In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.
Interchangeable designations for adalimumab biosimilars will not be “a primary factor in driving adoption,” argued a report from CVS Health, despite other sources conveying that providers will look for interchangeability when making decisions on what to prescribe patients with autoimmune conditions, including rheumatoid arthritis and inflammatory bowel disease.
The report offered stakeholders insight into how the US introduction of adalimumab biosimilars referencing Humira might go and predicted which factors will influence adoption for autoimmune biosimilars and formulary decisions among pharmacy benefit managers.
The global anti-inflammatory biologics market is expected to reach $150 billion by 2027, and despite only accounting for 1% of prescriptions, spending on anti-inflammatory medicines within commercial insurance plans accounted for 42% of all specialty spending in 2022. Spending on biosimilars has been projected to reach $75 billion through 2030 and the global biosimilars market is predicted to hit $30 billion by 2025.
In 2023, up to 10 adalimumab biosimilars will enter the market. The first, Amgen’s Amjevita, launched at the end of January 2023; the others are scheduled to launch starting in July 2023. Furthermore, biosimilars referencing Stelara (ustekinumab) are expected to begin entering the market in late 2023.
CVS’ prediction on the value of interchangeability contradicts Cardinal Health’s 2023 Biosimilars Report, which found that over 60% of surveyed products plan to only prescribe interchangeable adalimumab biosimilars.
Interchangeability designations are a contentious topic in the US biosimilars space as there is a lot of confusion over what the label means and its purpose. Interchangeability is a regulatory designation that allows for pharmacists to exchange a reference biologic for a biosimilar without having to wait for a physician’s approval. It is intended to increase patient access and convenience when obtaining their medications; it does not mean that a biosimilars is better, safer, or more effective than another biosimilar or its originator.
Additionally, the United States is the only country to have the interchangeable label, despite regulatory agencies in the European Union and the United Kingdom publishing statements declaring all biosimilars as interchangeable with their originators. To show the range of division on interchangeability, some biosimilar experts have argued for the FDA to get rid of the label and 4 states plus Puerto Rico have banned pharmacists from making any substitution without provider permission, regardless of whether a product is deemed interchangeable.
CVS based its prediction on its experience with adding authorized generic insulins to formulary. Authorized generics are products that are biosimilars by definition, and may be considered biosimilars in international markets, but are not officially classified as biosimilars in the United States because they were approved before a biosimilars approval pathway was established. In 2017, more than 93% of prescriptions for Lantus (reference insulin glargine) were transitioned to Basaglar (an authorized generic of insulin glargine) without interchangeable status.
“We have seen that these products can provide additional safe and high-quality options for patients living with chronic conditions, and create competition that drives significant savings,” the authors wrote. "The pipeline is robust, and our strategies will continue to evolve to support a vibrant biosimilars market."
When considering which products to add to formulary, CVS said that it uses new-to-market evaluation to review “critical features” of biosimilars and their possible impacts on adoption, including formulation, delivery mechanism, adequate supply, and member experience. CVS also noted that it considers clinical appropriateness and efficacy, product attributes and availability, and price when making formulary decisions.
“Taken together, all of these considerations are essential to making thoughtful, deliberate formulary decisions. Initially, we believe this will likely result from a combination of the reference product, biosimilar competitors, and other branded products,” the authors explained.
CVS argued that competition will be a driver for reduced costs, especially as autoimmune conditions are the number one driver of spend for plan sponsors. “A robust biosimilar pipeline creates an opportunity to meaningfully reduce drug costs in the autoimmune category; we expect plan sponsors will benefit from significant savings.”
The report cited the average sales price (ASP) trends for the Remicade (infliximab) market after the introduction of infliximab biosimilars. From 2018 to 2022, the ASP of Remicade dropped by 50% and the prices of the infliximab biosimilars Renflexis and Inflectra had similar decreases.
Regarding its formulary strategy, CVS said, “We believe the lowest net cost strategy in this category will be a combination of the reference product, biosimilar competitors, and other branded products.”