BBCIC Seeks to Provide Stakeholders With Real-World Data on Biosimilars

At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.

Mark Cziraky, PharmD, CLS, vice president of research for Healthcore, one of the founding participants of BBCIC, recalled a 2015 survey that showed that 78% of US physicians were “very concerned” about safety and immunogenicity of biosimilars. That number made Cziraky concerned that the US market could be repeating the mistakes it made with generic medicines. While generics eventually gained wide acceptance and have since saved the United States $1 trillion in the past decade, the timeline for their acceptability was lengthy, said Cziraky.

In order to provide real-world data that can help to generate confidence in the safety and efficacy of these products, the BBCIC uses the FDA’s Sentinel Initiative to monitor biosimilars using anonymized data from approximately 150 million patients, and also has the ability to make requests of its partners to provide specific data runs, via a secure network portal, that it can provide to stakeholders. The group is currently convening a working group that will define best practices for characterizing switching patterns, said Cziraky.

Cate Lockhart, PharmD, PhD, program director of the BBCIC, gave examples of the organization’s progress on research to date; the BBCIC has produced descriptive analyses of 3 categories biosimilars and 1 follow-on: granulocyte-colony stimulating factor (G-CSF) agents, anti-inflammatories, erythropoietin stimulating agents, and insulins. According to Lockhart, these descriptive analyses were undertaken to identify gaps in the data sources or methodologies that must be in place before moving into comparative effectiveness research on these products.

In their descriptive analyses of G-CSF agents, the BBCIC found that, using its data, it was able to arrive at outcomes for febrile neutropenia that were similar to those found in published studies of randomized controlled trials and observational studies. Among drugs that treat inflammatory conditions, however, the group found it challenging to identify effectiveness measures beyond surrogate measures, such as dosage or therapy changes, so it is now pursuing a study to link patient-reported outcomes and clinical measures with administrative claims.

In looking at insulins, the BBCIC’s goal was to describe treatment patterns and outcomes, such as major cardiac events and hypoglycemic events. However, “Lab data are not always part of the picture,” said Lockhart, and that, along with variation in dosing among patients, poses a challenge in describing these patterns. Additionally, they found that some patients’ claims showed diagnoses of both type 1 diabetes and type 2 diabetes; they had to carefully identify and separate out such patients because of the clinical impossibility of a single patient having both conditions. Erythropoietin stimulating agents were also challenging to describe, as BBCIC’s current dataset does not include Medicare data. Lacking such information, they found that they could not produce data comparable to other data sets for these therapies.

Currently, BBCIC is convening working group that focus on improving the data that they are able to provide. The groups will address switching, comparative effectiveness research methods, national drug codes and J-Codes, and mapping IDC-9 codes to IDC-10 codes to address exposures and outcomes past October 2015, when IDC-10 codes came into use.