Policy

As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.

Stakeholders testified before a House of Representatives subcommittee about the impact of the rising costs of insulin, while the FDA announced it will hold a public hearing May 13 about its plan to transition follow-on insulins to a regulatory pathway for biosimilars.

Yet another class action lawsuit has been filed against AbbVie, maker of the brand-name adalimumab, Humira. The latest suit, brought by the mayor and city council of Baltimore, Maryland, on behalf of themselves and others similarly situated, alleges that, absent AbbVie’s conduct, biosimilar adalimumab could have been available in the United States as early as 2016. It also alleges that biosimilar developer Amgen was paid by AbbVie to delay its marketing of a biosimilar adalimumab.

While policymakers are grappling with ways to reduce to cost of expensive prescription drugs, one of the proposed solutions—targeting rebates negotiated by pharmacy benefit managers (PBMs)—will not on its own be enough to reduce overall pharmaceutical spending, according to a new brief from The Commonwealth Fund.

The Center for Biosimilars® recaps the top news for the week of March 25, 2019.

During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a group of experts addressed successes, challenges, and learnings from biosimilar procurement processes.

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

The House Ways and Means Subcommittee on Trade heard testimony this week from labor leaders and others about a revised trade agreement that some say will hurt the biosimilar industry in the United States.

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

The Affordable Care Act was signed into law 9 years ago and created a biosimilars market in the United States, but what could happen if the Trump administration is successful in persuading the Fifth Circuit Court of Appeals to affirm a lower court ruling that the law is invalid?

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.

Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.

The Center for Biosimilars® recaps the top news for the week of March 18, 2019.

As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about the factors holding back biosimilars in the United States.

Some stakeholders raised questions about how orphan drugs or biosimilars would be analyzed in the report. The Institute for Clinical and Economic Review's (ICER's) response to both were similar: it did not understand why drugs for orphan diseases or the market entry of biosimilars would lead to rapid price increases.

Branded drug products have fewer potential cost-saving limits on them in Medicare Part D formularies, researchers at John Hopkins University have found.

The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe has successfully sustained its multisource biosimilars market for the past 10 years. The forum also suggests that the United States make structural changes in order to achieve similar success.

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

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.

On Wednesday, the House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition.

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.

The Trump administration has released its proposed budget for the fiscal year 2020, and contained within it are a variety of proposals that impact biosimilars.

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.

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.

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

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.

The Center for Biosimilars® recaps the top news for the week of February 25, 2019.