May 14th 2024
The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
More Biosimilars on the Market Could Decrease Drug Prices, Panelists Say
June 16th 2018In a webcast hosted by the Alliance for Health Policy that took place earlier this week, Robert Langreth, senior health reporter for Bloomberg News, Dora Hughes, MD, MPH, senior policy advisor at Sidley Austin, LLP, and Sameer Awsare, MD, associate executive director of the Permanente Medical Group at Kaiser Permanente, came together to discuss the best ways to bring down the steadily increasing drug prices in the United States. The panel was moderated by Mary Ella Payne, RN, MSPH, president of the Alliance for Health Policy.
Panel Grapples With the Role of Biosimilars in Oncology
June 1st 2018On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.
COA Sues HHS, OMB Over Medicare Sequester Cuts
June 1st 2018This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.
FDA Issues 2 Draft Guidance Documents on REMS Programs
May 31st 2018FDA Commissioner Scott Gottlieb, MD, on Thursday announced new draft guidance documents aimed at limiting the potential for drug makers to abuse Risk Evaluation and Mitigation Strategy (REMS) requirements. The announcement comes on the heels of President Donald Trump’s drug pricing plan, which called on the agency to issue guidance on how manufacturers use REMS programs to delay competition from follow-on products.
ACR Members Push for Legislation on Rising Costs and Barriers to Care
May 19th 2018This week, rheumatologists and rheumatology stakeholders from the American College of Rheumatology (ACR) took to Capitol Hill to advocate on pressing issues in rheumatology care, such as the rising costs of treatment and lack of access to care.
Regulatory Divergence From EMA Would Have Serious Consequences, Says UK Report
May 18th 2018Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.
FDA Names Companies That Restrict Access to Drug Samples for Generic Testing
May 17th 2018Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.
CMS Dashboards Show Rising Costs for Drugs Targeted by Biosimilar Competition
May 16th 2018Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.
Commonwealth Fund Survey Finds Americans' Concerns Over Healthcare Costs Growing
May 12th 2018This week, the Commonwealth Fund released new findings from its Affordable Care Act Tracking Survey. The survey is a nationally representative telephone poll that tracks coverage rates among 19- to 64-year olds.
BPC's Nonmedical Switching Guidelines Seek to Preserve Physician–Patient Relationship
May 10th 2018In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."
USPTO Proposes Amendments to Rules for Inter Partes Review
May 9th 2018The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.
Utilization Management Strategies Are Impacting Biosimilar Uptake, Says Report
May 8th 2018The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.
AMCP Session Provides a Closer Look at State Legislation on Biosimilars
May 1st 2018During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.