Payers, Pharma

Study highlights role of doctor conflicts of interest in Medicare spending on Mallinckrodt drug Acthar

Study published in JAMA indicates nearly 90 percent of doctors prescribing HP Acthar Gel took payments from drug's manufacturer.

Medicare

A new study evaluating the prescribing habits of physicians with financial ties to a drugmaker found that nearly 90 percent of doctors prescribing one of its medications took payment from the company.

The study incorporated data from a public database on 235 specialist physicians who frequently prescribe Mallinckrodt Pharmaceuticals’ HP Acthar Gel – known generically as corticotropin – to Medicare beneficiaries, finding that 88 percent of them received a monetary payment from Mallinckrodt, including 20 percent who received payments worth more than $10,000. Acthar is used in adults to treat exacerbations of multiple sclerosis, along with rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory and edematous diseases, though the drug itself originally received FDA approval in the 1950s.

Study author and Oregon Health and Science University associate professor of pharmacy Daniel Hartung said in a phone interview that the study’s findings are consistent with research on the relationship between industry payments and prescribing patterns. What makes Acthar a special case, he said, is the sheer scope of payments, with nearly 90 percent of prescribers receiving them, compared with the 30-50 percent of prescribers in other studies receiving such payments. Payments, according to the study, took the form of consulting fees, honoraria, gifts, entertainment, food and beverages, travel, research payments and ownership interests.

A Mallinckrodt spokesperson said that in 2015 and 2016, respectively 76 and 73 percent of all healthcare practitioners prescribing Acthar as a Medicare Part D claim received either no payments or transfers of value or only modest meals or nominally priced clinical reprints.

According to ProPublica’s Dollars for Docs database, Mallinckrodt ranks 56th on the list of companies paying doctors, making 212,166 payments worth $31.4 million. Of those, 92,356 – totaling $15.5 million – were related to Acthar. However, inquiries sent to the doctors receiving the highest aggregate payments related to Acthar – including rheumatologists, nephrologists and neurologists – went unanswered. Between August 2013 and December 2016, those 10 doctors received amounts ranging from $329,000 to $476,000, though the database – which is distinct from the one the study used – does not include prescribing rates.

The decision by Hartung and his colleagues to focus on Acthar was because of the publicity around it over the past decade, he said. In addition, Hartung said it is one of the top drugs in terms of gross Medicare spending. The study noted that the government health insurance program spent more than $1 billion on it between 2011 and 2015, including more than $500 million in 2015 alone, making it one of Medicare’s most expensive drugs.

Questcor Pharmaceuticals spent $100,000 on a license for the drug in 2001 and, in 2007, increased the price for a 5-milliliter vial from $1,650 to $23,269. Mallinckrodt bought Questcor in 2014, and the drug’s current acquisition cost stands at $38,892. Indeed, drug prices have become a highly contentious topic, with a recent VICE documentary on HBO showing some of the extreme measures patients have considered to overcome them. While drugs for niche disease states that undergo such aggressive escalations in price like Acthar and Turing Pharmaceuticals’ toxoplasmosis drug Daraprim tend to get the most attention, Hartung said those drugs targeting widespread diseases that see increases of 10-15 percent per year deserve attention as well.

Yet, the study remarked, the Acthar’s prescription growth is “peculiar” given its high cost, negative media coverage and lack of evidence supporting its use over cheaper synthetic corticosteroids. Consequently, aggressive marketing of the drug in response to those factors may partly account for increased use.

Hartung called the evidence supporting Acthar’s use – particularly in comparison with corticosteroids – “shaky and poor” given that at the time of its approval, the FDA did not require controlled trials to prove efficacy, a requirement the agency implemented following 1962 amendments to the US Food, Drug and Cosmetics Act. Furthermore, the only randomized clinical trials of the drug in relapses of multiple sclerosis showed it was superior to placebo, but no better than the corticosteroid methylprednisolone.

The Mallinckrodt spokesperson countered that there is significant clinical evidence to support Acthar’s efficacy, including controlled trials, investigator-initiated studies at “top hospitals and medical centers by some of the country’s preeminent physicians,” health economic and outcomes research data and decades of clinical experience.

Photo: designer491, Getty Images

CORRECTION: A previous version of this article named a doctor as a recipient of payments from Mallinckrodt, per the ProPublica database. Subsequent to publication, the doctor clarified that while she had received payments from the company, she had not prescribed Acthar. This version of the story removes the reference to the doctor.

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