Division of Urogynecology, Department of Obstetrics and Gynecology, Stanford University Hospital, Palo Alto, CA.
Division of Urogynecology, Department of Obstetrics and Gynecology, Stanford University Hospital, Palo Alto, CA.
Am J Obstet Gynecol. 2020 Dec;223(6):890.e1-890.e12. doi: 10.1016/j.ajog.2020.06.032. Epub 2020 Jun 17.
Topical vaginal estrogen therapy is considered the gold standard treatment for genitourinary syndrome of menopause-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or those who are refractory to vaginal estrogen cream therapy. Although evaluating safety, efficacy, and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared with existing therapies is also critically important but often understudied.
We sought to perform a cost-effectiveness analysis of 3 therapies for genitourinary syndrome of menopause, including vaginal estrogen therapy, oral ospemifene therapy, and vaginal CO laser therapy and determine if vaginal laser therapy is a cost-effective treatment strategy for dyspareunia associated with genitourinary syndrome of menopause.
An institutional review board-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc, Williamstown, MA) using integrated empirical data from the published literature. Tornado plots and 1-way and 2-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness analysis model.
All 3 treatment methods were found to be cost-effective below the willingness-to-pay threshold of $50,000.00 per quality-adjusted life year for moderate dyspareunia. The incremental cost-effectiveness ratio for vaginal CO2 laser therapy was $16,372.01 and the incremental cost-effectiveness ratio for ospemifene therapy was $5711.14. Although all 3 treatment strategies were on the efficient frontier, vaginal CO laser therapy was the optimal treatment strategy with the highest effectiveness. In a 1-way sensitivity analysis of treatment adherence, vaginal CO laser therapy was no longer cost-effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene therapies remained cost-effective treatment strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene therapy was "dominated" by both vaginal CO laser therapy and vaginal estrogen cream therapy. In a 2-way sensitivity analysis of vaginal CO laser therapy adherence and vaginal CO laser therapy cost, vaginal CO laser therapy still remained the optimal treatment strategy at 200% of its current cost ($5554.00) when the adherence was >55%. When the cost fell to 20% of its current cost ($555.40), it was the optimal treatment strategy at all adherence values above 29%.
This study showed that vaginal fractional CO laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM, as are both vaginal estrogen and oral ospemifene therapies. In our model, vaginal CO laser therapy is the optimal cost-effective treatment strategy, and insurance coverage should be considered for this treatment option if it is proven to be safe and effective in FDA trials.
局部阴道用雌激素治疗被认为是绝经相关性交困难的泌尿生殖系统综合征的金标准治疗方法,但早期能量为基础的设备研究显示,对于有禁忌症或对阴道用雌激素乳膏治疗有抵抗的患者有希望。虽然在新技术出现以满足未满足的医疗需求时,评估新技术的安全性、有效性和长期结果非常重要,但评估这些新技术与现有治疗方法相比的成本也非常重要,但往往研究不足。
我们旨在对 3 种治疗绝经相关泌尿生殖系统综合征的疗法(包括阴道用雌激素治疗、口服奥昔孕肽治疗和阴道 CO2 激光治疗)进行成本效益分析,并确定阴道激光治疗是否是治疗绝经相关泌尿生殖系统综合征相关性交困难的一种具有成本效益的治疗策略。
使用决策分析软件(TreeAge Pro;TreeAge Software,Inc,马萨诸塞州威廉斯敦)构建决策树,通过综合已发表文献中的经验数据,对机构审查委员会豁免的成本效益分析进行了分析。使用龙卷风图和单因素和双因素敏感性分析来评估模型输入参数的变化如何改变成本效益分析模型的总体结果。
在中度性交困难的情况下,所有 3 种治疗方法的成本效益均低于 50000.00 美元/质量调整生命年的意愿支付阈值。阴道 CO2 激光治疗的增量成本效益比为 16372.01 美元,奥昔孕肽治疗的增量成本效益比为 5711.14 美元。尽管所有 3 种治疗策略都在有效边界上,但阴道 CO2 激光治疗的效果最高,是最佳的治疗策略。在对治疗依从性的单因素敏感性分析中,当依从性低于 38.8%时,阴道 CO2 激光治疗不再具有成本效益。阴道雌激素乳膏和奥昔孕肽治疗在所有依从性范围内仍然是具有成本效益的治疗策略。当将所有策略的依从性调整为 100%时,口服奥昔孕肽治疗在阴道 CO2 激光治疗和阴道雌激素乳膏治疗方面均具有“优势”。在阴道 CO2 激光治疗依从性和阴道 CO2 激光治疗成本的双因素敏感性分析中,当依从性大于 55%时,阴道 CO2 激光治疗仍然是最佳治疗策略,此时其成本为当前成本的 200%(5554.00 美元)。当成本降至当前成本的 20%(555.40 美元)时,它是所有依从性值大于 29%时的最佳治疗策略。
本研究表明,阴道分数 CO2 激光治疗是治疗与 GSM 相关性交困难的一种具有成本效益的治疗方法,阴道雌激素和口服奥昔孕肽治疗也是如此。在我们的模型中,阴道 CO2 激光治疗是最佳的具有成本效益的治疗策略,如果在 FDA 试验中证明其安全有效,应考虑为该治疗选择提供保险覆盖。