CER Daily Newsfeed

National Pharmaceutical Council Research Identifies Unintended Consequences of the IRA on Post-Approval Clinical Trials

(4/28, Katie McCool, The Evidence Base) reports “...[T]he study authors propose several policy recommendations to safeguard innovation and patient access. These include aligning small-molecule drug eligibility timelines for Medicare drug price negotiations with those of large-molecule therapies, delaying negotiation eligibility for new indications, excluding orphan drugs treating rare diseases from early negotiation, and establishing a transparent framework for determining a medicine's Maximum Fair Price (MFP). ‘The evidence tells us that manufacturers are likely already adjusting their investment strategies in response to the reduced incentives for post-approval research and development,’ stressed author Jon D Campbell, PhD. ‘It is crucial that future research continues to evaluate the long-term effects of the IRA, particularly on drug subgroups that may be disproportionately affected.’” Full

Video: Managed Care Has Experienced Numerous Changes Since the First Publication of AJMC®: John M. O'Brien, PharmD, MPH

(4/25, Julia Bonavitacola, Christina Mattina, John Michael O'Brien, PharmD, MPH, The American Journal of Managed Care) “...[John Michael O'Brien, PharmD, MPH:] When you think about the drug side, patients are more likely to use a pharmacy more often than they are to see a physician or be admitted to a hospital, and that's a good thing, but the pharmacy counter is oftentimes where patients experience delays, denials, or higher out-of-pocket costs, and that's not good for patients. This is something we spend a lot of time thinking about here at NPC. We envision a world where advances in medicine are accessible to patients, valued by society, and sustainably reimbursed by payers to ensure continued innovation. Payers are and always should be concerned about the cost of care, but making sure we have an informed conversation about the bang for the buck that medicines deliver and how they help people get well, stay healthy, and avoid more costly care settings is really important to the future of managed care.” View Video

Video: Employers Play a Big Part in Future Changes to Managed Care: John M. O'Brien, PharmD, MPH

(4/28, Julia Bonavitacola, Christina Mattina, John Michael O'Brien, PharmD, MPH, The American Journal of Managed Care) “...[John Michael O'Brien, PharmD, MPH:] There's a real backlash right now against the restrictions that payers place between a patient, their provider, and the appropriate and needed treatment that's best for them. For example, look at the co-pay accumulators and maximizers or alternative funding programs; our recent work highlighted the negative impact of these programs and other cost-shifting programs on patients. When you look the new restrictions that we're seeing from payers on nononcology medicines via the accelerated approval pathway, that prevents patients with rare diseases or conditions that have no available treatments from accessing something that they've been waiting a long time for. Again, this isn't good for patients, so this is why I'm hopeful about the focus that I see in President [Donald] Trump's executive order, when they talk about the value chain.” View Video

Explore the Future of Technologies and Innovations in Health Care

(4/25, PCORI Blog) comments “...PCORI’s Health Care Horizon Scanning System is a forward-looking digital tool that helps the healthcare community stay alert to potential changes early. This system identifies and tracks promising technologies and innovations with the potential to disrupt U.S. health care within the next three years, helping stakeholders navigate a shifting landscape with greater clarity and confidence.” Full

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

(4/28, Eliza Slawther, Pink Sheet) reports “...The EU Health Technology Assessment (HTA) Regulation will require companies to ‘get smart on their own clinical trial development,’ according to Mark Mayhew, head of portfolio and strategy at the international life sciences consultancy Treehill Partners.” Subscription Required