The 340B Drug Discount Program, launched in 1992, is designed to give Medicaid-like discounts on covered outpatient drugs to qualifying healthcare providers. In the first quarter of recent years, IQVIA has published estimates of the 340B program’s size and growth as part of an ongoing program-related series of articles1, 2。
Findings
在2021年，340B计划的销售达到936亿美元（图1），与6683亿美元的药品销售额相比（有关所使用的数据和方法的更多详细信息，请参见分析方法）。2021年的340B销售额同比增长15.9％，总销售额增长了6.6％，分别增长了2020年，增长了18.1％和4.0％。
图1. 340B计划按年增长。基于WAC定价的销售。
Disease areas with specialty products, such as targeted oncology, immunology, and anti-arthritics including well-known blockbuster biologic products, continued to show some of the highest 340B growth in 2021 (Figure 2). 340B sales of diabetes products showed a reverse trend, falling 7.4% year-on-year in 2021 versus the 22% growth they'd experienced in 2020, due in large part to contract pharmacy restrictions. Diabetes was disproportionately impacted by those restrictions (see next section) because among some of the largest diabetes products, more than half of their 340B sales flowed through retail channels, they were penny priced, and their manufacturers were among the first to implement contract pharmacy restrictions.
Fig. 2. 340B program growth for the 10 USC2 disease areas with the highest total sales in 2021 (sales decrease down the vertical axis).
合同药学限制政策的影响
九家制药商在2021年或之前实施了合同药学限制政策3(manufacturers that changed policies for orphan drugs were not included, since this is a separate issue). The policies limited the number of contract pharmacies that could be used by covered entities to deliver 340B product to patients and the circumstances under which this occurred. Entity-owned pharmacies were not restricted.
合同药房限制的影响，如图3所示，显示了由分销渠道损坏的340B增长。合同药房是零售或邮件/专业邮件分销渠道的一部分。零售渠道的340B销售在2021年基本上是持平的，而在2020年达到22％的增长，而邮件销售额在2021年增长了34％，低于2020年的56％。
Fig. 3. 340B program growth by distribution channel.
Splitting the retail channel into its individual components of chain pharmacies, independents, food stores, and mass merchandizers presents further insights. 340B sales in chain pharmacies were down 5% year-on-year, while sales in independent pharmacies were up 15%. 340B growth in independent pharmacies may be due to the fact that most manufacturers didn't place restrictions on federal grantees, which are more likely to use independent pharmacies, and because 340B prescription discount cards, which some covered entities use to share 340B discounts with patients, are typically used at independent pharmacies. IQVIA is currently conducting further studies of 340B discount sharing.
Fig. 4. 340B growth in the four components of the retail distribution channel.
当2021年制造商的合同药学限制状态对340B的销售进行分割时，限制的影响变得更加明显（图5）。对于2021年某些或全部限制的九个制造商，零售和邮件340B销售分别下降了32％和20％。对于所有其他制造商的销售，零售和邮件340B销售分别增长了16％和44％。两个制造商组的医院和诊所渠道的340B销售相似。大众商品渠道渠道的340B销售额下降了60％，该制造商在2021年受到限制（数据未显示），这部分解释了为什么同一渠道总体销售额下降了30％30％（参见图4）。
图5. 340B计划按分配渠道分段合同药房限制的增长。
An additional seven manufacturers have announced they have implemented or are planning to implement contract pharmacy restrictions in 20223。
分析方法
当前的研究使用了IQVIA的DDD亚国家销售数据库中的供应商卖方数据。数据跨越2018年至2021年，包括所有疾病领域，专业和非专业产品，品牌药物和仿制药，处方和非处方产品以及所有分销渠道。使用WAC定价在产品/包水平上进行销售，而增长统计数据计算为使用美元销售的日历年度的同比百分比变化。这是供应商的销售数据，折扣未考虑，因此美元估计（但不是％340B估计）可能比文献中其他地方报告的大。
Pharma products were grouped into disease areas following the Uniform System of Classification (USC) system4. The analysis used USC2 level groupings which define approximately 70 therapeutic categories. This includes diabetes drugs, targeted oncology drugs (e.g., growth factor inhibitors, immune checkpoint inhibitors, CDK inhibitors, and tyrosine kinase inhibitors), immunologic agents (e.g., monoclonal antibodies and glutarimide derivatives), anti-arthritics (including biologics for Crohn's disease, inflammatory bowel disease, psoriasis, and rheumatoid arthritis), anti-virals (e.g., drugs for HIV and HEP-C), respiratory therapy (drugs for asthma and COPD), hemostatic agents (such as heparins and anti-coagulants), psychotherapeutics (antipsychotics, anti-depressants, and ADHD products), neurological agents (drugs for Parkinson's disease, epilepsy, Alzheimer's disease, and migraine), and gastrointestinal agents (infused biologics and proton pump inhibitors).
Categories for distribution channels were retail (chain pharmacies, independent pharmacies, food stores, and mass merchandizers), mail/specialty mail, hospitals, and clinics. Three additional channels—long-term care, miscellaneous and plan—which together represent only 2% of 340B sales were omitted.
1340B药物折扣计划：复杂性，挑战和变化，Martin＆Krikorian，Iqvia白皮书，2020年8月
22020年340B计划的增长加速，伊克维亚博客，2021年3月
3340B制造商更新，AmerisourceBergen, March 2022
4"The Uniform System of Classification (USC)," IQVIA Report 2018. USC was created by IQVIA and the Pharmaceutical Marketing Research Group as a standard way of grouping drugs that compete in the same market.
