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August 22, 2018
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The Cost of Biosimilars, Lessons from Hepatitis C

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Leonard H. Calabrese

In reading this month’s cover story, one can see that the cost/charge structure for biologic drugs in our country appears to involve a Byzantine system of agents and middlemen that I think can only be described as ‘bug-nutty.’ Who would design anything this way?

I have only one motivation to use biosimilars: To bring some cost saving to my patients who are struggling every day for approval of their medications or to meet their co-pays. In the U.S. — if anyone in political leadership is listening — we need to do better.

This brings me to the world of hepatitis C, which I have a foot in, by virtue of my infectious disease appointment and work. Let us start by asking: Have you ever wondered why, after 20 years of biologic agents in rheumatoid arthritis and, subsequently, inflammatory bowel disease, centered on the sequential approval of five TNF inhibitors, none has a clear cost advantage to your patients? Yes, so have I! The same scenario is working itself out in the rapidly advancing field of direct acting antiviral agents for hepatitis C but compressed over just a few years and there is something interesting happening there.

Everyone is aware that the early agents in this remarkable pipeline — able to cure 99% of patients with HCV — were expensive; at nearly $1,000 a pill, this cost makes even rheumatology drugs sound cheap. Remember, however, that HCV patients take these for only a few months rather than for life.

Over a period of just a few years a series of subsequent new agents have entered the marketplace, which Michael S. Saag, MD, medical editor of HCV Next, called “Me too” and “Me three” drugs. These drugs, similar to each new TNF inhibitor we welcomed in rheumatology, represented more variations on theme rather than major advances in the field and had little overall impact on costs within the class. Sound familiar?

Then something happened. In August 2017, Mavyret (glecaprevir/pibrentasvir, AbbVie) was approved and priced at two-thirds of the initial cost of the original drug in class, Harvoni (sofosbuvir/ledipasvir) by Gilead Sciences. I for one am both surprised and encouraged that a blockbuster class could usher in a new drug which uses price as a market differentiator. Ironically, this price differential came from the same company that just last month announced a 9.7% increase in the price of Humira (adalimumab, AbbVie), which, according to one drug pricing analyst, could add more than $1 billion to the U.S. health care system’s drug bill this year.

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Imagine a world where, in the fields of rheumatology and gastroenterology, we would witness a major price correction with the approval of each new biologic within the class. Imagine that the originator TNF inhibitors approved nearly 2 decades ago would have their prices tumble as new drugs entered the marketplace. Imagine this happening as each new biosimilar is approved as well. Well in 1967, the Summer of Love, Eric Burdon sang a song called “Down in Monterey.” Maybe some of you can even remember it; for most of you, I suggest a YouTube interlude. In this iconic song, he describes a world of peace and love and social order that sounds even better today than it did back then. Near the end of the song Burdon pauses and says, “I think that maybe I’m dreaming.” Yeah, me too — next patient.