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While stereotactic body radiotherapy (SBRT) increasingly gained interest and was progressively implemented across Belgium, reimbursement was not granted in 2011 for lacking data on outcome, costs, cost-effectiveness and budget impact of SBRT from a Belgian perspective. To allow early access of patients to this promising treatment technique, and to support real-life data collection, a coverage with evidence development (CED) program started in 2013. The aim was to examine the conditions under which SBRT could be included in the medical nomenclature.

After defining the level for provisional financing with time-driven activity-based costing, a prospective 'Innovative Radiotherapy Techniques' registration project was initiated by the Belgian National Institute for Health and Disability Insurance (NIHDI), enrolling radiation oncology centers using SBRT in clinical practice. Participating centers signed the ‘NIHDI convention’, agreeing to treat patients from pre-determined target groups (primary tumors (PT) or oligometastatic disease (OMD)) with SBRT and to register clinical and technical data in exchange for temporary research funding. ‘Standard’ vs. ‘non-standard’ indications were defined, the latter requiring additional enrollment in a clinical trial to be eligible for registration and financing. A dedicated registration module was available online at the Belgian Cancer Registry website. Survival outcome was obtained by August, 9^th 2021.

The project ran from 10/2013 until 12/2019. The centers registering patients progressively increased from 3 (out of 25 accredited radiation oncology centers) in 2013 to 18/25 in 2019. During the entire period, 20 RT centers participated. A total of 6,296 registrations were included in the project. After data cleaning, 5,675 SBRTs were retained for final analysis, with an average of 284 per center (range 21-951). 2,885 (51%) pertained to PT, with a majority of lung, prostate and (para)vertebral tumors (n=2,801, 97%; n=49, 1.7% and n=16, 0.6%, respectively), all ‘standard’ indications. For OMD, 2,348 ‘standard indications’ were registered (lung: n=1,484, 53%; (para)spinal: n=537, 19%; and liver metastases: n=327, 12%); and 442 (16%) ‘non-standard’ metastases, mainly lymph nodes and non-paraspinal bones. Over time, SBRT for OMD progressively outnumbered PTs. Moreover, outcome seems to improve while implementation progresses. Most important variables are shown in Table 1; Kaplan-Meyer overall survival curves for the 6 most frequent indications, in Figure 1.

This prospective CED registration program demonstrates that it is feasible to monitor practice patterns and outcome of innovative radiotherapy techniques, such as SBRT, in the real-life setting. Although patient, disease and treatment characteristics varied, survival data conformed to those reported in the literature. On this basis, SBRT has been formally included in the Belgian reimbursement system as of January 2020.