Journal of Clinical Pathways spoke with Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, president of the Association of Community Cancer Centers (ACCC), regarding the reasons why oncology biosimilar uptake in the US has been a lengthy process and whether these products will be viable options for payer-based and provider-based clinical pathways in the future.
There is extensive data suggesting that biosimilars are associated with positive outcomes in breast and lung cancers, among other cancer types. However, uptake in the US market has been slow, despite many FDA approvals in the US. Can you explain why this is the case, specifically for oncology biosimilars?
Dr McBride: A good example to illustrate why this is the case would be filgrastim-sndz. Before the drug was approved, it had issues in terms of patent infringement and in terms of discussion about the 6‑month wait period for notification. There was a litany of lawsuits which finally led to the release of that drug. But it took many months.
Even after that drug was approved, it was not yet released. This is one of the main issues related to biosimilar use today – the prevention of release into the US market.
There are currently several biosimilar drugs which are approved that have not been released and are expected to be released in late 2019 or early 2020 due to patent lawsuits and other infringements, among other reasons. These patent lawsuits and infringements have prevented the mass release of biosimilars into the US market, specifically for oncology biosimilars.
Without the ability to release those drugs into the US market, biosimilars are not viable options for formularies, workflows, and current treatment regimens. We will not see mass integration of these therapies into EMR systems, workflows, and smaller infusion clinics if these practices do not have the ability to get that drug on-hand.
Releasing the drug is actually the largest issue. Any hold‑ups, lack of availability in the US market, and inability to purchase that drug are causing the majority of the delays toward full integration into the US market. I have often said that 2020 will be the year of the biosimilar. Health care systems, community oncology centers, and payers will need to decide how to delineate what the role of biosimilars will be in the US market and how it will be addressed between different sites of care across the country. The first step toward this delineation is releasing those drugs.
The second largest issue has to do with preferred products by different payers. This year, UnitedHealthcare decided to have pegfilgrastim as their preferred long‑acting growth factor. Other payers (ie, Aetna) prefer the biosimilar. If one payer decides not to have uptake of the biosimilar while another does, then there will be a bit of havoc in the health care system.
The third largest issue is the introduction of two new biosimilars that will be priced differently. It is not too large of a concern at the moment, but it will start to be a bit more as we see more competition among rituximab, bevacizumab, and trastuzumab. The expectation is at least 20% or 30% price difference to move the market. Currently, there is only a 12% or 13% drop in difference with the biosimilars compared to the brand name therapies.
We may actually be in a holding pattern because the introduction of competition was the goal of biosimilars. Unfortunately, due to the inability to get to the market, we have not seen that price drop yet. I believe that we will within 6 months.
Thus, we are in a watch-and-wait period at the moment. Until there is a bit more competition, legalization will be halted, along with the embracement of utilizing biosimilars. The beginning of 2020—when all of these biosimilars are released in the same setting—should put things in motion.
Could you speak to the importance of education for physicians in regard to the latest biosimilars reaching the US market?
Dr McBride: There is a significant lack of understanding of reimbursement when it comes to biosimilars. Reimbursement is probably the poorest acumen level for understanding among health care providers and professionals. It will likely take another 5 or 6 years of continued biosimilar education for physicians, pharmacists, nurse practitioners and advanced practitioners, nurses, and health care providers.
There is a documented sense of hesitancy among physicians regarding the use of biosimilars. The American Society of Clinical Oncology (ASCO) 2018 survey showed that a lack of familiarity with rituximab biosimilars is keeping from integration of these therapies. With this in mind, there will need to be education that ensures that as these products come out, there is a continued understanding of how these products are approved. Also, if these products have limited or skinny labels for their indications, that needs to be addressed in the education efforts.
Furthermore, there is a general lack of pharmacoeconomic data available for biosimilars, especially data showing cost reductions and OCM implications with biosimilars. That is a poorly published area for the time being.
Once we see a bit more data for the overall reduction of the total cost of care with biosimilars and OCM implications, then we will probably see more of an uptake as well, not only from the outcome standpoint, but from the financial standpoint to reduced overall burden of health care costs.
Which oncology biosimilar products do you believe will be next to reach the US market?
Dr McBride: There are many therapies in the pipeline that could reach the US market in the near future. However, everyone seems to be looking to when the immunotherapies (ie, nivolumab and pembrolizumab) will break into the biosimilar market.
Of course, the immunotherapy sector is likely the area which will see immunotherapy phase I studies continue to arise. There has been an announcement for some nivolumab phase I biosimilar studies. This announcement is a good indication of where the market is going in terms of biosimilar‑based developments.
Do you believe that biosimilars will find their place in the standard-of-care for certain oncology populations in the near future? Do you believe that biosimilars are compatible with clinical pathways?
Dr McBride: I think they will. We have already seen biosimilars integrated into NCCN guidelines, which should lead to integration into payer‑based pathways and institutional pathways.
I believe that we will see a large uptake of biosimilars in standard-of-care protocols and pathways in the next year or so. We have already seen this uptake in supportive care therapies as well as short‑acting and long‑acting growth factors for colony‑stimulating factor.
It may take a year or two, but we will likely see a switch between one biosimilar and the next being interchanged based on cost, preference with particular payers, or preference with health systems in order to achieve cost savings. It will be interesting to see the wave of research to come regarding biosimilar use within pathways at OCM practices. Will these practices achieve cost savings as a result of this switch?