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Hartung DM, Johnston K, Van Leuven S, Deodhar A, Cohen DM, Bourdette DN. Trends and Characteristics of US Medicare Spending on Repository Corticotropin. JAMA Intern Med. 2017;177(11):1680–1682. doi:10.1001/jamainternmed.2017.3631
Repository corticotropin (rACTH) injection (H. P. Acthar gel; Mallinckrodt Pharmaceuticals) has been under intense scrutiny for its very high cost.1,2 Because rACTH is approved for a variety of immunologic conditions prevalent in the US Medicare population, prescriptions for rACTH may have a significant financial impact on Medicare expenditures. The objectives of this study were to (1) estimate the cost of rACTH to the Medicare program, and (2) assess the within-specialty prescribing patterns for this medication.
We summarized aggregate rACTH spending, prescriptions, and beneficiaries from 2011 to 2015 using Medicare Drug Spending Dashboard data.3 We used Medicare Part D Public Use Files (PUFs) to determine rACTH utilization by physician specialty.3 For frequent prescribers (those with more than 10 rACTH claims; drugs with 10 or fewer claims are suppressed for privacy), we summarized expenditures, prescription counts, and unique beneficiaries by physician specialties we anticipated to be the largest prescribers of rACTH: rheumatology, neurology, and nephrology. We also estimated rACTH utilization for those with 10 or fewer rACTH claims (infrequent prescribers) by extrapolating the residual aggregate rACTH utilization (total minus frequent prescriber utilization) across all other Part D prescribing rheumatologists, neurologists, and nephrologists. We used the Provider Summary PUF to estimate non-rACTH drug utilization by subtracting rACTH utilization from their total drug utilization for both frequent and infrequent prescribers. Analyses were conducted using SAS statistical software (version 9.4; SAS Institute) and Excel (Microsoft). The research used publicly available data sources and was exempt from institutional review board approval.
Medicare spending on rACTH increased 10-fold and totaled $1.3 billion from 2011 to 2015 (Table 1). This spending increase was driven by a 109% increase prescriptions per beneficiary, a 264% increase in the number of beneficiaries prescribed rACTH, and a 180% increase in spending per beneficiary.
In 2014, 1621 of 1 072 997 Part D prescribers (0.2%) were responsible for $391.2 million in rACTH spending. As shown in Table 2, rheumatologists (n = 94), neurologists (n = 55), and nephrologists (n = 54) represented 84% of all frequent prescribers of rACTH (n = 243), and accounted for 42% ($165.0 million) of all rACTH spending. These frequent prescribers represented only 0.4% to 2.1% of all prescribers within their respective specialties. Despite comprising fewer than 0.5% of their total prescriptions, rACTH accounted for more than one-third of total Part D expenditures for these frequent specialist prescribers.
rACTH spending per prescriber was 128 times higher for frequent prescribers than their specialty peers ($812 749 vs $6327). While the number of rACTH prescriptions per beneficiary were similar between frequent and infrequent prescribers (3.5 vs 3.1 per beneficiary), frequent prescribers had substantially more beneficiaries receiving rACTH prescriptions (5.9 vs 0.05 per prescriber). Other prescriptions per beneficiary were only 25% higher (11.6 vs 9.3 other drug prescriptions per beneficiary) among frequent vs infrequent prescribers.
Medicare expenditures for rACTH have risen dramatically in recent years. In 2015, Medicare spent over half a billion dollars on rACTH, making it the 52nd most costly medication for the program. We attribute much of this growth to increased prescribing intensity across a very small number of rheumatologists, neurologists, and nephrologists, who wrote 100 times more rACTH prescriptions than their colleagues. Other prescriptions written per beneficiary were only modestly increased among frequent prescribers, suggesting that differences in intensity of rACTH use is not entirely explained by frequent prescribers treating more severely ill beneficiaries. Three of us (A.D., D.M.C., and D.N.B.) have met with representatives of Questcor or Mallinckrodt Pharmaceuticals and have experienced high-pressure sales tactics. It s unknown how broadly used and how much influence accrue to such tactics. rACTH use may be driven by financial conflicts of interest.2
A lack of confidential rebate data prevents estimating Medicare’s net expenditures. Transcripts from a recent earnings report call suggest rebates are likely around 10%.4
For adult indications, there is little evidence that rACTH is superior to cheaper synthetic corticosteroids.5 Despite this, Mallinckrodt Pharmaceuticals reported $1.03 billion in worldwide sales from rACTH in 2015, roughly half of which is likely derived from the Medicare program.6 Physicians should be aware of this lack of evidence when prescribing this highly expensive drug.
Corresponding Author: Daniel M. Hartung, PharmD, MPH, College of Pharmacy, Oregon State University/Oregon Health & Science University, 2730 SW Moody Ave, CL5CP, Collaborative Life Sciences Building (CLSB), Portland, OR 97201-5042 (firstname.lastname@example.org).
Accepted for Publication: June 1, 2017.
Published Online: September 11, 2017. doi:10.1001/jamainternmed.2017.3631
Author Contributions: Dr Hartung had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Hartung, Deodhar, Cohen, Bourdette.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Hartung, Johnson, Van Leuven.
Critical revision of the manuscript for important intellectual content: Hartung, Deodhar, Cohen, Bourdette.
Statistical analysis: Hartung, Johnston, Van Leuven.
Obtained funding: Hartung, Bourdette.
Administrative, technical, or material support: Johnston, Van Leuven.
Study supervision: Hartung, Bourdette.
Conflict of Interest Disclosures: Dr Deodhar reports receiving research grants from Amgen, Abbvie, Janssen, GSK, Eli Lilly, Novartis, Pfizer, Sun Pharma, and UCB. He also services on advisory boards for Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, and UCB. No other disclosures are reported.
Funding/Support: This study was supported by the National Multiple Sclerosis Society.
Role of the Funder/Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Luke Middleton, BS, College of Pharmacy, Oregon State University/Oregon Health & Science University, Portland, for assistance with data management.