A more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilars in the United States—is necessary, says the guideline.
The American College of Rheumatology, the Spondylitis Association of America, and the Spondyloarthritis Research and Treatment Network, have released an updated treatment guideline for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. In the guideline, the organizations strongly recommend that patients who are stable on their therapy not be made to switch to a biosimilar of their anti—tumor necrosis factor (anti-TNF) therapies.
The guideline update, write the authors, which analyzed 26 new clinical questions since the previous guideline was issued in 2015, was primarily motivated by the availability of new treatment options, including biosimilars, and to answer questions among both patients and providers as to how these new products fit within the pharmacologic treatment strategy.
“While the efficacy of originator and biosimilar…is comparable, and although either could be chosen to initiate new courses of [anti-TNF] treatment, it was the opinion of the panel to recommend against mandated switching to a biosimilar during the course of treatment, in the absence of evidence of interchangeability,” write the guideline’s authors. They add that medication changes can increase the risk of destabilizing a patient’s condition, and that a more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilar anti-TNFs in the United States—is necessary.
In addition to its recommendation against mandatory switching, the guideline also strongly recommends against switching to a biosimilar of the first anti-TNF treatment in patients whose disease is still active despite anti-TNF treatment, as response to a biosimilar can be expected to be the same as response to an originator.
For patients who have primary nonresponse to a first anti-TNF agent, the guideline conditionally recommends treatment with secukinumab or ixekizumab rather than cycling to a different anti-TNF. However, for patients with secondary nonresponse to anti-TNF, the guideline recommends cycling to a different anti-TNF agent rather than switching to a biologic with a different mechanism of action. These recommendations diverge from the 2015 guideline, which conditionally recommended a trial of a second anti-TNF for cases of nonresponse, whether primary or secondary.
The guideline also recommends that, in patients for whom nonsteroidal anti-inflammatory drugs have not been adequate, anti-TNF agents are recommended, though no particular anti-TNF agent is the preferred choice; treatment decisions should take into account patient preferences regarding frequency and route of administration.
Anti-TNFs are recommended over secukinumab or tofacitinib, and the guideline strongly recommends against systemic glucocorticoid use.
Discontinuing or tapering biologics in stable patients is not recommended, and if tapering is being considered, patients should be counseled about their risk for increased disease activity. Treat-to-target strategies are also not recommended.
Finally, concomitant low-dose methotrexate in patients whose disease is either active or stable under anti-TNF therapy is not recommended.
Reference
Ward MM, Deodhar A, Gensler LS, et al. 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis [published online August 22, 2019]. Arthritis Care Res. doi: 10.1002/acr.24025.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Study: Biosimilar Use, Dose Rounding Produce More Cost Savings Than Either Strategy Alone
November 18th 2023A retrospective study of New England patients receiving trastuzumab or bevacizumab found that combining dose rounding and biosimilar use resulted in greater cost savings than either strategy alone.
Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars
April 16th 2023What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.
Panelists Deliberate Strategies to Enhance Biosimilar Integration in Managed Care Spaces
November 13th 2023At the recent Academy of Managed Care Pharmacy Nexus meeting, panelists discussed the impact of introducing biosimilars in new medical fields, emphasizing the need for more education and collaboration to ensure their smooth integration into health care systems.
Public Payer in Poland Saves €243 Million by Using Biosimilar TNF Inhibitors
November 11th 2023The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.