Implementation of Risk-Sharing Agreement in Patients with Lung Cancer Treated with Immunotherapy Based on RWD in the Czech Republic

OBJECTIVES: This analysis aimed to assess the impact of risk-sharing agreements on budgetary considerations and immunotherapy treatment outcomes for locally advanced and metastatic NSCLC in the Czech Republic.

METHODS: Collaborating with the Masaryk Memorial Cancer Institute in Brno, a retrospective analysis was conducted on 127 lung cancer patients treated with immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab and nivolumab in combination with ipilimumab) from 2018 to 2022. Real-world clinical data on progression-free survival (PFS) were compared to the PFS benchmarks established in registration studies for the respective checkpoint inhibitors. A budget impact analysis was performed to assess the overall cost of treatment, including patients classified as "unsuccessfully treated." A hypothetical scenario was also explored, considering the potential implementation of risk-sharing agreements.

RESULTS: Due to the insufficient number of patients in other subgroups, the risk-sharing model encompassed two immunotherapeutic agents, pembrolizumab and nivolumab. Findings indicated that over five years, the insurance company incurred costs exceeding 373,300 EUR for pembrolizumab treatment provided to 22 patients classified as "unsuccessful" (out of 43 patients analyzed). By implementing risk-sharing agreements, manufacturers have the potential to share up to 75% of the treatment costs, approximately 281,500 EUR, resulting in substantial savings for insurance companies and the possibility of treating three additional patients. In the case of nivolumab monotherapy, out of 42 patients, 13 received treatment exceeding 136,800 EUR without meeting the defined success criteria. In such situations, the drug manufacturer could contribute up to 63% of the total cost, amounting to 86,760 EUR.

CONCLUSIONS: These findings suggest that implementing risk-sharing agreements holds promise in managing healthcare costs associated with immunotherapy for lung cancer in the Czech Republic. By sharing the financial burden, such agreements can help reduce expenses for insurance companies while ensuring patient access to these innovative therapies. Furthermore, risk-sharing agreements allow manufacturers to facilitate market access.