Four things for CMS to keep in mind as they implement changes to Part D
The Inflation Reduction Act (IRA) makes significant changes to Part D ’s benefit structure and coverage, which will require careful policy development and thoughtful implementation. On Monday, PhRMA submittedcomments on the Calendar Year 2025 Part D Redesign changes, outlining key considerations for the Centers for Medicare and Medicaid Services (CMS) to help mitigate against potential disruptions to seniors ’ access to medicines through Part D. (Source: The Catalyst)
Source: The Catalyst - June 7, 2023 Category: Pharmaceuticals Tags: Part D Medicare Government Price Setting Source Type: news

ICYMI: PBM exec admits choosing profits over patients
With Congress discussing policy changes that would lower drug costs for patients and rein in powerful middlemen, insurers and their PBMs are dusting off their old playbook and once again threatening to increase costs for employers if required to do their job and actually provide meaningful coverage to patients. But recent remarks by one executive make clear that the PBM industry has a choice: protect its profits or lower costs for patients. It seems the PBM industry prefers profits over patients. According toa new report by STAT News: (Source: The Catalyst)
Source: The Catalyst - June 2, 2023 Category: Pharmaceuticals Authors: Brian Newell Tags: Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Source Type: news

Addressing Mental Health: A conversation with Barry Greene, CEO of Sage Therapeutics
As we recognize Mental Health Awareness Month, I had the opportunity to connect with PhRMA board member Barry Greene, CEO of Sage Therapeutics, about the company ’s efforts to address mental health.  (Source: The Catalyst)
Source: The Catalyst - May 30, 2023 Category: Pharmaceuticals Tags: PhRMA Member Company Mental Health Government Price Setting Source Type: news

New calculator demonstrates how improved adherence to anti-diabetic medicines can benefit people in Medicaid
Diabetes is a scary diagnosis for anyone. When people with the disease struggle to manage their blood sugar levels, they can experience significant, life-threatening and costly complications such as heart attack, stroke, kidney failure, amputation and blindness. Fortunately, diabetescan be well-managed with comprehensive access to health care services, including medicines. (Source: The Catalyst)
Source: The Catalyst - May 25, 2023 Category: Pharmaceuticals Authors: Reid Porter Tags: Diabetes Adherence Medicaid Source Type: news

Biopharmaceutical manufacturing companies continue to expand their economic footprint across the United States
Before 2020, the importance of robust and resilient supply chains and how they can affect access to life-saving treatments probably wasn ’t top of mind for many outside the biopharmaceutical industry. Then, in a sudden and very real way, theCOVID-19 pandemic showed just how critical it is to have manufacturing facilities capable of scaling up quickly to meet an urgent public health demand. America ’s biopharmaceutical companies rose to the challenge, researching and developing vaccines and therapeutics in record time, ramping up manufacturing to meet global demand and avoiding sustained supply chain disruptions. (Source: The Catalyst)
Source: The Catalyst - May 24, 2023 Category: Pharmaceuticals Authors: Tim McClung Tags: Manufacturing Source Type: news

Setting the record straight on accelerated approval
As we ’ve discussed on thisblogbefore, the U.S. Food and Drug Administration ’s (FDA)accelerated approval program has served as a critical lifeline for patients with serious and life-threatening conditions. The program was originally established at the urging of patient advocates during the height of the HIV/AIDS epidemic, in which patients waited years for the FDA to review and approve new treatments. From its inception three decades ago, the pathway ’s purpose has always been to get medicines to patients most in need, especially those who lack any viable treatment options. Without accelerated approval, patients in ...
Source: The Catalyst - May 22, 2023 Category: Pharmaceuticals Tags: FDA Rare Diseases Accelerated Approval Source Type: news

Four ways that America ’s biopharmaceutical industry supports jobs and fuels economic growth
May is World Trade Month — an opportunity to remind the Biden Administration of the importance of international trade. America’s biopharmaceutical industry, and the hundreds of thousands of Americans that it employs, depends on an open andrules-based global trading system to ensure that innovative medicines can be developed, manufactured and distributed to health systems and patients worldwide.  (Source: The Catalyst)
Source: The Catalyst - May 18, 2023 Category: Pharmaceuticals Authors: Douglas Petersen Tags: Economic Impact Intellectual Property Trade Source Type: news

ICYMI: PhRMA CMO Dr. Michael Ybarra speaks with Dr. Fabian Sandoval about clinical trial diversity
Enhancing clinical trial diversity is a challenge, but with a multi-faceted, community-centered approach, we can help underrepresented patients be more involved in the research and development of potential life-saving medical treatments. (Source: The Catalyst)
Source: The Catalyst - May 16, 2023 Category: Pharmaceuticals Authors: Michael Ybarra Tags: Clinical Trials Equity Source Type: news

3 things about the PhRMA Foundation
To achieve a healthier world where all people have access to life-changing medicines, we must support researchers working to advance biopharmaceutical innovation and value-driven health care. This is the purpose of the PhRMA Foundation, a 58-year-old nonprofit that catalyzes the careers of promising researchers through competitive, peer-reviewed grants and fellowships.  (Source: The Catalyst)
Source: The Catalyst - May 15, 2023 Category: Pharmaceuticals Authors: Lori Reilly Tags: PhRMA Foundation Source Type: news

Mental Health Awareness Month: Fighting the growing mental health crisis and supporting innovation
America is currently facing a mental health crisis — one that is impacting families and individuals in every community, with the COVID-19 pandemic only exacerbating these trends. Mental Health Awareness Month, which is held each year in May, presents an opportunity to discuss ways to address the growing burden of, and stigma surrounding, mental il lness.  (Source: The Catalyst)
Source: The Catalyst - May 11, 2023 Category: Pharmaceuticals Tags: Medicines in Development Research and Development Mental Health Government Price Setting Source Type: news

Setting the record straight on the Bayh-Dole Act and March-in
The National Institutes of Health (NIH) recently made the right decision to uphold the Bayh-Dole Act and not seize patent rights on an innovative medicine by exploiting part of the law known as the “march-in” provision. However, the issue of future patent right seizures remains a concern because the Biden Administration has left the door open to revising the longstanding Bayh-Dole framework. Erosion of Bayh-Dole would put the entire U.S. innovation ecosystem at risk. It’s important to un derstand the immense success of Bayh-Dole and the potential devastating impacts of rewriting the march-in provision to allow the go...
Source: The Catalyst - May 10, 2023 Category: Pharmaceuticals Authors: Megan Van Etten Tags: Intellectual Property Source Type: news

Insulin: Key Facts on Access & Affordability
Today, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) will examine the cost of insulin and how to make this lifesaving medicine more affordable for patients. The nation ’s largest pharmacy benefit managers (PBMs) are expected to testify. These are the middlemen that insurance companies use to determine what’s covered and what patients pay out of pocket at the pharmacy. We expect the hearing will shed light on the misaligned incentives in the system that allow t hese middlemen and insurance companies to drive affordability and access challenges for patients. (Source: The Catalyst)
Source: The Catalyst - May 10, 2023 Category: Pharmaceuticals Authors: Sarah Ryan Tags: Drug Cost Health Insurance Pharmacy Benefit Managers Source Type: news

4 key facts on medicine prices and spending
This week, policymakers on Capitol Hill will continue to discuss the cost of lifesaving medicines and how to make them more affordable for Americans. It ’s an important discussion that the biopharmaceutical industry believes we need to have. A new treatment or cure can’t improve a patient’s life if they can’t get it. As the conversation continues in Congress, IQVIA is out with anew and timely report on medicine prices and spending. Here are four key facts from IQVIA that are important to keep in mind: (Source: The Catalyst)
Source: The Catalyst - May 9, 2023 Category: Pharmaceuticals Authors: Sarah Ryan Tags: Diabetes Drug Cost Health Insurance Out-of-Pocket Costs Pharmacy Benefit Managers Policy Solutions Source Type: news

Support for continued progress is critical for pediatric drug development
Researching and developing new medicinesfor children is a priority for the biopharmaceutical industry. Despite the scientific complexity and challenges inherent to developing treatments for our youngest patients, there has never been more progress in pediatric health outcomes.  The progress we are seeing in pediatric health outcomes is in part due to the advancement in medicines that have been specifically studied in and approved for use in children. To help advance the development of pediatric medicines, Congress, in a bipartisan fashion, passed provisions ultimately permanently reauthorization in two laws: theP...
Source: The Catalyst - May 8, 2023 Category: Pharmaceuticals Authors: Abigail Lore Tags: Medicines in Development Research and Development Pediatrics Government Price Setting Source Type: news

A win for Indiana patients: “Sharing the savings” legislation now law
Indiana just joinedWest Virginia andArkansasin delivering an important win for Hoosiers who are struggling to afford their medicines. This week, Governor Holcomb signed into law Senate Bill 8 recently passed by the Indiana legislature. This new law will ensure that Indiana patients aren ’t paying more for their medicines than their health insurance company or the middlemen known as pharmacy benefit managers (PBMs). This concept, known as “share the savings, ” puts money back in patients’ pockets by requiring insurers and the PBMs they work with to share the rebates, discounts, and other price concessions they ...
Source: The Catalyst - May 8, 2023 Category: Pharmaceuticals Authors: Reid Porter Tags: state policy share the savings Source Type: news