July 12, 2021– The pharmaceutical giant Boehringer Ingelheim (BI), a manufacturer headquartered in Germany, is the latest company to announce it is cutting off discounts to safety-net hospitals participating in the 340B drug pricing program. If BI goes through with its threat on Aug. 1, it will become the seventh drug company to limit 340B discounts despite strong warnings by the federal government. 340B Health has called on the company to withdraw its policy.
BI recently sent a letter to 340B hospitals saying it no longer will ship discounted drugs to community-based pharmacies with which hospitals partner to dispense drugs to eligible patients. The company also sent a long list of drugs that will be affected by the new policy, including nearly all the company’s top-selling therapies. BI is a major manufacturer of drugs needed by patients with cardiovascular, oncological, respiratory, metabolic, immunologic, and retinal conditions. BI exempted federally qualified health centers and eligible public health clinics from the policy, so it only applies to hospitals. The letter also spelled out certain exceptions to the policy for hospitals that have common ownership with their community pharmacies and hospitals that do not have in-house pharmacies that can dispense 340B drugs.
In a statement, 340B Health President and CEO Maureen Testoni urged BI to withdraw its threat before Aug. 1 and continue to abide by federal law. She said if the company does not back off, the association of more than 1,400 hospitals participating in 340B will call on HHS to take similar enforcement actions against BI as the department has against the first six to take this step.
“The decision of Boehringer Ingelheim, a multi-billion-dollar drug company, to violate the 340B law and withhold required discounts to many hospitals serving low-income and rural communities is appalling,” Testoni said. “By circumventing the law, BI will harm the financial health of safety-net providers across the country and the health and well-being of the patients they serve. The federal government has clearly stated actions like these are unlawful and must stop, but the company is ignoring this unequivocal directive and daring regulators to try to stop them.”
The BI development is worrisome to covered entities because the company is taking this step despite six other drugmakers – Eli Lilly, Novo Nordisk, Novartis, Sanofi, AstraZeneca, and United Therapeutics – already being on official notice that pricing denials on drugs dispensed at community pharmacies are violations of federal law. In May, the Department of Health and Human Services (HHS) sent enforcement letters to those six companies ordering them into compliance. HHS said the companies must restore the discounted pricing and repay 340B covered entities for lost savings that the government projects will cost providers $3.2 billion in a year.
Patients Caught Up in the Fight
Some of the companies that preceded BI in taking this step have boasted to their shareholders about how withholding the savings have boosted their already large revenue and profit figures. In 2020, BI raked in nearly $20 billion in revenue and more than $3 billion in profits for its drugs, many of which are costly therapies for patients living with chronic conditions such as diabetes, asthma, chronic obstructive pulmonary disease (COPD), and heart disease.
One of those patients is Dan Hargrave, a patient at MetroHealth in Cleveland who is living with COPD and a heart condition. Hargrave struggles to breathe without Spiriva (tiotropium), an inhaler medication that BI manufactures. But he also struggled to afford the medication on his fixed income until MetroHealth used its 340B discounts to cut his out-of-pocket costs by nearly $50 a month.
“If the 340B program was not available to me, I wouldn’t be able to afford all of my medications every single month,” Hargrave said in his Faces of 340B video profile. “So then it becomes a question of, ‘Do I skip my heart meds to take my breathing meds? And if my heart’s not functioning right, are my breathing meds as important?’ … The 340B program gets you a lot closer to being able to do everything.”
Many 340B hospitals use their community pharmacy partnerships to help even more patients like Hargrave access drugs that they need for free or at a reduced price. Many hospitals also use the program savings through such partnerships to fund critical health services and support that the hospital otherwise would not be able to offer. The hospitals warn that companies such as BI put those patient care investments in grave jeopardy when they unilaterally halt the discounts that the 340B law requires.
The stories of harm to safety-net providers and the patients who rely on them have been increasing over the past year as the damage of these drugmaker actions has been worsening. If BI follows through on its threat, hospitals say it will pile even more strain on the system and might encourage even more companies to follow their lead.