The dangers of expanding the TRIPS waiver
World Trade Organization (WTO) members, including the United States, are considering waiving commitments to honor certain intellectual property (IP) rights on COVID-19 treatments, following aharmful and unnecessary decision to do the same for COVID-19 vaccines. This is referred to as the TRIPS waiver. (Source: The Catalyst)
Source: The Catalyst - September 19, 2022 Category: Pharmaceuticals Authors: Megan Van Etten Tags: Patents Trade IP Explained Coronavirus TRIPS Waiver Source Type: news
New data: The 340B program is driving up costs for patients and our health care system
Guess what? The 340B program grew, yet again, hitting a whopping$43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growthin care provided to vulnerable patients at340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole. The program of today is having the opposite effect of what Congress intended when they created 340B. That ’s a problem. (Source: The Catalyst)
Source: The Catalyst - September 15, 2022 Category: Pharmaceuticals Tags: 340B Source Type: news
Timely reauthorization of PDUFA and BsUFA is vital to the FDA ’s review of medicines
As we ’ve discussed on this blog before, timely reauthorization of thePrescription Drug User Fee Act (PDUFA) and theBiosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration ’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline. (Source: The Catalyst)
Source: The Catalyst - September 12, 2022 Category: Pharmaceuticals Tags: PDUFA Biologics and Biosimilars Source Type: news
Navigating the patient experience: Burdens and barriers standing between patients and their care
Health care affordability is not the only hurdle facing patients, according to PhRMA ’s third Patient Experience Survey (PES). Thelatest PES report exposes another crucial problem: the frustration and confusion people have around how to use their coverage. Administrative hurdles and other barriers imposed by health insurers and pharmacy benefit managers (PBMs), such as time-consuming paperwork or prior authorization, are a challenge for many insured Americans, including more vulnerable communities. (Source: The Catalyst)
Source: The Catalyst - September 12, 2022 Category: Pharmaceuticals Authors: Mark Keida Tags: Patients Health Insurance Burden on Patients Out-of-Pocket Costs Pharmacy Benefit Managers Polling Source Type: news
Rejecting ICER ’s bad advice
America leads the world in biomedical innovation today because our system rewards investment in research and discovery of new treatments. Now, with the passage of theInflation Reduction Act, Dr. Steven Pearson, president of the Institute for Clinical and Economic Review (ICER), coolly admits we will see fewer new cures and treatments and suggests that trade-off is one we need to make. (Source: The Catalyst)
Source: The Catalyst - September 9, 2022 Category: Pharmaceuticals Authors: Priscilla VanderVeer Tags: Government Price Setting Source Type: news
CMS coverage policies restrict patient access to important treatment options for Alzheimer ’s disease
There ’s been a lot of discussion this year about the Centers for Medicare& Medicaid Services (CMS)national coverage determination (NCD) for new Alzheimer ’s treatments finalized earlier this year in April. Their policy, finalized this past April, puts in place barriers between Alzheimer ’s patients in Medicare and potentially life-changing treatment. But, unfortunately, this new NCD isn’t the only coverage barrier these patients face. (Source: The Catalyst)
Source: The Catalyst - September 1, 2022 Category: Pharmaceuticals Authors: Gabby Migliara Tags: Alzheimer's Medicare Source Type: news
What is a 340B covered entity?
We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make appropriate decisions about their own health but also help enable constructive conversations on how we can support a regulatory and policy environment that helps patients access life-saving medications. In this ongoing series, we are choosing to spotlight terms fundamental to the biopharmaceutical ecosystem and illustrate their significance in promoting innovation and timely patient access to medicines. This week, we are taking a look...
Source: The Catalyst - August 29, 2022 Category: Pharmaceuticals Tags: 340B Source Type: news
Making coupons count for patients at the pharmacy counter
Too many patients face high out-of-pocket costs for brand medicines, even when they have insurance. (Source: The Catalyst)
Source: The Catalyst - August 25, 2022 Category: Pharmaceuticals Authors: Katie Koziara Tags: Drug Cost Health Insurance Out-of-Pocket Costs Source Type: news
Frazier PhRMA Scholarship awarded to four college-bound students in Philadelphia and DC
TheKenneth C. Frazier PhRMA Scholars Program is going strong in 2022 —and we are expanding our horizons to a new city. This summer, we are thrilled to announce four new recipients: Arianna Camacho-Mendez and Axel Orellana from Washington, D.C.; and Michelle Tanujaya and Jackie Zhao, our first students from Philadelphia. Congratulations to these amazing scholars! (Source: The Catalyst)
Source: The Catalyst - August 22, 2022 Category: Pharmaceuticals Authors: Rachel Weissman Tags: Equity Source Type: news
ICYMI: New research builds upon growing body of evidence on value of COVID-19 treatments and vaccines
Innovative biopharmaceutical research companies have been dedicated to fighting COVID-19 for over two years. Since the start of the pandemic, America ’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made unprecedented progress in a short time thanks to decades of experience having produced over 14 billion vaccines globally to date. What’s more,lessons learned during the pandemic are already informing the future of fighting disease. (Source: The Catalyst)
Source: The Catalyst - August 16, 2022 Category: Pharmaceuticals Tags: Research and Development Economic Impact Intellectual Property Coronavirus Source Type: news
Insulin and reconciliation
With Congress sending to the president a partisan reconciliation spending bill, the cost of insulin is receiving greater attention. Numerous proposals have been introduced in recent months aimed at capping what patients pay out of pocket for insulin. Despite what theWhite House ’s talking points falsely suggest, PhRMA hasn ’t taken a position on these bills. The same can’t be said, however, of pharmacy benefit managers – middlemen who work for insurers. Their association has been running ads urging lawmakers to reject lower insulin costs for patients: (Source: The Catalyst)
Source: The Catalyst - August 15, 2022 Category: Pharmaceuticals Authors: Brian Newell Tags: Diabetes Health Insurance Pharmacy Benefit Managers Source Type: news
New survey: Voters seriously concerned about fine print in reconciliation bill
With a final vote in Congress expected on a reconciliation spending bill, a new Morning Consult survey explores what this legislation actually does – and does not do – and finds that voters are skeptical of its impact on inflation, worried about the consequences of Medicare “negotiation” and concerned the bill doesn’t do enough to help make medicines affordable for patients. (Source: The Catalyst)
Source: The Catalyst - August 12, 2022 Category: Pharmaceuticals Authors: Mark Keida Tags: Policy Solutions Polling Government Price Setting Source Type: news
This week ’s reading list: All the reasons the Senate-passed drug pricing bill is bad policy
Last weekend, the Senate passed theInflation Reduction Act which includes dangerous price-setting provisions. The bill now heads to the House for consideration, where it is not too late for them to stand up for patients and medical innovation by opposing the bill. (Source: The Catalyst)
Source: The Catalyst - August 10, 2022 Category: Pharmaceuticals Tags: Research and Development Patients Government Price Setting Source Type: news
Value assessment should include all aspects of value that matter to patients
We need to move toward a more value-driven health care system that centers around patients ’ needs. Sound evidence can help guide us toward that, and we’re committed to developing tools to help patients, physicians and others make informed decisions. (Source: The Catalyst)
Source: The Catalyst - August 10, 2022 Category: Pharmaceuticals Authors: Emilie Signora Tags: Value Assessment Source Type: news
Making coupons count for patients with HIV
Despite having insurance, too many patients with HIV face high out-of-pocket costs for brand medicines. This is largely driven by insurer-imposed barriers that shift the cost of life-saving care onto patients. (Source: The Catalyst)
Source: The Catalyst - August 8, 2022 Category: Pharmaceuticals Authors: Emilie Signora Tags: Health Insurance HIV/AIDS Patient Assistance Programs Out-of-Pocket Costs Source Type: news
