From

来自

record-high drug shortages

创纪录的药物短缺

to the explosive popularity of GLP-1 medications and the intensifying battle over the 340B drug discount program, many of the biggest healthcare stories of 2024 centered on pharmacy issues.

随着GLP-1药物的爆炸式普及和340B药物折扣计划的激烈斗争，2024年许多最大的医疗保健故事都集中在药房问题上。

Attorneys for both big pharma and the federal government will be busy in 2025. Regulators will have their work cut out for them under a new administration that has expressed an anti-regulatory preference. Republicans next year will control the White House, Senate and House. What will it all mean for pharmacy leaders? Let’s review..

2025年，大型制药公司和联邦政府的律师都将忙得不可开交。在表达了反监管偏好的新一届政府的领导下，监管机构将为其工作。共和党明年将控制白宫、参议院和众议院。这对药房领导者意味着什么？让我们回顾一下。。

The rise of GLP-1 medications

GLP-1药物的兴起

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使用数据帮助医疗保健实践取得成功

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Relatient的一份新报告强调了关注数据准确性和相关性如何提高医疗保健实践的绩效。Relatient是一份数据驱动的患者访问成功指南。

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Amid a

在

national obesity epidemic

全国肥胖流行

, it’s little surprise that GLP-1 agonist medications continue to climb in popularity, with one

，GLP-1激动剂药物的受欢迎程度继续攀升也就不足为奇了，其中一种

report

报告

predicting they would surpass PD-1 inhibitors in 2024 to become the top-selling drug class.

预测它们将在2024年超过PD-1抑制剂，成为最畅销的药物类别。

That explosive popularity has landed medications like Eli Lilly’s Mounjaro and Zepbound on the FDA’s drug shortage list, spurring a robust market for compounded versions of GLP-1s from brands like Weight Watchers and Hims & Hers. The FDA removed the brand-name medications from the shortage list in October and barred compounding pharmacies from making their versions of the medications, which tend to be far less expensive.

如此火爆的人气使得礼来（EliLilly）的Mounjaro和Zepbound等药物被列入FDA的药物短缺名单，刺激了来自Weight Watchers和Hims＆Hers等品牌的GLP-1s复合版本的强劲市场。美国食品和药物管理局（FDA）于10月份将这些名牌药物从短缺名单中删除，并禁止复配药店生产价格往往要便宜得多的药物。

But the agency later reversed course, resulting in an ongoing standoff between the FDA, compounding pharmacies and the drug manufacturers who want to restore their exclusivity..

但该机构后来改变了方向，导致FDA、复配药店和希望恢复其排他性的药品制造商之间持续僵持不下。。

The bigger issue centers on the high costs. Brand-name GLP-1 medications can

更大的问题集中在高成本上。品牌名称GLP-1药物可以

exceed $11,000

超过11000美元

for an annual supply and have been used by an

每年供应，并已被

estimated 12%

估计12%

of Americans, according to a poll from the Kaiser Family Foundation. Commercial insurers and employers have been slow to cover GLP-1 medications, but that may be coming to a head.

根据凯撒家庭基金会的一项民意调查，这是美国人中的一员。商业保险公司和雇主对GLP-1药物的承保速度较慢，但这可能会达到顶点。

The Biden administration has proposed a rule to allow Medicare and Medicaid to cover weight-loss medications, making GLP-1s available to an estimated 7.4 million beneficiaries should the Trump administration allow it to take effect. The president-elect’s pick to lead the FDA, Dr. Marty Makary, is

拜登政府提出了一项规则，允许医疗保险和医疗补助涵盖减肥药物，如果特朗普政府允许GLP-1生效，估计将有740万受益人获得GLP-1。当选总统马蒂·马卡里（MartyMakary）博士被选为FDA的负责人

CMO of a telehealth weight-loss company

远程保健减肥公司的首席营销官

that sells compounded GLP-1 medications.

销售复合GLP-1药物。

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缩小癌症健康公平差距需要通过新的资助方法实现医学突破。

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Self-injectable GLP-1 agonists are getting all the attention now, but there are plenty of other high-priced medications coming through the pipeline. In a few years, we may be talking about them instead of Ozempic or Wegovy — meaning debates over coverage for high cost medications will continue.

自注射GLP-1激动剂现在受到了所有关注，但还有许多其他高价药物正在开发中。几年后，我们可能会谈论它们，而不是Ozempic或Wegovy，这意味着关于高成本药物覆盖率的辩论将继续下去。

Insurance coverage of GLP-1 medications is likely to remain a hot topic, as is the strain on retail pharmacies due to

GLP-1药物的保险范围可能仍然是一个热门话题，零售药店由于

losses

损失

associated with these medications.

与这些药物有关。

The battle over 340B

340B之战

In August, Johnson & Johnson opened up a new front in the drug industry’s assault on the 340B discount drug program with its plan to switch from traditional upfront 340B discounts to a rebate model for Stelara and Xarelto, two of its best-selling medications. Then the Health Resources and Services Administration threatened to revoke its access to Medicaid and Medicare, and J&J backed down. .

8月，强生公司（Johnson＆Johnson）计划从传统的340B预付折扣转变为Stelara和Xarelto（两种畅销药物）的折扣模式，为制药行业打击340B折扣药物计划开辟了一条新的战线。随后，美国卫生资源和服务管理局（Health Resources and Services Administration）威胁要撤销其获得医疗补助（Medicaid）和医疗保险（Medicare）的权利，强生公司（J＆J）做出了让步。。

Now, J&J is among four drugmakers

现在，强生是四家制药商之一

suing the government

起诉政府

for blocking their 340B rebate proposals, joining Eli Lilly, Bristol Myers Squibb and Sanofi.

加入礼来、百时美施贵宝和赛诺菲，阻止了他们340亿美元的退税计划。

The dispute adds to an ongoing battle over the role of contract pharmacies in the 340B program, where a decision is

这一争议加剧了一场关于合同药店在340B计划中的作用的持续斗争，该计划的决定是

still pending

仍在等待

from a federal circuit court involving Eli Lilly after courts in two similar cases ruled largely against the government. The pharmaceutical industry is also contesting a growing number of state laws that prohibit restrictions on 340B contract pharmacies.

在两起类似案件中，法院作出了对政府不利的判决后，一家涉及礼来的联邦巡回法院发出了警告。制药行业还对越来越多禁止限制340B合同药店的州法律提出质疑。

In both cases, drugmakers argue they need stronger protections, in the form of reams of pharmacy claims data, to prevent paying duplicate 340B and Medicaid discounts on the same prescription. However, the federal government has permitted 340B rebates only once, for the AIDS Drug Assistance Program, in 1998..

在这两种情况下，制药商都辩称，他们需要以大量药房索赔数据的形式加强保护，以防止在同一处方上重复支付340B和医疗补助折扣。然而，1998年，联邦政府只允许对艾滋病药物援助计划给予3400亿美元的回扣一次。。

There is a grudging sense among many 340B stakeholders that rebates may be inevitable. If so, it could pose major challenges to covered entities, many of whom lack the cash flow to pay the list price for medications while hoping for rebates down the line. It could also drive many 340B providers to consider clinically appropriate alternatives for popular brand medications affected by rebate policies..

许多3400亿利益相关者不情愿地认为，回扣可能是不可避免的。。这也可能促使许多340B提供商考虑临床上适合受退税政策影响的流行品牌药物的替代品。。

For now, covered entities are urging continued advocacy and outreach to elected leaders for help defeating these proposals. Safety net clinics and hospitals have traditionally relied on elected leaders to help defend the program as a critical financial lifeline — as when 189 Republicans and Democrats co-signed a letter urging the government to block J&J’s proposal..

目前，受报道的实体正在敦促继续向当选领导人进行宣传和外联，以帮助他们挫败这些提议。安全网诊所和医院传统上依靠民选领导人来帮助捍卫该计划，将其视为一条至关重要的财政生命线，就像189名共和党人和民主党人共同签署一封信，敦促政府阻止强生的提议一样。。

Now that the issue has largely moved to the courts, will these efforts continue? And will they matter?

既然这个问题已经在很大程度上转移到了法院，这些努力还会继续吗？它们重要吗？

Meanwhile, the failure of a bipartisan “gang of six” Senate workgroup to introduce

与此同时，两党“六人帮”参议院工作组未能引入

major 340B legislation

340B主要法规

it promised in 2024 does not bode well for the chances of comprehensive reform in 2025.

它在2024年作出的承诺对于2025年全面改革的机会来说并不是一个好兆头。

IRA and 340B

IRA和340B

Another reason drug manufacturers are proposing rebates has to do with how the Inflation Reduction Act, the Biden administration’s signature achievement, affects Medicare Part D.

药品制造商提出退税的另一个原因与拜登政府的标志性成就《降低通货膨胀法案》如何影响医疗保险D部分有关。

Under the law’s

根据法律

drug-price negotiation

药品价格谈判

provision, manufacturers must offer covered entities the lower of 340B ceiling pricing or newly negotiated maximum fair price (MFP) when they go into effect starting in 2026. Separately, the law requires drug companies to issue rebates when the prices of their products rise faster than the rate of inflation..

规定，制造商必须在2026年开始生效时，向受保实体提供340B的最高定价或新谈判的最高公平价格（MFP）中较低的一个。另外，该法律要求制药公司在产品价格上涨速度快于通货膨胀率时发放退税。。

The government has yet to clarify how to resolve two key issues for manufacturers, safety net hospitals and 340B pharmacies alike:

政府尚未澄清如何解决制造商、安全网医院和340B药店的两个关键问题：

How to exclude 340B claims from calculating the Part D inflation rebates

How MFP will work with 340B, keeping the two separate, so manufacturers avoid paying duplicate discounts, covered entities aren’t burdened with additional claims submission or other burdensome administrative requirements, and contract pharmacies are made whole

MFP将如何与340B合作，将两者分开，以便制造商避免支付重复的折扣，涵盖的实体不必承担额外的索赔提交或其他繁重的管理要求，合同药房也将完整无缺

These issues are incredibly complicated and have generated plenty of confusion among stakeholders. Many believe manufacturers are pursuing 340B rebates as a way to avoid duplicate discounts under the MFP provision — and snuff out 340B pharmacies altogether.

这些问题极其复杂，在利益相关者之间产生了很多困惑。许多人认为，制造商正在寻求3400亿美元的折扣，以避免MFP条款下的重复折扣，并完全扼杀了3400亿家药店。

The government has a year before both provisions take effect. Given the changing guard in Washington D.C. and the challenges of implementing new data systems, many worry a fix may not arrive in time.

政府还有一年时间这两项规定才能生效。考虑到华盛顿特区不断变化的防范措施以及实施新数据系统的挑战，许多人担心修复可能不会及时到来。

PBM crackdown?

PBM镇压？

Last but not least, pharmacy benefit managers have come under bipartisan condemnation.

最后但并非最不重要的一点是，药房福利经理受到了两党的谴责。

In July, the Federal Trade Commission released a

7月，联邦贸易委员会发布了

scathing interim report

严厉的中期报告

alleging that PBMs used their market power to hurt small independent pharmacies and drive up prices.

指控PBM利用其市场力量伤害小型独立药店并抬高价格。

Then in September, the agency sued CVS Caremark, Express Scripts and OptumRx, the three largest PBMs, alleging collusion to drive up the prices of insulin. The three companies have also countersued to block the administrative proceedings.

然后在9月，该机构起诉CVS Caremark、Express Scripts和OptumRx这三家最大的PBM，指控它们串通抬高胰岛素价格。这三家公司还反诉，以阻止行政诉讼。

It’s tempting to believe that regulators and the incoming Republican-controlled Congress will rein in PBMs — and in fact, a bipartisan bill has

人们很容易相信监管机构和即将到来的共和党控制的国会将控制PBM，事实上，一项两党法案已经

already been introduced

已经引入

to do just that. But it’s hard to be optimistic. PBMs are deeply embedded in U.S. healthcare. With their strong lobbying, the anti-regulatory stance of the Trump administration and the difficulty of unwinding their business practices, transformative change remains a steep uphill climb.

这样做。但很难乐观。PBM深深植根于美国医疗保健领域。由于他们的大力游说，特朗普政府的反监管立场以及解除商业惯例的困难，变革仍然是一个陡峭的爬坡过程。

Other predictions

其他预测

With the evolution of pharmacy beyond traditional retail pharmacies and inpatient services to specialty pharmacies, centralized operations and home infusion services, we’ll see a broader recognition of pharmacy’s role in contributing to the financial health of hospitals and health systems. As drug prices continue to climb, responsibly run pharmacy programs that generate a positive margin will secure their seat at the executive leadership table..

随着药房从传统零售药房和住院服务向专业药房、集中运营和家庭输液服务的演变，我们将看到药房在促进医院和卫生系统财务健康方面的作用得到更广泛的认可。随着药品价格持续攀升，负责任地运营产生积极利润的药房项目将确保其在高管领导层席位上的地位。。

Photo: grThirteen, Getty Images

照片：GR十三，盖蒂图片

Tara Hanuscak

塔拉 汉努斯克

Tara Hanuscak PharmD, MS

塔拉·哈努萨克医学博士

, Chief Transformation Officer,

，首席转型官，

The Craneware Group

, served in hospitals, clinics, and retail pharmacies for 20 years. She received her Master of Science in Health-System Pharmacy Administration and Doctorate of Pharmacy from The Ohio State University.

，在医院，诊所和零售药店服务了20年。她获得了俄亥俄州立大学卫生系统药学管理理学硕士和药学博士学位。

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Topics

主题

340B

340B

biopharma nl

生物制药 nl

GLP-1 drugs

GLP-1药物

inflation reduction act

PBM

PBM

Pharmacy

药房

pharmacy benefit manager

药房福利经理

predictions

预测

retail pharmacy

零售药房

specialty pharmacy

专业药房

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