Is It Time We Started Asking Manufacturers to Be Bolder When Incorporating Patient Insights as Part of HTA Submissions?

OBJECTIVES: ‘Patient centricity’, ‘patient engagement’, and ‘the patient voice’ are terms that are used often and interchangeably and, as an industry, the value patients add throughout the product life cycle is not disputed, but is it time to be more ambitious to ensure that the patient voice is truly central to any submission?

METHODS: A targeted gray literature search was conducted to explore how HTA organizations in England, France, and Germany incorporate the patient voice into their submissions. HTA websites were searched assessing their policies and processes for patient engagement as well as publications relating to general patient engagement and HTA. A selection of manufacturer submissions were explored to evaluate the types of evidence submitted.

RESULTS: All HTA organizations reviewed solicit input from patients; in the case of HAS (France), representatives sit on the committee and convey information collected via an online portal; for Germany, patients or their representatives contribute via the patient involvement office, which feeds into the IQWiG process; and at NICE (England), patient experts sit on the NICE committees. Some HTA submissions include patient preference studies, qualitative data from patients, and real-world evidence from patient registries; however, this is not mandatory.

CONCLUSIONS: HTA bodies and regulators do not specify detailed study design and evidence requirements for HTA submissions for patient involvement, but should more implicit guidance be provided by HTA bodies for technology manufacturers? Should manufacturers be asked to provide more detailed evidence describing the patient voice in their HTA submissions? For example, including patient preference studies and clinical trial exit interviews to their evidence submissions to complement the patient representation at the HTA committee?