Telling Your Biosimilar's Story: What Data Are Necessary?
By Anna Rose Welch, Director, Cell & Gene Collaborative
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Over the past year, I have been paying close attention to the initiatives cropping up across the U.S. healthcare system to bolster biosimilar education and/or uptake. These efforts have included health care provider education programs, formulary management, site of care shifts, and value-based care models. Though the U.S. (and all nations, really) have gotten off to a bumpy start with misinformation and disparagement, the FDA and FTC recently came out with guidance taking a stance against misinformation. A recent BioDrugs publication highlighted a long list of the ways disparagement can masquerade as truth and how the industry, clinicians, and regulators can work together to overcome this.
We are at an interesting point in this industry as it relates to competition and education. While the supportive care oncology products and the anti-TNF products entered (or will enter) the U.S. several years after launching in the EU, the emergence of Rituxan, Avastin, and Herceptin biosimilars is occurring almost simultaneously in the U.S. and EU. In other words, both nations are now learning together the needs of patients and physicians to improve uptake of these curative biosimilar products. This also means that the amount of real-world evidence (RWE) for these products is currently less than that of the supportive care and immunology products.
This raises two questions in my mind, one being, what types of data have played an important role in biosimilar education and uptake today in the oncology space? And, secondly, what other types of information or evidence could be used to improve current and future biosimilar uptake? A recent MJH Life Sciences webinar featuring two oncologists and a pharmacist provided some interesting insights.
What Data Is Important In Physician, Health System Decision-Making & Education?
A handful of recent Biosimilar Development articles have discussed the challenges oncologists are beginning to face in terms of product selection. With the influx of competitors, payer policies have been drifting more steadily toward preferring the originator or a specific biosimilar as opposed to covering both at parity. In turn, physician choice is often dictated by what the payer will cover.
Throughout the MJH panel, there was a lot of chatter emerging about the notion of an “institutional biosimilar,” which, in an ideal world, would be established by the individual clinics in coordination with their regional payers. (This model is essentially what we are seeing today with the Kaiser Permanente’s and other IDNs of the world.) Not only did the physicians emphasize how much this would simplify clinical operations (i.e., inventory and administration), but it has also proven helpful from an educational standpoint. As KP’s Timothy Chiu, pharmacist, evidence analyst, and strategist, explained, this enabled there to be a “cohesive message” about the transition to the chosen product at KP.
“The ability to administer just one chosen biosimilar product is helpful in that it allows the educational materials to speak to some of the specifics of that particular biosimilar,” he explained. “For example, the conditions in which the biosimilars have undergone clinical study can be a differentiator and help showcase the benefit of a specific biosimilar in a certain indication. Some trastuzumab biosimilars were studied in advanced breast cancer in the palliative care setting. But if the product was also investigated in early breast cancer or was used for treatment in the adjuvant setting, this helped increase patient and provider trust and willingness to use that particular biosimilar. These are the types of information we try to utilize.”
Both oncologists on the panel emphasized how important ongoing education will be for the curative treatments moving forward. Ali McBride, clinical coordinator of Hematology/Oncology for The University of Arizona Cancer Center in Tucson, noted hesitance among patients and physicians in transitioning to rituximab and trastuzumab biosimilars. In fact, this fabulous publication homed in on rituximab biosimilars in particular, highlighting several types of RWE that could encourage greater uptake. (Oddly enough, transitioning to bevacizumab biosimilars has not raised as many eyebrows thus far, at least in these panelists’ experiences.)
As the industry continues to advance and there are more competitors in each treatment class, one of the questions raised was around how health care providers and health systems are planning for future (multiple) competitors. Though product choice may ultimately be dependent on payer policy as opposed to direct physician choice, I appreciated Chiu’s response on how manufacturers and healthcare systems can better drive understanding of how their biosimilar fits into a broader class of medicine. At the base level, this means manufacturers sharing information about the biosimilar products’ similarity — for example, showcasing information on the analytics behind regulatory approval or the company’s approach toward the clinical studies for that molecule. Showcasing how the product has performed in other nations is also a good option.
But even beyond regulatory approval data and safety and efficacy, Chiu emphasized the importance of both biosimilar manufacturers and healthcare systems publicizing the work being done in a real-world setting with each biosimilar.
“Are there opportunities or ongoing studies that are looking at the potential for switching, for example, or are there institutional experiences that may help contribute to a specific product’s story?” Chiu offered. Not only does he anticipate this would be helpful for biosimilar uptake and education overall, but this type of information could also be beneficial for care settings seeking buy-in on the institutional level for their chosen biosimilar(s).