Shades of Questcor 5

More than 80% of doctors who filed Medicare claims in 2016 for H.P. Acthar Gel -- a drug best known for treating a rare infant seizure disorder -- received money or other perks from the drugmakers, according to a CNN analysis of publicly identified prescribers.

The analysis, which looked at doctors who filed more than 10 Part D claims, found that the drugmakers -- Mallinckrodt and Questcor -- paid 288 prescribers more than $6.5 million for consulting, promotional speaking and other Acthar-related services between 2013 and 2016. Mallinckrodt purchased Questcor in 2014.

At about the same time, Medicare spending on Acthar rose dramatically -- more than tenfold over six years.

Medicare spent nearly $2 billion on Acthar from 2011-2016, according to the agency's data -- even though some doctors say an equally effective treatment would have cost a tiny fraction of that amount. Medicare spending on Acthar from 2013-2016 accounted for nearly $1.8 billion.

Much of the rise in Medicare spending coincided with a marketing push by Mallinckrodt to target adults, especially seniors, after it purchased Acthar's previous manufacturer, Questcor, in 2014, according to company documents CNN has reviewed.

On Friday, a separate study of Acthar payments and prescribing patterns found results similar to CNN's analysis. The authors of that study, published in JAMA Network Open, said their findings "suggest financial conflicts of interest may be driving the use of [Acthar] in the Medicare
program." "We clearly found that as you ratchet up the payments to doctors, there were more prescriptions generated and more spending in the Medicare program on this drug," said Daniel Hartung, the study's lead author.

Acthar is best known for treating babies with infantile spasms, a rare and catastrophic form of epilepsy. Hartung, an associate professor at Oregon State's College of Pharmacy, said he found it troubling the drug is being marketed in adult medicine, with taxpayers footing the bill for hundreds of millions of dollars.

"The evidence that this drug is any better than synthetic steroids is either weak or does not exist," Hartung told CNN.

Mallinckrodt's recent push in the fields of rheumatology, nephrology and multiple sclerosis, he said, was the result of the drugmaker's "aggressive marketing for a number of conditions that, while having an FDA indication, are poorly supported by the medical evidence."

Dennis Bourdette, another of the study's six authors, told CNN the nearly $2 billion spent by Medicare was the result of a tiny fraction of doctors "going along with prescribing [Acthar] without worrying about the cost."

H.P. Acthar Gel makes a significant difference in the lives of very sick patients with unmet medical needs. We are proud of the drug and the important investment we are making in it.

"The issue is that it is incredibly more expensive than synthetic corticosteroids and for some reason -- maybe financial gain -- a small number of doctors will prescribe it," Bourdette, chair of neurology at Oregon Health & Science University, told CNN.

However, some doctors who prescribed Acthar in adult medicine and received money from Mallinckrodt told CNN they used Acthar only after steroids and other treatments failed. While Acthar is not a steroid, it replicates some of its anti-inflammatory benefits.

A steroid like prednisone can cost as little as $2.50 for a bottle of pills -- less than a venti coffee from Starbucks -- compared to Acthar at nearly $39,000 a vial of injectable liquid. Over a course of treatment, those figures get even more dramatic: $7.50 for three bottles of prednisone vs. $117,000 for three vials of Acthar.

"The continued growth in [Acthar] use is peculiar given its very high cost, widespread negative media coverage, and notable lack of evidence supporting its use over lower-cost corticosteroids," the authors wrote.

The findings in Friday's study, which focused on 2015 Medicare claims and 2015 payment data, appeared to back up much of CNN's data analysis, which looked at Medicare claims for 2016 -- the latest year for which data is available -- and payments dating back to 2013, the first year for which those numbers are available.

The drugmakers have paid at least 18,810 doctors nearly $27.5 million in Acthar-related payments from 2013 to 2016, CNN's analysis of government data shows.

In response to questions from CNN about its findings, Mallinckrodt issued a statement in which it strongly defended its payments to doctors:

"In the period of 2013-2016, of all healthcare practitioners prescribing H.P. Acthar Gel to whom Mallinckrodt or the prior owner made payments, more than 95% received only modest meals or nominally priced clinical reprints [of medical journal articles] -- well within regulations and guidelines."

Mallinckrodt said the "vast majority" of the remaining doctors were "engaged for peer-to-peer speaking engagements" and that a small fraction of them were involved in other consulting services, such as speaking to employees or investors and participating in expert Physician Advisory Boards. "It is our belief that many physicians prefer peer-to-peer presentations and dialogue over other methods of learning about the value a product may bring to appropriate patients they are treating. The physicians who present to their peers must take time away from their practice and frequently travel to other cities -- incurring normal, but sometimes substantial travel expenses. Any payments reported include reimbursement for these expenses."

The drugmaker stressed that Acthar is FDA approved for 19 indications including multiple sclerosis, rheumatoid arthritis and kidney disease and "is largely used as a later line treatment, prescribed by skilled healthcare providers to a small subset of appropriate patients who need an alternative treatment option." The drug is also the "gold standard" in treatment for infantile spasms, Mallinckrodt said.

"H.P. Acthar Gel makes a significant difference in the lives of very sick patients with unmet medical needs. We are proud of the drug and the important investment we are making in it," the drugmaker said.

https://www.cnn.com/2018/06/29/health/acthar-mallinckrodt-medicare-claims-doctor-payments/index.html

Courtesy of a colleague