AIM: Given the rapid developing technology in precision medicine, this qualitative study aimed to explore the challenges and opportunities faced by HTA decision-makers evaluating precision medicine technologies (omics, artificial intelligence, advanced imaging) for skin cancers (including melanoma) and other diseases.
METHODS: Semi-structured interviews were conducted with HTA experts for their perspectives on the following topics until data saturation: definitions of precision medicine; value and appraisal of precision medicine using current frameworks; challenges and opportunities around the exponential development of precision medicines; equity of access; and the shelf-life of HTA frameworks and recommendations. Transcripts were analysed thematically.
RESULTS: 22 participants (13 health economists, 6 epidemiologists, 3 consumers) with mean (±SD) age: 54±4 years participated representing academic/government (67%) or industry (33%) involvement in HTA. Mean time working in HTA was 22±7 years. Precision medicine technologies accounted for 5%-50% of their HTA-related work.
Six themes (and subthemes) were identified: (1) Remaining abreast (pace of HTA system unable to keep up with rapidly changing technologies, complexities of the tech and personalisation, classifications could rapidly become outdated); (2) Inequity of access to precision medicine (issues with minority representation, generalisability of genomics, assessment applicability for diagnostics, existing process is currently tax-payer-centric); (3) Missing metrics (to adequately assess all aspects of evolving technologies, lack of robust real-world evidence, consumer involvement is essential); (4) Streamline submission process (lack of flexibility around submissions, tailoring applications, co-dependent technologies require adjustments only); (5) Opportunity costs (risk of listing something that should/not have been listed on MSAC/PBAC); (6) Control for uncertainty (roadblock when there is not existing test in Australia, concerns around data sharing and intellectual property).
CONCLUSION: Stakeholders urgently need to collaborate to identify best action to optimise procedures and frameworks that can keep up with the rapidly changing environment involving precision medicine technologies in skin cancer screening and diagnostics.