In August 2016, CVS Healthcare announced its 2017 formulary exclusion list. The formulary exclusion list is a list of drugs that pharmacy benefits managers (PBM) like CVS Healthcare have decided to stop paying for in favor of a different, preferred drug. While preferred drugs may be chosen for safety or efficacy reasons, oftentimes economics plays a strong role.
One of those exclusions sent shockwaves throughout the pharmaceutical drug industry—the exclusion of Lantus (insulin glargine recombinant) in favor of its biosimilar Basaglar. That exclusion by CVS is expected to significantly impact Lantus’ sales. EvaluatePharma shows revenue for Lantus dropping from $7 billion in 2015 to $2.9 billion in 2022.
To prepare for more exclusions and continued pressure by payers that favor biosimilars, pharma CI, Medical teams, HEOR, and other commercial and R&D teams within drug manufacturers need to be prepared to fully understand any potential differences the biosimilar may show compared to the reference product. The data will be used for competitive insight as well as evidence generation to position the reference product as a safer choice, as soon as any potential differences are seen.
An evidence aggregation platform is the perfect tool to create dashboards to monitor multiple sources of data on both reference drug and biosimilar products and begin to make comparisons. There are three key data sources that should be used.
Clinical trial results data. It will be important to quickly understand any differences in clinical profiles as evidence is generated. An evidence aggregation platform that is equipped to assemble multiple data points from various trials into pooled results provides a view of what occurred across all trials.
Spontaneous reporting from FDA Adverse Event Reporting System (FAERS). With over 8 million case reports and over 1.5 million more being added each year, the passive surveillance pharmacovigilance system that has been the standard bearer for post-marketing FDA action on a drug, is an extremely valuable dataset. When coupled with powerful signaling algorithms, differences in reporting rates can start to be identified as early as 2-3 months on market. Using this data does come with a warning- the raw data files on the FDA.gov website and through the OpenFDA API are horribly unstandardized and “messy”. Without a proper methodology in place to clean, optimize, and process the data, they should be used cautiously.
Other Real World Data such as pharmacy claims or EHR datasets. Known as active surveillance, one can mine real world datasets to detect occurrences of potential adverse events, using methodology similar to that was used in the OBSERVE-5 study. FDA’s Sentinel initiative and Biosimilar monitoring initiatives such as AMCP’s Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) are both based on active surveillance. In order for active surveillance to work, you need to know what adverse events to look for. An evidence aggregation platform can significantly enhance active surveillance when used in conjunction with spontaneous reporting. With MedDRA to ICD-9/10 mapping, an evidence aggregation platform can use the adverse events reported into FAERS as starting points for active surveillance, thus identifying potential issues that would have otherwise been missed.
The main reason to use an evidence aggregation platform to monitor biosimilars is in its access to multiple data sources. Relying on one source of data or methodology is inefficient and may cause important issues to be overlooked. In order to ensure they are positioned to better identify potential differences to the reference product, at-risk manufactures should begin setting up an evidence aggregation platform immediately.
In response to this market need, Advera Health is developing a framework in the Evidex™ platform for custom biosimilar dashboards for our clients that combines multiple data sources using passive and active market surveillance, comparing the biosimilar to reference product.
Interested in learning more about how Biosimilar's compare to reference products? See our comprehensive guide to using drug safety data.
Jim Davis, EVP Advera Health Analytics