OBJECTIVES : In 2018, the European Patients’ Academy on Therapeutic Innovation (EUPATI) released guidance about patient involvement in HTAs. We explored practical implications at the country level and how the patient’s voice affects HTA recommendations.

METHODS : A review of recently published HTA advice on immuno-oncology treatments was used to inform in-depth, qualitative interviews with HTA advisors in 7 European countries. Publicly available, English-language HTAs by IQWiG and NICE were used to gauge the practical impact of PEI and patient involvement in HTAs.

RESULTS : Interviews with HTA advisors revealed that all HTA agencies surveyed require patient participation except in Italy, where AIFA must make a formal request. In Germany, PEI can lead to an additional benefit evaluation by following IQWiG’s prescriptive requirements and scientific rigor. In France, there is an opportunity for manufacturers to provide quantitative PEI; however, monetizing outcomes will not be well received by the HAS transparency commission. In Italy and Spain, PEI provides a competitive opportunity, and postprogression PEI translated into budget impact could be influential. In cost-effectiveness countries (Netherlands, Sweden, UK), PEI must be translated into cost/quality-adjusted life years (QALYs) to maximize its impact, and postprogression PEI may lead to improved cost/QALYs over extended time periods. There are opportunities (e.g., patient interviews, patient testimonials) beyond classic PRO data, but HTA agencies may require additional analysis to address bias concerns. Pharmaceutical manufacturers play a critical role in bringing the patient perspective into HTA decision-making.

CONCLUSIONS : Current European HTAs do not meet EUPATI guidelines regarding level of patient involvement. There are opportunities for PEI to provide differentiation among treatment options and affect HTA decisions. Manufacturers should collect PEI in clinical trials and real-world evidence studies, analyze these data with scientific rigor, and translate the information into market-specific outcomes (e.g., cost/QALYs, budget impact) to maximize the influence of the patient’s voice with European HTA bodies.