Lower out-of-pocket prescription drugs costs spread more manageably across the calendar year. That’s what patients and policymakers alike hope to get from the Inflation Reduction Act.
But a newly released report suggests there could also be unintended consequences.
Potential Impact on Cardiovascular Medications
According to new research, breakthrough drugs to treat cardiovascular disease — the leading cause of death in the United States — may be more difficult to develop under the Inflation Reduction Act’s new framework. A report by Avalere Health argues that, by allowing Medicare to negotiate prices on certain prescription drugs, the law could unintentionally slow development of new treatments for cardiovascular conditions.
Developing innovative medications is difficult even in the best of circumstances. But cardiovascular drugs take an especially long time and require significant investment.
Just consider that clinical trials for new cardiovascular drugs:
- Demand two times more patients per clinical trial
- Require 50% more clinical trial sites
- Face a high likelihood of failure in FDA trials
- Experience longer trial timelines compared to other medications
If Medicare price negotiations make it difficult to recoup development costs, pharmaceutical companies will face tough financial choices. Developing a new drug and moving it through the FDA approval process is expensive. If companies cannot profit from the finished products, they likely will become more cautious and selective about which medications they develop.
And patients could pay the price.
Policy Solutions to Protect Patient Access
Policymakers have several options for mitigating these risks.
One way to is to extend a grace period, holding off on price negotiation for a time after medications are approved for new uses. Another option is adopting a transparent process for price determination, a process that also incorporates patients’ preferences.
Clinicians and advocates are right to worry that the Inflation Reduction Act would weaken patients’ access to existing drugs, limit the development of new drugs and reduce the incentive for manufacturers to apply for FDA approval of new uses for existing drugs.
Making health care more affordable is needed to ensure access to vital health care, but only through approaches that preserve heart patients’ access to innovative and necessary treatments.