Reframing access to innovative oncology medicines: The impact of policy and governance reform in a Bismarck-type system in Bosnia and Herzegovina.

Abstract

1645 Background: Access to innovative oncology medicines is often assumed to depend primarily on available financial resources. In health systems organized under the Bismarck model, however, access is frequently constrained by structural and policy-related factors, including fragmented governance, rigid reimbursement pathways, and infrequent updating of positive drug lists. These limitations may result in delayed access, restricted indications, and misalignment with contemporary clinical standards, even in the absence of absolute budget shortages. In Bosnia and Herzegovina, such constraints are compounded by complex administrative arrangements, leading to pronounced regional disparities in cancer care. In Sarajevo Canton prolonged waiting times and loss of treatment eligibility underscored that the key barrier was not lack of money, but lack of timely policy action. In October 2024, Sarajevo Canton launched a program shifting financing responsibility locally to improve timely access. Methods: We analyzed drug access before and after program initiation in 641 patients, assessing waiting times from indication to treatment approval and the proportion of patients losing indication prior to therapy availability. Results: Patients whose indication was established before the program were significantly more likely to remain without therapy compared to those after initiation (23.8% vs. 10.3%, p < 0.001). Among 547 patients with available waiting time data, mean waiting time decreased from 251.6 days (SD ≈ 190; range 21–910) to 40.4 days (SD ≈ 21; range 6–199), representing a >6-fold reduction. Variability also decreased, making access more predictable and equitable. Levene’s test indicated unequal variances (F = 517.3, p < 0.001), and Welch’s t-test confirmed the difference (t(157.5) = 13.91, p < 0.001; 95% CI 181–241 days), with a very large effect size (Cohen’s d ≈ 2.0). Conclusions: This policy intervention dramatically reduced waiting times and improved equity in therapy access. This demonstrates that substantial improvements in oncology drug access can be achieved without increasing overall healthcare spending. The observed gains were the result of a deliberate policy and governance shift—redefining responsibility, prioritization, and accountability—rather than additional financial input. This intervention highlights that, within Bismarck-type systems, access gaps are often policy failures rather than funding failures, and that targeted policy change can serve as a powerful lever to rapidly improve equity and quality of cancer care.