OBJECTIVES:

Payers & Health Technology Assessment bodies (HTA) are faced with an increasingly complex healthcare landscape with treatments that are increasingly effective. Taking into Quality of Life (QoL) is becoming a new parameter in the evaluation of treatments' value. However, this seems difficult to achieve in France. We aimed to identify obstacles and potential opportunities by comparing three health systems.

METHODS:

We reviewed 312 HTA appraisals from 2019-21 from the Haute Authorité de la Santé (HAS), & 175 appraisals from IQWiG as well as their guidelines. We also setup an advisory board of 11 ex-HTA leaders, payers, methodologists, healthcare providers and patient advocates, from France, the UK and Germany, to discuss potential opportunities to improve adoption of QoL data in France.

RESULTS:

Our analysis of the guidelines and recent appraisals showed differing approaches and methodologies: depending on the therapeutic area, 14-75% of the HTA reviews mentioned QoL data (69% and 59% in oncology and rare diseases vs only 23% and 14% in paediatrics and cardiovascular diseases). In >75% of cases the QoL data submitted was not accepted (eg. because of data being considered exploratory). Overall, we found the CT to be more restrictive in its approach than IQWiG.

CONCLUSIONS:

Based on these findings we articulate collaborative proposals for industry and the HAS to improve adoption of QoL data and create a positive feedback loop between HAS and industry. We also include implementation considerations for other stakeholders along four dimensions (1) patient perception, (2) testing hierarchy, (3) trial design and (4) data collection. We strongly believe these would enable faster patient access to innovative, life-changing medicines which meet the need of patients beyond the core efficacy and safety that are usually the focus. We also believe that mobilising the wider group of stakeholders will be critical to implementing our proposals.