Policy and Innovation.' (17th and 18th April, Brussels). The event was co-organised by the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI), and the Belgian Health Care Knowledge Centre (KCE). Conclusions from the conference emphasised the criticality of evidence-based decision-making and underscored the necessity of establishing an evidence database on unmet needs at the EU level. A concise brochure that describes the full NEED framework, was developed specifically for this conference.
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© Belgian Presidency of the Council of the European Union / Julien Nizet |
- We presented the NEED framework and approach at the Joint Meeting of the Heads of Medicines Agencies (HMA), Health Technology Assessment bodies (HTA), and National Competent Authorities for Pharmaceuticals Regulation (NCAPR) (18th April, Brussels). Participants underscored the importance of precise definitions, ethical considerations, and adopting a longer-term strategic outlook to showcase the relevance of the NEED framework for shaping policy-making and fostering innovation in healthcare.
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- The NEED assessment framework was presented during an oral poster presentation at the 5th PPRI Conference 2024, themed 'Ensuring Access to Affordable Medicines Through Innovative Policies' (25th and 27th April, Vienna). Our abstract can be found in the Conference Supplement to the Journal of Pharmaceutical Policy and Practice.
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- We organised a call for proposals from January 2024 until 31st March 2024 to help us identify health conditions with potentially high unmet needs that should be studied in our two next case studies. We received a total of 352 proposals from patients, healthcare providers and the general public in Belgium, and 73 from the EU. Evaluation of the proposals is ongoing.
- To validate the NEED assessment framework, a Delphi survey at the EU level has been launched. Experts from various institutions of the EU have been contacted to participate. The second round of the Delphi is ongoing and publication of the results is expected by January 2025.
- The construction of the NEED database, which will -for now- contain the findings from the evaluation of unmet health-related needs for Crohn’s disease and malignant melanoma, is currently underway. We anticipate the publication of the database before the summer of 2024. This tool will be openly accessible to all, and users will be able to download the data.
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- Presentation of the NEED initiative at the European Health Management Conference (EHMA) 2024 in Bucharest, Romania: 5-7 June 2024. More info here.
- NEED international advisory committee meeting, Brussels: 11 June 2024.
- Presentation of the NEED initiative at the HTAi Annual Meeting in Seville, Spain: 17-19 June 2024. More info here.
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What we are reading - Interesting publications |
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"Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study"
Brinkhuis et al., 2024.
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This retrospective cohort study aimed to assess the correlation between added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020. Findings revealed that while revenues generally corresponded with added benefit, a significant proportion of drugs recovered research and development costs within a short timeframe despite offering limited added benefit, particularly those approved via conditional marketing authorisations, suggesting a need for policymakers to reassess regulatory and reimbursement incentives to ensure the development of more effective drugs for patients with significant needs. More info here.
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"Cost of non Europe in health policy"
Fernandes et al., 2024
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The findings underscore the fragmented nature of health research and development in the EU, leading to inefficiencies and hindering innovation. National pricing and reimbursement policies result in unequal access to medicines across Member States, exacerbating health disparities. Additionally, underutilization of screening technologies contributes to suboptimal disease detection rates. Addressing these challenges through EU action could yield economic, societal, and environmental benefits, including bolstering the health industry, improving patient outcomes, and promoting green healthcare practices. More info here.
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"Health for All – transforming economies to deliver what matters: final report of the WHO Council on the Economics of Health for All"
World Health Organization, 2023
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The WHO Council on the Economics of Health for All, established in response to the COVID-19 pandemic, aims to reorient global economic systems to prioritize health and well-being. The Council's final report emphasizes four key themes: valuing health through new economic metrics, financing health as a long-term investment, fostering innovation for public good, and strengthening public sector capacities. This approach proposes a paradigm shift to ensure that economic policies and structures are designed to achieve universal health coverage and address both human and planetary health needs. More info here.
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"Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis"
Naci et al., 2024
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This study of cancer drugs approved by the FDA from 2001 to 2018 with immature survival data found that only 32% demonstrated a statistically significant overall survival benefit post-approval. The reporting of these survival benefits varied widely in timing and availability across different sources. This inconsistency highlights the need for improved reporting standards to ensure timely and accessible survival data. More info here.
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"Improving access to medicines and promoting pharmaceutical innovation"
European Parliament's Science and Technology Options Assessment (STOA) Panel, 2023
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The study explores the impact of regulatory mechanisms on public health and proposes reforms to balance innovation and access to medicines. It identifies issues in the current pharmaceutical system, such as market exclusivities and disparities in pricing and access, and suggests five policy options ranging from strengthening EU coordination in IPR and procurement to creating a European infrastructure for pharmaceutical R&D. The recommended approach, Policy Option 5, combines these strategies to address unmet medical needs and stimulate research while ensuring affordability and accessibility More info here.
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"European pharmaceutical research and development"
European Parliament's Science and Technology Options Assessment (STOA) Panel, 2021
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Europe's pharmaceutical sector significantly contributes to the EU economy, but the COVID-19 pandemic highlighted issues in R&D prioritization and public funding policies. The European Commission's pharmaceutical strategy aims to ensure safe, affordable medicines and support innovation. The study explores creating a European public infrastructure for R&D and medicine delivery to address market failures and improve public health, proposing various policy options ranging from focused R&D on infectious diseases to a broad, mission-oriented infrastructure similar to the US National Institutes of Health.. More info here.
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NEED is financially supported by the Belgian Federal Science Policy (BELSPO) through the INFRA-FED call. |
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