Millions may see lower out-of-pocket costs for heart medications

Cardiovascular disease is the leading cause of death worldwide, including in the United States, where about 20% of all deaths are caused by heart disease. Highly effective medications can lower the rates of death and disability related to cardiovascular diseases. However, the expense of long-term prescription medications represents a significant barrier to care for many patients with chronic cardiovascular conditions.

The Inflation Reduction Act—signed into law in August 2022—includes several clauses related to drug benefits that are expected to lower prescription medication costs for Medicare Part D beneficiaries over time and expand low-income subsidies.

In two studies simultaneously published in the Journal of the American College of Cardiology, Harvard Medicine School researchers at Beth Israel Deaconess Medical Center analyzed data to estimate how the provisions in the Inflation Reduction Act (IRA) may affect Medicare beneficiaries with cardiovascular risk factors and conditions. The analysis projects that millions of beneficiaries will experience lower out-of-pocket drug costs.

The first study looked at out-of-pocket prescription drug costs, which have "risen steadily in the United States," according to the study's senior author, Rishi Wadhera, HMS assistant professor of medicine and section head of health policy and equity at the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess.

"Because high costs impede access to medications and create financial hardship for many patients, addressing high and rising drug costs has become a national priority. By capping out-of-pocket prescription drug costs and expanding full subsidies to low-income individuals, the IRA could lead to improvement in medication adherence and ultimately health outcomes for Medicare beneficiaries with cardiovascular risk factors or conditions."

Using federal data collected in 2016–2019, Wadhera and colleagues found that, presently, more than 34 million U.S. adults 65 years or older are covered by Part D and report at least one cardiovascular risk factor or condition.

Medicare Part D provides prescription drug coverage to Medicare beneficiaries; however, deductibles, co-payments, lack of an out-of-pocket maximum, and the infamous coverage gap known as the donut hole—which limits coverage for drugs only once certain spending thresholds have been reached—mean patients who need high-cost and/or long-term medications to manage chronic conditions could be responsible for thousands of dollars every year. Provisions in the IRA are expected to address these out-of-pocket expenses for cardiovascular drugs by eliminating the donut hole prescription coverage gap and placing a $2,000 cap on annual out-of-pocket expenses.

Wadhera and colleagues' analysis revealed that the IRA's annual spending cap would likely benefit more than one million beneficiaries who currently experience out-of-pocket drug costs in excess of $2,000 a year. Further, the team estimated that this population would save a combined $1.7 billion annually as a result of the spending cap. And they estimated that under the IRA's expansion of income eligibility criteria, approximately 1.3 million more Medicare beneficiaries with cardiovascular risk factors or conditions will qualify for low-income subsidies.

"The expansion of full low-income subsidies is critically important, as nearly one third of this population will be individuals from underserved racial and ethnic backgrounds, and highlights the potential equity implications of the IRA," said first author Prihatha Narasimmaraj, HMS instructor in medicine, part-time, at Beth Israel Deaconess.

Led by Dhruv Kazi, HMS associate professor of medicine and associate director of the Smith Center at Beth Israel Deaconess, the second study projected the impact of the Inflation Reduction Act on four cardiovascular conditions which frequently require long-term, high-cost treatment regimens: severe high cholesterol, two forms of heart failure, and a rare, progressive disease of the heart muscle called cardiac transthyretin amyloidosis.

The team analyzed more than 4,000 Part D plans nationwide and compared projected out-of-pocket drug costs for each condition from 2022 to 2025. The researchers found that by 2025, the IRA would lower out-of-pocket drug costs for all four conditions, with reductions ranging from a few hundred dollars to several thousand dollars. For instance, patients with cardiac transthyretin amyloidosis, the condition with the most expensive treatment in the study, would see an 87% reduction in their out-of-pocket costs.

"These reductions in costs for patients and Medicare is a win-win, as we know that affordability is a big challenge to accessing potentially life-saving cardiovascular therapies," said Kazi. "For the first time since the launch of Medicare's prescription drug program, IRA will lead to directly negotiated prices with manufacturers.

"While I am optimistic about what this means for the millions of Americans living with heart disease, it's important to remember that cardiovascular therapies may still remain beyond the reach of some patients even with these markedly reduced out-of-pocket costs. Clinicians should continue to have regular conversations about medication affordability with their patients."