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Editorial |

Finding Common Ground: Professionalism and Acthar Prescribing Practices FREE TO VIEW

Don Liss, MD; Troyen A. Brennan, MD, JD, MPH; Scott Manaker, MD, PhD, FCCP
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: D. L. is Vice President for Clinical Programs and Policy at Independence Blue Cross and serves on the Board of Directors of the HealthWell Foundation. T. A. B. owns stock at CVS Health and works as an employee at CVS Health. S. M. has received fees as a grand rounds speaker, lecturer, consultant, and expert witness on documentation, coding, billing, and reimbursement from hospitals, physicians, departments, practice groups, professional societies, insurers, and various attorneys. In March 2011, he received payment from Aetna Inc for consultation on diagnosis coding. He serves on the Hospital Outpatient Panel, a federal advisory commission to the Centers for Medicare & Medicaid Services; serves on the Contractor Advisory Committee for Novitas Solutions, Inc, a Medicare contractor; and chairs the Practice Expense Subcommittee of the American Medical Association, Specialty Society Relative Value Unit Update Committee. He also serves on the board of directors of ACCP Enterprises, Inc, a wholly owned, for-profit subsidiary of the American College of Chest Physicians.

CORRESPONDENCE TO: Scott Manaker, MD, PhD, FCCP, Department of Medicine, Hospital of the University of Pennsylvania, 100 Centrex Bldg, 3400 Spruce St, Philadelphia, PA 19104


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(3):611-612. doi:10.1016/j.chest.2015.12.020
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“Reasonable people can reasonably disagree on policy.” The profoundly personal, multidimensional, and nuanced nature of clinical medicine makes it particularly ripe for disagreements. Such disagreements often serve to call valid questions, and the ensuing debate furthers our knowledge. So long as the fundamental basis for taking a position includes the obligation to serve the best interest of a patient, respectful disagreement around the interpretation of a given fact pattern is a legitimate, even laudatory, exercise of professionalism.

FOR RELATED ARTICLE SEE PAGE 886

Evidence-based medicine, in which diagnostic approaches and therapeutic interventions are scientifically assessed and compared against objective standards, has emerged as a generally accepted tenet. As the expense of various health-care interventions challenge our ability to afford them, cost has become a dimension that appropriately gets factored into debate over relative effectiveness and incorporated into guidelines. We increasingly see reports of new therapies that offer limited—and sometimes only the promise of limited—marginal improvements in outcomes at phenomenal marginal additional cost. Reasonable people can reasonably disagree over whether crizotinib is worth $100,000 for a 4-month increase in survival in patients with alk-positive non-small cell lung cancer, or whether lumacaftor/ivacaftor is worth $250,000 per year to slow the progression of cystic fibrosis.

In this issue of CHEST (see page 886), a letter from Metersky presents a very different question. Commenting on an advertisement appearing in a recent issue of this journal, Metersky somewhat rhetorically asks Mallinckrodt Pharmaceuticals to present credible evidence demonstrating that H.P. Acthar Gel is safer or more effective than oral corticosteroids in the treatment of sarcoidosis. H.P. Acthar Gel, a repository corticotropin injection, is an adrenocorticotropin analog that is US Food and Drug Administration (FDA)-approved for the treatment of respiratory manifestations of symptomatic sarcoidosis. The current average wholesale price for H.P. Acthar Gel ranges between $25,000 and more than $50,000 for a 1 month’s supply at the most common dosing used for pulmonary sarcoidosis., Before even addressing questions of cost-effectiveness, Metersky appropriately requests evidence for marginal effectiveness over oral corticosteroids, the generally accepted treatment, which he notes is completely absent from the searchable medical literature.

Importantly, by statute the FDA does not consider cost, marginal costs, or cost-effectiveness in their approval processes. In contrast, those responsible for paying for health care must increasingly confront such issues as affordability is challenged.,, Furthermore, the FDA approval of a drug or device does not automatically confer coverage. Newly introduced drugs and devices often confront the barrier of noncoverage by Medicare and other payers, as clear evidence for greater effectiveness (including consideration of fewer side effects, less-complicated dosing, and similar factors in addition to efficacy) than existing and generally less costly alternatives is typically required before Medicare and private insurers determine a drug, device, or other service is eligible for coverage.,

We should continue to debate whether advances in diagnostic approaches and therapeutic interventions are worth their cost. The conclusions from such debate need to be incorporated into clinical guidelines. But first, physicians should agree to agree on demanding evidence for effectiveness before we order a test, initiate a therapy, or create a guideline recommendation. Prescribing treatments such as H.P. Acthar Gel, when there is no evidence for marginal effectiveness at any cost, let alone $25,000 a month above a standard alternative, is wasteful and unprofessional. We applaud Dr Metersky for drawing our attention to this issue, and calling out this question for our profession and our nation.

Supplementary Data

McKinnon M.http://www.brainyquote.com/quotes/quotes/m/markmckinn546865.html. Accessed December 12, 2015.
 
Sackett D.L. .Straus S.E. .Richardson W.S. .et al Evidence-Based Medicine: How To Practice and Teach EBM.  2000;:- [PubMed] Churchill Livingstone Edinburghjournal
 
Blumenthal D. .Stremikis K. .Cutler D. . Health care spending—a giant slain or sleeping? N Engl J Med. 2013;369:2551-2557 [PubMed]journal. [CrossRef] [PubMed]
 
Schwartz J.A.T. .Pearson S.D. . Cost consideration in the clinical guidance documents of physician specialty societies in the United States. JAMA Intern Med. 2013;173:1091-1097 [PubMed]journal. [CrossRef] [PubMed]
 
Atherly A.J. .Camidge D.R. . The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br J Cancer. 2012;106:1100-1106 [PubMed]journal. [CrossRef] [PubMed]
 
Djalalov S. .Beca J. .Hoch J.S. .et al Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-positive non-small-cell lung cancer. J Clin Oncol. 2014;32:1012-1019 [PubMed]journal. [CrossRef] [PubMed]
 
Whiting P. .Al M. .Burgers L. .et al Ivacaftor for the treatment of patients with cystic fibrosis and the G551D mutation: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2014;18:1-106 [PubMed]journal
 
Metersky M.L. . Is there any reliable clinical evidence to suggest that Acthar is more effective than other forms of corticosteroids in treating sarcoidosis and other diseases it is being marketed to treat? Chest. 2016;149:886- [PubMed]journal. [CrossRef] [PubMed]
 
Gettig J. .Cummings J.P. .Matuszewski K.H.P. . Acthar gel and cosyntropin review: clinical and financial implications. P T. 2009;34:250-257 [PubMed]journal. [PubMed]
 
GoodRx Inc. H.P Acthar: corticotropin.http://www.goodrx.com/h.p.-acthar. Accessed December 12, 2015.
 
Neumann P.J. .Claxton K. .Weinstein M.C. . The FDA’s regulation of health economic information. Health Aff (Millwood). 2000;19:129-137 [PubMed]journal
 
Neumann P.J. .Rosen A.B. .Weinstein M.C. . Medicare and cost-effectiveness analysis. N Engl J Med. 2005;353:1516-1522 [PubMed]journal. [CrossRef] [PubMed]
 

Figures

Tables

References

McKinnon M.http://www.brainyquote.com/quotes/quotes/m/markmckinn546865.html. Accessed December 12, 2015.
 
Sackett D.L. .Straus S.E. .Richardson W.S. .et al Evidence-Based Medicine: How To Practice and Teach EBM.  2000;:- [PubMed] Churchill Livingstone Edinburghjournal
 
Blumenthal D. .Stremikis K. .Cutler D. . Health care spending—a giant slain or sleeping? N Engl J Med. 2013;369:2551-2557 [PubMed]journal. [CrossRef] [PubMed]
 
Schwartz J.A.T. .Pearson S.D. . Cost consideration in the clinical guidance documents of physician specialty societies in the United States. JAMA Intern Med. 2013;173:1091-1097 [PubMed]journal. [CrossRef] [PubMed]
 
Atherly A.J. .Camidge D.R. . The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br J Cancer. 2012;106:1100-1106 [PubMed]journal. [CrossRef] [PubMed]
 
Djalalov S. .Beca J. .Hoch J.S. .et al Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-positive non-small-cell lung cancer. J Clin Oncol. 2014;32:1012-1019 [PubMed]journal. [CrossRef] [PubMed]
 
Whiting P. .Al M. .Burgers L. .et al Ivacaftor for the treatment of patients with cystic fibrosis and the G551D mutation: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2014;18:1-106 [PubMed]journal
 
Metersky M.L. . Is there any reliable clinical evidence to suggest that Acthar is more effective than other forms of corticosteroids in treating sarcoidosis and other diseases it is being marketed to treat? Chest. 2016;149:886- [PubMed]journal. [CrossRef] [PubMed]
 
Gettig J. .Cummings J.P. .Matuszewski K.H.P. . Acthar gel and cosyntropin review: clinical and financial implications. P T. 2009;34:250-257 [PubMed]journal. [PubMed]
 
GoodRx Inc. H.P Acthar: corticotropin.http://www.goodrx.com/h.p.-acthar. Accessed December 12, 2015.
 
Neumann P.J. .Claxton K. .Weinstein M.C. . The FDA’s regulation of health economic information. Health Aff (Millwood). 2000;19:129-137 [PubMed]journal
 
Neumann P.J. .Rosen A.B. .Weinstein M.C. . Medicare and cost-effectiveness analysis. N Engl J Med. 2005;353:1516-1522 [PubMed]journal. [CrossRef] [PubMed]
 
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