OP06 Percutaneous Transforaminal Endoscopic Discectomy: From Insufficient Evidence To Reimbursement

Introduction The standard surgical technique for lumbosacral radicular syndrome in the Netherlands is open microdiscectomy (OM). An alternative technique, preferred by some Dutch physicians, is percutaneous transforaminal endoscopic discectomy (PTED). However, in 2006 the Dutch National Health Care Institute (Zorginstituut Netherland [ZIN]) concluded that the available evidence was insufficient, and a high quality randomized controlled trial (RCT) was needed to assess the cost-effectiveness of PTED compared to OM. The relevant physician group agreed with this conclusion, but they were unable to perform this RCT due to lack of funding and high treatment costs. Methods In 2012, the Netherlands introduced a conditional reimbursement (CR) program to give patients earlier access to promising treatments. Researchers, in collaboration with physicians and patients, submitted a grant proposal and in 2016 the Dutch Ministry of Health approved the CR of PTED. Due to this decision, insurance companies were obliged to reimburse PTED for patients participating in the PTED-study (NCT02602093). The Netherlands Organization for Health Research and Development (ZonMw) also provided a research grant to fund the PTED-study. In total, 682 adult patients with greater than 10 weeks of radiating pain, or greater than 6 weeks of excessive radiating pain and an indication for surgery were included. After 4 years and 5 months the PTED-study was completed. Results Outcomes of published studies and the unpublished PTED-study were used in the HTA reassessment. Results showed that PTED was noninferior to OM with regards to leg pain (Visual Analogue Scale: mean difference (MD) -0.73; 95% confidence interval [CI] -5.04, 3.59), functional status (Oswestry Disability Index: MD -2.07; 95% CI -3.61, -0.53), and rate of complications (relative risk 0.45; 95% CI 0.18, 1.12) after 6 months (GRADE level ‘moderate’). Furthermore PTED was, after the surgeons’ learning-curve, cost-effective. Conclusions This CR project was successful and PTED is now reimbursed as part of the Dutch healthcare package. However, in order to maintain high quality care in clinical practice, safeguards should be developed (including the appropriate training of surgeons). This example shows that CR programs are essential for promising treatments without ‘wealthy’ manufacturers. Additionally, all stakeholders are needed to make a CR-study successful.