Survival analysis of time to reimbursement of novel medicines in five Eurasian countries.

backgroundAccess to novel medications matters quality-adjusted life years and the opportunity cost associated with productivity lost. Gaps in patient access to novel medicines exist due to insufficient public funding reimbursement in emerging countries. Evidence of time from regulatory approval to reimbursement decision by public funding, referred to as time to reimbursement (TTR), remained limited in emerging countries. This study compared and analyzed public funding reimbursement of novel medicines approved in five Eurasian countries that are global leaders in pharmaceutical innovation. All of them have a centralized mechanism for reimbursement decisions on novel medicines, allowing identification of a clear date of public funding reimbursement. By exploring the facilitators of rapid application of pharmaceutical innovations, we expected to inform the public funding reimbursement decision-making in emerging countries, so as to improve patient access and contribute to addressing the global health challenge in achieving universal health coverage.

methodsThis is a retrospective study which investigated the public funding reimbursement and TTR of novel medicines that obtained marketing authorization between 2018 and 2023 in China, Japan, France, the United Kingdom (UK) and Switzerland. We firstly conducted descriptive analyses of TTR across countries, followed by the pairwise comparisons using Kruskal-Wallis H tests with Bonferroni corrections. We then performed the survival analysis of time-to-event data using the multiple Cox proportional hazards regression by inclusion of country and year dummy variables. Other covariates associated with the characteristics of novel medicines and manufacturers, as well as the review and approval pathways were included in the regression. We estimated the differences of hazard ratios (HR) of novel medicines being reimbursed by public funding across countries. Subgroup analyses were conducted to assess the specific factors associated with the public funding reimbursement in different countries. Since China began to systematically publicly fund novel medicines in 2019, sensitivity analyses were conducted by removing the 2018 data and repeating the same analyses.

resultsAs of July 1st, 2024, Japan had the highest proportion and fastest rate of public funding reimbursement of novel medicines, which were approved between 2018 and 2023 (HR = 11.29, [95% CI 8.63, 14.77], P < 0.001). In contrast, the TTR of novel medicines approved in China was generally longer than those in the other four countries. Factors associated with a higher likelihood of being reimbursed by public funding included priority review procedure in China and the UK, medicines for rare diseases approved in Japan and France, anti-cancer medicines approved in the UK, locally developed novel medicines approved in China and Switzerland, and medicines launched by large multinational pharmaceutical companies in France and Switzerland. China was the only country in which novel medicines approved through conditional market authorization were less likely to be publicly funded (HR = 0.42, 95% CI [0.27, 0.68], P < 0.001).

conclusionsCompared to other global pharmaceutical innovation leaders, China still needs to make further efforts in strengthening public funding reimbursement of novel medicines. A forward-thinking strategy for health technology assessment that provides advanced technical support in conjunction with the regulatory authority to pharmaceutical innovation companies at the early research and development stage is critical for reducing TTR of novel medicines and accelerating patient access. To balance timely patient access and risk control, strategies such as risk-sharing mechanisms for novel medicines with clinical and cost uncertainties, and temporary reimbursement with alternative sources of funding to support real-world evidence collection could be considered.