How Government Price-Setting Hurts Patients
Enacted in 2022, the Inflation Reduction Act (IRA) jeopardizes drug development and patient access to critical treatments, notably through its Medicare “price negotiation” provision, which is effectively government price-setting. Europe’s experience with similar policies led to a collapse in drug development and worse health outcomes including significantly higher cancer mortality rates. Consequently, numerous patient advocacy groups are opposing the implementation of government price-setting in the U.S.
400,000 more deaths each year
If U.S. cancer patients had European cancer death rates
60% of new drugs
90% of new medicines
The Inflation Reduction Act’s First Potential Impact on Biosimilars
On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services (“CMS”) as one of the first 10 drugs subject to the Inflation Reduction Act’s (“IRA’s”) price negotiations. Because of price caps that the IRA will impose on Stelara, Wezlana will face a different competitive landscape than the six interchangeables for other drugs approved to date. Wezlana’s example calls into question whether the IRA will disincentivize the development of biosimilars for the most popular biologics at a time when more biosimilars are critical to reducing healthcare costs.
In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars
Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes
Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B. This shortsighted move won”t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM.
Medicare Drug Price Negotiation Program Guidance
The Inflation Reduction Act – Implications for Biopharma Companies and Patients
“ASBM fears that the downstream effects of broad government price setting will ultimately reduce consumers’ choice of plans and formularies in Part D—aspects considered to be hallmarks of the program.”
In the NEws
In the drug space, sources ranging from the Congressional Budget Office and analytics firms to university economists, and health-industry analysts warn that IRA price setting will also deter crucial investments in research and development, resulting in fewer new medicines.
International BUsiness Times | Joel White – View onLINE
The Biden administration just announced a new initiative to improve cancer outcomes in low-income communities across the United States. It’s sorely needed. Research shows cancer mortality is more than 10 percent higher in communities experiencing persistent poverty compared to those that aren’t.
Hartford Courant | Kenneth E. Thorpe – View on Press Reader
Drug-pricing rules in Inflation Reduction Act will stymie efforts to develop new treatments.
Reading Eagle | Andrew Spiegel
If an assailant points a gun at your head and threatens to shoot if you don’t hand over your wallet, is that a negotiation? This describes the Inflation Reduction Act’s Medicare drug-price scheme, which Merck & Co. claims is “extortion” and unconstitutional in a compelling lawsuit filed Tuesday. Merck v. Becerra may be destined for the Supreme Court.
WSJ | Editorial Board
The number of backordered medicines in Sweden increased by over 50 per cent in 2022. Drug shortages, which are major problems across the EU, have led to a lively debate on how the region can ensure a stable flow of essential medicines. Right now, all EU countries’ medicines agencies are meeting in Malmö to discuss how to resolve the situation.
BioStock | Staff
The purported goal of the Inflation Reduction Act (IRA) of 2022 is to lower healthcare costs for Americans.
USC Schaeffer | Dana Goldman, PhD, Joseph Grogan, JD,Darius Lakdawalla, PhD,Barry Liden, JD,Jason Shafrin, PhD,Kyi-Sin Than, MPHandErin Trish, PhD
Democrats have nudged the U.S. healthcare system closer to Canadian-style socialism with their recently signed, and dubiously named, Inflation Reduction Act.
Forbes | Sally Pipes
Learn more about IRA price controls and spread the word with these print and digital materials.
Eli Lilly & Co. CEO David Ricks highlighted how Medicare drug price negotiation policies are already impacting R&D investment during a J.P. Morgan investor call.
Features an interview with Dr. Barbara L. McAneny, MD, FASCO, MACP Former President for the American Medical Association and the New Mexico Medical Society (NMMS); and currently CEO, New Mexico Cancer Center.
With Dr. Steve Potts CEO, Anticipate Bioscience
May 26, 2023