Policy

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses policy challenges with biosimilars.

Irish hospitals will be offered a €500 (US $561) incentive for each patient switched from brand-name Humira or Enbrel to a biosimilar option.

The Center for Biosimilars® recaps the top stories for the week of June 10, 2019.

The American Medical Association (AMA), which is holding its annual meeting this week in Chicago, Illinois, has issued a call for intensified oversight of the pharmacy benefit manager (PBM) industry.

“Do I think these numbers are reasonable and achievable? Potentially,” said Christina Corridon, MPH, MBA, a principal with the consulting firm ZS.

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called "biomimics," or copy biologics.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

A bill supported by a coalition of physician specialty organizations was introduced in the House of Representatives this week to alleviate the growing use of prior authorizations in Medicare Advantage. At the same time, the group released survey results saying that PAs are increasing physician burdens and leading to delays in patient care.

The Center for Biosimilars® recaps the top stories for the week of June 3, 2019.

Competition has done little to keep the lid on rising pharmaceutical prices for brand-name products, especially insulins and anti-inflammatory drugs, and costs will continue to rise unless action is taken, according to a recent paper written by researchers from the Scripps Research Translational Institute.

The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.

With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.

In May 2019 policy news, bills touching on various aspects of biosimilars progressed through Congress, and HHS finalized 2 proposals affecting drug pricing. One state capped monthly insulin prices, while in Canada, one province will move patients taking reference biologics for rheumatological diseases and diabetes to biosimilars within 6 months.

The Center for Biosimilars® recaps the top news for the week of May 27, 2019.

The Biosimilars Forum said this week that if Congress enacted certain changes, the federal government and beneficiaries could save billions of dollars in Medicare Part B.

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.

Officials in British Columbia announced on Monday that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months.

Another piece of bipartisan legislation was introduced last week that seeks to promote biosimilars.

This week, Colorado Governor Jared Polis, D, signed the nation’s first bill that will cap insulin co-pays at $100 per month for people with health insurance.

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

The Center for Biosimilars® recaps the top news for the week of May 20, 2019.

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

During the ISPOR 2019 annual meeting, teams of investigators presented data estimating just how much healthcare systems could save by adopting biosimilar adalimumab for all indications of its reference in adult patients. The results highlighted both the scale of potential savings and the variability among European nations.

Last week, CMS issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B.

With the expanded use of step therapy on the horizon in 2020, an advocacy initiative of rheumatology, arthritis, and gastroenterology and other associations recently released a report “grading” payers and pharmacy benefit managers (PBMs) for the extent of their prescription coverage of medications for patients with autoimmune disorders.

The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.

During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.

During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.