| Abstrakt: |
Introduction: Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy. Methods: A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy. Results: Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results. Conclusion: In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs. Plain Language Summary: The rotator cuff refers to a group of four muscles, with tendons connected to the upper arm bone, which act together to allow lifting and rotating the shoulder. A tear of the rotator cuff can affect either a single tendon or multiple tendons. Typical first-line treatment includes conservative therapies, which aim to alleviate pain and reduce functional impairment, but are often ineffective. Persisting disease is usually managed through conventional surgical repair. Recently, REGENETEN, a collagen-based bioinductive implant derived from purified bovine Achilles tendon, positioned over the site of the damaged rotator cuff, achieved successful rotator cuff tendon repair with an increase in healed tears of 17.80% at 1 year compared to conventional surgery. Considering the National Healthcare Service perspective in Italy, the cost needed to achieve one additional healed tear using REGENETEN compared to conventional surgery is €17,857. From the societal perspective, which includes patients' productivity losses from hospital admission to return to work, the use of REGENETEN may be cost-saving compared to conventional surgery. The findings of our study provide evidence for clinicians and payers to support the value of a new treatment option for patients with rotator cuff lesions. [ABSTRACT FROM AUTHOR] |
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