As an organization led by patients, we understand the need to address elevated drug prices, including a focus on affordability and access to those who rely on complex treatments to treat complex diseases. We also realize access to our medications are most challenging for those on Medicare and, as such, we support efforts that will address the need for these patients to obtain their treatments at a reasonable price. While we applaud the Biden Administration for recognizing there is an issue, we are concerned to learn their approach to address this includes expanding price setting initiatives by the Centers for Medicare and Medicaid Services (CMS), when initial Inflation Reduction Act (IRA) price negotiations of the first 10 drugs have demonstrated some process flaws and have yet to yield data demonstrating cost savings to patients. (REF 1) Furthermore, we are uncertain at this time how the process will impact prescribers and providers, in addition to its impact on patient access to new and existing medications.

Yet in his State of the Union address, the Administration mentioned plans to expand efforts to 500 drugs over the next decade  (average 50 a year), doubling down on a process we are not certain will work in the first place. CMS is open and willing to work with patient organizations and other stakeholders to identify and fix already identified limitations and potential unintended consequences of the negotiations, so the Administration should not be prematurely focusing on expansion. Instead, until we figure out the impact of the negotiations, the Administration should focus their efforts on addressing other health care actors, including pharmacy benefit managers (PBMs), that drive up the cost of medicines by pocketing profits and failing to pass the savings on to patients. One thing that is known already - drug price reform will happen if legislation addressing PBM transparency and reform is the priority.

REF 1: AiArthritis Comments CMS IRA Negotiation Process