PhRMA submits comments urging CMS to withdraw coverage proposal
In comments submitted this week, PhRMA urged the Centers for Medicare& Medicaid Services (CMS) to withdraw its proposed national coverage determination (NCD) for monoclonal antibodies (mAbs) for the treatment of Alzheimer ’s disease. The proposed policy would set a dangerous precedent of CMS severely restricting patient access to FDA-approved medicines, putting in place barriers to treatment options for a devastating illness, especially for patients in underserved communities. We urge CMS to instead provide Medicar e patients with appropriate and timely access to Alzheimer’s disease treatments. (Source: The Catalyst)
Source: The Catalyst - February 11, 2022 Category: Pharmaceuticals Tags: Research and Development Alzheimer's Health Insurance Medicare Policy Solutions Source Type: news
340B 101: Three charts show the program maximizes hospitals ’ bottom line with little consideration for patients
The 340B program was created 30 years ago to support safety-net clinics and qualifying hospitals by establishing a discounted medicine program funded by biopharmaceutical manufacturers. The aim was to help vulnerable patients access medicines at these safety-net providers. Unfortunately, the program today has become largely unrecognizable as profit incentives have fueled rapid program expansion, particularly by large hospital systems and often at the expense of patients ’ wellbeing. Here are three facts about the 340B program you may not know. (Source: The Catalyst)
Source: The Catalyst - February 8, 2022 Category: Pharmaceuticals Tags: Drug Cost 340B Hospitals Source Type: news
Medicaid 101: Three charts on access and spending
Did you knowMedicaidand the Children ’s Health Insurance Programprovide health coverage for more than83millionvulnerable Americans, including children and their parents, pregnant women, the elderly and people living with disabilities?This state-federal partnershipprovidesAmericans across the country withaccess to needed medications with low to no cost sharing.Here are three facts about Medicaid that you may not know. (Source: The Catalyst)
Source: The Catalyst - February 3, 2022 Category: Pharmaceuticals Authors: Jasmine Gossett Tags: Out-of-Pocket Costs Medicaid Policy Solutions Proactive Agenda Source Type: news
The importance of timely PDUFA and BsUFA reauthorization
Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and Commerce Subcommittee on Health discussing the user fee programs which are under consideration by policymakers for reauthorization this year. This follows the U.S. Department of Health and Human Services ’ transmittal of the proposedPrescription Drug User Fee Act (PDUFA) VII andBiosimilar User Fee Act (BsUFA) III packages to Congress last month. The beginning of the legislative phase marks an important milestone in the reauthori...
Source: The Catalyst - February 3, 2022 Category: Pharmaceuticals Authors: Lucy Vereshchagina Tags: Research and Development FDA PDUFA Biologics and Biosimilars Source Type: news
Government price setting won ’t stop insurers from shifting costs to patients
The drug pricing provisions in the Build Back Better Act (BBBA) would allow the government to set the price of certain medicines in Medicare. This is a misguided approach that threatens future advances and won ’t stop insurers from pocketing savings rather than lowering costs for patients. (Source: The Catalyst)
Source: The Catalyst - February 2, 2022 Category: Pharmaceuticals Tags: Medicare Out-of-Pocket Costs Pharmacy Benefit Managers Policy Solutions Proactive Agenda Government Price Setting Source Type: news
Research and development continues long after a medicine is initially approved
The government ’s flawed price setting plan under the Build Back Better Act will significantly upend the biopharmaceutical research and development (R&D) process, risking important advances in patient care that are only discovered through continued research on already approved medicines. The plan gives the government a new authority to set prices for selected medicines in Medicareafter a medicine has been approved for a certain number of years, unless there is a generic or biosimilar version of the medicine available on the market at the time of selection. The plan guts existing incentives necessary to support furthe...
Source: The Catalyst - February 1, 2022 Category: Pharmaceuticals Authors: Jocelyn Ulrich Tags: Research and Development Intellectual Property Drug Cost Medicare International Reference Pricing Source Type: news
Protecting U.S. innovation abroad to support economic and pandemic recovery
PhRMA ’srecently submitted comments to the Office of the U.S. Trade Representative (USTR) ’s 2022 Special 301 Report reinforce how the United States can confirm its strong commitment to defend American inventions in overseas markets and address damaging market access and intellectual property barriers abroad. These barriers harm America’s innovative and creative industries and the mo re than45 million jobs they support across the country, with an economic and investment footprint in all 50 states. (Source: The Catalyst)
Source: The Catalyst - February 1, 2022 Category: Pharmaceuticals Authors: Ernest Kawka Tags: Research and Development Intellectual Property Coronavirus Source Type: news
New comments outline ways to counteract cost-shifting insurance trends
PhRMA submitted comments this week in response to the Department of Health& Human Services ’ (HHS) 2023 Notice of Benefit and Payment Parameters (NBPP) proposed rule. As outlined inour comments, PhRMA supports many of the policies in the proposed rule that would help improve the affordability of and access to health care, particularly among disadvantaged populations, including the following: (Source: The Catalyst)
Source: The Catalyst - January 28, 2022 Category: Pharmaceuticals Authors: Ashley Czin Tags: Affordable Care Act Health Insurance Out-of-Pocket Costs Policy Solutions Source Type: news
Patients need to pay less for their medicines. States can help.
No one should struggle to afford the medicines they need. Unfortunately, some patients continue to bear more of their medicine costs at the pharmacy counter. Patients with deductibles have seen their out-of-pocket costs for brand medicines in some areas increase50% since 2015. (Source: The Catalyst)
Source: The Catalyst - January 27, 2022 Category: Pharmaceuticals Authors: Scott LaGanga Tags: Health Insurance Out-of-Pocket Costs Proactive Agenda Source Type: news
ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients
The U.S. Food and Drug Administration (FDA) approved a total of 60 new drugs in 2021. Anew report from the FDA catalogs 50 new approvals by the Center for Drug Evaluation and Research (CDER). Separately, the Center for Biologics Evaluation and Research (CBER)approved 10. These novel medicines offer to transform many debilitating diseases, resulting in improved survival, better health outcomes, enhanced quality of life — and in many cases, they provide a first-time treatment option for patients. (Source: The Catalyst)
Source: The Catalyst - January 26, 2022 Category: Pharmaceuticals Authors: Richard Moscicki, M.D. Tags: Research and Development FDA PDUFA New Era of Medicine & D Focus Source Type: news
It ’s a new year, but sadly Congress is still pursuing flawed price setting policies
As we kick off 2022, Congress has a number of priorities they are aiming to tackle, including the Build Back Better Act (BBBA). Unfortunately, the bill includes policies that would take the unprecedented step of allowing the government to set the price of certain medicines in Medicare. Here ’s a refresher on why the drug pricing provisions in the BBBA are bad policy. (Source: The Catalyst)
Source: The Catalyst - January 25, 2022 Category: Pharmaceuticals Tags: Part D Medicare Out-of-Pocket Costs Part B Proactive Agenda Source Type: news
New poll of all 50 states and 435 Congressional Districts shows perils of so-called Medicare “negotiation”
A new large-scalesurvey of 20,000 Americans covering all states and Congressional districts shows a majority find health care coverage costs unreasonable and a top priority health care issue for policymakers to address today. At the same time, the survey conducted with Morning Consult also shows Americans reject so-called government “negotiation” once they learn it could restrict access and choice and chill the innovation of new treatments and cures. (Source: The Catalyst)
Source: The Catalyst - January 25, 2022 Category: Pharmaceuticals Authors: Cynthia Hicks Tags: Drug Cost Out-of-Pocket Costs Polling Proactive Agenda Source Type: news
ICYMI: New report demonstrates growing global impact of antimicrobial resistance
New research published inThe Lancet shows for the first time the global impact of antimicrobial resistance (AMR), which poses an increasingly serious threat to human health around the world. The study found AMR is directly associated with at least 1.27 million deaths per year, making AMR a leading cause of death globally, higher than HIV/AIDS and malaria. In the United States alone, the CDC estimates AMR affects at least 3 million Americans and results in 48,000 U.S. deaths annually. Today ’s report also builds upona body of evidence further confirming the growing fear about the link betweenCOVID-19 and increasing levels...
Source: The Catalyst - January 24, 2022 Category: Pharmaceuticals Authors: Jocelyn Ulrich Tags: Research and Development Coronavirus Antimicrobial Resistance Source Type: news
CBO reaffirms our innovation ecosystem leads to improved lives, long-term savings
The Congressional Budget Office (CBO) recentlyreleased a new report looking at trends in spending, prices and use of prescription drugs. While some politicians are trying to use the report to justify a flawed policy that would let the federal government set the price of medicines, a closer, less partisan look at CBO ’s findings reaffirms that the biopharmaceutical lifecycle is working exactly as intended.Even with the introduction of many new treatments and cures, theCBO found that the average net price per prescription fell from $57 in 2009 to $50 in 2018 in the Medicare Part D program and from $63 to $48 in the Medicai...
Source: The Catalyst - January 21, 2022 Category: Pharmaceuticals Authors: Brian Newell Tags: Drug Cost Health Insurance Proactive Agenda Source Type: news
New data show continued decline in death rates for cancer patients related to treatment advances
According to a new report from American Cancer Society (ACS), death rates for cancer patients in the United States continue to decrease. Each year, ACS details a range of incidence, mortality and survival statistics along with information on risk factors, early detection and treatment for cancer patients. Over the past 30 years we ’ve seen significant progress with fewer and fewer deaths due to cancer year after year. (Source: The Catalyst)
Source: The Catalyst - January 20, 2022 Category: Pharmaceuticals Tags: Research and Development Cancer Source Type: news
