Economic value of contact X-ray brachytherapy boost for organ preservation in early low rectal cancer: An OPERA-informed Italian cost-utility analysis.

PURPOSE: The OPERA phase 3 randomized trial showed that contact X-ray brachytherapy (CXB/Papillon) boost improved 3-year organ preservation compared with external-beam radiotherapy (EBRT) boost in operable early low or mid-low rectal cancer. We estimated the economic implications of CXB in an Italian reimbursement-proxy framework.

METHODS AND MATERIALS: We developed an OPERA-informed decision-analytic cost-utility and illustrative budget-impact model comparing neoadjuvant chemoradiotherapy plus EBRT boost with neoadjuvant chemoradiotherapy plus CXB boost from an Italian National Health Service perspective. Clinical probabilities were populated from OPERA. Unit costs were derived from Italian DRG proxies and the 2026 Sardinia outpatient tariff catalog, and were interpreted as reimbursement proxies rather than micro-costed hospital or societal costs. The base case assumed established CXB access; program cost, referral, low-volume implementation, and probabilistic sensitivity analyses explored uncertainty.

RESULTS

In the 3-year base case, CXB increased organ preservation from 59% to 81% and reduced expected permanent stoma probability from 18.5% to 8.5%. Mean costs were EUR 22,043 for EBRT boost and EUR 20,337 for CXB boost, whereas QALYs were 2.340 and 2.391, respectively. In probabilistic sensitivity analysis, mean incremental cost was EUR -1626, mean incremental QALYs were 0.048, and CXB was dominant in 81.4% of simulations.

CONCLUSIONS

In OPERA-like patients treated in experienced programs, CXB may be economically attractive compared with EBRT boost. Findings should be interpreted as tariff-proxy, hypothesis-generating estimates requiring local validation of reimbursement, actual program costs, utility values and surveillance capacity.