Health Technology Assessment

Health Technology Assessment (HTA) - or the ‘multi-disciplinary field of policy analysis, which studies the medical, social, ethical and economic implications of development, diffusion and use of health technology.”

The biotech industry proposes the development of the following series of shared European standards for Health Technology Assessment (HTA) 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:

A broader perspective.

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.

 An improved early-stage dialogue

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.

Flexibility

HTA is a flexible process that should be 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.

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. 

Managing uncertainty

Uncertainty in economic evaluation of innovative therapies is often managed by a call for more evidence.  However, the willingness to invest in research to obtain additional evidence may be limited by the number of patients, the heterogeneity and natural history of the disease, the mechanism of action of the therapy, and the ethical issues surrounding a specific patient population.  If the region of uncertainty is wide, but if the treatment has significant potential benefits, interim of conditional funding should be considered, provided that data are collected during further use of the therapy in order to improve an informed decision.

Patient and public involvement

Both patients and the public have to be regularly informed about what the use and procedures of HTA are and how it fits in making the healthcare system more efficient for them.  They should have the same right as other stakeholders and actors of the process in the evaluation of new therapies, which should not just be based on economics but also on other, including social values.  Patient and public involvement needs to be clear, transparent and become a key structural element of any evaluation of innovative therapies.

With the above six standards for HTA, the European biotech industry is calling for a robust and transparent framework in which HTA would be a tool to encourage development of new and innovative therapies for the benefit of patients, whilst allowing health care planners to appropriately fund and manage resources effectively. 

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