International Spine, Pain & Performance Center, Washington DC, USA.
George Washington University, School of Medicine & Health Sciences, Washington DC, USA.
BMC Musculoskelet Disord. 2022 May 24;23(1):491. doi: 10.1186/s12891-022-05445-z.
Effective symptom control in painful knee osteoarthritis (OA) may improve patient quality of life. In a randomised crossover trial (NCT03381248), COOLIEF* cooled radiofrequency ablation (CRFA) reduced pain and stiffness and improved physical function and quality of life compared with intra-articular hyaluronan (HA) injections. The present study aimed to establish the cost effectiveness of CRFA versus intra-articular HA injections for treating moderate-to-severe OA knee pain from a US Medicare perspective.
We conducted a cost-effectiveness analysis using utility data (EQ-5D) from the randomised crossover trial of CRFA versus intra-articular HA injections, which had follow-ups at 1, 3, 6, and 12 months. Patients in the HA group with unsatisfactory outcomes (e.g., continued pain) at 6 months could cross over to CRFA. Economic analysis outcomes included quality-adjusted life-years (QALYs), costs, and cost effectiveness (cost per QALY gained). Base-case analyses were modelled on a 6-month time horizon (to trial crossover). Due to limited trial data in the HA arm beyond 6 months, scenarios explored potential outcomes to 12 months if: 1) Utility with HA persisted for a further 6 months; 2) A second HA injection was received at 6 months and achieved the same utility change for the second 6 months. In both scenarios, the CRFA arm used trial data for patients who received CRFA from baseline to 12 months. Alternative costing scenarios were also explored.
CRFA resulted in an incremental QALY gain of 0.020 at an incremental cost of US$1707, equating to an incremental cost-effectiveness ratio (ICER) of US$84,392 per QALY over 6 months, versus intra-articular HA injections. Extending the analysis to 12 months and assuming persistence in utility in the HA arm resulted in a larger utility gain for CRFA (0.056 QALYs) and a lower ICER of US$30,275 per QALY. If patients received a second HA injection, the incremental benefit of CRFA out to 12 months was reduced (QALY gain 0.043) but was offset by the costs of the second HA injection (incremental cost US$832). This resulted in an ICER of US$19,316 per QALY.
CRFA is a cost-effective treatment option for patients with OA-related knee pain considering the typical US threshold of US$100,000/QALY.
有效控制膝关节骨关节炎（OA）疼痛可能会提高患者的生活质量。在一项随机交叉试验（NCT03381248）中，COOLIEF*冷却射频消融术（CRFA）与关节内透明质酸（HA）注射相比，可减轻疼痛和僵硬，改善身体功能和生活质量。本研究旨在从美国医疗保险的角度评估 CRFA 与关节内 HA 注射治疗中重度 OA 膝关节疼痛的成本效益。
我们使用 CRFA 与关节内 HA 注射随机交叉试验的效用数据（EQ-5D）进行了成本效益分析，该试验的随访时间为 1、3、6 和 12 个月。如果在 6 个月时 HA 组的结果不理想（例如持续疼痛），患者可以交叉到 CRFA 组。经济分析结果包括质量调整生命年（QALY）、成本和成本效益（每获得一个 QALY 的成本）。基础案例分析基于 6 个月的时间范围（到试验交叉）。由于 HA 组在 6 个月后超过 6 个月的数据有限，因此，如果出现以下两种情况，探索了到 12 个月的潜在结果：1）如果 HA 的效用持续 6 个月；2）在 6 个月时接受第二次 HA 注射，并在接下来的 6 个月内实现相同的效用变化。在这两种情况下，CRFA 组使用从基线到 12 个月接受 CRFA 的患者的试验数据。还探讨了替代成本核算方案。
CRFA 在增加 1707 美元的成本下，获得了 0.020 个 QALY 的增量，相当于每 6 个月增加 84392 美元/QALY，优于关节内 HA 注射。将分析扩展到 12 个月，并假设 HA 组的效用持续，CRFA 的效用增益更大（0.056 QALY），ICER 为每 QALY 30275 美元。如果患者接受第二次 HA 注射，那么到 12 个月时 CRFA 的增量效益将会减少（0.043 QALY），但会被第二次 HA 注射的成本所抵消（增量成本 832 美元）。这导致每 QALY 的 ICER 为 19316 美元。
考虑到美国典型的 10 万美元/QALY 阈值，CRFA 是一种治疗 OA 相关膝关节疼痛的具有成本效益的治疗选择。
