Allison Inserro

The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.

The American College of Rheumatology (ACR) and the Arthritis Foundation (AF) released guidelines for treating 2 subtypes of juvenile idiopathic arthritis (JIA), which affects nearly 300,000 children in the United States. One guideline discusses therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis; the other focuses on the screening, monitoring, and treatment of JIA with associated uveitis. The second guideline focuses on uveitis, which can be a chronic or acute disease.

Functional disabilities start to appear in patients with rheumatoid arthritis (RA) 1 to 2 years before diagnosis, signaling that earlier diagnosis and more aggressive treatment may lessen the burden of disease, according to a study released today.

“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.

A recent exploratory study found signs that retail pharmacies may be associated with higher nonadherence to rheumatoid arthritis (RA) medications.

New data from a subset analysis of MONITOR‐GCSF, a multicenter study from Europe, show that biosimilar filgrastim has similar effectiveness and safety to reference filgrastim (Neupogen).

Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration.

Adalimumab and infliximab showed the highest discontinuation rate due to patient remission, followed by golimumab, in the study of patients with rheumatoid arthritis (RA).

CMS’ final 2020 Payment Notice will allow insurers to stop counting the value of manufacturer drug coupons for branded drugs towards a beneficiary’s maximum out-of-pocket costs in order to promote the use of generic drugs.

Last year, the average rise of per employee cost of specialty drugs was 12%, with oncology making up the largest category.

The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.

During the last panel at the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed some of the administration’s proposals, such as moving Medicare Part B drugs to Part D, a proposal to end protected drug classes in Medicare, and the International Price Index.

Two leaders of the Alliance for Patient Access discussed results of a survey and focus group about nonmedical switching of patients from one drug to another by payers and pharmacy benefit managers for reasons of cost.

The theme of the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars meeting was all about value, and panelists from the Aimed Alliance and the Partnership to Advance Cardiovascular Health discussed how they used the concept of value in their discussions with payers.

At the 4th Annual Policy and Advocacy Summit on Biologics and Biosimilars of the Alliance for Patient Access, speakers discussed the fact that while numerous biosimilars have been approved, most have not reached the market in the United States.

Before the Senate Finance Committee, pharmacy benefit managers said legal issues, not their actions, were to blame for keeping biosimilars from reaching US patients.

An advocacy group for patients with breast cancer in Canada recently published a series of recommendations after convening roundtable discussions with both patients and providers about their knowledge of biosimilars.

Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

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.

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.

March 2019 kicked off with a surprise, when FDA Commissioner Scott Gottlieb, MD, announced he was leaving the administration. In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.

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.

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?

Roche Holding AG has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab (Rituxan).

Ontruzant, a biosimilar trastuzumab referencing Herceptin, shows comparable overall survival and cardiac safety, Samsung Bioepis says.

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.