Allan Gibofsky, MD, attending rheumatologist and Co-director of the Clinic for Inflammatory Arthritis at Hospital for Special Surgery, in New York City, met with Rheumatology Advisor to discuss the recent introduction of biosimilar agents into the treatment armamentarium for rheumatic disease. This video discusses issues related to insurance coverage and therapeutic substitution. This is part 2 of a 3 part video series on this topic. For part 1, please click here. 

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Video Transcript

The question always arises about insurance coverage for biosimilars as compared to bio-originators, and the very clear, unequivocal answer to that is, “We have no idea.” We do not yet have biosimilars for any of the autoimmune diseases available on the market. Indeed, even though the US Food and Drug Administration (FDA) has already approved 1 and is poised to approve 2 others based on a recent advisory committee meeting, we do not know when those drugs will actually be introduced into the United States. Best “guess-timates” are 2018 at the earliest, because even after their approval by the FDA, there will still be the need for plant inspections, as well as settling anticipated litigation between the bio-originator and the biosimilar manufacturers over issues related to patent infringement. 

As a result, one cannot readily anticipate that the insurance companies will be giving biosimilars a smooth ride. Personally, I think it would be naïve to expect that merely because biosimilars come to market somewhat cheaper, that will eliminate the preauthorization and prequalification requirements that we are obliged to go through for the bio-originator biologics themselves. 

In other words, if a drug currently costs $40,000 per year and because of a price reduction will cost $28,000 per year, I am not sure that will translate into an easier time for the physician who is prescribing the medication, nor will it necessarily translate into lower costs for the patient, who will likely still have to incur certain out-of-pocket copayments and deductibles. 

In general, I don’t really have reservations about prescribing biosimilars. I think that once the FDA assures me that they are safe and effective, notwithstanding minor differences in their chemical makeup that have been resolved to the satisfaction of the agency, then I think it will be safe and effective to use these drugs consistent with their indications.One interesting nuance, however, is the concept of extrapolation. 

In other words, for biosimilars – unlike bio-originators – there is no need or requirement to test them in all of the populations for which the bio-originator has an indication. As a matter of fact, the current biosimilar biologics that are coming to market have not been tested in more than 1 or 2 of the conditions, where the bio-originator may have [been tested in] 7 or 8. That is giving some people cause for concern; in particular, those specialists for whom the drug has not been tested in their condition 

For example, I am much more sanguine about using a drug that has been tested in rheumatoid arthritis in a population of patients who have psoriatic arthritis. My colleagues in gastroenterology, however, [may have]reservations about using that same biosimilar in populations of patients with Crohn’s disease or ulcerative colitis because no tests have been done in those particular populations. So, while I have no particular reservations about prescribing them, I think that this concept of extrapolation may cause some concern. 

However, if I do have concerns, it will be if I have a patient who is stable on the bio-originator and I am forced to switch them nomedically to a biosimilar. The concept of nonmedical switching is an important one. Nonmedical switching generally means that the switch is determined not by the prescribing physician for the scientific or clinical benefit of the patient, but as a direct mandate by the insurance company to use a less-expensive agent, even though the more expensive one is available. 

So, I think we are going to see instances where stable patients on the bio-originator may be asked/forced to switch to the biosimilar. What that may mean for the maintenance of their stable clinical effect remains to be seen.There have been several patient series reported where nonmedical switching has been done and, in general, the results have been encouraging. However, I like many others would prefer to see additional numbers of patients take part in nonmedical switching, or even medical switching, to assess immunogenicity, stability, and clinical efficacy over time. 

The question is often asked, “Are there patients in whom biosimilars should be avoided?” The answer is, “Probably not.” However, as I previously indicated, I do have some concerns about switching a stable patient on a bio-originator to a biosimilar. For that matter, going forward, when we have multiple biosimilars of the same bio-originator, I would be equally uncomfortable, or less comfortable, about switching a patient who is stable on one biosimilar of a molecule to another biosimilar of the same molecule. 

There are several manufacturers currently working on biosimilars of the same bio-originator and, as years go by, we will have multiple biosimilars of the same bio-originator. Therefore, it will be equally as important to resolve concerns about switching among those as it will be for switching stable patients from the bio-originator molecule to the biosimilar.

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