Cost savings from infliximab biosimilars ‘insufficient’ to promote use in US
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Current cost savings alone from infliximab biosimilars are “insufficient to promote their widespread use” in the United States, and comparable savings to those achieved in some European countries may not be possible without systemic reform of the U.S. pharmaceutical market, according to findings published in Arthritis & Rheumatology.
“Currently in the United States, other TNF inhibitor biosimilars — such as those for adalimumab or etanercept — are not available despite many of them being FDA approved,” Seoyoung C. Kim, MD, ScD, MSCE, of Harvard Medical School and Brigham and Women's Hospital, told Healio Rheumatology. “Our research has an important message as we report a disappointingly low uptake — less than 1% — of infliximab’s biosimilars since first quarter of 2017.”
To examine whether the entry of infliximab (Remicade, Janssen) biosimilars into the marketplace was associated with changes in the use and cost of TNF inhibitors, Kim and colleagues studied claims data from a large U.S. commercial health plan that covers more than 14 million individuals in 50 states. Using this database, the researchers identified approximately 1.1 million prescriptions or infusions of TNF inhibitors, to 95,906 individual patients, in the period between Jan. 1, 2016, and March 31, 2019, for their final analysis.
The researchers then calculated the use of five originator products, as well as infliximab biosimilars for each calendar quarter by aggregating patients with at least one prescription or infusion of each product, reporting the use as a proportion of total TNF inhibitor use. In addition, they estimated the quarterly mean insurance-paid cost per treated patient for each product, aggregating amounts paid by insurance across all prescriptions or infusions of a specific product during a calendar quarter, and dividing that by the total number of patients treated with that product in that quarter. According to the researchers, this method accounted for varying frequency with which the drugs are administered.
According to the researchers, following their entry into the marketplace, the biosimilars infliximab-dyyb (Inflectra, Pfizer) and infliximab-abda (Renflexis, Samsung) experienced slow uptake, accounting for 0.1% of total TNF inhibitor use in the second quarter of 2017 and later 0.9% in the first quarter of 2019. The mean quarterly insurance-paid amount per treated patient gradually increased from the first quarter of 2016 to the first quarter of 2019 for all five originator products analyzed — adalimumab (Humira, AbbVie), etanercept (Enbrel, Amgen), golimumab (Simponi, Janssen), certolizumab pegol (Cimzia, UCB) and infliximab.
The mean quarterly insurance-paid amount per treated patient was $8,322 for the infliximab biosimilars, compared with $8,656 for the originator, in the second quarter of 2017. In the second quarter of 2018, those figures were $10,112 and $9,795 respectively, and $8,111 compared with $9,535 in the third quarter of 2018, maintaining a difference of more than $1,000 thereafter. In addition, the median out-of-pocket costs for patients per dispensing during the study period were $37 for adalimumab, $37 for certolizumab, $61 for etanercept, $36 for golimumab, $0 for infliximab and $0 for infliximab’s biosimilars.
“Our results suggest that current modest cost savings from infliximab biosimilars in the United States are insufficient to promote their widespread use,” Kim said. “In other words, substantial savings achieved in some European countries, such as Denmark, may not be possible without systemic reform of the U.S. pharmaceutical market.” – by Jason Laday
Disclosure: Kim reports research grants to Brigham and Women’s Hospital from Pfizer, AbbVie, Bristol-Myers Squibb and Roche. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Kim and colleges have illuminated — and given us some fine documentation regarding — the “the myth of the biosimilars” in rheumatology. They have shown with real world data what most of us have known intuitively from our practice experience; that is, that biosimilars in their present state have not significantly lowered the cost of biologics for patients.
This could be considered a medical tragedy, or at least a Shakespearean farce with bumblers and bumpkins galore and a large sprinkling of greedy villains added to the mix. There are many bills dating back at least a decade designed to level the playing field between patent-holding pharmaceutical companies and the makers of biologically-similar products that would be presumably cheaper. These products must have similar, if not identical, effects with allowance for some minor statistical variability. In other words, these drugs can be no better or worse than the parent drug and, at their very best, would only be as good as the parent drug.
In short, the only advantage for a biosimilar is cost and if that cost reduction is not passed on to patients, there is really no justification for their existence. In spite of the millions of words written about biosimilars and the endless lectures, the best we can get is what we already have. Are there any real cost saving with these drugs? Yes — if you are living in Europe, where the price may be as low as 40-50% of the parent drug.
If we are trying to follow the money here, we need look no further than the insurance companies and the PBMs' endless cycle of “rebates”. Why prescribe a drug that, at the very best, can only be as good as the parent compound and is no cheaper for the patient and gives the insurance companies, PBMs, hospitals, and others more profit?
As with most farces, the behavior of the characters in the story become stranger and stranger as events unfold. Many companies with patented drugs are now developing biosimilars to other companies’ biologics so they are standing on both sides of the fence. Additionally, the FDA and the Federal Trade Commission are doubling down on this failed biosimilar effort by announcing a joint project to crack down on “false or misleading” marketing claims about biosimilars as an important fact in the failure to realize cost savings.
In their statement, the agencies restated their faith “in market forces” and that “the market for biosimilars is still maturing.” However, no mention was made of the PBMs, insurance companies, or other forces that are syphoning off the profits from biosimilars. Not only did the agencies miss the point, but they are heading in the wrong direction.
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