OBJECTIVES: The number of healthcare interventions that can facilitate personalised medicine (PM) is increasing, and several international and national initiatives have been launched to support the PM translation into clinical practice. Tumour agnostic drugs (Vitrakvi), gene therapies (Luxturna) and companion diagnostics (OncotypeDX) have made it into the clinic, however, translation remains variable, partly due to reimbursement challenges. Reimbursement delays discourage investment in PM research and development (R&D). Current landscape and promising examples in PM financing and reimbursement should be described to facilitate the engagement of stakeholders into providing models that would pave the way for the uptake of PM. Therefore, our objective was to review financing and reimbursement models for PM and summarise to what extent these models incentivise and facilitate uptake.

METHODS: We performed a systematic literature review in Medline, Embase, Web of Science, Econlit, Google Scholar, Google and subject-specific webpages to identify publications in English between 2009 and 2019 that described financing and reimbursement of PM. Data were synthesised narratively to report on the models, and on incentives and disincentives, facilitators and barriers for PM uptake.

RESULTS: We included 114 papers. R&D of PM was financed through public and private sources. PM was reimbursed mainly through single fees, DRGs, and bundled payments. Risk-sharing outcome-based payments were applied primarily to gene, cell and targeted therapies (Luxturna, Kymriah, Strimvelis), and some companion diagnostics (OncotypeDX). The main barriers and disincentives to adoption of PM were the lack of demonstrable benefit in HTA, and existing reimbursement through billing and coding. Few examples of public-private risk-sharing outcome-based agreements showed potential to facilitate reimbursement and incentivise investment in R&D of PM.

CONCLUSIONS: Public-private financing agreements and risk-sharing outcome-based reimbursement could overcome current limitations in the development and uptake of PM, and pave the way to realise the full benefits of PM on individual health and healthcare system sustainability.