Kruse Gregory B, Amonkar Mayur M, Smith Gregory, Skonieczny Dean C, Stavrakas Spyros
The Wharton School, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104, USA.
J Manag Care Pharm. 2008 Nov-Dec;14(9):844-57. doi: 10.18553/jmcp.2008.14.9.844.
An estimated $8.1 billion (in 2004 dollars) is spent annually on total health care costs for the treatment of breast cancer in the United States. Breast cancer has traditionally been treated with intravenous (IV) cancer therapies that entail not only the drug acquisition cost, but additional costs of personnel time, supplies, and equipment used in the preparation and administration of the IV drug. A systematic study of the costs of IV administration in the metastatic breast cancer (MBC) population has not been performed.
To assess the cost components, overall and by payer type and patient age group, for administering a single-agent IV breast cancer drug to women with MBC in the United States.
Women diagnosed with MBC (ICD-9-CM codes 174.XX and 196.XX-198.XX) reported any time between January 1, 2003, and May 31, 2006, and receiving single-agent IV breast cancer therapy (including intramuscular fulvestrant) during a visit were identified (using HCPCS and CPT codes) from an administrative claims database supporting 46 general/oncology clinics in the United States. Study drugs were either FDA-approved for breast cancer or recommended for use as preferred single agents per National Comprehensive Cancer Network (NCCN) clinical practice guidelines for breast cancer. Costs were estimated using the contracted allowed payment, which is the amount that the provider is eligible to receive from all parties, including payers and patients. Costs were measured using 2 approaches-average cost per IV-administration visit and average cost per patient per month (PPPM).
Over the 41-month study period (through May 31, 2006), 46,273 patients had a breast cancer diagnosis, of which 8,533 (18.4%) were metastatic; 828 (9.7%) of these patients received 1 of 11 single-agent IV breast cancer drugs over 7,406 visits. Mean (SD) total payments across all drugs and cost components were $2,477 ($1,842) per visit and $4,966 ($3,841) PPPM, of which IV administration costs were 10.2% of per-visit and 11.4% of PPPM costs, and other drugs and services provided during IV administration were 30.8% of per-visit and 32.2% of PPPM costs. In both the per-visit and PPPM analyses, approximately 80% of costs for other drugs and services (approximately 25% of total treatment costs) were attributed to (a) antihypercalcemic agents (e.g., zoledronic acid: 6%-8% of total treatment cost), (b) colony-stimulating factors (CSFs) (e.g., pegfilgrastim, epoetin: 6%-7%), or (c) other anticancer agents being used off-label or for other conditions (e.g., bevacizumab, irinotecan, carboplatin, vincristine: 11%-12%). The remaining 20% of costs for other drugs and services (about 6% of total costs) were attributable primarily to antiemetic agents (e.g., palonosetron, granisetron) and miscellaneous or unclassified products. Non-protein-bound paclitaxel was the most commonly used IV therapy at a mean cost of $2,804 per visit, with IV administration accounting for $353 (12.6%) and other services accounting for $1,237 (44.1%) of total costs per visit. The second most commonly used IV therapy was trastuzumab at a mean cost of $2,526 per visit, with IV administration accounting for $214 (8.5%) and other services accounting for $336 (13.3%) of total costs per visit.
For patients being administered a single FDA-approved or NCCN-recommended IV drug for treatment of MBC, IV administration costs accounted for approximately 10%-11% of total cost, and the study drugs accounted for 56%-59%. Other drugs and services accounted for 31%-32%, most of which was attributable to antihypercalcemic agents, CSFs, anticancer drugs being used off-label for breast cancer or for other conditions, and antiemetic agents. Although costs of IV administration are 10%-11% of total IV chemotherapy costs for MBC and would clearly be avoided with the use of oral agents, the extent to which other costs would be avoided or incurred with use of oral agents is unknown and requires further research.
在美国，每年用于乳腺癌治疗的总医疗费用估计为81亿美元（按2004年美元计算）。传统上，乳腺癌采用静脉注射（IV）癌症治疗方法，这不仅需要药物购置成本，还包括人员时间、耗材以及静脉注射药物配制和给药过程中使用的设备等额外成本。尚未对转移性乳腺癌（MBC）患者群体的静脉给药成本进行系统研究。
评估在美国为MBC女性患者静脉注射单药乳腺癌药物的成本构成，包括总体成本、按支付方类型和患者年龄组划分的成本。
从支持美国46家综合/肿瘤诊所的行政索赔数据库中，识别出在2003年1月1日至2006年5月31日期间被诊断为MBC（ICD - 9 - CM编码174.XX和196.XX - 198.XX）且在就诊期间接受单药静脉乳腺癌治疗（包括肌肉注射氟维司群）的女性患者（使用HCPCS和CPT编码）。研究药物要么是FDA批准用于乳腺癌的，要么是根据美国国立综合癌症网络（NCCN）乳腺癌临床实践指南推荐用作首选单药的。成本使用合同允许支付金额进行估算，即提供者有资格从包括支付方和患者在内的所有各方获得的金额。成本采用两种方法衡量——每次静脉给药就诊的平均成本和每位患者每月的平均成本（PPPM）。
在41个月的研究期间（截至2006年5月31日），46,273名患者被诊断患有乳腺癌，其中8,533名（18.4%）为转移性乳腺癌；这些患者中有828名（9.7%）在7,406次就诊中接受了11种单药静脉乳腺癌药物中的一种。所有药物和成本构成的平均（标准差）总支付额为每次就诊2,477美元（1,842美元），PPPM为4,966美元（3,841美元），其中静脉给药成本占每次就诊成本的10.2%，占PPPM成本的11.4%，静脉给药期间提供的其他药物和服务占每次就诊成本的30.8%，占PPPM成本的32.2%。在每次就诊和PPPM分析中，其他药物和服务成本的约80%（约占总治疗成本的25%）归因于：（a）抗高钙血症药物（如唑来膦酸：占总治疗成本的6% - 8%），（b）集落刺激因子（CSF）（如培非格司亭、促红细胞生成素：6% - 7%），或（c）其他用于非适应证或其他病症的抗癌药物（如贝伐单抗、伊立替康、卡铂、长春新碱：11% - 12%）。其他药物和服务成本的其余20%（约占总成本的6%）主要归因于止吐药物（如帕洛诺司琼、格拉司琼）以及其他杂项或未分类产品。非蛋白结合型紫杉醇是最常用的静脉治疗药物，每次就诊平均成本为2,804美元，其中静脉给药占每次就诊总成本的353美元（12.6%），其他服务占1,237美元（44.1%）。第二常用的静脉治疗药物是曲妥珠单抗，每次就诊平均成本为2,526美元，其中静脉给药占每次就诊总成本的214美元（8.5%），其他服务占336美元（13.3%）。
对于接受FDA批准或NCCN推荐的单药静脉注射治疗MBC的患者，静脉给药成本约占总成本的10% - 11%，研究药物占56% - 59%。其他药物和服务占31% - 32%，其中大部分归因于抗高钙血症药物、CSF、用于乳腺癌非适应证或其他病症的抗癌药物以及止吐药物。尽管静脉给药成本占MBC静脉化疗总成本的10% - 11%，使用口服药物显然可避免这部分成本，但使用口服药物可避免或产生的其他成本程度尚不清楚，需要进一步研究。
