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Majority of Top Acthar Gel Prescribers Received Manufacturer Payments
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Among rheumatologists, nephrologists and neurologists who issued more than 10 prescriptions for corticotropin in 2015, 88% received payments from its manufacturer — with more than 20% receiving more than $10,000 — despite the drug’s considerable cost and the dearth of evidence in support of its use, according to findings published in JAMA Network Open.
“Expensive therapies with uncertain or insufficient evidence supporting their use should be particularly scrutinized,” Daniel M. Hartung, PharmD, MPH, of the Oregon Health and Science University College of Pharmacy, and colleagues wrote. “A prime example of such a treatment is repository corticotropin (H.P. Acthar Gel, Mallinckrodt Pharmaceuticals). ... The continued growth in corticotropin use is peculiar given its very high cost, widespread negative media coverage and notable lack of evidence supporting its use over lower-cost synthetic corticosteroids. Our experience suggests aggressive marketing of the drug partly accounts for increasing use.”
According to the researchers, corticotropin, a biologic with a proprietary manufacturing process, was for decades available for $50 per vial. After Questcor Pharmaceuticals purchased the license for corticotropin in 2001, it raised the price 14-fold from $1,650 for a 5-mL vial to $23,269. Mallinckrodt Pharmaceuticals acquired Questcor in 2014 and has since raised the price of a vial to $38,892. Medicare spending on corticotropin from 2011 to 2015 has increased 10-fold, totaling more than $1 billion during that time.
In addition, the only clinical evidence assessing corticotropin either show it to be less effective than corticosteroids, or are the result of small or uncontrolled trials, the researchers wrote.
To characterize payments from Mallinckrodt Pharmaceuticals to physicians who prescribe corticotropin to patients on Medicare, Hartung and colleagues conducted a cross-sectional analysis of data from CMS, including the Medicare Part D Public Use Files. Focusing on 2015, the researchers used the database to identify physicians, and their specialties, who prescribed corticotropin more than 10 times that year, characterizing them as “frequent prescribers.” In total, they identified 300 frequent prescribers, 235 of whom were rheumatologists, nephrologists or neurologists.
The researchers then linked that those findings to data in the 2015 Open Payments program. Payments from Mallinckrodt were only included in the analysis if the data indicated it was for corticotropin. For the purpose of the study, payments were defined as honoraria or consulting fees, as well as research and ownership payments. Outcome measures including frequency, category and magnitude of payments related to corticotropin from Mallinckrodt, and corticotropin prescriptions and exposures for Medicare patients.
Among the 235 top corticotropin prescribers included in the study, 111 were rheumatologists, 65 were nephrologists and 59 were neurologists. According to the researchers, 88% of those physicians received payments from Mallinckrodt related to corticotropin in 2015, ranging from $11 to $138,321. In addition, more than 20% of the included physicians received more than $10,000 from the company, with the top quartile of frequent prescribers each receiving total payments ranging from $9,934 to $138,321.
Payments from Mallinckrodt were positively associated with greater Medicare spending on corticotropin ( = 1.079; 95% CI, 1.044-1.115),. In addition, every $10,000 in payments was associated with a 7.9% increase — or approximately $53,000 — in Medicare spending on the drug.
“Transparency remains a necessary part of conflict-of-interest management, and we advocate that physicians who receive significant payments from Mallinckrodt disclose this to patients before prescribing corticotropin for them, or consider not receiving any payments from Mallinckrodt,” Hartung and colleagues wrote. “However, disclosure alone may not be sufficient. While academic medical institutions have implemented conflict-of-interest policies intended to limit many of the activities observed in this study, those in private practice, like most prescribers in this study, are subject to little oversight.”
The researches continued, “Given the financial consequences for many expensive therapies (both new and old), other stakeholders, including payers, may need to explore other strategies to manage these conflicts.” – by Jason Laday
Disclosure: Hartung reports grant funding from the National Multiple Sclerosis Society. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Brian F. Mandell, MD, PhD
This is a complicated relationship: Key opinion leaders who consult for companies, speak on their behalf or do research on the drug tend to know much more about the drug and thus are more comfortable prescribing it and, hopefully, using it appropriately. I see no issue with this arrangement — unless, of course, there is a cheaper, readily available and equally efficacious and safe drug, and that may well be the case with corticotropin.
Personally, I have not been convinced by data that I have seen, including some marketing materials, that corticotropin is truly safer or “better” than common variety steroids — certainly not enough to warrant the cost. As I have never consulted for this company, in keeping with my initial comments, I readily concede that I am not an expert on corticotropin. Nonetheless, I have not seen published studies that convince me of its unique value across the board.
As a separate issue, for physicians being paid $50,000-$100,000 by the company for activities related to this medication, these are full-time jobs that essentially make them employees of the company. I see nothing wrong with receiving funds to compensate taking time away from one’s family and practice to give educational talks — including “branded” company talks — consistent with the FDA labeling provided that the physician speaker is addressing issues honestly, completely and consistently with their academic and clinical experience.
Do physician-led educational activities sponsored by companies increase sales? Undoubtedly or companies wouldn’t do it. On the other end, there may be few other effective ways for other clinicians to learn about these drugs other than from “opinion leaders”. Having time to read or attend regular CME lectures is limited, so the onus of professional responsibility is on the shoulders of the physician speaker.
Does eliminating this type of behavior make a dent in potential overall health care costs? Likely not, and hopefully clinicians can critically listen to presentations and read through the overhyped published marketing studies to make their own informed decisions. At the end of the day, it is the individual clinicians who write the prescription for their individual patient. More information is better, and having an informed opinion based on critical thinking as well as the available information is essential — no matter who has provided the information.
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Hartung DM, et al. JAMA Netw Open. 2018;doi:10.1001/jamanetworkopen.2018.0482.
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