OBJECTIVES:

On August 16, 2022, Congress passed the Inflation Reduction Act (IRA), which could impact drug pricing and payment in the United States. There are three key provisions in the IRA, with a focus on inflation rebates, Part D reform and drug price negotiations. For the first time, the US federal government will place direct price controls on some drugs covered by Medicare, selecting and “negotiating” a set number of high-spend, mature drugs that span Part D and Part B starting in 2026. The aim of this study is to understand how payers will navigate the new and evolving landscape as a result of the implementation of the IRA; determine payer expectations for manufacturers; and understand how approaches payers may vary between oncology and non-oncology drugs.

METHODS: Qualitative research with key opinion leaders (KOLs) and subject matter experts was performed to understand a mix of varied stakeholder perspectives, including payer expertise, policy and oncology experience, payer innovation expertise and focus on business and financial management at organized customers and pharmacies.

RESULTS: Our research evaluated potential impacts of impacts of the IRA on key stakeholders in the healthcare sector, including manufacturers, payers, providers, and patients. Additionally, our research identified key scenarios and developed model structure outlining current flow of funds and stakeholder cost dynamics, mechanism for depicting potential changes, and able to evaluate a variety of scenarios regarding IRA-driven pricing, cost, and reimbursement changes.

CONCLUSIONS: As the IRA rolls out, there is no doubt it will lead to fundamental changes in the pharmaceutical industry. Although there is uncertainty around how the IRA will be implemented, manufacturers should be prepared for potential scenarios to ensure the oncolytic products in their portfolio remain available and affordable to patients who need it most.