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Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies

  • Alexander C. Egilman
  • Joshua D. Wallach
  • Sanket S. Dhruva
  • Gregg S. Gonsalves
  • Joseph S. RossEmail author
Concise Research Reports

INTRODUCTION

The United States (US) spends more on prescription medications than any other country.1 Many countries have created a central health technology assessment (HTA) agency to analyze available evidence on clinical safety and efficacy, as well as cost-effectiveness, of approved medical products and then recommend whether they should be covered by their respective national health program, including Australia (Pharmaceutical Benefits Advisory Committee [PBAC]), Canada (Canadian Agency for Drugs and Technologies in Health [CADTH]), and England (National Institute for Health and Care Excellence [NICE]). In contrast, the US has no single national health program and HTA is fragmented across several uncoordinated public and private initiatives.2The Centers for Medicare and Medicaid Services (CMS), which administers Medicare, the US’ largest publicly funded health insurance program, makes both local and national coverage determinations but is statutorily prohibited from considering...

Notes

Contributors

All authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. ACE and JSR contributed to study concept and design; ACE abstracted the data; JDW and SSD verified the data; all authors contributed to the analysis and interpretation of the data; ACE drafted the manuscript; all authors contributed to the critical revision of the manuscript; and JSR provided study supervision. The corresponding author affirms that he has listed everyone who contributed significantly to the work.

Funding

This project was conducted as part of the Collaboration for Research Integrity and Transparency (CRIT) at Yale, funded by the Laura and John Arnold Foundation, which supports Mr. Egilman and Drs. Wallach, Gonsalves, and Ross. Dr. Dhruva is supported by the National Clinician Scholars Program and the Department of Veterans Affairs.

Compliance with Ethical Standards

Conflict of Interest

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: In the past 36 months, Dr. Wallach has received research support through the Meta Research Innovation Center at Stanford (METRICS) from the Laura and John Arnold Foundation; Dr. Gonsalves has received research support from the National Institutes of Mental Health (R01MH105203) and the National Institute on Drug Abuse (R01DA015612); and Dr. Ross has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. In addition, Dr. Ross serves as an ad hoc member of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Mr. Egilman and Dr. Dhruva have no additional potential competing interests to disclose.

Disclaimer

The Laura and John Arnold Foundation played 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. The authors assume full responsibility for the accuracy and completeness of the ideas presented, which do not represent the views of the Department of Veterans Affairs or any other supporting institutions.

References

  1. 1.
    Sarnak DO, Squires D, Kuzmak G, Bishop S. Paying for Prescription Drugs Around the World: Why Is the U.S. an Outlier? The Commonwealth Fund. 5 October 2017. Available at: http://www.commonwealthfund.org/publications/issue-briefs/2017/oct/prescription-drug-costs-us-outlier. Accessed May 9, 2019.
  2. 2.
    Luce B, Cohen RS. Health technology assessment in the United States. Int J Technol Assess Health Care. 2009 Jul;25 (Suppl 1):S33–41.CrossRefGoogle Scholar
  3. 3.
    Neumann PJ, Rosen AB, Weinstein MC. Medicare and Cost-Effectiveness Analysis. N Engl J Med. 2005 Oct 6;353(14):1516–22.CrossRefPubMedGoogle Scholar
  4. 4.
    Hoadley J, Cubanski J, Neuman T. Medicare Part D in 2016 and Trends over Time. Henry J. Kaiser Family Foundation. 16 September 2016. Available at: https://www.kff.org/report-section/medicare-part-d-in-2016-and-trends-over-time-section-1-part-d-enrollment-and-plan-availability/. Accessed May 9, 2019.
  5. 5.
    Centers for Medicare and Medicaid Services. Medicare Part D and Part B Spending Data. Available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartD.html. Accessed May 9, 2019.

Copyright information

© Society of General Internal Medicine 2019

Authors and Affiliations

  • Alexander C. Egilman
    • 1
    • 2
  • Joshua D. Wallach
    • 1
    • 2
    • 3
  • Sanket S. Dhruva
    • 4
  • Gregg S. Gonsalves
    • 1
    • 5
  • Joseph S. Ross
    • 1
    • 2
    • 6
    • 7
    • 8
    Email author
  1. 1.Collaboration for Research Integrity and TransparencyYale Law SchoolNew HavenUSA
  2. 2.Center for Outcomes Research and Evaluation (CORE)Yale New Haven HospitalNew HavenUSA
  3. 3.Department of Environmental Health SciencesYale School of Public HealthNew HavenUSA
  4. 4.Department of Medicine, University of CaliforniaSan Francisco School of MedicineSan FranciscoUSA
  5. 5.Department of Epidemiology of Microbial DiseasesYale School of Public HealthNew HavenUSA
  6. 6.Section of General Medicine, Department of Internal MedicineYale School of MedicineNew HavenUSA
  7. 7.Department of Health Policy and ManagementYale School of Public HealthNew HavenUSA
  8. 8.National Clinician Scholars Program, Department of Internal MedicineYale School of MedicineNew HavenUSA

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