Medicare spending on repository corticotropin (rACTH) injection (H. P. Acthar gel; Mallinckrodt Pharmaceuticals) has increased more than 900% since 2011 and totaled more than $1 billion, a new study shows.
Aggressive marketing, price increases, and “financial conflicts of interest,” rather than medical need, may have driven much of this spending, the researchers write. “For adult indications, there is little evidence that rACTH is superior to cheaper synthetic corticosteroids.”
Daniel M. Hartung, PharmD, from the College of Pharmacy, Oregon State University/Oregon Health & Science University, Portland, and colleagues report their findings in a research letter published online September 11 in JAMA Internal Medicine.
Questcor acquired manufacturing rights to rACTH in 2001 and increased the price to Medicare from $1650 to more than $24,000 per 5-mL vial, Saate Shakil, MD, and Rita F. Redberg, MD, both from the Department of Medicine, University of California, San Francisco, write in an accompanying editorial. Mallinckrodt acquired Questcor in 2014 and increased the price further, to its current price of $34,034.
Concerned about the burden to Medicare these price changes might impose, the researchers used data from Medicare Part D Public Use Files to study aggregate rACTH spending and the number of beneficiaries from 2011 to 2015.
Medicare spent a total of $1.3 billion on rACTH during the study period, and more than half a billion dollars in 2015 alone, making it “the 52nd most costly medication for the program,” they write. Medicare spending on rACTH increased from $49,456,911 in 2011 to $503,999,371 in 2015, an increase of 919%. The number of claims increased by 662%, going from 1471 to 11,209, accounted for by both a 264% increase in the number of beneficiaries and a 109% increase in the number of claims per beneficiary. During those years, the cost per beneficiary rose by 180%.
The authors also found that a small number of “frequent prescribers,” defined as those with more than 10 rACTH claims annually, accounted for a disproportionate number of prescriptions and were clustered in rheumatology, neurology, and nephrology. For example, in 2014, those three specialties accounted for 203 of 243 identified frequent prescribers (84%) and $165.0 million (42%) of all Medicare spending on rACTH for that year.
The frequent prescribers “represented only 0.4% to 2.1% of all prescribers within their respective specialties,” and rACTH accounted for less than 0.5% of their total prescriptions, the authors point out. Nevertheless, that was “more than one-third of total Part D expenditures for these frequent specialist subscribers.”
Medicare spent $812,749 on rACTH per prescriber among frequent prescribers compared with $6327 among their specialty peers who prescribed it less frequently, nearly a 128-fold differential.
As the number of other prescriptions per beneficiary “only modestly increased” during the study period, an increase in sicker patients cannot account for these changes, the authors write. Three of the six authors recalled “high-pressure sales tactics” from company representatives, although they could not determine “how broadly used and how much influence accrue to such tactics. rACTH use may be driven by financial conflicts of interest.”
“The strongest data for rACTH are for infantile spasms, which include randomized clinical trials performed in the 1980s. However, in adult medicine, it is being prescribed primarily by rheumatologists, neurologists, and nephrologists despite the lack of evidence for its efficacy in any adult conditions,” Dr Shakil and Dr Redberg write in the editorial.
“In addition…multiple authors have conflicts of interest owing to ties with the manufacturer of Acthar gel, and some of these studies are supported by grants from Mallinckrodt (née Questcor),” they explain.
The paucity of evidence supporting the use of ACTH, “along with the unconscionable price increase by the manufacturer, should give pause to all practitioners.” These findings “should cause us to reexamine and strengthen our standards for [US Food and Drug Administration] approval, Medicare and private business coverage, and professional use patterns,” Dr Shakil and Dr Redberg conclude.
One author reports receiving research grants from Amgen, AbbVie, Janssen, GSK, Eli Lilly, Novartis, Pfizer, Sun Pharma, and UCB, and serving on advisory boards for Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, and UCB. The remaining coauthors and editorialists have disclosed no relevant financial relationships.
JAMA Intern Med. Published online September 11, 2017. Letter extract, Editorial extract
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