Allison Inserro

The administration said the update to the dashboards is part of its effort to improve transparency around drug pricing; the administration also wants to shift some Part B coverage to Part D as part of its plan to reduce total drug spending, with the idea that Part D plan sponsors would have more negotiating room with pharmaceutical companies.

Patients using expensive specialty medications, such as those that treat inflammatory diseases, are particularly impacted by pharmacy benefit manager (PBM) rebates, given the relationship of rebates to price. In the case of biosimilars, rebate strategies may lead to reference biologics being placed on preferred formularies in the United States while less expensive options are kept off the formulary.

A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.

A survey of health plan benefit sponsors representing employers found that most are using prior authorization (PA) or step therapy to encourage the use of biosimilars, but fewer are considering mandatory switching, cost-sharing differentials, or higher cost-sharing for reference biologics for new patients, according to a report from The Pharmacy Benefit Management Institute.

Two senators from either side of the aisle introduced a bill this week that is aimed squarely at the patent strategies that are used to block biosimilars from coming to market.

The Medicare Payment Advisory Commission (MedPAC) begins its 2-day March meeting Thursday, and the first item on the agenda is a discussion about reference pricing and binding arbitration for Part B drugs in order to improve price competition and value.

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.

The industry group for pharmacy benefit managers (PBMs) launched a public relations blitz in the wake of scrutiny regarding their role in prescription drug prices.

A California legislator wants to make the state the first to bar “pay-for-delay” tactics used by drug companies to prevent competition, targeting both generics and biosimilars, in a move that would create the first piece of state law about this issue.

Researchers say they validated whole blood expression of a gene involved in inflammatory response as an accurate biomarker predicting response to anti–tumor necrosis factor (TNF) for endoscopic remission in patients with Crohn disease (CD) and ulcerative colitis (UC), both types of inflammatory bowel disease (IBD) in a finding that could assist in deciding whether biologic-naïve patients should receive anti-TNF therapy.

As part of its investigation into drug pricing, the Senate Finance Committee is launching a bipartisan probe into insulin prices, while a Democratic congressman from Vermont announced a bill to allow the importation of insulin from Canada and other countries.

Newly published research reports on an analytical characterization of Samsung Bioepis’ biosimilar adalimumab, SB5, in comparison with the reference, Humira, using 3 different guidelines, showed that the 2 products are largely similar, and any of the minor differences are not clinically meaningful.

More payers began to significantly adjust their reimbursement strategies for biosimilars last year, according to pharmacy benefit manager (PBM) Magellan Rx Management.

The World Health Organization has long recognized the need for a global harmonization of standards for biologics worldwide. In response, the United Kingdom's National Institute for Biological Standards and Control has developed the first international standard for infliximab.

Pfizer received authorization from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.

A study of cost trends for tumor necrosis factor (TNF) inhibitors for rheumatoid arthritis (RA) after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose by $17,390. Taxpayer funds shouldered all of the increases, and the “findings illustrate a market failure contributing to the rising costs of prescription drugs,” according to the researchers.

The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace. Separately, it also updated its “name and shame” list.

The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”

An American Medical Association survey of 1000 physicians regarding the impact of prior authorization (PA) found that most providers reported a significant or negative impact on patient care, and more than a quarter reported a serious adverse event.

A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.

Express Scripts said this week that it expects US drug spending to rise about 2% over the next 3 years, lower than projected inflation rates. However, a lack of competition will affect 2 of the costliest categories of pharmaceuticals—inflammatory conditions and diabetes—between 2019 and 2021.

The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.

A recent white paper recaps the many barriers to biosimilar adoption in the United States and proposes a few ways that plans could change their reimbursement policies to help boost uptake.

A raft of biosimilars possibly coming to market is not expected to relieve the burden of healthcare costs in 2019, but it is possible that the combination of products in the queue, as well as reimbursement changes, could be the beginning of change, according to a drug pricing forecast out this week from Vizient.

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

At a panel discussion at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, representatives of employer groups discussed the role that businesses have in driving the discussion about raising awareness and adoption of biosimilars. Employer groups can help overcome barriers, such as patient fears and misinformation, and create confidence about using biosimilars, speakers said.

Before launching into a discussion of what firms need to consider when identifying “best practices” to get a biosimilar up and running in a new market, Mylan’s global commercial head for biologics and insulin gave a quick history lesson about how far the field has come in a keynote address at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

The current administration in Washington, DC, is one of the most active when it comes to policy and regulation that affects biosimilars, said a presenter who recapped recent changes for the attendees at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.