Biosimilars

https://www.pharmacytimes.org/on-demand/managed-care-considerations-for-navigating-biosimilar-and-her2-directed-therapies-for-the-treatment-of-her2-positive-breast-cancer

The Patent Trial and Appeals Board delivered a setback to Gilead Sciences, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC; Merck is spinning off some businesses in order to focus on its oncology drug pembrolizumab, including its biosimilars operations; Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare.

Results for Truxima, recently launched in the United States, and complement inhibitors were presented at the 61st American Society of Hematology Annual Meeting and Exposition.

As part of our anniversary celebration, today we launch “Paper of the Week,” which will look back at some of the most influential research articles and commentary that have appeared in The American Journal of Managed Care® over the past 25 years, and why they are important today.

The biosimilar candidate treats paroxysmal nocturnal hemoglobinuria, a rare blood condition that features destruction of red blood cells, thrombosis, and impaired bone marrow function.

The availability of biosimilars introduces competition based on price, offering a lower-cost alternative in the short term and helping to restrict—or even reverse—longer-term price growth.

More than 7 months after Scott Gottlieb, MD, resigned from his position as FDA commissioner, the Senate confirmed Stephen Hahn, MD, FASTRO, to be the next head of the agency.

Lee Schwartzberg, MD, FACP, executive director, West Cancer Center, discusses the importance of working with physicians to make sure they're comfortable prescribing biosimilars.

Nina Chavez, MBA, FACMPE, chief operating officer, New Mexico Oncology Hematology Consultants, Ltd., discusses if she thinks biosimilars will play a role in lowering costs in coming years.

While biosimilars have brought down the cost of therapies, the savings are not quite as huge as providers may have been led to believe when biosimilars were initially under development, said Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic.

This year has been an exciting time for rheumatologists with impressive clinical trial results and promising outcomes for patients, said Susan Manzi, MD, MPH, codirector of the Lupus Center of Excellence and chair of the Department of Medicine of West Penn Allegheny Health System, during a session at the American College of Rheumatology annual meeting in Atlanta, Georgia.

Medicaid work requirements were front and center in the outcomes of Kentucky governor's race as well as the statehouse in Virginia; the Trump administration called the drug plan from House Speaker Nancy Pelosi, D-California, "unworkable;" UnitedHealthcare is switching patients to biosimilar epoetin alfa in 2020;

We really believe that biosimilars line up as a value accretion for every constituency, whether it’s the patient, the practice, or the payer, said Lee Schwartzberg, MD, FACP, executive director, West Cancer Center.

Tesh Khullar, senior vice president & advisor, Flatiron Health, outlines changes that could impact community oncologists when it comes to reimbursement for biosimilars.

Increased competition is making its way into the specialty drug market, affecting orphan conditions, cancer types, and even common specialty conditions, which is presenting some cost savings opportunities, explained Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts, who presented on the specialty pharmaceutical pipeline during her regular session at AMCP Nexus 2019.

Heading into 2019, the idea that oncology practices would fully embrace financial responsibility for clinical decisions still seemed far-fetched for many. And yet, when it was time to make the call, moving to 2-sided risk proved a “simple” decision, said Travis Brewer of Texas Oncology, who took part in a panel offering an update on the Oncology Care Model (OCM) at the start of the Community Oncology Alliance (COA) Payer Exchange Summit, which opened Monday in Tyson’s Corner, Virginia.

Tesh Khullar, senior vice president & advisor, Flatiron Health, explains what efforts are needed to make sure providers are comfortable prescribing biosimilars.

Practices are going to have to decide which biosimilar manufacturers they want to be able to partner with, explained Tesh Khullar, senior vice president & advisor, Flatiron Health.

Tesh Khullar, senior vice president & advisor, Flatiron Health, discusses the first to anticancer biosimilars having recently entered the market.

From the Center for Biosimilars®, a discussion on giving patients new, less expensive alternatives for managing diabetes.

From The Center for Biosimilars®, a discussion of a regulatory change coming in 2020: Insulins have always been biologics from a scientific perspective, and the products themselves will not change as a result of bringing them under regulation as biologics as a matter of law. However, labeling for these products will change.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

This week, the top managed care stories included CMS giving chimeric antigen receptor T-cell payments a boost; a US task force announcing that those at risk for pancreatic cancer should be screened; FDA revealing Novartis withheld data about a high-cost gene therapy.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

Research on biosimilars presented at the 2019 Annual Meeting of the American Society of Clinical Oncology.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.

During ISPOR 2019 annual meeting, a session featured biosimilar experts who reviewed the current state of affairs and various challenges related to uptake, while also sounding some notes of optimism.

Nearly 700 people at California State University and the University of California, both in Los Angeles, were still in quarantine over the weekend after possibly being exposed to measles; the world’s largest seller of cancer drugs, pharma company Roche Holding AG, will lose its top spot with competition from lower-cost drugs, namely biosimilars; findings from a new study showed that blood pressure regulation at or below 130/80 mm Hg lowered the risk of heart attack, stroke, or other complications in patients with type 2 diabetes (T2D).

Policy updates from the National Comprehensive Cancer Network's annual meeting.

Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.