The Inflation Reduction Act (IRA) is expected to have broad negative impacts on patients, most notably through less access to future cures and treatments. The latest research shows that patients with heart disease may be especially affected, given the unique challenges surrounding cardiovascular treatments.
What’s happening with the IRA and heart disease therapies?
The IRA’s impact on heart disease therapies is likely to take two forms:
- Dampen investment in innovation, especially innovation that broadens the use of existing cardiovascular therapies.
- Result in new access barriers and higher costs that fall disproportionately on patients with heart disease.
The result will be fewer cardiovascular treatments.
Numerous reports have found that government price setting will result in less innovation and fewer new treatments. To make matters worse, the IRA targets medicines for government price setting based on the day they are first approved, which will discourage researchers from taking on the risk necessary to investigate the benefit of existing treatments in additional patient populations. This post-approval research has been critical in the fight against heart disease where innovation is already extremely difficult.
What does the research say?
- According to research coauthored by BIO, cardiovascular disease ranks 14th out of 15 disease areas in the chance of a medicine making it from Phase 1 to Food and Drug Administration (FDA) approval. Companies take that risk because the need around heart disease is so great.
- Cardiovascular clinical trials are not only riskier, but they are also longer and more expensive. An Avalere assessment found that Phase 3 trials in heart disease had enrollment that was 67% larger than trials for respiratory disease and more than twice the size of metabolic disease trials. Cardiovascular trials also took between 28% and 32% longer than studies of metabolic or respiratory diseases.
- According to a new study from Duke University, 65 cardiovascular or antithrombotic treatments were approved between 1995 and 2001. The study found that, of those treatments, 49% of indications and 76% of industry-funded clinical trials were completed after the treatment was first approved.
The IRA is jeopardizing access.
The IRA offers no guarantee that patients will benefit from government-set prices. Pharmacy benefit managers, or PBMs, profit from rebates they negotiate with biopharma companies, and they don’t have to share these rebates directly with patients. The IRA exacerbates perverse incentives for PBMs to steer patients toward medicines with large rebates, even if they aren’t medically appropriate or consumers would face higher costs. Heart disease treatments are more likely to be selected for government price setting given the large patient population at risk for cardiovascular disease, which is the number one killer of Americans. This elevates the risks that patients with heart disease are caught in this dynamic.
What does BIO say?
Successive waves of innovation around heart disease have had a profound and positive impact on patients and public health, with death rates from cardiovascular disease falling by double-digits between 2009 and 2019. The IRA threatens this success with a series of disincentives that hit heart disease innovation especially hard, which is why Congress must take up bipartisan solutions that would fix flaws in the law and protect patients’ ability to get the cures and treatments they need.
