Abbreviations and Acronyms:
FDA (US Food and Drug Administration)- •Cancer will affect 1 in 3 individuals over their lifetime
- •Recent trends in insurance coverage put a heavy financial burden on patients, with their out-of-pocket share increasing to 20% to 30% of the total cost3
Neuman T, Cubanski J, Huang J, Damico A. How much “skin in the game” is enough? the financial burden of health spending for people on Medicare; an updated analysis of out-of-pocket spending as a share of income. Henry J. Kaiser Family Foundation website. https://kaiserfamilyfoundation.files.wordpress.com/2013/01/8170.pdf. Published June 2011. Accessed April 1, 2015.
- •In 2014, all new US Food and Drug Administration (FDA)–approved cancer drugs were priced above $120,000 per year of use4
Ackerman T. MD Anderson doctor planning online petition against cancer drug sosts. Houston Chronicle website. http://www.houstonchronicle.com/news/houston-texas/houston/article/MD-Anderson-doctor-planning-online-petition-6083743.php. Published February 16, 2015. Updated February 17, 2015. Accessed May 8, 2015.
- •The average annual household gross income in the United States is about $52,0005
Household income in the United States. Wikipedia website. http://en.wikipedia.org/wiki/Household_income_in_the_United_States. Updated June 5, 2015. Accessed April 1, 2015.
- •For a patient with cancer who needs one cancer drug that costs $120,000 per year, the out-of-pocket expenses could be as high as $25,000 to $30,000—more than half the average household income and possibly more than the median take-home pay for a year. Patients with cancer then have to make difficult choices between spending their incomes (and liquidating assets) on potentially lifesaving therapies or foregoing treatment to provide for family necessities (food, housing, education). This decision is even more critical for senior citizens who are more frequently affected by cancers and have lower incomes and limited assets.6Because of costs, about 10% to 20% of patients with cancer do not take the prescribed treatment or compromise it.
Medicare at a glance. Henry J. Kaiser Family Foundation website. http://kff.org/medicare/fact-sheet/medicare-at-a-glance-fact-sheet/. Published September 2, 2014. Accessed April 1, 2015.
7It is documented that the greater the out-of-pocket cost for oral cancer therapies, the lower the compliance.8This is a structural disincentive for compliance with some of the most effective and transformative drugs in the history of cancer treatment8 - •Given the rising incidence of cancer in our aging population, high cancer drug prices will affect millions of Americans and their immediate families, often repeatedly
Das K, Petigara T, Anderson G. Price negotiations for drugs in the U.S. Health Policy Monitor website. http://hpm.org/en/Surveys/Johns_Hopkins_Bloomberg_School_of__Publ._H_-_USA/09/Price_Negotiations_for_Drugs_in_the_U.S..html. Published April 2007. Accessed April 1, 2015.
Big pharma pockets $711 billion in profits by price-gouging taxpayers and seniors. Health Care for America Now website. http://healthcareforamericanow.org/2013/04/08/pharma-711-billion-profits-price-gouging-seniors/. Published April 8, 2013. Accessed May 27, 2015.
Big pharma CEOs pocket $1.57 billion in total pay as they preside over sharp rise in marketing violations, Medicare price-gouging. Health Care for America Now website. http://healthcareforamericanow.org/2013/04/08/pharma-711-billion-profits-price-gouging-seniors/. Published May 8, 2013. Accessed May 27, 2015.
Mailankody S, Prasad V. Five years of cancer drug approvals: innovation, efficacy, and costs [published online ahead of print April 2, 2015]. JAMA Oncol. http://dx.doi.org/10.1001/jamaoncol.2015.0373. Accessed June 25, 2015.
- (1)Creating a post-FDA drug approval review mechanism to propose a fair price for new treatments, based on the value to patients and heath care
- (2)Allowing Medicare to negotiate drug prices
- (3)Allowing the Patient-Centered Outcomes Research Institute, created through the Affordable Care Act initiatives to evaluate the benefits of new treatments, and similar organizations to include drug prices in their assessments of the treatment value
- (4)Allowing importation of cancer drugs across borders for personal use (eg, prices in Canada are about half of prices in the United States)
- (5)Passing legislation to prevent drug companies from delaying access to generic drugs (pay-for-delay)13
Klobuchar, Grassley reintroduce legislation to crack down on anti-competitive pay-for-delay deals [news release]. Chuck Grassley website. http://www.grassley.senate.gov/news/news-releases/klobuchar-grassley-reintroduce-legislation-crack-down-anti-competitive-pay-delay. Published February 5, 2013. Accessed April 1, 2015.
- (6)Reforming the patent system to make it more difficult to prolong product exclusivity unnecessarily (patent “evergreening”)
- (7)Encouraging organizations that represent cancer specialists and patients (eg, American Society of Clinical Oncology, American Society of Hematology, American Association for Cancer Research, American Cancer Society, National Comprehensive Cancer Network) to consider the overall value of drugs and treatments in formulating treatment guidelines
Kantarjian H. Does the United States have the best health-care system in the world? ASCO Post website. http://www.ascopost.com/issues/august-15,-2014/does-the-united-states-have-the-best-health-care-system-in-the-world.aspx. Published August 15, 2014. Accessed April 1, 2015.
Treatments for HIV & AIDS. AIDSMEDS website. http://aidsmeds.com/list.shtml. Updated March 13, 2015. Accessed April 1, 2015.
Acknowledgments
Supplemental Online Material
References
- Why are cancer drugs so expensive in the United States, and what are the solutions?.Mayo Clin Proc. 2015; 90: 500-504
- Pricing in the market for anticancer drugs.J Economic Perspect. 2015; 29 (Accessed June 4, 2015.): 139-162
Neuman T, Cubanski J, Huang J, Damico A. How much “skin in the game” is enough? the financial burden of health spending for people on Medicare; an updated analysis of out-of-pocket spending as a share of income. Henry J. Kaiser Family Foundation website. https://kaiserfamilyfoundation.files.wordpress.com/2013/01/8170.pdf. Published June 2011. Accessed April 1, 2015.
Ackerman T. MD Anderson doctor planning online petition against cancer drug sosts. Houston Chronicle website. http://www.houstonchronicle.com/news/houston-texas/houston/article/MD-Anderson-doctor-planning-online-petition-6083743.php. Published February 16, 2015. Updated February 17, 2015. Accessed May 8, 2015.
Household income in the United States. Wikipedia website. http://en.wikipedia.org/wiki/Household_income_in_the_United_States. Updated June 5, 2015. Accessed April 1, 2015.
Medicare at a glance. Henry J. Kaiser Family Foundation website. http://kff.org/medicare/fact-sheet/medicare-at-a-glance-fact-sheet/. Published September 2, 2014. Accessed April 1, 2015.
- The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience.Oncologist. 2013; 18: 381-390
- Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia.J Clin Oncol. 2014; 32: 306-311
Das K, Petigara T, Anderson G. Price negotiations for drugs in the U.S. Health Policy Monitor website. http://hpm.org/en/Surveys/Johns_Hopkins_Bloomberg_School_of__Publ._H_-_USA/09/Price_Negotiations_for_Drugs_in_the_U.S..html. Published April 2007. Accessed April 1, 2015.
Big pharma pockets $711 billion in profits by price-gouging taxpayers and seniors. Health Care for America Now website. http://healthcareforamericanow.org/2013/04/08/pharma-711-billion-profits-price-gouging-seniors/. Published April 8, 2013. Accessed May 27, 2015.
Big pharma CEOs pocket $1.57 billion in total pay as they preside over sharp rise in marketing violations, Medicare price-gouging. Health Care for America Now website. http://healthcareforamericanow.org/2013/04/08/pharma-711-billion-profits-price-gouging-seniors/. Published May 8, 2013. Accessed May 27, 2015.
Mailankody S, Prasad V. Five years of cancer drug approvals: innovation, efficacy, and costs [published online ahead of print April 2, 2015]. JAMA Oncol. http://dx.doi.org/10.1001/jamaoncol.2015.0373. Accessed June 25, 2015.
Klobuchar, Grassley reintroduce legislation to crack down on anti-competitive pay-for-delay deals [news release]. Chuck Grassley website. http://www.grassley.senate.gov/news/news-releases/klobuchar-grassley-reintroduce-legislation-crack-down-anti-competitive-pay-delay. Published February 5, 2013. Accessed April 1, 2015.
Kantarjian H. Does the United States have the best health-care system in the world? ASCO Post website. http://www.ascopost.com/issues/august-15,-2014/does-the-united-states-have-the-best-health-care-system-in-the-world.aspx. Published August 15, 2014. Accessed April 1, 2015.
Treatments for HIV & AIDS. AIDSMEDS website. http://aidsmeds.com/list.shtml. Updated March 13, 2015. Accessed April 1, 2015.
Article Info
Publication History
Footnotes
Potential Competing Interests: Dr Antman reports he is a member of the Data Monitoring Committee, and has received grants, personal fees, nonfinancial support, and other as Dean of Boston University School of Medicine, outside the submitted work; he also serves as a trustee of the Faculty Practice Plan and of the principal teaching hospital. Dr Baker reports personal fees from Morphotek, Immune Design, Marathon Pharmaceutical, INC Research, and Cyt Rx, outside the submitted work. Dr Bennett reports personal fees from Celgene Corp, Amgen, Novartis, and Glaxo, outside the submitted work. Dr Bhojwani reports participation on the Advisory Board at Amgen and Incyte Pharmaceuticals. Dr Broxmeyer reports receiving an honorarium from Corduse, a Cord Blood Banking Company, outside the submitted work. Dr Chabner reports personal fees from Epizyme, Merrimack, PharmaMar, Sanofi Aventis, Eli Lilly, Celgene, Biomarin, Clovis, Gilead, Seattle Genetics, and Biogen, outside the submitted work. Dr Chesson worked as consultant for Astellas, AstraZeneca, Celgene, Genetech, Gilead, Pfizer, Pharmacyclics, Amgen, Spectrum, Seattle Genetics; his institution received research support from AbbVie, Acerta, Celgene, Genentech, Gilead, Medimmune, Pharmacyclics, Teva, and Seattle Genetics. Dr Colon-Otero reports grants from Novartis, during the conduct of the study. Dr Daley reports a consulting or scientific advisory relationship and holder of equity or options with the following entities: MPM Capital, Epizyme, Verastem, Solasia, KK, True North, Ocata, Raze; in addition, Dr. Daley holds patents broadly related to cancer biology (See http://www.faqs.org/patents/inventor/george-q-daley-weston-US-1/). Dr DeAngelo reports personal fees from Novartis, Ariad, BMS, Pfizer, Astra-Zeneca, Boehringer Ingelheim, Amgen, and Incyte, outside the submitted work. Dr Einhorn served on the scientific advisory board for Celgene and Ziopharm and owns stock at Amgen and Biogenetics. Dr Erba reports personal fees from Novartis, Incyte, Celgene, Sunesis, Pfizer, and Ariad; grants from Celator, grants and personal fees from Seattle Genetics, grants and personal fees from Amgen, and grants from Millennium/Takeda and Astellas, outside the submitted work. Dr Hortobagyi reports personal fees from Bayer HealthCare Pharmaceuticals, Metastat, Peregrine Pharmaceuticals, Inc, Celgene Corp, Pfizer Inc, Society for Translational Oncology, Antigen Express, Galena Biopharma, Genentech, Inc, Amgen Inc, Rockpointe, AstraZeneca Pharmaceuticals, and grants and personal fees from Novartis Pharmaceuticals Corp, outside the submitted work. Dr Issa reports grants from Astex and AACR/Stand Up To Cancer, during the conduct of the study; grants and personal fees from Astex, and personal fees from Janssen Teva, and Boehringer, outside the submitted work. Dr Johnson reports personal fees from Novartis, Merck, AstraZeneca, Clovis Oncology, Chugai Pharmacuticals, Transgene, Genentech, Otsuka, and Eli Lilly, outside the submitted work; in addition, Dr Johnson has a patent on EGFR Mutation Testing with royalties paid and is a stockholder of KEW Group. Dr. Lonial reports personal fees from Millennium, Celgene, Novartis, BMS, Onyx, and Janssen, outside the submitted work. Dr Mendelsohn reports personal fees and other from Merrimack Pharmaceuticals, outside the submitted work; in addition, Dr. Mendelsohn has a UCSD patent on Erbitux with royalties paid. Dr Meropol reports personal fees from biomotiv, outside the submitted work; in addition, Dr. Meropol has a US Patent Office 20020031515 “Methods of therapy for cancers characterized by over expression of the HER2 receptor protein” (expires May 14, 2021) issued and is an elected board member of the American Society of Clinical Oncology and Eastern Cooperative Oncology Group Research and Education Foundation. Dr Messinger reports personal fees from Jazz Pharmaceuticals and Sigma Tau, outside the submitted work, in both cases honorarium for one-time advisory board participation. Dr Press reports personal fees from Algeta and Roche/Genentech, and other from Emergent Biosolutions, PhaseRx, and Roche/Genentech, outside the submitted work. Dr Rugo reports other from Novartis, outside the submitted work. Dr Sekeres reports personal fees from Celgene, Boehringer-Ingelheim, Amgen, MEI, and Seattle Genetics, outside the submitted work. Dr Steensma reports personal fees from Celgene, Novartis, Genoptix, Amgen, Onconova, and from MEI Pharma, outside the submitted work. Dr Stewart received compensation from NGCN and George Washington University for speaking. Dr Stock reports personal fees from Amgen, Gilead, ADC Pharmaceutical, Sigma Tau, Up to Date, and American Society of Hematology, outside the submitted work. Dr Stone reports personal fees from Agios, Amgen, Abbvie, Arog, BMS, Celator, Celgene, Pfizer, Roche/Genetech, Karyopharm, and Merck, outside the submitted work. Dr Van Etten reports personal fees and other from Deciphera Pharmaceuticals, Sunesis Pharmaceuticals, Karyopharm Pharmaceuticals, and grants from Verastem, outside the submitted work. Dr Zelenet reports fees from Adaptive Biotechnologies Corp, Alissa Pharma, Amgen, Boehringer Ingelheim, Celgene, Clinical Care Options, Dr. Reddy's Laboratories, Genentech/Roche, Gilead, Hospira, Novartis, Onyx Pharmaceuticals, Pfizer, Sandoz, and Sanofi Aventis, outside the submitted work. The remaining authors report no competing interests.
Author Affiliations: Ayalew Tefferi, MD, S. Vincent Rajkumar, MD, Morie A. Gertz, MD, Robert A. Kyle, MD, Mayo Clinic, Rochester, MN; Hagop Kantarjian, MD, James Allison, Robert C. Bast, Jr, Jorge Cortes, MD, Isaiah J. Fidler, DVM, PhD, Emil Freireich, MD, Jordan Gutterman, Waun Ki Hong, Gabriel N. Hortobagyi, MD, John Mendelsohn, MD, Louise C. Strong, MD, Naoto T. Ueno, MD, PhD, Charles A. LeMaistre, MD, University of Texas MD Anderson Cancer Center, Houston; Lawrence H. Baker, DO, Theodore S. Lawrence, MD, PhD, University of Michigan, Ann Arbor; Jan L. Abkowitz, MD, H. Joachim Deeg, MD, Elihu Estey, MD, Gary H. Lyman, MD, MPH, University of Washington Medical School, Seattle; John W. Adamson, MD, University of California, San Diego School of Medicine, La Jolla; Ranjana Hira Advani, MD, Steven Coutre, Peter Greenberg, MD, Michael P. Link, MD, Saul A. Rosenberg, Stanford University School of Medicine, Stanford, CA; Karen H. Antman, MD, Boston University School of Medicine, Boston, MA; John M. Bennett, MD, University of Rochester Medical Center, Rochester, NY; Edward J. Benz, Jr, MD, George Peter Canellos, MD, George Q. Daley, MD, PhD, Daniel J. DeAngelo, Charles Fuchs, MD, MPH, Robert I. Handin, MD, Philip W. Kantoff, MD, David P. Steensma, MD, Richard Stone, Eric P. Winer, MD, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA; Nancy Berliner, MD, Robert I. Handin, MD, Brigham and Women’s Hospital, Boston, MA; Joseph Bertino, Rutgers Cancer Institute of New Jersey, New Brunswick; Ravi Bhatia, MD, Smita Bhatia, MD, Harry P. Erba, MD, PhD, University of Alabama at Birmingham; Deepa Bhojwani, MD, Children’s Hospital Los Angeles, Los Angeles, CA; Charles D. Blanke, MD, Oregon Health & Science University, Portland; Clara D. Bloomfield, MD, John C. Byrd, MD, Raphael Pollock, MD, PhD, Ohio State University Comprehensive Cancer Center, Columbus; Linda Bosserman, MD, Stephen Forman, MD, City of Hope Medical Foundation, Duarte, CA; Hal E. Broxmeyer, PhD, Lawrence H. Einhorn, MD, Indiana University School of Medicine, Indianapolis; Fernando Cabanillas, MD, Auxilio Cancer Center, Hato Rey, Puerto Rico; Bruce A. Chabner, MD, Gerardo Colon-Otero, MD, Massachusetts General Hospital, Boston; Asher Chanan-Khan, MD, James Foran, Mayo Clinic Cancer Center, Jacksonville, FL; Bruce Cheson, MD, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC; Bayard Clarkson, MD, Sergio Giralt, Clifford Hudis, MD, Ross Levine, MD, Martin S. Tallman, Anas Younes, MD, Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, New York, NY; Susan L. Cohn, MD, Harvey Golomb, MD, Samuel Hellman, MD, Richard A. Larson, MD, Wendy Stock, MD, MA, University of Chicago, Chicago, IL; Massimo Cristofanilli, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA; Walter J. Curran, Jr, MD, Fadlo R. Khuri, MD, Sagar Lonial, MD, Winship Cancer Institute of Emory University, Atlanta, GA; George Q. Daley, MD, PhD, Boston Children’s Hospital, Boston, MA; H. Joachim Deeg, MD, Gary H. Lyman, MD, MPH, Oliver Press, MD, PhD, Jerald Radich, MD, Brenda M. Sandmaier, Rainer Stone, Fred Hutchinson Cancer Research Center, Seattle, WA; Francisco J. Esteva, MD, PhD, New York University Langone Medical Center, New York City; James N. George, MD, University of Oklahoma Health Sciences Center, Oklahoma City; Paulo Marcelo Hoff, MD, Universidade de São Paulo, São Paulo, Brazil; Ronald Hoffman, Icahn School of Medicine at Mount Sinai, New York, NY; Mary Horowitz, MD, MS, Medical College of Wisconsin, Milwaukee; Jean Pierre Issa, MD, Temple University, Philadelphia, PA; Bruce Evan Johnson, MD, Lowe Center for Thoracic Oncology, Boston, MA; Kenneth Kaushansky, MD, Stony Brook University, Stony Brook, NY; David Khayat, MD, PhD, Pitié-Salpêtrière Hospital, Paris, France; Thomas J. Kipps, MD, PhD, Scott M. Lippman, MD, University of California, San Diego Moores Cancer Center, La Jolla; Margaret Kripke, Cancer Prevention and Research Institute of Texas, Austin; Maurie Markman, MD, Cancer Treatment Centers of America, Eastern Regional Medical Center, Philadelphia, PA; Neal J. Neropol, MD, University Hospitals Case Medical Center and Case Western Reserve University, Cleveland, OH; Yoav Messinger, MD, Children's Hospitals and Clinics of Minnesota, Minneapolis-St Paul, MN; Therese M. Mulvey, MD, Southcoast Centers for Cancer Care, Fairhaven, MA; Susan O’Brien, MD, Richard A. Van Etten, MD, PhD, University of California, Irvine; Roman Perez-Soler, Albert Einstein College of Medicine, Bronx, NY; Josef Prchal, MD, University of Utah, Salt Lake City; Kanti Rai, North Shore-LIJ Cancer Institute, New Hyde Park, NY; Jacob M. Rowe, Northwestern University Feinberg School of Medicine, Chicago, IL; Hope Rugo, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center; Carolyn D. Runowicz, MD, Florida International University Herbert Wertheim College of Medicine, Miami; Alan Saven, MD, Richard T. Silver, MD, Scripps Clinic Medical Group, La Jolla, CA; Andrew I. Schafer, MD, Weill Cornell Medical College, New York, NY; Charles Schiffer, Barbara Ann Karmanos Cancer Institute, Detroit, MI; Mikkael A. Sekeres, MD, MS, Cleveland Clinic, Cleveland OH; Lillian L. Siu, MD, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada; F. Marc Stewart, MD, Seattle Cancer Care Alliance, Seattle, WA; Michael Thompson, MD, PhD, Aurora Research Institute, Aurora Health Care, Milwaukee, WI; Julie M. Vose, MD, MBA, University of Nebraska Medical Center, Omaha; Peter H. Wiernik, MD, Dhc, Cancer Research Foundation, Bronx, NY.
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- Lowering the High Cost of Cancer Drugs—IVMayo Clinic ProceedingsVol. 91Issue 3
- PreviewThe astonishing cost of selected drugs to treat cancer1 also extends to medications used in the supportive care of patients with cancer. A recent phase 3 placebo-controlled study of liquid doxepin (a tricyclic antidepressant drug) for painful stomatitis related to cancer treatment found a highly significant benefit for doxepin.2 After the results of this study became available, I started to prescribe doxepin regularly for this indication. Initially, my patients had some problems with insurance denial because treatment of stomatitis with doxepin is not a US Food and Drug Administration–approved indication.
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- Lowering the High Cost of Cancer Drugs—IIMayo Clinic ProceedingsVol. 91Issue 3
- PreviewWe read with interest the article by Kantarjian and Rajkumar1 in the April 2015 issue of Mayo Clinic Proceedings in which the authors explored the main controversies surrounding the pricing of new innovative drugs, particularly drugs used in oncology and hepatology. Subsequently, in the August 2015 issue of the Proceedings, Tefferi and more than 100 cancer-specialist coauthors2 addressed the same issue by emphasizing that cancer patients' out-of-pocket expenses have dramatically increased over the past few years and that these price increases are unsustainable.
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- PreviewIn their commentary published in the August 2015 issue of Mayo Clinic Proceedings, Tefferi et al1 correctly argue that new cancer medicines in the United States are priced above international norms, at times prohibitively so. However, their recommendation that patients import cancer medicines for “personal use,” while pointing out that “prices in Canada are about half of prices in the United States,” is so fraught with danger as to be foolish.
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