The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.
The Institute for Clinical and Economic Review (ICER) released a Final Condition Update report and a Report-at-a-Glance on immunomodulators for the treatment of moderate to severe plaque psoriasis.
The updated report incorporates new clinical data and cost information for therapies that have been previously reviewed, as well as analyses of more recently approved medications such as guselkumab (Tremfya), tildrakizumab (Ilumya) and certolizumab pegol (Cimzia). Also included within the report were data on risankizumab, which is currently under review by the FDA.
Click here to read more about IL-23 inhibitors.
At a July 2018 public meeting of the New England Comparative Effectiveness Public Advisory Council, the group voted that, compared with anti—tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.
“Similar to the findings of our 2016 report, we again found that many targeted therapies offer benefit over non-targeted therapies, and we are able to further clarify which agents may be most effective,” said Dan Ollendorf, PhD, ICER’s Chief Scientific Officer in a statement.
In addition to the clinical benefits of these medications, ICER recognized that these therapies appear to reduce complexity of care, reduce burdens on family members and caregivers, and improve patients’ ability to work. The report also noted that these therapies use a novel mechanism of action, which allows for new treatments to be effective for patients for whom previous therapies have failed.
However, ICER noted that the evidence was not adequate to show a net health benefit of tildrakizumab compared with anti-TNF agents, or of the anti-TNF agent certolizumab pegol over other subcutaneously administered TNF inhibitors, such as adalimumab (Humira) and etanercept (Enbrel).
Based on the findings of the report, ICER updated its policy recommendations to say that insurers should consider the limitation or cancellation of step therapy approaches to coverage for these drugs, as patients and clinicians have reiterated that step therapy delays improvements to patients’ quality of life. Manufacturers, it adds, should be transparent in the rationale for any increases in drug prices.
“While many of these therapies currently represent reasonable value, patients continue to face insurance barriers that interfere with their access to these potentially life-changing therapies, and recent price increases for many agents may further limit access,” said Ollendorf.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.