Eli Lilly And Co. (NYSE:LLY) has filed a lawsuit against the Health Resources and Services Administration (HRSA). The pharmaceutical giant claims that HRSA obstructed its attempt to alter drug discount offerings to hospitals.
What Happened: As per Eli Lilly's official statement on Thursday, the conflict centers on the federal 340B program, which requires drug manufacturers to offer discounts to healthcare providers serving low-income communities. Participation in this program is crucial for drug companies to secure funding from government health insurance programs like Medicare and Medicaid.
Eli Lilly proposed a plan to ensure 340B entities pay no more than the ceiling price by providing them with cash directly on a weekly basis. However, HRSA, a division of the U.S. Health and Human Services Department, rejected this approach, stating it was inconsistent with the 340B law.
"HRSA does not have the authority to arbitrarily reject this model, which serves the original goals of the 340B program and improves transparency, efficiency, and program integrity," the statement read.
Why It Matters: The lawsuit comes amid ongoing scrutiny of drug pricing practices. Recently, Doctors Without Borders criticized Eli Lilly and other insulin manufacturers for maintaining high prices, urging them to provide affordable insulin to low- and middle-income countries.
This legal action also follows a similar lawsuit by Johnson & Johnson, which alleged the Health and Human Services Department of blocking its drug rebate plans. The 340B program has been subject to extensive legal challenges, with a U.S. appeals court previously allowing drugmakers to limit the use of outside pharmacies for dispensing under the program.
Meanwhile, Eli Lilly has been in the spotlight for its Phase 3 trial data of tirzepatide, marketed as Mounjaro and Zepbound. The study showed promising results in reducing the risk of type 2 diabetes in patients with pre-diabetes and obesity, highlighting the company's focus on innovative treatments.
Price Action: Eli Lilly was down by 0.28% during pre-market hours on Friday at the time of writing, as per Benzinga Pro.
Eli Lilly And Co.紐約證券交易所代碼：LLY）已對衛生資源與服務管理局（HRSA）提起訴訟。這家制藥巨頭聲稱，HRSA阻礙了其改變向醫院提供的藥品折扣的企圖。
發生了什麼：根據禮來公司週四的官方聲明，衝突集中在聯邦3400計劃上，該計劃要求藥品製造商向爲低收入社區服務的醫療保健提供者提供折扣。參與該計劃對於製藥公司從Medicare和Medicaid等政府健康保險計劃中獲得資金至關重要。
禮來公司提出了一項計劃，通過每週直接向他們提供現金，確保3400家實體支付的費用不超過上限價格。但是，美國衛生與公共服務部下屬的HRSA拒絕了這種做法，理由是它與3400法律不一致。
聲明說：「HRSA無權任意拒絕這種模式，該模式符合3400計劃的最初目標，提高了透明度、效率和計劃完整性。」
爲何重要：該訴訟是在對藥品定價行爲的持續審查之際提起的。最近，無國界醫生組織批評禮來公司和其他胰島素製造商維持高價格，敦促他們向低收入和中等收入國家提供負擔得起的胰島素。
該法律訴訟也是在強生公司提起類似訴訟之後提起的，該訴訟指控衛生與公共服務部阻止了其藥品退稅計劃。3400計劃受到了廣泛的法律挑戰，美國上訴法院此前曾允許製藥商根據該計劃限制使用外部藥房進行配藥。
同時，禮來公司因其以Mounjaro和Zepbound的名義銷售的替塞帕肽的3期試驗數據而備受關注。該研究顯示，在降低糖尿病前期和肥胖患者患2型糖尿病的風險方面取得了令人鼓舞的結果，凸顯了該公司對創新療法的關注。
價格走勢：根據Benzinga Pro的數據，在撰寫本文時，禮來公司在週五的盤前時段下跌了0.28％。
