Practice

During this week’s International Society for Pharmacoeconomics and Outcomes Research 2018 European meeting, the role of biosimilars in oncology is the subject of several research presentations, all of which underscore the importance of these agents in increasing patient access and driving down costs.

This week, healthcare economics stakeholders have gathered in Barcelona, Spain, for the 2018 annual European meeting of the International Society for Pharmacoeconomics and Outcomes Research. During the meeting, research teams from around the globe are presenting findings that support the use of biosimilar infliximab as a cost-saving measure.

Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.

During the Community Oncology Alliance Payer Summit, held October 29-30, 2018, The Center for Biosimilars® had the opportunity to sit down with several oncologists to discuss their opinions on and experiences with biosimilars.

At the Department of Abdominal Oncology at the National Cancer Institute of Naples in Italy, an expert pharmacist was involved in evaluating the economic impact of improving the Italian registry of high-cost drugs, particularly bevacizumab, cetuximab, panitumumab, and trastuzumab.

Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.

While US patients with HER2-positive cancers do not have an available subcutaneous trastuzumab option, Brazil, Canada, and the European Union have an approved product that has been shown in a phase 3 trial to be noninferior to intravenous trastuzumab.

Given the high burden of cancer in the senior population, and given the increasingly high cost of cancer care, there is a growing interest in value-based oncology care payment models, particularly within CMS.

Current treatment for cutaneous lupus erythematosus (CLE) commonly focuses on photoprotection, topical therapies, corticosteroids, antimalarial drugs, and immunosuppressive drugs. More recently, B-cell depleting therapies, such as rituximab, have shown promise in treating systemic lupus erythematosus, though the feasibility of treating CLE with rituximab has not been well described.

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

A recent population-based study examined the prescribing and utilization of CT-P13 versus the reference infliximab in infliximab-naïve patients and found that discontinuation and switching were more common among patients who began therapy with the biosimilar.

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.

While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease and ulcerative colitis.

Anemia is a common complication for patients who are undergoing chemotherapy, and one that has implications for patients’ quality of life, especially with respect to fatigue. During the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, Jérôme Desrame, MD, reported on results of the CIROCO study, which assessed fatigue in patients with chemotherapy-induced anemia who were treated with biosimilar epoetin alfa.

While provider education on biosimilars presents a hurdle for health systems worldwide, patient education is also an area of significant need. During the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, several stakeholders addressed this challenge.

The potential for the development of antidrug antibodies is a key concern among prescribers who use all biologics that target tumor necrosis factor (TNF). Two presentations at the American College of Rheumatology Annual Meeting in Chicago, Illinois, which will be held from October 19-24, 2018, will address the immunogenicity of biosimilars in patients with rheumatoid arthritis and other inflammatory diseases.

As biosimilar etanercept SB4, sold in many markets as Benepali, has entered the rheumatoid arthritis treatment space, researchers have recognized the need to investigate the retention rates and disease activity scores among patients receiving SB4 and its reference.

A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.

Stakeholders hoping to see increased uptake of biosimilars in the United States are increasingly pointing to a lack of provider awareness as a key hindrance to the biosimilars marketplace. New research, to be presented at the American College of Rheumatology Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, suggests that, despite efforts to educate providers, awareness of biosimilars—as well as awareness of patients’ attitudes toward them—remains low.

As more biosimilars are poised to become available to US patients, American rheumatologists are looking to their European counterparts for lessons learned from nonmedical switches from reference products to biosimilars. During the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, several research teams will present on nonmedical switching in the European context.

Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.

Kashyap Patel, MD, a medical oncologist at Carolina Blood and Cancer Care, said after the FDA’s Oncologic Drug Advisory Committee (ODAC) hearing on CT-P10 that "Clearly, the mood has changed to be a lot more favorable for the biosimilars.”

According to the authors, the medical literature points to 3 key triggers of the nocebo effect, all of which offer possible solutions to overcoming the nocebo effect in switches to biosimilars.

Infliximab accounts for substantial drug spending in the United States, and dose rounding has become a common practice at many facilities as a way to avoid wasting vials that have only been partially used. However, many institutions do not have standardized approaches to rounding doses, and because infliximab requires a weight-based dose, rounding becomes even more complex.

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

In explaining why some patients who switch to biosimilars from reference biologics discontinue their therapy at a higher rate than those who remain on a therapy without interruption, some authors have referenced the so-called “nocebo” effect. This effect, whereby a patient experiences disease worsening or adverse events due to negative beliefs about a drug, has been controversial, however, and not all clinicians agree that the effect is to blame for differences in discontinuation.

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).

The National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.