Maximilian Vargas, PhD, MBA: The Impact of the Inflation Reduction Act on Biosimilar Uptake

In an interview with HCPLive, Maximilian Vargas, PhD, MBA, vice president of the United States (US) Access Strategy and Account Management within Certara’s Evidence and Access Group, discussed the Inflation Reduction Act (IRA) and what the means for creating a more positive market and treatment environment for biosimilars.

Maximilian Vargas, PhD, MBA

Credit: Certara.com

Why do you believe that the adoption of biosimilars in the US has been somewhat underwhelming, especially when compared with other European countries?

The adoption of biosimilars in the US has been underwhelming compared to other European countries due to complex pricing incentives. While biosimilars may have similar list prices to originator products, net prices may not be significantly lower due to rebates and access issues. Plans may continue to cover the originator product, making it more difficult for patients to access biosimilars. Additionally, physicians have a financial incentive to administer originator products rather than biosimilars, as they may receive a higher margin on acquisition costs. Although the IRA has changed some of these incentives, there are still barriers to biosimilar adoption in the US.
Can you give me a bit of background on the IRA?

The intent of the legislation is to lower out-of-pocket costs for patients by bringing down list prices of drugs. Medicare now has the ability to negotiate prices, which should reduce cost-sharing for patients. The legislation also contains a provision that lowers the out-of-pocket spend for Medicare beneficiaries, resulting in less annual spending to access additional benefits. However, biosimilars have been launching at or close to the list prices of their originator products, which does not benefit patients. The IRA contains a provision that boosts reimbursement to physicians to encourage adoption of biosimilars and allows biosimilars to have lower list prices, benefiting patients' out-of-pocket costs. These are the primary objectives of the legislation, although there are other provisions as well.

How will this act help to create a more positive market and treatment environment for biosimilars?

The changes brought about by the IRA will have a significant impact on patients and clinicians, particularly in terms of access and cost savings. Patients will benefit from lower out-of-pocket costs due to the lower list prices of biosimilars, as well as the increased adoption of these products resulting from the change in reimbursement structure for physicians. Clinicians will also benefit from the increased reimbursement for biosimilars, which will hopefully remove the disincentives against using these products over branded originators. It is important for both patients and clinicians to be aware of these changes and to work together to ensure that patients have access to the most cost-effective and clinically appropriate treatments. Overall, the clinical significance of these changes is that they have the potential to improve patient outcomes and reduce healthcare costs, which is a win for both patients and the healthcare system as a whole.

What do patients and clinicians need to know about these changes? What is the clinical significance?

So essentially, these changes remove any disincentives for physicians to use biosimilars and actually provide an economic incentive to use them instead of originator biologics. This should help to confirm the fact that biosimilars are largely clinically interchangeable with originators, and may help to change any perceptions that biosimilars are somehow different from originators. From a patient perspective, the lower list prices of biosimilars compared to originator biologics should result in lower out-of-pocket costs for patients who receive biosimilars recommended by their physicians. Overall, these changes are aimed at increasing the use of biosimilars to help lower costs for patients while maintaining the same level of quality and efficacy as originator biologics.

This transcript was edited for clarity.