U.S. must address IP and market access barriers abroad to protect American innovation
PhRMA recentlysubmitted comments to the Office of the U.S. Trade Representative (USTR) ’s 2023 Special 301 Report. The comments highlight foreign government actions and policies that undermine American innovation, biopharmaceutical leadership and more than 4.4 millionAmerican jobs.   (Source: The Catalyst)
Source: The Catalyst - January 31, 2023 Category: Pharmaceuticals Authors: Ernest Kawka Tags: Intellectual Property Coronavirus TRIPS Waiver Source Type: news

Minnesota lawmakers are letting PBMs off the hook, and threatening patients ’ access to medicines
Middlemen don ’t want patients to know how they are stacking the deck against them. (Source: The Catalyst)
Source: The Catalyst - January 31, 2023 Category: Pharmaceuticals Authors: Reid Porter Tags: Access Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Source Type: news

New Report: More than 160 medicines in development for mental illness
Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together. In severe cases, mental illnesses can cause serious functional impairment and substantially interfere with or place limits on life activities –– these are consideredserious mental ill...
Source: The Catalyst - January 26, 2023 Category: Pharmaceuticals Authors: Matthew Norawong Tags: Medicines in Development Mental Health Source Type: news

ICYMI: Cancer death rate continues to decline due to treatment advances
This report is the latest to document this progress. A growing body of evidence underscores the role of new medicines in recent accelerated declines in mortality across a range of cancers.One study found, between 2000 and 2016 alone, new cancer medicines were associated with nearly 1.3 million averted cancer deaths across the 15 most common tumor types. In particular, new cancer medicines were associated with nearly 130,000 prevented breast cancer deaths, nearly 400,000 prevented lung cancer deaths, and over 6500 melanoma deaths. While the ACS report highlights tremendous progress in the fight against cancer, it also ...
Source: The Catalyst - January 25, 2023 Category: Pharmaceuticals Authors: Matthew Norawong Tags: Medicines in Development Cancer Drug Cost Equity Source Type: news

Novel medicines approved in 2022 offer increased treatment options for patients
2022 marked another year of significant progress by biopharmaceutical research companies conducting lifesaving research and development for innovative medicines with a total of 45 new medicine approvals by the U.S. Food and Drug Administration (FDA). According toa new report released by the FDA ’s Center for Drug Evaluation and Research (CDER), 37 novel medicines were approved by CDER last year. The Center for Biologics Evaluation and Research (CBER) also approved8 new medicines in 2022 — including several gene therapies treating two rare blood disorders and a devastating neurodegenerative disease impacting young boys....
Source: The Catalyst - January 23, 2023 Category: Pharmaceuticals Tags: Research and Development Cancer Drug Cost PDUFA & D Focus Source Type: news

ICYMI: PhRMA kicks off the year at the 2023 J.P. Morgan Health Care Conference
This January, PhRMA joined health care leaders, investors, R&D experts and members of the media at the 2023 J.P. Morgan Health Care Conference in San Francisco, CA. During this week, we discussed ways to improve patient outcomes, access and affordability in our health care system. Here are some highlights from the conference: (Source: The Catalyst)
Source: The Catalyst - January 19, 2023 Category: Pharmaceuticals Authors: Katie Koziara Tags: Research and Development Drug Cost 340B Out-of-Pocket Costs Policy Solutions Source Type: news

Biden administration should prioritize innovation in U.S.-Taiwan Initiative on 21st-Century Trade
Last summer, the United States and Taiwanlaunched the U.S.-Taiwan Initiative on 21st-Century Trade to deepen economic and trade relations. In detailedcomments to the U.S. Trade Representative (USTR), PhRMA encouraged the Biden administration to pursue an agreement that is as comprehensive and ambitious as possible to the benefit of both American and Taiwanese citizens. To achieve USTR ’s stated objective to promote innovation in both the United States and Taiwan, any eventual agreement should include strong intellectual property (IP) protections, predictable and transparent market access commitments, and other provisions...
Source: The Catalyst - January 17, 2023 Category: Pharmaceuticals Authors: Douglas Petersen Tags: Intellectual Property Trade Source Type: news

WTAS: Inflation Reduction Act already impacting R & D decisions
The Inflation Reduction Act ’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical research& development (R&D) decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA ’s price setting provisions area loss for patients everywhere. (Source: The Catalyst)
Source: The Catalyst - January 17, 2023 Category: Pharmaceuticals Tags: Research and Development PhRMA Member Company Government Price Setting Source Type: news

Study finds hepatitis C cure saved Medicaid $15 billion
New research published in theAmerican Journal of Managed Care (AJMC) underscores the critical role that medicines play in improving health and reducing disease complications and other, often costly, medical care and services. The study finds that since curative direct-acting antiviral medications for hepatitis C were approved in 2013, even after factoring in the cost of treatment, Medicaid has saved an estimated $15 billion in avoided health care costs and nearly 285,000 Medicaid enrollees are estimated to have been cured. (Source: The Catalyst)
Source: The Catalyst - January 5, 2023 Category: Pharmaceuticals Authors: Lindsey Seidlitz Tags: Drug Cost Hepatitis C Medicaid Source Type: news

What you should know about real-world evidence and drug development
Recently, industry leaders, regulators, academics, data partners, and patient advocates gathered in Washington, D.C., to discuss using real-world data and real-world evidence for regulatory decision-making. The discussion explored emerging analytical methodologies to address the challenge of mitigating sources of bias and confounding variables that come up in nearly all sources of real-word data. (Source: The Catalyst)
Source: The Catalyst - December 19, 2022 Category: Pharmaceuticals Authors: Sarah K. Martin Tags: FDA Source Type: news

340B program continues to drive shift in care to more expensive hospital settings
Yet another study highlights the unintended consequences of the 340B program, which is increasing costs for patients and the health care system as a whole. In this case, the Berkeley Research Group (BRG) found that nearly36% of all Medicare Part B therapy sales occurred at 340B hospitals in 2021, up nearly 17 percentage points since 2012, meaning care is moving from physician offices and non-340B hospitals to 340B hospitals. Given that 340B hospitalsmark up the price of medicines significantly more than physician offices, this shift in site of care is driving up costs for the entire system.  (Source: The Catalyst)
Source: The Catalyst - December 15, 2022 Category: Pharmaceuticals Tags: 340B Hospitals Source Type: news

In their own words: Insured Americans support policy reforms that address access and affordability concerns
A survey of more than 5,000 Americans conducted with Ipsos found that insured Americans want better health care coverage. These insights come from the third installment of thePatient Experience Survey and show how Americans favor policy solutions that improve their ability to navigate and access their care by seeking to remove barriers imposed by insurers and middlemen such as pharmacy benefit managers (PBMs). (Source: The Catalyst)
Source: The Catalyst - December 14, 2022 Category: Pharmaceuticals Authors: Tom Wilbur Tags: Access Patients Polling Source Type: news

Using traditional HTAs to determine coverage threatens patient access to medicine
Concerns about the cost of health care have led to calls for the use of health technology assessments or HTAs by the federal government. This would allow government agencies to make important decisions about patient access to health care based on their determination of the value of new tests and treatments. Inthis series, we ’ll explore how this controversial practice: (Source: The Catalyst)
Source: The Catalyst - December 14, 2022 Category: Pharmaceuticals Authors: Katie Koziara Tags: Value Assessment Health Equity Source Type: news

Three things to know about the accelerated approval pathway
If you or a loved one were to receive a diagnosis of a serious or life-threatening disease, you would likely want access to a U.S. Food and Drug Administration (FDA) approved safe and effective medicine as soon as possible. That ’s precisely why the accelerated approval pathway was created back in 1992 at the urging of patient advocates. Since then, it has been a lifeline for millions of patients. Primarily utilized for cancers, rare diseases and HIV/AIDS, the pathway allows patients earlier access to potentially lifesavi ng medicines – often when no other treatment is available and when patients are facing difficult o...
Source: The Catalyst - December 12, 2022 Category: Pharmaceuticals Authors: Lucy Vereshchagina Tags: FDA Prescription Drug Safety Source Type: news

ICYMI: PhRMA COO Lori Reilly speaks about the health care agenda for the next Congress
With a divided Congress, bipartisan action will be necessary to move the needle on health care policy. On December 7, 2022, PhRMA sponsored the Axios event, “The Post-Midterm Health Care Agenda, ” where I participated in a View from the Top segment with Nicholas Johnston, publisher of Axios. We discussed PhRMA’s focus on passing the PASTEUR Act in the last few weeks of 2022, and laid out PhRMA’s priorities heading into 2023 that will support and protect patients. (Source: The Catalyst)
Source: The Catalyst - December 9, 2022 Category: Pharmaceuticals Authors: Lori Reilly Tags: Health Insurance Pharmacy Benefit Managers Policy Solutions Antimicrobial Resistance Government Price Setting Source Type: news