FDA should remain the authority on the safety and effectiveness of medicines
Recent district court rulings set an alarming precedent that calls into question the authority of the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of new medicines. (Source: The Catalyst)
Source: The Catalyst - April 12, 2023 Category: Pharmaceuticals Authors: Jim C. Stansel Tags: FDA Source Type: news
ICYMI: PhRMA President and CEO Stephen J. Ubl discusses patient affordability
PhRMA president and CEO Stephen J. Ubl spoke recently atThe Hill ’s event, “Pathways to Patient Affordability. ” He spotlighted patients’ affordability challenges, the unintended consequences we’re already seeing from the government price setting provisions in the Inflation Reduction Act (IRA) and how policymakers can address harmful pharmacy benefit manager (PBM) practices. (Source: The Catalyst)
Source: The Catalyst - April 7, 2023 Category: Pharmaceuticals Authors: Emilie Signora Tags: Research and Development Health Insurance Pharmacy Benefit Managers Government Price Setting Source Type: news
MedPAC proposal threatens access to medicines in Part B
Next week, the Medicare Payment Advisory Commission (MedPAC) will vote on a number of policy proposals for changing Medicare Part B. One of the proposals would recommend that Congress adjust the payment for Part B medicines withaccelerated approval, including medicines for serious and life-threatening diseases like cancers, rare diseases and HIV. This could compromise patient access to medicines, which is the opposite of what accelerated approval is designed to do. Here are three reasons why MedPAC should vote no on this proposal. (Source: The Catalyst)
Source: The Catalyst - April 6, 2023 Category: Pharmaceuticals Tags: Medicare Part B Accelerated Approval Source Type: news
States can support access to medicine as COVID-19 Public Health Emergency ends
The United States will soon reach an important milestone in the COVID-19 pandemic: the official end of the federal public health emergency (PHE). According to the U.S. Department of Health and Human Services (HHS), the COVID-19 PHEwill expire on May 11, 2023. This significant transition has been made possible, in part, by the biopharmaceutical industry ’s continuing efforts to research, develop and manufacture safe, effective treatments and vaccines for COVID-19. The industry leveraged decades of research and investments into developing medical solutions to prevent and treat COVID-19 and remains committed to supporting i...
Source: The Catalyst - April 5, 2023 Category: Pharmaceuticals Authors: Scott LaGanga Tags: Access Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Policy Solutions Source Type: news
CMS coverage policy is detrimental to Alzheimer ’s patients
This week marks a somber anniversary for patients with Alzheimer ’s. Last year, the Centers for Medicare& Medicaid Services (CMS) finalized a national coverage determination (NCD) that, for the first time ever, uses a coverage with evidence development (CED) policy that forces Medicare patients into highly restrictive research studies to simply gain access to new Alzheimer ’s medicines that have been approved by the U.S. Food and Drug Administration (FDA). PhRMA has consistently raised the alarm about the discriminatory nature of this policy,urging CMS to withdraw its proposal in February of last year. Unfortunatel...
Source: The Catalyst - April 4, 2023 Category: Pharmaceuticals Authors: Gabby Migliara Tags: Alzheimer's Medicare Part B Source Type: news
Arkansas puts patients first with new share the savings law
Recently, Arkansas became the latest state to enact a law so that many patients aren ’t paying more for their medicines than their insurance company or pharmacy benefit manager (PBM). The policy, commonly referred to as “share the savings,” requires insurers and the PBMs they work with to share the rebates, discounts, and other price concessions they receive from manufacturers directly with patients at the pharmacy counter. The policy stands to helphundreds of thousands of Arkansans save at the pharmacy counter. (Source: The Catalyst)
Source: The Catalyst - April 4, 2023 Category: Pharmaceuticals Authors: Hannah Loiacono Tags: Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Policy Solutions Source Type: news
PhRMA provides comments and testimony to USITC investigation on COVID-19 medicines and the TRIPS Agreement
At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting aninvestigation and will issue an accompanying report concerning theTRIPS Agreement and a variety of issues related to COVID-19 diagnostics and therapeutics. According to USTR, the USITC report will inform future discussions within the United States and at the World Trade Organization (WTO) concerningpotential TRIPS waiver expansion. (Source: The Catalyst)
Source: The Catalyst - March 30, 2023 Category: Pharmaceuticals Authors: Kevin Haninger Tags: Intellectual Property Vaccines Coronavirus TRIPS Waiver Source Type: news
How Part B ’s ASP system helps control costs for the government and seniors
Between Congress, the Medicare Payment Advisory Commission (MedPAC) and the Center for Medicare& Medicaid Innovation (CMMI), there have been a number of policy proposals of late that would change reimbursement for medicines covered by Medicare Part B, some of which may harm patient access to important treatments. As we debate these proposals, it ’s important to levelset on how reimbursement works in the program today. Part B uses a unique payment mechanism known as average sales price (ASP) to calculate the price of most of the wide range of medicines it covers. Why is it so unique? ASP takes into account commercial ...
Source: The Catalyst - March 30, 2023 Category: Pharmaceuticals Tags: Medicare Part B Source Type: news
Key Trends: Patient experience data reveal how insurers and middlemen impose barriers in health care
ThePatient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatment s that they need. (Source: The Catalyst)
Source: The Catalyst - March 29, 2023 Category: Pharmaceuticals Authors: Cynthia Hicks Tags: Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Polling Source Type: news
Medicare Part B spending in four points
It ’s that time of year again when the president releases his budget and questions arise about the solvency of the Medicare trust fund and Medicare spending more generally. Too often, critics point to spending on Medicare Part B medicines as a key driver of Medicare spending, but the data tells a dif ferent story. For example, next month the Medicare Payment Advisory Comission plans to vote on policy proposals that ignore the facts around Medicare Part B, and could harm patient access to both currently marketed and future medicines. (Source: The Catalyst)
Source: The Catalyst - March 28, 2023 Category: Pharmaceuticals Tags: Medicare Part B Source Type: news
New Report: More than 400 medicines in development for leading chronic conditions affecting older Americans
Chronic diseases like Alzheimer ’s disease, diabetes and kidney disease disproportionately affect older adults. In the United States, nearly 95% of older adults haveat least one chronic condition and almost 80% have two or more. Chronic diseases can often limit an older adult ’s ability to work, perform daily activities, cause them to lose their independence and lead to the need for long-term care. Furthermore, the economic burden imposed by chronic conditions is substantial, but this burden is concentrated among older Americans covered under Medicare. In fact, the com bined costs of managing chronic diseases account f...
Source: The Catalyst - March 28, 2023 Category: Pharmaceuticals Authors: Lucy Vereshchagina Tags: Medicines in Development Research and Development Chronic Disease Government Price Setting Source Type: news
Celebrating the success of the COVID-19 vaccines, and looking to the future
It ’s been over three years since I saw my first COVID-19 patient in the emergency department. The image of that x-ray is burned into my memory: clusters of white spots spread out across both sides of the patient’s lung. A dramatic, and not all that common, clinical finding. The patient in front of me already had a fever and was breathing quickly, in need of extra oxygen support. I didn't know then the significance that patient would have on me, but three years later I think about them often, and how they marked the start of a three plus year journey that changed the world. (Source: The Catalyst)
Source: The Catalyst - March 27, 2023 Category: Pharmaceuticals Authors: Michael Ybarra Tags: Research and Development Vaccines Coronavirus Government Price Setting Source Type: news
IRA Impacts: Cancer treatment research and development
Last month marked the one-year anniversary of the reignited Cancer Moonshot, the White House ’s ambitious goal of reducing the death rate from cancer by at least 50% over the next 25 years. Much of thepositive trends in declining cancer mortality, down 33% since peaking in 1991, is driven in large part by innovative medicines researched and developed by America ’s biopharmaceutical companies. But more needs to be done. Eradicating the hundreds of different diseases that make up cancer is a commitment we share with the administration, and the science has never been more promising. (Source: The Catalyst)
Source: The Catalyst - March 23, 2023 Category: Pharmaceuticals Tags: Research and Development Cancer Government Price Setting Source Type: news
Food Allergy Highlights Opportunities for Inclusive, Representative Research Studies
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today ’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. (Source: The Catalyst)
Source: The Catalyst - March 22, 2023 Category: Pharmaceuticals Authors: Anita Roach M.S. Source Type: news
PhRMA submits comments to OSTP on enhancing clinical trial diversity
The White House ’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments. PhRMA shares OSTP’s recognition of the importance of having a clinical trial infrastructure that su pports sites that are ready to respond to emergency situations like COVID-19. We also agree that one goal of such an infrastructure should be to support the expansion of clinical research into underserved communities by increasing diversity among both trial participants and clinical trial investigat ors. (Source: The Catalyst)
Source: The Catalyst - March 21, 2023 Category: Pharmaceuticals Authors: Maria Apostolaros Tags: Research and Development Clinical Trials Coronavirus Source Type: news
