OBJECTIVES :

This poster seeks to showcase the frequency with which PROs and QoL measures are cited as decision drivers in the markets of France, Germany, Canada, and Spain and to extrapolate what those decisions may implicate for future importance of these type of data.

METHODS

We examined the language of all brand + brand 2017 and 2018 Oncology combination decisions as case studies to understand in what manner and decision-context PROs and QoL metrics were used by HTA bodies in Germany, France, Canada, and Spain to inform access decisions. Each decision was classified through denoting what QoL / PRO information was submitted, in what instances it was understood as a positive / neutral / negative factor in decision-making, and what HTA outcome was ultimately achieved per combination.

RESULTS

Our examination revealed that all dossiers submitted include PRO and QoL metrics. The relationship between impact of QoL metrics and HTA decision was consistent across markets for the same dossier (ex. TAFINLAR + MEKINIST received multiple positive QoL citations). Markets placed different levels of emphasis on QoL metrics; the majority (81.8%) of decisions in France cited QoL positively or negatively, with only two decisions not mentioning QoL impact. Though strength of QoL metrics alone was often insufficient to ensure positive reimbursement negotiations, their consideration as decision-making factors demonstrates their increased importance in terms of demonstrating value and achieving positive reimbursement outcomes.

CONCLUSIONS

Over 2017 and 2018, PROs and QoL metrics were cited as positive, neutral and negative considerations in a high proportion of HTA evaluations of brand + brand oncology decisions. France had the highest proportion of decisions impacted by QoL data, relative to decisions where QoL was not cited. Other markets are still evolving and are likely to increasingly value PRO endpoints in decision-making.