Biosimilars

Payers view the National Comprehensive Cancer Network (NCCN) guidelines as a gold standard for making reimbursement decisions, according to a panel of experts who spoke recently about biosimilar uptake.

The analysis looked at 13 of America’s largest employers, including energy, hospitality, retail, transportation, and finance companies.

The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context.

China’s biosimilar development engine is supercharged and running on octane, a recent report said.

Clinical trials for biosimilars and other agents are likely to slow down, if not stall, as coronavirus disease 2019 (COVID-19) wends its course, according to a UT Health expert.

This week, the top managed care news includes a $2 trillion package to address economic damage from coronavirus heads to President Trump, a regulatory change could change the fortunes for biosimilars, and the world’s biggest cardiology meeting goes virtual.

An expert panel discussed the systemic and policy barriers to the uptake of biosimilars.

The speed and extent of biosimilar penetration differ across provider types. Provider awareness and incentives are significantly associated with biosimilar uptake.

The FDA called it “a historic day” as insulin and certain other biologic drugs transitioned to a different regulatory pathway.

The FDA Tuesday cleared a new dose of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which is yet to be launched in the United States. The approval is for a 420-mg multidose vial of Ontruzant. The biosimilar was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all indications for the reference product, Herceptin.

Giving statins to women before they undergo treatment for breast cancer may help prevent the heart damage caused by some well-known therapies, including trastuzumab.

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.