Presentation (CTI)

OBJECTIVES: A growing number of therapies are being developed or repurposed to target the biological mechanisms of ageing. Critically, ageing is not currently recognised as a disease or treatable condition by any major regulatory agency. This research aims to assess EU5 payer awareness, concern, and expected reimbursement criteria for emerging anti-ageing therapeutics, including identifying the endpoints, trial durations and classifications that would underpin coverage decisions for anti-ageing therapies.
METHODS: A structured survey was conducted with N=15 ex-payer experts across EU5 markets (N=3 per market). Respondents rated awareness and concern (1-5 Likert), recommended payer-ready trial designs (including clinical endpoints and minimum pivotal-trial duration), and assessed whether their system would consider anti-ageing therapies for public reimbursement.
RESULTS: Both awareness of anti-ageing therapies (mean 2.4/5.0) and level of concern (mean 2.2/5.0) were generally low. Top-ranked concerns were the potentially enormous eligible population, the absence of regulatory recognition of ageing as a disease, and the requirement for very long-term horizons to demonstrate “hard” patient-relevant outcomes. 60% of all respondents stated their system would not consider reimbursement, primarily due to budget impact concerns as well as the likely lifestyle-drug classification. Among those ‘open in principle’ (40%), reimbursement was conditional on robust long-term data, clearly defined “hard” endpoints, and cost effectiveness in the UK. In terms of evidence requirements, the majority of respondents (60%) required ≥5-year follow-up, with none accepting <2-years. Preferred endpoints included reduction in all-cause mortality, and delay of onset in age related diseases, while biomarkers of biological ageing (epigenetic clocks, telomere length) were ranked consistently low.
CONCLUSIONS: EU5 payers exhibit low awareness, yet scepticism toward anti-ageing therapeutics. Successful entry will likely require disease-specific indications and robust design of pivotal trial designs (>5-year follow-up, “hard” patient-relevant endpoints). Furthermore, without regulatory recognition of ageing as a treatable disease, manufacturers face foundational reimbursement barriers.