Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

Abstract

Background The number of healthcare interventions described as ‘personalised medicine’ (PM) is increasing rapidly. As healthcare systems struggle to decide whether to fund PM innovations, it is unclear what models for financing and reimbursement are appropriate to apply in this context. Objective To review financing and reimbursement models for PM, summarise their key characteristics, and describe whether they can influence the development and uptake of PM. Methods A literature review was conducted in Medline, Embase, Web of Science, and Econlit to identify studies published in English between 2009 and 2021, and reviews published before 2009. Grey literature was identified through Google Scholar, Google and subject-specific webpages. Articles that described financing and reimbursement of PM, and financing of non-PM were included. Data were extracted and synthesised narratively to report on the models, as well as facilitators, incentives, barriers and disincentives that could influence PM development and uptake. Results One hundred and fifty-three papers were included. Research and development of PM was financed through both public and private sources and reimbursed largely through traditional models such as single fees, Diagnosis-Related Groups, and bundled payments. Financial-based reimbursement, including rebates and price-volume agreements, was mainly applied to targeted therapies. Performance-based reimbursement was identified mainly for gene and targeted therapies, and some companion diagnostics. Gene therapy manufacturers offered outcome-based rebates for treatment failure for interventions including Luxturna ® , Kymriah ® , Yescarta ® , Zynteglo ®, Zolgensma ® and Strimvelis ® , and coverage with evidence development for Kymriah ® and Yescarta ® . Targeted testing with OncotypeDX ® was granted value-based reimbursement through initial coverage with evidence development. The main barriers and disincentives to PM financing and reimbursement were the lack of strong links between stakeholders and the lack of demonstrable benefit and value of PM. Conclusions Public-private financing agreements and performance-based reimbursement models could help facilitate the development and uptake of PM interventions with proven clinical benefit. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-021-00714-9.

Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?

“…Proposals to change coverage frameworks have been well described and are intended to address payer risk through performance-based payment or coverage with evidence development [ 63 , 64 ]. While a step forward, these solutions may still be difficult to implement in practice, given the inherent limitations of using real-world data to establish the clinical utility of testing [ 65 ].…”

“…The anticipated rate of entry of new tests also requires a nimble financing approach, allowing funds to be released for new tests once decisions to reimburse are made. This may require a shift in thinking for many insurers, who have historically allocated funding for laboratory services on an annual basis based on test volumes [ 64 ]. Unlike traditional tests, funding formulas for genetic testing must consider the need for additional human resources associated with development and proficiency testing [ 67 ].…”

“…Unlike traditional tests, funding formulas for genetic testing must consider the need for additional human resources associated with development and proficiency testing [ 67 ]. Payment models for care may, in turn, drive laboratory utilization and require re-thinking [ 64 , 68 ].…”

Barriers and Facilitators to the Implementation of Personalised Medicine across Europe

“…Importantly, appropriate founding and reimbursement models for PM are also very important to stimulate the development and adoption of these interventions if their clear clinical benefits can be demonstrated [ 17 ].…”

“…Also, public–private financing agreements and performance-based reimbursement models could also facilitate the development and adoption of PM interventions [ 17 ].…”