HSSP : Innovations in Health Care: Managing the Benefits and Costs of New Drugs and Other
Brandeis University
Program in Health Science Society and Policy
HSSP 107b: Health care technology and its assessment
Tuesday & Friday, 12:30-1:50
SYLLABUS SPRING 2018
Professor: Cindy Parks Thomas, Schneider Bldg Rm 216 x63921 ()
Office hours: By appointment.
Administrator: Wendy Colnon ()
Course Overview
Medical technology is defined as the drugs, devices, procedures and services that are a foundation of medical practice. While advances in medical technology have transformed the potential to diagnose and manage disease and disability, there are critical issues that arise as they are incorporated, such as escalating costs, risks, and equitable access to expensive new therapies. This course will provide an overview of the role of new medical technology in the U.S. health care system, with a focus on technology assessment, prescription drugs and the industry in which they are developed and marketed, with a focus on learning through case studies. Students learn to evaluate the impact of new pharmaceutical and other technological advances on the health care system, their promise for the future, and the inherent costs and risks. Guest lecturers will present perspectives from industry, clinical experience, and research, on new health care technologies, assessment and use.
This course will be divided into several segments. The first section of the course (weeks 1-3) will be devoted to developing an understanding of medical technology and its role in health care practice, how it is disseminated, and why innovation is an important driver of the health care system. This segment will address health policy issues that are relevant to evaluating, monitoring, and managing medical technologies in the U.S. and other health care systems. The next segment (weeks 4 -6) will include sessions on methods of evaluating new technologies, such as cost-benefit and cost-effectiveness analysis, comparative effectiveness, pharmaco-epidemiology, economic models, and examples of the application of these methods.
The second half of the course (weeks 8-12) will focus on issues specific to prescription drug policy, building upon the tools and ideas developed in the first half of the course, and will include a series of guest speakers. Sessions will be held on the complex market for prescription drugs and the many stakeholders; clinical and non-clinical factors motivating prescribing decisions (such as advertising); issues regarding research, development and drug pricing; the value of prescription drugs in offsetting the cost of other medical care services and improving health outcomes; risks of new medications; the role of managed care and other organizational types including management innovations such as e-prescribing; special issues regarding seniors and the Medicare prescription drug benefit; the promise of biotechnology and the issue of rationing. The final sessions will be devoted to looking forward to what a future health system may look like and may require in terms of regulation, financing, and organization. Case studies of particular medical technologies and other special issues will be interspersed with other readings.
Course objectives
Students shall develop an understanding of the critical role that new technologies play in the medical care system, both in the U.S. and elsewhere. The class will learn how new technologies, particularly prescription drug innovations, are incorporated into practice, and techniques used to evaluate these innovations in terms of value to clinical practice and to society. Students will become familiar with the issues related to the prescription drug market and industry, and why medications are valued and priced as they are. Also, students will learn the importance of public and private policies designed to manage and monitor new prescription drugs and other medical technologies as they are incorporated into medical practice.
Course requirements and grading: Specific instructions for paper and class requirements are provided separately
- Class attendance and participation: 25%
Class participation includes active participation in discussion, and/or posting on the class forum regularly. This also includes occasional assignments to bring new technology articles to class. You must notify the professor if you are going to miss a class, and you may be required to provide a one page summary of the readings.
- Homework: 25%
Three times during the semester, once prior to February vacation and twice after, you will be required to submit a one-page comment paper, related to the readings of through that day, or response to specific reading questions provided in advance. These must be submitted on line prior to the class in which they are due.
- Two in-class exams: 25%
Short essays, to assess learning of foundational material.
- Technology assessment term paper: 25%
10-12 page paper assessing your choice of new technology. Guidelines will be provided on separate page.
If you are a student with a documented disability on record at Brandeis University and wish to have reasonable accommodations made for you in class, please see the instructor immediately.
Required Textbook:
Robinson, James C. Purchasing Medical Innovation. Oakland: University of California Press, 2015.
Course readings will be made available to students through Latte, and reference copies of texts will be made available.
Course outline:
1/12/18 Session 1: Introduction to health care technology / overview of course
Introduction. Defining technology/ innovation. Course overview, expectations, goals and requirements.
Readings:
Fuchs VR. How and why US health care differs from that in other OECD countries. JAMA. 2013;309(1):33-4.
NY Times: The upshot: In forecasting health care costs, let technology be your guide. March 9, 2015.
1/16/18 Session 2: Adopting new medical technology and its role in the U.S. health care system
Required readings:
Text Introduction, pages 1-18.
Rosenthal, E. The Odd Math of Medical Tests: Two tests, both high. The New York Times, December 16, 2014.
Hofman BM. Too much technology. The British Medical Journal. 2015. 350:1-7.
Reference:
Backgrounder (good referece but dated): Kaiser Family Foundation. How changes in medical technology affect health care costs. March 2007. Available at:
1/19/18 Session 3: Development and regulation of innovations – medical devices
Required readings:
Text, Chapter 1, pages 19-40.
Faris and Shuren. An FDA Viewpoint on Unique Considerations
for Medical-Device Clinical Trials. The New England Journal of Medicine 2017; 76:1350-7.
FDA case study: Bringing coronary stents to market: FDA, June 2014.
1/23/18 Session 4: FDA and drug development
Required readings:
Hamburg M. Shattuck Lecture: Innovation, Regulation, and the FDA. The New England Journal of Medicine 2010;363(23):2228-32.
Bothwell LE et al. Assessing the Gold Standard — Lessons from the History of RCTs. The New England Journal of Medicine 2016; 374(22):2175-2181.
FDA case study: Lowagliflozin, a new diabetes drug applying for FDA approval.
FDA Center for Drug Evaluation Research, September 2015.
Reference/ Supplemental:
Borchers AT et al. The history and contemporary challenges of the Food and Drug Administration. Clinical Therapeutics, 2007.
Kesselheim A. Drug development and approval infographic, New England Journal of Medicine 2014;370(39). http://www.nejm.org.resources.library.brandeis.edu/doi/full/10.1056/NEJMp1402114
1/26/18 Session 5: Insurance coverage and reimbursement for new technology
Required readings:
Text, Chapter 2, pages 41-58.
Case study: Fiorentino DM and King AB. Medicare Payment Cuts For Osteoporosis Testing Reduced Use Despite Tests’ Benefit In Reducing Fractures. Health Affairs 20(12), December 2011. (
1/30/18 Session 6: Paying for new technologies
Required readings:
Text, Chapter 3, pages 59-78.
Shih and Berliner, Diffusion of new technology and payment policies: Coronary Stents. Health Affairs 2008:27(6):1566-1576.
2/2/18 Session 7: Technology adoption in organizations: The hospital
Required readings:
Text, Chapters 4 and 5, pages 79-119.
Bring laptops for case study / class exercise of hospital technology adoption.
2/6/18 Session 8: Disruptive innovation – The surgical checklist and class exercise
Required readings:
Conley DM. Effective surgical checklist implementation. Journal of the American College of Surgeons 2011;212:873–879.
Christensen C. Will disruptive innovations cure health care? Harvard Business Review 2000.
2/9/18 Session 9: International - management of technology in other health systems
Required readings:
Case study: Exubera® and NICE
Steinbrook R. Saying No Isn’t NICE — The Travails of Britain’s
National Institute for Health and Clinical Excellence. The New England Journal of Medicine 2008;359(19):2577.
Background/ Reference / Supplemental:
Squires D. The Commonwealth Fund. Explaining High Health Care Spending
in the United States: An International Comparison of Supply, Utilization,
Prices, and Quality.
The Commonwealth Fund. International Profiles of Health Care Systems, 2017.
2/13/18 Session 10: Disparities and healthcare technology – health IT
Required reading:
Case Study Report: Howard University Hospital Diabetes Treatment Center – using multi-modal health IT tools to improve quality and delivery of care in an urban setting, June 2012.
Background/Reference:
Understanding the Impact of Health IT in Underserved Communities and those with Health Disparities. Briefing paper for the US Department of Health and Human Services, October 29, 2010.
2/16/18 Session 11: Exam
****Vacation: February 17-February 25****
2/27/18 Session 12: Deciding on technology in the hospital: Dr. Baggins
Required readings:
Case study: Dr. Baggins and the cardiac catheterization lab (posted on latte)
3/2/18 Session 13: OPEN Friday to explore options for technology policy paper
Section 2: Methods of technology assessment and pharmacoeconomics: cost benefit and cost effectiveness analyses
3/6/18 Session 14: Intro to technology assessment, cost effectiveness, cost benefit analysis: techniques; measuring costs
Required readings:
Neuman P. Costing and Perspective in Published Cost-Effectiveness
Analysis. Medical Care Volume 47, Number 7 Suppl 1, July 2009: S28-S32.
Pharmacoeconomics, Chapters 3-4 (on Latte)
Background:
3/9/18 Session 15: Measuring cost effectiveness of drugs – outcomes and case study
Required readings:
Pharmacoeconomics, Chapter 5.
CEA case and in-class analysis: Semel et al, Adopting A Surgical Safety Checklist Could Save Money And Improve The Quality Of Care In U.S. Hospitals. Health Affairs 2010; 29(9):1593-1599.
3/13/18 Session 16: CEA case study of value of two innovations
Required readings:
CEA case study: Quality-Adjusted Cost Of Care: A Meaningful Way To Measure Growth In Innovation Cost Versus The Value Of Health Gains. Health Affairs 2015; 34 (4): 555–561.
3/13/18 Session 16: ****Exam ****
Section 3: Prescription drugs: Industry, innovation, and special issues
3/16/18 Session 17: Pharmaceuticals as health technology – an introduction
Required readings:
Getz K, Kaitin K. Open innovation: the new face of
pharmaceutical research and development. Expert Rev. Clin. Pharmacol. 5(5), 481–483 (2012).
Kaitin K, DiMasi J. Pharmaceutical Innovation in the 21st Century:
New Drug Approvals in the First Decade, 2000–2009. Clinical pharmacology & Therapeutics 89(2), Feb 2011:183-187.
Reference: US Assistant Secretary for Planning and Evaluation (ASPE)
Observations on Trends in Prescription Drug Spending 2016 https://aspe.hhs.gov/pdf-report/observations-trends-prescription-drug-spending
3/20/18 Session 18: Pharmaceutical industry and prices
Required readings:
Health Affairs Health Policy Brief Series 12: Prescription drug pricing. Pharmacy Benefits Managers.
Kanavos P et al. Higher US Branded Drug Prices And Spending Compared To Other Countries May Stem Partly From Quick Uptake Of New Drugs. Health Affairs 2013; 32(4): 753–761.
3/23/18 Session 19: Drug pricing case study: The case of specialty drugs for Hepatitis C
Required readings:
Case study: Gilead: Hepatitis C– Sovaldi
Selected pages US Senate committee report on Gilead pricing of Sovaldi (see Latte)
Reference:
Chambers JD et al. Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs. Health Affairs 2014 (October); 33(10):1751-1760.
3/27/18 Session 20: Managing the cost of drugs: Overview of demand and supply side approaches and their impact on drug utilization.
Case study: Medicare Part D (bring laptops to class)
Required readings:
Hoadley J, Cubanski J, Neuman T. Medicare’s Part D Drug benefit at 10 years. Health Affairs 2015; 34(10):1682-1687.
Health Affairs Policy Brief 11: Formularies.
****Vacation: March 30-April 8****
4/10/18 Session 21: Direct to consumer advertising: Promotion or public service?
Class assignment: Bring in drug advertisements (or post link). We will analyze selected ads in class.
Required readings:
Donohue J. A history of drug advertising: The evolving roles of consumers and consumer protection. The Milbank Quarterly 2006;84(4):659-663; 673-683; 685-691.
Greene JA and Kesselheim AS. Pharmaceutical marketing and the new social media. New England Journal of Medicine. 2010 Nov 25;363(22):2087-9.
4/13/18 Session 22: Vaccines and public health: The case of HPV vaccine
Required reading:
Case study: To vaccinate or not to vaccinate: The story of Hamilton, Columbia [a hypothetical US State].
Roles will be assigned for class debate.
4/17/18 Session 23: Health information technology and advances in data capabilities
Required readings:
Washington V et al. The HITECH Era and the Path Forward. The New England Journal of Medicine 2017; 377(10):904-906.
Halamka J and Tripathi M. The HITECH era in retrospect. The New England Journal of Medicine 2017; 377(10):907-909.
Reference: Office of the US National Coordinator. Adoption of EHRs by physicians. https://www.healthit.gov/sites/default/files/briefs/oncdatabrief28_certified_vs_basic.pdf
4/20/18 Session 24: Genomics and testing: The case of 23 and me
Required readings:
Case study: 23 and Me: Genetic testing for consumers.
4/24/18 Session 25: Social media, apps and health
Required readings:
Case study: American Well: The doctor will E-see you now.
Social media article/case.
4/25/18 Session 26: Homework due: Selected questions to be assigned to prepare for discussion
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