A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices.

The European Commission defines HTA as a means to assess the ways science and technology are used in healthcare and disease prevention.  It covers medical, social, economic, and ethical issues and provides policy-makers with objective information, so they can formulate health policies that are safe, effective, patient-focused and cost-effective.  According to the Commission, HTA should be transparent, unbiased, robust and systematic, firmly rooted in research and the scientific method.

In practice, HTA is an important part of the pricing and reimbursement decision-making process in EU Member States.  As pricing and reimbursement is a purely national competence in the EU, the Commission has set up a voluntary European HTA Network, aiming to facilitate efficient use of HTA resources, knowledge sharing and exchange of good practices at a European level.

In 2013 the European Commission awarded a tender contract to the SEED Consortium (Shaping European Early Dialogues) to perform a pilot series of early dialogues between HTA bodies and healthcare product developers during the development phase of medicinal products and medical devices.  The SEED Consortium comprises 14 HTA bodies from 10 EU Member States, including the lead partner, the French Haute Autorité de Santé (HAS), as well as the UK NICE and the German bodies G-BA and IQWIG.

The project will consist of ten multi-HTA pilot EDs for new health technologies, seven of which will concern pharmaceuticals, including advanced therapy medicinal products and three of which will concern medical devices, including procedures and/or diagnostics, whether or not combined with other technologies.  The EDs will focus on key aspects of the development of the chosen products and on identifying specific HTA needs related to the relative effectiveness and cost-effectiveness assessment, depending on patient population and type of evidence, such as trial design, duration, comparative health technology or type of endpoints.

The pilot EDs are also expected to offer non-binding, timely advice on health technology development, which will take into account potential differences in HTA and regulatory requirements and contribute to the production of clinical trial data of a higher quality and relevance, thus leading to quicker HTA and reimbursement decisions and to an overall smoother market access.

An equally important aspect of the pilot project is that it is expected to bring HTA bodies together and enable exchange of approaches, arguments and experiences.  This is a procedure that might eventually foster greater consistency and harmonization among HTA bodies and contribute to a more transparent and coherent assessment in terms of requirements.

The EDs will also consider involvement of more stakeholders, such as regulators, payers and patients, and will include proposals to extend the pilot project into a more permanent ED model.  Such proposals will be further submitted to the EUnetHTA Plenary Assembly, the HTA Network and the European Commission.

Interested companies may express their interest until October 2014 by sending a Letter of Intent to the SEED coordinating team at earlydialogues@has-sante.fr.  According to the call, the SEED Consortium will select technologies for a multi-HTA ED based on the following criteria:

  • Advice should be prospective in nature, requested before the start of pivotal clinical trials before phase III for medicinal products, as well as before or after exploratory or proof of concept or performance trials for medical devices;
  • Already available clinical data should be submitted;
  • The health technology should be supposed to have an added benefit for the target patient population in relation to the best standard of care treatment for achieving the desired results, measured with adequate endpoints, when provided under the usual healthcare practice circumstances.

The multi-HTA EDs are free of charge for participating companies that are expected, in return, to provide adequate and timely background information, respect timelines and answer to surveys that they may receive.

HAS will start examining responses to the call upon receipt.  If it receives more than ten requests that fulfill the set criteria, the Consortium may hold a vote for the final selection of technologies.  Additional applications that are not selected will be considered for a “reserve” list to be used if a scheduled ED is cancelled by the company due to cessation of the development.  Face-to-face meetings will be held once per month, between March 2014 and January 2015.

Additional information regarding timelines, procedures and documentation will be made available via the SEED website.