Mesh : United States Drug Costs Humans Negotiating Benchmarking Medicare Part D / economics Centers for Medicare and Medicaid Services, U.S. Drug Industry / economics

来  源:   DOI:10.18553/jmcp.2024.24153   PDF(Pubmed)

Abstract:
UNASSIGNED: The Centers for Medicare and Medicaid Services (CMS) are currently negotiating prices with pharmaceutical manufacturers for the first 10 Part D drugs selected for Medicare drug price negotiation. Non-publicly available data, including the net prices of selected drugs and their therapeutic alternatives, will play a central role in the determination of the maximum fair prices (MFPs).
UNASSIGNED: To estimate price benchmarks involved in the derivation of the starting point of the CMS initial price offer for the 10 drugs selected for Medicare price negotiation.
UNASSIGNED: For the 10 drugs selected for negotiation, we reported (1) the list price, (2) the net price after manufacturer discounts, (3) the maximum negotiated price based on the minimum statutory discount, and (4) the ceiling of the MFP, estimated as the lowest of the latter 2. We also estimated net prices for therapeutic alternatives to the selected drugs. Net prices were estimated using peer-reviewed methodology that isolates commercial discounts negotiated between payers and manufacturers from mandatory discounts under government programs. All price benchmarks were estimated at the product level, for 30-day equivalent dosing, using 2021 data.
UNASSIGNED: 6 products (apixaban, rivaroxaban, empagliflozin, sacubitril/valsartan, etanercept, and insulin aspart) had therapeutic alternatives with lower net prices, which will be integrated with clinical benefit data in the derivation of initial price offers. The other 4 products (ustekinumab, ibrutinib, sitagliptin, and dapagliflozin) had therapeutic alternatives with higher net prices than the drugs selected for negotiation. For ibrutinib and ustekinumab, prices based on the minimum discounts were considerably lower than the estimated net prices and will likely set the starting point of the initial price offer. For dapagliflozin and sitagliptin, the starting point of the initial price offer will likely resemble their existing net prices.
UNASSIGNED: Our analyses identify different negotiation scenarios for the first 10 drugs selected for Medicare price negotiation, based on key elements involved in the derivation of the initial price offer. Our analyses can help improve transparency in the negotiation process, because the CMS is not required to reveal the information used in the derivation of price offers.
摘要:
医疗保险和医疗补助服务中心(CMS)目前正在与药品制造商就医疗保险药品价格谈判中选择的前10种D部分药品的价格进行谈判。非公开数据,包括选定药物及其治疗替代品的净价,将在确定最高公平价格(MFP)方面发挥核心作用。
用于估算为Medicare价格谈判选择的10种药物的CMS初始价格报价的起点所涉及的价格基准。
对于选择谈判的10种药物,我们报告了(1)标价,(2)制造商折扣后的净价,(3)以最低法定折扣为基础的最高协商价格,和(4)MFP的天花板,估计是后者中最低的2。我们还估计了选定药物的治疗替代品的净价。净价是使用同行评审的方法估算的,该方法将付款人和制造商之间协商的商业折扣与政府计划下的强制性折扣隔离开来。所有价格基准都是在产品层面估计的,30天等效剂量,使用2021年的数据。
6种产品(阿哌沙班,利伐沙班,empagliflozin,沙库巴曲/缬沙坦,依那西普,和门冬胰岛素)有较低净价的治疗替代品,这将与临床效益数据整合在初始价格报价的推导中。其他4种产品(ustekinumab,伊布替尼,西格列汀,和dapagliflozin)的治疗替代品的净价高于选择谈判的药物。对于ibrutinib和ustekinumab,基于最低折扣的价格大大低于估计的净价,并可能设定初始价格报价的起点。对于达格列净和西格列汀,最初报价的起点可能会类似于他们现有的净价。
我们的分析确定了为医疗保险价格谈判选择的前10种药物的不同谈判方案,基于推导初始报价所涉及的关键要素。我们的分析可以帮助提高谈判过程的透明度,因为CMS不需要透露价格优惠推导中使用的信息。
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