Reviewers found that costs of reference infliximab and its biosimilars make it the most cost-effective therapy for ulcerative colitis (UC) among targeted immune modulators.
A report from the Institute for Clinical and Economic Review (ICER) found that of 6 targeted immune modulators (TIMs), infliximab molecules are the most cost-effective for ulcerative colitis (UC), largely thanks to biosimilar competition.
“Prices are generally too high, even for the significant clinical benefits obtained, but the advent of biosimilars for infliximab has led to dramatic price decreases for this one agent and its biosimilars, displaying the potential cost savings that biosimilars may be able to deliver more broadly in the [United States],” Pamela Brandt, MD, ICER’s chief scientific officer, said in a statement.
UC is a chronic inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. An estimated 900,000 individuals in the United States have UC, and the estimated economic burden is $15 billion to $32 billion in lost work, schooling, and productivity, ICER said.
ICER evaluated the comparative clinical effectiveness of popular drugs to treat UC, including adalimumab (Humira), golimumab (Simponi), tofacitinib (Xeljanz), ustekinumab (Stelara), vendolizumab (Entyvio), reference infliximab (Remicade), and 2 infliximab biosimilars (Renflexis and Inflectra).
Superior Cost Effectiveness
The group found that infliximab biosimilars had superior cost-effectiveness in the treatment-naïve patient population, although it said discounts of at least 25% would be needed to align achievable health benefits with the costs of these agents. The lowest cost infliximab biosimilar by annual wholesale acquisition cost (WAC) was Renflexis ($18,000). Annual WAC costs of adalimumab, golimumab, ustekinumab, and vedolizumab ranged from $43,800 to $72,400.
ICER said evidence is largely insufficient to differentiate these 6 agents by efficacy, although it concluded that all of these TIMs “produce net health benefits at least comparable to adalimumab” and “vedolizumab was found to produce greater rates of clinical response and remission over adalimumab” in both treatment naïve and pretreated patients.
ICER said that prices for infliximab products are still “marginally” too high for cost-effectiveness; however, members of the independent appraisal committee that evaluated these costs decided that infliximab molecules represent “intermediate” long term value because they improve patients’ ability to work, receive education, and achieve better health.
Among the 6 molecules, infliximab is the only one that has biosimilars in the US market. To date, there are 6 FDA-approved adalimumab biosimilars; however, none have launched in the United States. A biosimilar for vendolizumab is currently in development by Polpharma Biologics. Bio-Thera Solutions is developing biosimilars for ustekinumab, tocilizumab, and golimumab.
Recommended Price Ranges
For the indication of UC, ICER found that the prices net of rebates for reference infliximab and its biosimilars were the closest to meeting ICER's recommended health benefit price benchmark (HBPB), a range that suggests the highest price a manufacturer should charge for a therapy based on how much improvement, both physically and financially, a patient receives from the treatment.
“In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good,” the authors wrote.
Whereas the minimum discount needed for infliximab biosimilars to reach HBPB was 25%, ICER said, noninfliximab TIMs require a significantly larger discount in addition to their current estimated rebates to achieve their respective HBPB ranges, including 85% for adalimumab and 82% for ustekinumab.
The recommended HBPB per year is $8800 to $10,900 for infliximab molecules, $5800 to $6900 for adalimumab, $6300 to $7600 for golimumab, $9200 to $12,000 for vendolizumab, and $9000 to $17,200 for ustekinumab.
The report includes policy recommendations from ICER’s California Technology Assessment Forum (CTAF), based on ICER’s evidence on cost-effectiveness, in order to help stakeholders, interpret and use the information found to improve the quality and value of health care.
CTAF recommended that all stakeholders collaborate to ensure that patients with UC are increasingly benefiting from TIM biosimilars as they enter the market.
It said payers should structure their coverage to prevent struggles for patients where cost determines what treatment approach they get. Specialty society guidelines and drug labels should be routinely checked for changes and policy adjustments.
CTAF also said prior authorization criteria may be helpful to manage drug costs and price negotiations for costly TIMs because there are no clear biomarkers or predictors for whether any treatment for UC would work for a given patient. If prior authorization is used, criteria should be based on clinical evidence, specialty society guidelines, and the opinions of clinical experts and patient groups.
CTAF also recommended that active control arms should be included in phase 3 clinical trials for UC therapies and that investigators should make a strong commitment to obtain real world evidence to fill in gaps from previously conducted randomized control trials and allow for TIMs to be accurately compared with one another. Active control arms enable comparisons of investigational drugs with standard therapy.
An at-a-glance report from ICER covers the above topics in abbreviated form and is available by clicking here.