Abstract

ObjectivesBecoming the bottleneck of patient access to new drugs, the reimbursement coverage process in China started to engage health economic evaluations. This study aimed to quantify the potential impacts of cost-effectiveness profiles on reimbursement coverage in China. MethodsCost and effectiveness measures of both reimbursable and non-reimbursable indications of newly covered anti-cancer drugs from 2017 to 2021 were collected from the literature since official documents were not accessible. The measures included incremental costs-effectiveness ratios (ICERs), incremental quality-adjusted life years (QALYs), incremental costs, acquisition costs, population sizes of target patient groups, availability of overall survival evidence in clinical trials, the language of literature, country of origin of the drug, and the year of initial coverage. Logistic regressions were used to examine the impacts of cost and effectiveness measures. ResultsSeventy-four anti-cancer drugs were newly covered from 2017 to 2021. We identified 64 and eight ICERs of reimbursable and non-reimbursable indications of the newly covered anti-cancer drugs. Of note, nine reimbursable indications of the newly covered anti-cancer drugs did not have corresponding literature evidence. The regression results suggested that ICER was not associated with reimbursement coverage. By contrast, incremental QALYs and patient population size by cancer type were positively associated with coverage, while acquisition costs were negatively associated with coverage. ConclusionsClinical benefits, acquisition costs, and the disease burden of the target population associated with new anti-cancer drugs are likely important considerations of reimbursement decisions in China. However, the importance of value-based pricing should be reinforced and investigated in the future when official documents become accessible. Public interest summaryAccess to new health technologies through reimbursement is critical to the public. Since 2017, Chinese healthcare and health insurance agencies have adopted health technology appraisals to expedite reimbursement decisions of new drugs, among which anti-cancer drugs accounted for the greatest proportion. The appraisals largely relied on health economic evaluations. In the current study, we quantified the potential impacts of cost-effectiveness profiles on the reimbursement of new anti-cancer drugs in China. We did not identify any significant association between reimbursement and incremental cost-effectiveness ratio, the latter of which is the primary measure of drug economic profiles. On the upside, incremental quality-adjusted life years (QALYs) were positively associated with reimbursement coverage, whereas acquisition costs had a negative association. To secure patient access to high-value anti-cancer drugs via reimbursement in China, it is vital to reinforce the consideration of cost-effectiveness evidence.

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