FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. FDA Law Blog readers can receive a 10% discount off the conference registration price.

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Drug Pricing 64

HealthPartners

MAY 5, 2021

Understanding pharmacy benefit management and drug pricing The U.S. prescription drug supply chain is extraordinarily complex. It captures, with strong simplification, the web of stakeholders in the prescription drug market and the myriad of contractual agreements that drives the cash flows between them.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Putting Patients First Blog

SEPTEMBER 3, 2024

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

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Putting Patients First Blog

SEPTEMBER 7, 2023

Learn more about The Duchenne Registry at DuchenneRegistry.org and download the 15 Year Registry Report here.

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Putting Patients First Blog

NOVEMBER 14, 2023

NHC Comments on Request for Information: Medicare Transaction Facilitator (MTF) for the Medicare Drug Price Negotiation Program (PDF) November 13, 2023 Benjamin Stidham, Contract Specialist Centers for Medicare & Medicaid Services U.S. The right to encryption: privacy as preventing unlawful access.

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FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

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Putting Patients First Blog

MAY 22, 2023

Rutta Chief Executive Officer The post NHC Comments on Information Collection Request for Drug Price Negotiation by IRA appeared first on National Health Council. Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.

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Express Pharma

AUGUST 7, 2023

Our people are never affected by the hospital charges or doctors’ fees but they experience a volcanic impact by the fuel prices and drug prices. To bring down the cost of treatment, we are all out to fight for the allopathic drug prices, I think it may be possible, otherwise how the 10 to 90 per cent discount is offered.

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

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Putting Patients First Blog

MAY 1, 2023

Other Blogs: What You Need to Know about Celiac Disease 05/01/2023 Read More NHC Medicare Drug Price Negotiation Program Comments 04/27/2023 Read More Minority Health: The Importance of Patient Navigation and Access to Timely Care 04/25/2023 Read More The post What You Need to Know about Celiac Disease appeared first on National Health Council.

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Drug Pricing 83

Drug Channels

NOVEMBER 15, 2021

Fein will share his latest thinking on a wide range of topics, including: The prescription market in 2022 Benefit design and plan sponsor strategies Federal and state drug pricing policy The 340B Drug Pricing Program Consolidation and vertical integration Specialty pharmacy trends Copay accumulators, maximizers, and utilization management tools Biosimilars (..)

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Drug Channels

SEPTEMBER 8, 2021

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data.

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Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

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Drug Pricing 52

Definitive Healthcare

FEBRUARY 23, 2024

Resource Type E-Books & How-To Guides Blog How-To Guide Healthcare Insight Medical claims 101: What you need to know How to sell effectively to healthcare facilities and executives using the right… Hospital payor mix by state Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToS

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Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

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Drug Pricing 52

Putting Patients First Blog

SEPTEMBER 25, 2024

The NHC looks forward to exploring future discussion and collaboration with these organizations and others in this field, including organizations representing active military, to advance our shared priorities on patient engagement and access to affordable and equitable health care.

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Department of Veterans Affairs Drug Pricing 52

Putting Patients First Blog

JULY 2, 2024

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). This includes collecting data on utilization management practices, formulary changes, and patient experiences.

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Putting Patients First Blog

APRIL 3, 2024

What we find challenging is that drug pricing discussions often sidestep the core issues in today’s complex health care system in the U.S. While our program represents a major step forward in improving access to our medicines, our work on behalf of patients is far from done — but we can’t fix the entire system alone.

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Drug Pricing 59

FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list.

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Putting Patients First Blog

OCTOBER 15, 2024

Individuals who choose a new plan will see changes to their coverage beginning January 1, 2025. This year’s Open Enrollment is marked by significant changes from the recent prescription drug pricing law. To learn more about Open Enrollment, visit Medicare.gov.

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Drug Pricing 52

FDA Law Blog: Biosimilars

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. We previously blogged on the district court’s decision last year. Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs.,

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Putting Patients First Blog

SEPTEMBER 11, 2023

If you have any questions about the NHC’s policy priorities or 2023 policy matrix, please contact Eric Gascho , Senior Vice President, Policy and Government Affairs.

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Drug Pricing 59

Putting Patients First Blog

SEPTEMBER 27, 2024

Other Blogs: Introducing NHC Connect’s Newest Member Resource: AI Connect! Together, let’s build a vibrant Health AI community that pushes the boundaries of what’s possible, while always putting patients first.

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Drug Pricing 52

Drug Channels

JUNE 1, 2021

The 340B Drug Pricing Program remains highly controversial. Read on for full details on pricing and registration. Fein will help you and your team stay on top of the current trends and market developments. PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions.

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Drug Pricing 52

Digital Pharmacist

APRIL 25, 2023

In this blog post, we will discuss the evolution of DIR fees leading up to the DIR fee changes coming in 2024, and the pros and cons independent pharmacies owners should prepare for. These fees are based on a variety of factors, including performance metrics and drug prices, and are typically calculated retroactively.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

The PERA Act would not only minimize these benefits of § 101, but it would make it easier for brand-name biologic companies to obtain less innovative patents, leading to higher drug prices. The PERA Act would abolish § 101’s careful test for eligibility and would open the floodgates to non-innovative patents. Who you ask?

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Express Pharma

JULY 27, 2024

Excessive IPR protection can lead to exorbitant drug prices, making life-saving medications inaccessible to millions of people, particularly in developing countries like India. A strong IPR regime can attract foreign investment, create jobs, and position India as a global leader in the pharmaceutical sector.

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Putting Patients First Blog

SEPTEMBER 21, 2023

Significant initiatives being undertaken by CMS and OPOLE include behavioral health, drug price affordability, maternity care, Medicaid unwinding, and rural health. Hammarlund also highlighted CMS’ ongoing efforts to expand coverage and advance health equity through the policymaking and implementation processes.

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Drug Pricing 52

Putting Patients First Blog

APRIL 3, 2024

What we find challenging is that drug pricing discussions often sidestep the core issues in today’s complex health care system in the U.S. While our program represents a major step forward in improving access to our medicines, our work on behalf of patients is far from done — but we can’t fix the entire system alone.

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Drug Pricing 40

STAT

SEPTEMBER 12, 2023

They have been staples of cancer treatment for decades, according to a White House blog post , but their supply in the United States has been nearly halved in the past year. The shortages have forced doctors to ration the drugs and alter treatment plans, leaving cancer patients to wonder whether their survival odds are hurt.

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FDA Law Blog: Biosimilars

JUNE 26, 2023

Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. By Faraz Siddiqui & Alan M. federal district court on June 6 (see our post here ).

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Drug Pricing 59

FDA Law Blog: Biosimilars

JUNE 2, 2023

Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drug price transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drug price transparency reporting.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D.

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Drug Pricing Pharmaceutical Manufacturing 59

Putting Patients First Blog

MAY 4, 2023

Other Blogs: CEO Update: 2023 Offers Opportunity for the Patient Community 05/04/2023 Read More What You Need to Know about Celiac Disease 05/01/2023 Read More NHC Medicare Drug Price Negotiation Program Comments 04/27/2023 Read More The post CEO Update: 2023 Offers Opportunity for the Patient Community appeared first on National Health Council.

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Drug Pricing 52

Express Pharma

SEPTEMBER 6, 2023

Not only will this precipitate into lower treatment costs and ensure equitable biopharma access for Indian patients, but could also peg Indian pharma companies to become global market leaders in the biosimilars segment and effect a major change in drug pricing standards. appeared first on Express Pharma.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

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