Faq

  • Is there such a thing as the “right” timing?

    A ‘one size fits all’ approach to the timing and methodology of appraisals will fail to take account of the complexity of conducting assessments and would ignore differences in diseases, treatments, and patient populations.  Often the sort of data needed to confirm cost- and clinical effectiveness, and efficiency is data on real-life clinical use of an intervention.  The data can only be collected once the intervention is on the market for some time, and will depend on prevalence.  Manufacturers should therefore be able to submit health outcomes information to the relevant government bodies throughout a product’s lifecycle.  This evidence should receive appropriate attention and reward from payers.

  • How could greater flexibility play a role?

    HTAs should be a flexible process used collaboratively.  The use of HTA to make reimbursement decisions should have as its key objective to improve health outcomes for patients through the rapid uptake of beneficial health innovations and technologies, without losing sight of social values.  A proper use of clinical and/or cost-effectiveness assessment of therapies should be aimed at increasing the understanding of its different benefits, value to patients and of public health and healthcare system impact.

  • What about early-stage dialogues on these assessments?

    HTA should be based on an in-depth interaction to discuss specific data required in order to decide on the reimbursement of a product, and looking at its specific field and patient need.  This would create predictability by clarifying payer expectations and the ability of industry to meet these expectations.  At present, dialogue generally starts when a therapy has been approved.  What constitutes therapeutic progress, and whether and at what level to fund this progress should be much clearer, and the rarity of the disease should be taken into account.

  • Should HTAs include a broader perspective?

    Yes. HTA evaluations should include all relevant stakeholders and take place in the context of the whole budget for healthcare, and be equally made for processes, procedures, service costs and products.  They should take account of issues such as the policy context, community need, alternative treatment, uniqueness, disease rarity, utilization patterns, cost-effectiveness, budget-impact, organization and staffing impact, future evidence that will become available, ethics, access and healthcare funding mechanisms within this framework, HTA may reach different conclusions on the same technology in different countries or regions.

  • What can be done to improve HTAs?

    The biotech industry proposes the development of shared European standards for HTAs to ensure the highest level of transparency, dialogue and trust amongst stakeholders and public authorities - including social values, which are part of our solidarity-based healthcare systems and are the foundation of our European society.

  • Is there a common European consensus to reward healthcare innovation in HTAs?

    There is no common European consensus on how to reward healthcare innovation. Different HTA mechanisms to evaluate clinical and/or cost-effectiveness are used in a majority of European Union member states, at all times separate from regulatory product registrations.

    Unfortunately, in a variety of healthcare systems cost-effectiveness or cost-utility models with a limited systematic review of clinical data are presented as HTA and "pretend" to have the statute of a holistic evaluation of technologies when they are not. Such HTA evaluations can have the impact of punishing research-intensive biotech SMEs and also threatening patient access by possible misuse as a tool of cost-containment/rationing policies in healthcare.

  • What is the aim of Health Technology Assessment?

    The purpose of HTA is to provide high-quality information to decision makers about the clinical effectiveness, cost-effectiveness, and broader impact of drugs, medical technologies, and health systems.

  • What is Health Technology Assessment?

    Health Technology Assessment (or HTA) is the ‘multi-disciplinary field of policy analysis, which studies the medical, social, ethical and economic implications of development, diffusion and use of health technology’ 1HTAs – are often used as the mechanism by which governments decide the value of new therapies.

    1INAHTA (International Network of Agencies of HTA)

  • What is ‘health technology’?

    Health technology refers to any method that is used to promote health prevent, diagnose and treat diseases or improve rehabilitation and long-term care. Technologies include drugs, devices, diagnostic agents, equipment, and medical and surgical procedures.

  • What is the Regulation for Advanced Therapies in Europe?

    Advanced Therapies refers to the Regulation (EC) No 1394/2007 on advanced therapy medicinal products that bring all advanced therapies (gene, cellular and tissue-based) together within a single, integrated European regulatory framework, thereby ensuring consistency across member states.

    The Regulation sets out tailor-made technical requirements for these innovative therapies and establishes new standards for clinical trials in the development of advanced medicinal products. A proper legal framework for the market authorisation of these products is to stimulate increased research in this field.

    The Regulation is providing one single centralized procedure, run by the European Medicines Agency (EMEA), for the whole of the European Union for assessing the safety, efficacy and quality of advanced therapies and giving them marketing authorization.

    The Regulation set up a Committee for Advanced Therapies (CAT) within the EMEA to ensure the most thorough scientific evaluation possible.

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