How Potential Unintended Impacts of the IRA May Affect Patients: Dr Julie Patterson

Julie Patterson, PharmD, PhD, senior director of research at the National Pharmaceutical Council, spoke to the ways in which possible unintended effects of the Inflation Reduction Act of 2022 (IRA) could impact patients.

Patterson and colleagues authored a study published in the February issue of The American Journal of Managed Care^® (AJMC^®), "Unintended Consequences of the Inflation Reduction Act: Clinical Development Toward Subsequent Indications," which details how the IRA could have unintended consequences on small molecule drug research and development.

In another video, Patterson discussed the study's findings and what they could mean for pharmaceutical innovation.

Transcript

How might the unintended consequences of the IRA impact the pharmaceutical industry and patients?

I'm so glad you asked about the potential unintended consequences of the IRA on patients. In the case of the first unintended consequence, we discussed seeing a delay in new launches. That would mean patients may have to wait longer to get access to new medicines.

In the case of the second unintended consequence we discussed, which is in the reduction of incentives to conduct clinical research needed to pursue subsequent indications, patients may see fewer diseases getting new treatment options approved. These approvals not only provide high-quality evidence on the drug's safety and effectiveness in new populations, but they're also often needed for insurers to cover drugs without access barriers for patients.

Other research showed that another potential unintended consequence of the IRA is related to patient access to the selected drugs after prices set by the government go into effect. Given the role of drug rebates and plan coverage decisions, insurers may be incentivized to restrict access for the selected drugs if nonselected drugs in the same class retain flexibility for higher rebates.

Right now, seniors have excellent access and experience few utilization management barriers—things like step therapy and prior authorization—to most of the first 10 drugs selected, but that may change. Increased utilization management requirements, which are likely in response to the IRA, could reduce patient access—exactly the opposite of what the program intends to do. That's why ensuring the patient perspective is incorporated into both the implementation process as well as the ongoing evaluation of the law's unintended consequences is so critical.