Practice

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

The experience of one hospital in the United Kingdom of switching patients to a rituximab biosimilar was described in a recent conference abstract, with the process of switching not going as well as it had previously for patients using infliximab and etanercept.

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.

Under the approach used by Kaiser Permanente, say the authors, in which oncologists have salaried incomes and are not reimbursed on a relationship to drug price, far higher generic uptake has been observed.

As more centers begin to switch patients from reference infliximab to biosimilar options, patients who have benefitted from rapid infusions of the reference product may want to continue to receive time-saving infusions that reduce the burden of lengthy visits to infusion centers.

Starting in 2017, the Henry Ford Cancer Institute started using follow-on filgrastim (tbo-filgrastim, a product approved prior to the establishment of the biosimilar approval pathway in the United States) and biosimilar filgrastim (Zarxio) in stem cell mobilization prior to transplant.

The European Specialist Nurses Organisation has launched 7 new translations of its guide to the management of switches between reference biologics and biosimilars.

June 2019 was a busy month for oncology biosimilars, in both the supportive care and anticancer contexts, with regulatory activity and the presentation of reassuring new data.

No statistically significant risk in terms of lack of effectiveness or safety was found for patients who switched therapies versus those who remained on their first therapy in either the reference group or the biosimilar group.

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.

A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.

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.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

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.

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.

All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.

A study presented at the recent ISPOR 2019 meeting assessed both the cost associated with treatment with infliximab for patients at US hospitals as well as reasons for discontinuation of therapy during follow-up, and it found that insurance coverage status is one factor that plays a role in discontinuation of this therapy that rose consistently in price over the study period.

Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.

Patients with rheumatoid arthritis (RA) have similar rates of infection after total knee or hip replacement no matter which biologic they take, but those using glucocorticoids, even moderate doses, appear to have an increased risk of postoperative infections, according to a study published today.

Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.

Research presented at this week’s ISPOR 2019 meeting sheds important light on the impact of biologics on the use of other healthcare resources.

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.

A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.

Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.