Roche Norge AS, Brynsengfaret 6 B, 0667, Oslo, Norway.
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City Hertfordshire, UK.
Appl Health Econ Health Policy. 2018 Aug;16(4):569-577. doi: 10.1007/s40258-018-0401-y.
To evaluate the cost-effectiveness of obinutuzumab in combination with bendamustine followed by obinituzumab maintenance (Obin-Benda) compared to bendamustine alone (Benda) in patients with refractory follicular lymphoma (FL) in a Norwegian setting.
A three-state area-under-the-curve (AUC) model was developed. The states included were progression-free-survival (PFS), progressed disease (PD), and death. Each state had costs and utilities assigned to it. The pivotal phase III randomized controlled trial GADOLIN was used for clinical input in the model along with Norwegian cost estimates. The trial demonstrated that Obin-Benda improved overall survival (OS), with a hazard ratio (HR) of 0.67 (95% CI 0.47-0.96), and reduced the likelihood of progression or death (HR 0.52, 95% CI 0.39-0.69) compared to Benda. The model used EQ-5D data collected in the GADOLIN trial, with UK tariffs assigned to the EQ-5D scores.
The total quality adjusted life-years (QALYs) for the patients on Obin-Benda were estimated to be 4.67, compared to 3.65 for Benda, while the total costs were estimated to be €98,849 and €51,570, respectively. Obin-Benda had an incremental gain of 1.02 QALYs compared to Benda, at an additional cost of €47,279. The estimated deterministic incremental cost-effectiveness ratio (ICER) was €46,438 per QALY gained, while the probabilistic ICER was €46,887 per QALY gained (95% CI €34,772-€59,443). The results were robust to changes in various sensitivity and scenario analyses.
The cost-effectiveness threshold in Norway is not public, but based on previous decisions it is estimated to be up to approximately €89,000 per QALY (NOK 800,000). The results of the analysis indicate that obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance may be cost-effective compared to bendamustine alone in Norway.
在挪威人群中,评估奥滨尤妥珠单抗联合苯达莫司汀序贯奥滨尤妥珠单抗维持治疗(Obin-Benda)对比苯达莫司汀单药(Benda)在复发滤泡性淋巴瘤(FL)患者中的成本效果。
建立一个三状态区域生存曲线(AUC)模型。模型中的状态包括无进展生存期(PFS)、疾病进展(PD)和死亡。每个状态都有相应的成本和效用赋值。关键的 III 期随机对照试验 GADOLIN 用于模型的临床输入,同时使用挪威成本估算。试验表明,与 Benda 相比,Obin-Benda 可改善总生存(OS),风险比(HR)为 0.67(95%CI 0.47-0.96),并降低进展或死亡的可能性(HR 0.52,95%CI 0.39-0.69)。模型使用 GADOLIN 试验中收集的 EQ-5D 数据,英国关税分配给 EQ-5D 评分。
Obin-Benda 治疗患者的总质量调整生命年(QALYs)估计为 4.67,而 Benda 为 3.65,总费用估计分别为€98849 和€51570。Obin-Benda 比 Benda 增加了 1.02 个 QALY,成本增加了€47279。估计的确定性增量成本效果比(ICER)为每获得 1 个 QALY 增加€46438,概率性 ICER 为每获得 1 个 QALY 增加€46887(95%CI €34772-€59443)。结果在各种敏感性和场景分析中具有稳健性。
挪威的成本效果阈值尚未公开,但根据以往的决策,预计在 89000 欧元/QALY(80 万挪威克朗)左右。分析结果表明,与苯达莫司汀单药相比,奥滨尤妥珠单抗联合苯达莫司汀序贯奥滨尤妥珠单抗维持治疗在挪威可能具有成本效果。