Together both organisations will seek to review the options about quantifying the value of information independent from health outcomes (also referred to as the “value of knowing” or the “value of certainty”); and also to identify the currently applied practices by HTA bodies, identify the gaps and deficiencies, and propose recommendations based on expert opinion on what should be the way forward for a complete assessment and economic evaluation of complementary diagnostics in Europe.

Context

Personalised medicine (PM) and “complementary” diagnostics (i.e., tests that can improve disease management, early diagnosis, patient risk stratification, and drug monitoring related to associated therapeutics; companion diagnostics and next generation sequencing (NGS) are a subset of them) have started coming into reality over the past few years. It is apparent that their value results from the value of the information they generate beyond health outcomes, and when they are used together with a drug, not only from the therapeutic aspect but also from the synergy with the companion diagnostic. However, their assessment from a HTA point of view remains a challenge for most of the relevant bodies worldwide. Some gaps and challenges in the field of HTA and reimbursement have been identified in the literature (Miller et al. 2011; Faulkner et al. 2012; Deverka and Dreyfus, 2014). Nevertheless, it is less clear how these challenges can be addressed by reimbursement authorities in countries with formal HTA, and therefore what can reasonably be expected of PM and complementary diagnostics manufacturers. Despite their potential benefits, diagnostic development has not been appropriately encouraged by cost-based, rather than value-based, reimbursement (Garrison and Austin, 2007; Goldman et al., 2013; Towse and Garrison, 2013; Garrison and Towse, 2014).

Objective

The aim of this project is to produce a white paper that identifies key issues facing the HTA of complementary diagnostics in Europe, defines options for addressing challenges and barriers, and recommends approaches for dealing with them.

The objectives of the white paper are twofold:

• To review approaches for addressing the lack of attention in current applied HTA practices to measuring the “value of certainty/ value of knowing” delivered by diagnostics.
• To identify the currently applied practices by HTA bodies for complementary diagnostics, identify the gaps and deficiencies, and propose recommendations to improve such practices.

Interested in joining?

This white paper will be funded by EPEMED and sponsored and overseen by an editorial committee of EPEMED members. As we are still recruiting new participants (member or non-member organisations) to join our editorial committee, do not hesitate to raise your interest at contact@epemed.org to get more information.