Brandeis University
Program in Health Science Society and Policy
HSSP 107b: Health care technology and its assessment
Tuesday & Friday, 12:30-1:50, Room Schneider G1
SYLLABUS
**PROVISIONAL SCHEDULE PENDING GUEST LECTURE CONFIRMATION**
SPRING 2016
Professor: Cindy Parks Thomas, cthomas@brandeis.edu
Office hours: By appointment.
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, pharmacoepidemiology, 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
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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
1. Class attendance and participation: 25%
Class participation includes active participation in discussion, and/or posting on the
class forum regularly.
2. Homework: 20%
Twice during the semester, once prior to February vacation and once after, you will
be required to submit a one-page problem set, related to the readings of that day.
These are due prior to the class in which they are due.
3. In-class mid-semester exam: 25%
Short essay, to assess learning of foundational material.
4. Technology assessment paper: 30%
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.
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Course outline:
1/15/16 Section 1: Introduction to health care technology / overview of course
Introduction to the course. Defining technology/innovation, and its role in the
health care system; Course overview, goals and requirements.
Background:
Fuchs VR. How and why US health care differs from that in other OECD
countries. JAMA. 2013;309(1):33-4.
1/19/16 Session 2: Value: Adopting new medical technology and its role in the health care
system
Required readings:
Text Introduction, pages 1-18.
Blue Cross Blue Shield, A Study of Cost Variations for Knee and Hip Replacement
Surgeries in the U.S., January 2015.
Rosenthal, E. The Odd Math of Medical Tests: Two tests, both high. The New
York Times, December 16, 2014.
http://www.nytimes.com/2014/12/16/health/the-odd-math-of-medical-testsone-echocardiogram-two-prices-both-high.html?_r=0
Backgrounders/ Reference/ Supplemental:
Kaiser Family Foundation. How changes in medical technology affect health care
costs. March 2007. Available at:
http://www.kff.org/insurance/snapshot/chcm030807oth.cfm
Congressional Budget Office. Technological change and the growth of health
care spending. January 2008. Available at:
http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/89xx/doc8947/01-31techhealth.pdf
1/22/16 Session 3: Development and regulation of innovations
Required readings:
Text, Chapter 1, pages 19-40
FDA case study: Bringing coronary stents to market: FDA, June 2014
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1/26/16 Session 4: FDA and drug development
Required readings:
FDA case study: Lowagliflozin, a new diabetes drug applying for FDA approval.
FDA Center for Drug Evaluation Research, September 2015.
Reference/ Resources / Supplemental :
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/NEJMp14
02114
Borchers AT et al. The history and contemporary challenges of the Food and
Drug Administration. Clinical Therapeutics, 2007.
1/29/15 Session 5: Insurance coverage and reimbursement for new technology
Required readings:
Text, Chapter 2,pages 41-58.
Medicare Payment Cuts For Osteoporosis Testing Reduced Use Despite Tests’
Benefit In Reducing Fractures
(http://content.healthaffairs.org/content/30/12/2362)
2/2/16 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.
2/5/16: Session 7: Technology adoption in organizations: the hospital
Required readings:
Text, Chapter 5, pages 100-119. Bring laptops for case study of hospital
technology adoption.
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2/9/16 Session 8: Guest speaker: Dr. Jon Chilingerian: Case study of technology adoption
Required readings:
Dr. Baggins and the cardiac cath lab
2/12/16 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:
The Commonwealth Fund. International Profiles of Health Care Systems, 2013.
http://www.commonwealthfund.org/~/media/files/publications/fundreport/2013/nov/1717_thomson_intl_profiles_hlt_care_sys_2013_v2.pdf
****Vacation: February 13-February 21****
2/23/16: Session 10: Policies regarding public health innovations: The case of HPV vaccine
Required reading:
Case study: To vaccinate or not to vaccinate: The story of Hamilton, Columbia [a
hypothetical US State].
2/26/16: Session 11: Disparities and healthcare technology
Required reading:
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.
Case Study Report: Howard University Hospital Diabetes Treatment Center – using multimodal health IT tools to improve quality and delivery of care in an urban setting, June
2012.
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Section 2: Methods of technology assessment and pharmacoeconomics: cost benefit and
cost effectiveness analysis
3/1/16 Session 12: 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:
http://www.nytimes.com/2014/12/16/upshot/forbidden-topic-in-health-policydebate-cost-effectiveness.html?partner=rss&emc=rss&abt=0002&abg=0&_r=0
3/4/16 Session 13: Guest lecture: Sarah Emond, COO Institute for Clinical and Effectiveness
Research
Required readings: To be added.
3/8/16 Session 14: Measuring cost effectiveness of drugs – outcomes and case study
Required readings:
Pharmacoeconomics, Chapter 5.
CEA Case study: Cost effectiveness of thrombolytic therapy with tissue
plasminogen activator as compared with streptokinase for acute myocardial
infarction. New England Journal of Medicine 1995; 332:1418-24.
3/11/16: Session 15: 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 34,
NO. 4 (2015): 555–561.
3/15/16: Session 16: Review of materials to date for exam
3/18/16: Session 17: Midterm exam
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Section 3: Prescription drugs: Industry, innovation, and special issues
3/22/16: Session 18: Pharmaceuticals as health technology - intro to the prescription drug
industry
Required readings:
Kaiser Family Foundation. Drug Trends 2010 Factsheet. Available at:
http://www.kff.org/rxdrugs/upload/3057-08.pdf.
3/29/16 Session 19: Drug pricing: the case of Solvadi for Hepatitis C
Required readings:
Case study: Gildead: Hepatitis C Access Strategy – Solvadi
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. http://content.healthaffairs.org/content/33/10/1751.short
4/1/16 Session 20: The pharmaceutical industry.
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.
4/5/16 Session 21: Direct to consumer advertising: Promotion or public service?
Class assignment to bring in drug advertisements (or post link). Will analyze selected ones 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.
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Greene JA and Kesselheim AS. Pharmaceutical marketing and the new social
media. New England Journal of Medicine. 2010 Nov 25;363(22):2087-9.
4/8/16: Session 22: 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:
J Blum, Kaiser Family Foundation Issue Brief, Medicare Prescription Drug
Benefit.
4/12/16: Session 23: Medicalizing disease, and cognitive enhancement: The case of mental
health medications and boundaries of well-being; case study of Adderal.
Required readings:
New York Times, The Selling of Attention Deficit Disorder. December 14, 2013.
http://www.nytimes.com/2013/12/15/health/the-selling-of-attention-deficitdisorder.html
Greeley, H. Toward responsible use of cognitive-enhancing drugs by the healthy.
Nature. December 7, 2008.
O’Brien PM, Thomas CP et al. The diminished pipeline for drugs to treat mental
health and substance use disorders. Psychiatric Services 2014; 65(12):14331438.
Supplemental:
New York Times. Attention Disorder or Not, Pills to Help in School. October 2012.
Available at:http://www.nytimes.com/2013/05/01/us/colleges-tackle-illicit-useof-adhd-pills.html?hp&_r=1&
4/15/16: Session 24: Prescribing and pain management: use and abuse of medications: public
health problems and solutions. Controlled medications: pain relief, misuse,
and abuse
Required readings:
To be added.
4/19/16 Session 25: Social media and health.
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Required readings:
Case study: American Well: The doctor will E-see you now.
Hawn C. Take two aspirin and tweet me in the morning: how Twitter, Facebook,
and other social media are reshaping health care. Health Affairs.
2009;28(2):361-8.
4/22/16: Session 26: Genomics and testing: The case of 23 and me
Required readings:
Case study: 23 and Me: Genetic testing for consumers.
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