BOSTON – A new analysis finds that some of the biggest neurologist prescribers of repository corticotropin gel (Acthar) – the extraordinarily expensive multiple sclerosis (MS) relapse drug – reaped extensive payments from its manufacturer, with one taking in $130,307 in a single year.
Together, 51 neurologists accounted for 980 Medicare claims worth more than $39 million in Acthar spending in 2014, almost half of the entire estimated $83 million in Medicare spending on neurologist-prescribed Acthar that year.
“There is a small group of neurologists – less than 1% – who are prescribing Acthar at considerable cost to Medicare and may do this in part because of financial relationships with the company that sells Acthar,” said study lead author Dennis Bourdette, MD, chair and research professor of neurology at Oregon Health and Science University, Portland.
Dr. Dennis Bourdette
Dr. Bourdette acknowledges that the research doesn’t prove a causal relationship between payments and prescriptions. In response to questions, Acthar manufacturer Mallinckrodt Pharmaceuticals, already under fire for the $34,000-per-vial cost of the drug, questioned the study design and denied wrongdoing in a statement: “Mallinckrodt is committed to following the highest standards for integrity and compliance in all of our business practices, including our collaboration with physicians.”
Acthar, also known as H.P. Acthar, is the poster child for stunningly expensive medication. According to the Federal Trade Commission, the cost of the drug rose from $40 per vial in 2001 to more than $34,000 this year. The New York Times reports that Medicare spending on Acthar topped half a billion in 2015.
Earlier this year, Mallinckrodt ARD (formerly Questcor) and its parent company agreed to pay a $100 million fine to settle charges that it created an illegal monopoly over the drug.
Dr. Bourdette and colleagues released their findings at the annual meeting of the American Academy of Neurology.
In an interview, Dr. Bourdette said the study’s roots lie in his concern about the medication, whose transformation from an inexpensive 1950s-era medication for pulmonary sarcoidosis to high-priced MS treatment has drawn national media attention.
“I believe that Acthar is tremendously overpriced and a waste of health care money,” Dr. Bourdette said. “I wanted to find out how extensive an economic problem it was and how much money Medicare was spending on it since this data was easily accessible.”
According to the study, Medicare spent $1.3 billion from 2011 to 2015 on Acthar, with about 25% of the cost due to prescriptions from neurologists. “When I discovered that a relatively small number of neurologists was prescribing it commonly at a cost of $40-$50 million a year to Medicare, I was interested in determining why they were prescribing this expensive therapy and postulated that it might be related to financial support they were receiving from the manufacturer,” Dr. Bourdette said.
The researchers examined the Medicare Part D Public Use File to determine which neurologists prescribed Acthar frequently in 2014. They identified 51 who prescribed Acthar 10 or more times that year and were frequent prescribers of MS disease-modifying therapy, indicating they treated many people with MS.
The 51 neurologists accounted for a mean of 19 Acthar claims each in 2014 (range, 11-50) totaling a mean annual cost of $770,145 (range, $354,479-$3,623,509). Together, the neurologists accounted for total Medicare spending on Acthar of $39,277,380.
The researchers also chose a control group – 51 neurologists who prescribed glatiramer acetate (Copaxone) more than 10 times in 2014 and also prescribed a similar frequency of all MS disease-modifying therapies as the high-frequency Acthar group.
“Acthar is used episodically to treat MS relapses, and glatiramer acetate is taken chronically to prevent relapses and disability,” Dr. Bourdette said. He added that glatiramer acetate is now available in a generic, but it wasn’t in 2014.
The Acthar and Copaxone groups were nearly identical in terms of gender (about two-thirds men) and years since graduation (a mean of 26), but the Acthar prescribers were more likely to work in small practices (1-10 doctors), file more prescription claims, see more Medicare patients, and practice in the South or West. The demographic information came from CMS Physician Compare.
In terms of overall drug maker payments, neurologists in the Acthar group accepted much more (median, $54,270; range, $623-$369,847) than did the Copaxone group (median, $1,747, range, $0-$256,305, P less than .001). Payment information came from the federal Open Payments database.
As for payments directly from the manufacturers of the two drugs, the Acthar prescribers accepted a median of $5,344 (range, $0-$130,307) from its manufacturer, while the Copaxone prescribers accepted a median of $137 (range, $0-$168,373) from Teva (P = .003).
“The payments are primarily for giving lectures or serving on advisory boards,” Dr. Bourdette said. “These types of payments are commonly made by pharmaceutical companies to physicians who participate in these types of activities.”
In a statement, Mallinckrodt Pharmaceuticals contends that the study inappropriately compares Acthar, often a later-line therapy, to Copaxone, which it says is often a first-line therapy.
Dr. Bourdette responded that the researchers chose a comparison group of top prescribers of Copaxone “as a marker of neurologists who treated a significant number of patients with MS.”
Mallinckrodt also notes that “there may be unmeasured confounding factors in the matching process between the comparator physician groups. These could include differences in the patient characteristics managed by these physicians including disease severity affecting prescribing patterns.”
The researchers agree that there may be differences between the groups, Dr. Bourdette said. However, he added, “the fact remains that the two groups differed in the amount of money they received as open-source payments from pharmaceutical companies. We doubt that the severity of their case mixes should lead to one group receiving more pharmaceutical open-source payments than another.”
Finally, Mallinckrodt says there’s no proof of a causal connection between the payments and the prescriptions; the study authors agree. And, the company says, “this pattern of correlation would be expected in any scenario where a small number of prescribers are the experts in the use of a later-line drug to treat a limited subset of patients.”
Dr. Bourdette rejects this contention. Few of the high Acthar prescribers practice at academic centers, he said, and few are recognized for their MS expertise. “So to suggest that they are experts in the use of Acthar for the treatment of MS when they are not as a group recognized as being experts on the treatment of MS in general is incredible,” he said. “Why a small group of neurologists prescribe Acthar remains a mystery, but it is not because the majority are leaders in the field of MS therapeutics.”
In an interview, Eric G. Campbell, PhD, professor of medicine and director of research at the Mongan Institute Health Policy Center at Harvard Medical School, Boston, said the study findings fit in with previous research that has found that “the more money that people get, the more they use the drug.
“Any reasonable person looking at this data would assume or at least consider very strongly that there is a causal relationship here,” he said.
What should be done? “There are lots of ways to stop this,” Dr. Campbell said. “One could simply impose rules that forbid doctors who accept payments for marketing drugs from billing Medicare or private payers for the care they provide. Large provider organizations could pass rules that forbid this kind of behavior. Finally, the government could vigorously pursue stiff penalties against physicians who accept payments that are really nothing more than incentives to encourage or sustain prescribing practices.”
The study was supported by a National Multiple Sclerosis Society grant. Dr. Bourdette said that he provides consulting to Magellan Healthcare, a company that provides recommendations to insurance companies on the approval of high-cost therapies. Dr. Campbell disclosed that he serves as an expert witness on law cases related to conflicts of interest in medicine.