January 17, 2025 (WASHINGTON, D.C.) Today, the Partnership to Fight Chronic Disease (PFCD) released the following statement in response to the Biden Administration’s announcement of 15 new drugs selected for Medicare price negotiations under the Inflation Reduction Act:
"Tens of millions of Americans living with chronic diseases like diabetes, cancer, and high blood pressure rely on prescription drugs to manage their conditions and avert costly and life-threatening health emergencies. Improving access to medications to treat these conditions is critical, but government pricing has the opposite effect. We encourage the incoming Administration and new Congress to revisit the flawed program and pursue reforms that preserve access and promote innovation for people living with chronic disease.
“Each of the drugs CMS selected for pricing are small molecule medicines that are not only essential to the treatment of many chronic diseases but also are favored by seniors for their ease of use and accessibility. IRA provisions disadvantage these medicines in favor of medicines that require administration by a healthcare provider, which greatly hinders access in rural and other underserved areas. Patient advocates have repeatedly called for reforms like the bipartisan EPIC Act to preserve access to small molecule medicines. CMS’s latest list makes the EPIC Act and other reforms even more urgent.
“CMS also continues to stretch its overly broad definition of “qualifying single source drug” to treat distinct products with different medical uses and subject to individual FDA approvals as a single selected drug. This action ignores clinical realities, the research and development efforts involved, and severely undermines the development of new products that address unmet medical needs.
“Despite concerns raised by patients and providers, CMS has refused to require protections for patient access including increased prior authorization requirements that risk patient health and burden providers. Along with significant premium increases and loss of Part D plan options, these flaws provide ample justification for the incoming Administration to delay implementation and allow time to revisit and reform the program.
"Moreover, government price setting policies are not addressing the true cost drivers in our health care system. Just this week, the Federal Trade Commission found that PBMs pocketed more than 7 billion dollars by inflating drug prices from 2017-2022 alone. Ignoring the role that insurers and pharmacy benefit managers play in increasing costs at the pharmacy counter isn’t going to deliver any savings to the people who need it.
"Currently, more than half of Medicare beneficiaries are managing three or more chronic conditions, and as Medicare enrollment continues to rise, so do the associated costs. Rather than attempting to curb these expenses with price controls, policymakers must work to better address the rise in chronic disease by elevating prevention and eliminating increasing barriers to care and treatment.
"There is great urgency to reform IRA policies that ignore the real needs of Medicare beneficiaries. Unresolved concerns over the significant harm to patient access and clear evidence of R&D funding shifting away from small molecule medicines highlight the immediate need to revisit and reform the IRA’s drug pricing program before allowing it to continue. PFCD stands ready to advance policies that realistically account for the true burden of chronic disease in our country and genuinely support effective chronic disease management aimed at better overall health outcomes in the U.S."