背景:胶原酶溶组织梭菌(CCH),FDA于2013年批准用于治疗Peyronie病(PD),这可能消除了手术的需要,但在向受影响的患者提供CCH与手术干预时,必须考虑其历史上的高成本。
目的:比较PD病灶内注射与手术治疗的趋势,并评估CCH与手术干预的当代治疗成本。
方法:我们回顾了2009-2019年MarketScan商业索赔数据,以确定所有18岁及以上患有PD的男性。CPT和HCPCS代码用于鉴定每个患者的PD治疗。每种治疗类型的相关保险索赔以美元为单位。
结果:总成本和自付费用,以及频率,每年计算治疗的频率,并使用Cochran-Armitage检验比较FDA批准CCH前后的频率.
结果:在89,205名被诊断为PD的男性中,21,605(24.2%)接受了治疗;大多数仅需要病灶内注射,然而,1,519人(7.0%)只接受了手术治疗,1,951人(9.0%)需要药物和手术治疗。2013年FDA批准后,病灶内CCH的使用急剧增加,同时病灶内维拉帕米的使用也随之减少。从2009年到2019年,手术折叠和斑块移植的使用稳步下降。在研究期间,所有3种治疗的每位患者的平均费用增加:1,856美元至3,196美元,斑块移植$2,233至$3,631,CCH每个周期6,940美元至8,895美元。自付中位数患者对折叠的贡献,斑块移植,在研究期间,每个周期的病灶内CCH注射量相似,从未超过300美元。
结论:CCH比任何手术治疗方案都要昂贵得多,然而,手术和CCH的患者自付费用相似.
UNASSIGNED:这项研究纳入了所有程序成本,是最现代的,全面,并准确反映手术和病灶内PD治疗患者的总体和自付费用。我们预计这些数据将允许患者和提供者之间就他们的护理进行更完整的讨论。商业索赔数据库的使用禁止对程序后成本和治疗结果进行评估。
结论:CCH的使用自2013年FDA批准以来已显著增加,尽管总治疗费用显著增加,但患者的自付费用与手术治疗相当。WaltonEL,奎因TP,MulloyE,etal.皮罗尼病的病灶内胶原酶梭状芽孢杆菌治疗与手术的成本:基于索赔的分析(2009-2019)。SexMed2022;10:100517。
BACKGROUND: Collagenase Clostridium histolyticum (CCH), which was approved by the FDA for the treatment of Peyronie\'s disease (PD) in 2013, may obviate the need for surgery but its historically high cost must be considered when offering CCH vs surgical intervention to affected patients.
OBJECTIVE: To compare trends of intralesional injections vs surgical treatment for PD and assess the contemporary cost of treatment with CCH vs surgical intervention.
METHODS: We reviewed 2009-2019 MarketScan Commercial Claims data to identify all men 18 years and older with PD. CPT and HCPCS codes were used to identify PD treatments for each patient. Associated insurance claims in USD were summed for each treatment type.
RESULTS: Total and out-of-pocket costs, as well as frequencies, for treatments were calculated on a yearly basis and the Cochran-Armitage test was used to compare frequencies before and after FDA approval of CCH.
RESULTS: Of 89,205 men diagnosed with PD, 21,605 (24.2%) underwent treatment; most required only intralesional injections, however 1,519 (7.0%) received only surgical therapy and 1,951 (9.0%) required medical and surgical therapy. Intralesional CCH use sharply increased after its FDA-approval in 2013 with a concomitant fall of intralesional verapamil use. The use of both surgical plication and plaque grafting decreased steadily from 2009 to 2019. The median cost per patient for all 3 treatments increased over the study time-period: $1,856 to $3,196 for plication, $2,233 to $3,631 for plaque grafting, and $6,940 to $8,895 per cycle for CCH. Out-of-pocket median patient contribution for plication, plaque grafting, and per cycle intralesional CCH injection were similar over the study period and never exceeded $300.
CONCLUSIONS: CCH is significantly more expensive than any surgical treatment option, however, the out-of-pocket patient contribution for surgery and CCH are similar.
UNASSIGNED: This study incorporated all procedure costs and is the most contemporary, comprehensive, and accurate reflection of overall and out-of-pocket costs to patients for surgical and intralesional PD therapies. We anticipate these data to allow for a more complete discussion between patients and providers regarding their care. The use of a commercial claims database prohibited assessment of post-procedural costs and treatment outcomes.
CONCLUSIONS: CCH use has increased significantly since its FDA approval in 2013 with out-of-pocket patient contribution comparable to surgical therapy despite significantly higher total treatment costs. Walton EL, Quinn TP, Mulloy E, et al. Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie\'s Disease: A Claims-Based Analysis (2009-2019). Sex Med 2022;10:100517.