In the past, we have addressed whether the use of the four-letter suffixes have enabled positive identification of biosimilar agents by providers and health plans or simply added to confusion over the quality of the products being prescribed. This issue had faded somewhat, with the realization that the suffixes have been superfluous in identifying which agent was prescribed—or so we assumed. A poster at last week’s Academy of Managed Care Pharmacy (AMCP) virtual annual meeting suggested this may not be the case.
Optum Epidemiology and the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) jointly presented findings on data sources that can be used to conduct real-world observational studies on oncology. This preliminary investigation is required, so the BBCIC can fulfill its mission: to generate reliable real-world evidence that examines the safety and effectiveness of biologics in order to improve public health.
The BBCIC relies on its distributed research network, composed of national and regional health insurers and integrated delivery networks that encompass administrative health care claims data on nearly 95 million patient lives, as its primary data source.
For the oncology biologic study, the investigators distributed questions to 18 potential real-world data sources, gaining responses from seven (39%). Two respondents relied on electronic health record (EHR) data, one was primarily based on claims, and four used a combination of claims and EHR data.
The survey included a hypothetical case study on the use of trastuzumab in patients with breast cancer. Here is what was truly fascinating about the results of this study: of the seven respondents, two (28%) reported that they could not positively identify which biologic or biosimilar was used. Perhaps less surprising is that only four (57%) could identify biomarker information (such as estrogen-receptor status).
One might assume that at this point in time, delivery systems, health plans, insurers, and claims data warehouses would be able to pinpoint the agent used through either the four-letter suffixes, national drug codes, brand names, or a combination of these. One of the data sources responding indicated that they have a “partial” ability to identify the exact biologic used.
We followed-up with Cate Lockhart, PharmD, PhD, Executive Director of the BBCIC, about this finding. Dr. Lockhart responded to BR&R via Email, “There are still some non-specific codes floating around out there that contribute to the challenge in differentiating products—and sometimes there is still a lag between launch and specific code assignment, and then updated coding in EHR/claims documentation.
“We know from our own research that suffixes, code modifiers, and NDCs are not uniformly captured in medical claims data,” stated Dr. Lockhart. “Some of the sources are relying on structured EHR data, so it is dependent upon how treatment is captured across clinics, for example. Even the two sources that suggested differentiation was not readily captured in their curated data did say it would be feasible to do so. You wouldn’t think product differentiation would be a problem, but that is why we specifically asked the question in the request for information.
“Data sources are getting much more robust in recent years as more and more research is being conducted with these data,” she wrote, “but we still have the legacy of trying to do research with data that were not originally captured for research purposes.”
Source: Seals RM, Lockhart CM, Lin L, et al. Characterization of real-world data sources to support observational studies of biologics, including biosimilars in oncology. Poster presented at the Academy of Managed Care Pharmacy 2021 annual meeting. April 12-16, 2021.
In Other Biosimilars News…Last week, Genentech and Centus Biotherapeutics, Ltd (a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics) filed a joint motion that settles their patent infringement litigation regarding a biosimilar for bevacizumab. This biosimilar received European approval for marketing in October 2020.