ICER to Assess Two Treatments for Lupus Nephritis
On August 10, the Institute for Clinical and Economic Review (ICER) announced it plans to assess two treatments for lupus nephritis, voclosporin (Aurinia Pharmaceuticals, Inc.) and belimumab (Benlysta, GlaxoSmithKline). This includes reviewing evidence on how well each drug works, how they compare to other existing treatment options, and the value they would bring to people with lupus nephritis.
The U.S. Food and Drug Administration (FDA) is currently reviewing voclosporin as a new treatment for lupus nephritis, while belimumab is seeking approval from the FDA to expand its use from lupus to lupus nephritis. Both treatments are expecting FDA decisions in early 2021.
Below are some important details about ICER and the role of the Lupus Foundation of America (LFA) during this review process, and most importantly, what this all means for people living with lupus.
Who is ICER?
ICER is a non-profit research organization that evaluates the clinical and economic value of prescription drugs, medical tests and other medical interventions. ICER uses a value assessment framework to determine value. The methods of this framework have been debated because of the use of the quality adjusted life year (QALY), a commonly used measure in health economics.
Why is this review important?
ICER reports can be influential when it comes to insurance coverage and reimbursement of treatments, access to treatments, and can influence the price and availability of treatments. ICER reports are increasingly reviewed by insurers and other payers. These reports can also impact drug development and the incentives for companies around whether or not to develop new treatments.
As ICER conducts reviews, the organization relies on publicly available clinical and health economic data, including data about the disease and the drugs under review that are available from scientific literature, clinical trials and expert analysis. ICER also examines the burden of a disease, quality of life and the unmet needs in a disease, so it is critical that ICER is made aware of the challenges of living with and managing lupus over a lifetime.
How long does a review take?
ICER reviews typically take 10 months. During this time, ICER will accept input from the community, review scientific literature and produce draft reports in advance of developing a final report.
LFA’s plans to engage
The Lupus Foundation of America is committed to engaging with ICER throughout the entire process to ensure the voice and experiences of people living with lupus is understood and included in their review. Additionally, the LFA will work to ensure that assessments of the value of new treatments do not simply rely on the clinical and economic value of a drug, but also the value of the drug to people with lupus when it comes to improving and making a difference in their lives.
Part of the LFA’s role will be to connect people with lupus, clinicians, researchers, and policy and economic experts to illuminate key issues around lupus nephritis, as well as bring forward critical data and research to help inform ICER’s review.
The LFA will have a number of opportunities to engage and participate in the review process during each period. We will keep you updated on the progress and ways you can be involved during each stage, and you can always follow us on Twitter and Facebook to learn about the latest developments during this review process.