The University of Florida College of Pharmacy Department of Pharmaceutical Outcomes & Policy PHA 5267: Critical Appraisal of Pharmacoeconomic Studies POP GRADUATE STUDENT SECTION Spring 2011 Friday 10:40 – 12:35pm Communicore C1-11 Course Coordinator & Instructor: Teresa L. Kauf, Ph.D., Associate Professor Office: HPNP 3338 Phone: (352) 273-6252 Email: tkauf@ufl.edu Office Hours: Combined office hours and question & answer sessions will be held via Elluminate on Wednesdays from 3 – 4:00pm (see below for more information). Otherwise, please email or phone to make an appointment. Course Description: A variety of technological and environmental factors are fueling continued increases in health care expenditures, including pharmaceuticals, in the United States and elsewhere. As a result, both public and private payers of health care have instituted various measures of cost containment, including the economic evaluation of pharmaceuticals, commonly referred to as “Pharmacoeconomics”. In this course, we will review decision making tools such as costeffectiveness and cost-benefit analysis and discuss their application to resource allocation, how these tools are used in practice, and what factors limit their use or interpretation. Why is this course important? Pharmacoeconomics techniques are becoming increasingly common in the medical and health outcomes literature and as a tool for health care decision making. Pharmacists, through their influence on drug therapy selection, must understand the tools of pharmacoeconomics so that such decisions will be made appropriately. Pharmacoeconomics is an important field of research within the pharmaceutical industry and the larger health care industry, and there are many career opportunities for pharmacists who wish to specialize in this field. Credit Hours = 1 1 Course Objectives: The primary objective of this course is to (1) introduce students to the fundamental methods of pharmacoeconomic analysis and (2) prepare them to read and interpret pharmacoeconomic studies. By the end of this course, students should have a working understanding of the tools for economic evaluation of pharmaceuticals and their use in decision making, including the following: Fundamental concepts behind rationing and economic evaluation of health care; The role of pharmacoeconomics in the drug development process and health care decision making; Strengths and weaknesses of standard pharmacoeconomic approaches available to assess the economic impact of pharmaceutical interventions, including costeffectiveness analysis, cost-utility analysis, cost-benefit analysis, and cost-minimization analysis; and The role of perspective in the selection of study parameters and their impact on study design, costs, and the interpretation of results. Students will be prepared to policy recommendations based on pharmacoeconomic information and constructively participate in the debate on health care rationing. Teaching Methods and Course Structure: This class will meet for 100 minutes on Fridays during 4th and 5th periods (10:40am – 12:35pm) for seven (7) weeks, beginning Friday, January 7, 2010. Attendance at the live lectures is encouraged, but not mandatory. Live lectures will employ the TurningPoint Classroom Student Response System (“clickers”). The clickers will be used in class to actively engage professional students through the use of general polling during discussions to gauge understanding of the material. Clickers will not be used for quizzes or other graded work. Graduate students are not required to purchase clickers for this course, although they are welcome to do so. For information on clickers, please visit the UF student guide on the TurningPoint ResponseCard RF Remotes. The final exam will be held on Thursday, February 24, 2010 from 4 – 6pm (Gainesville rooms TBD). Combined office hour and review sessions will be held via Elluminate on Wednesdays from 3 – 4pm, beginning January 12. These sessions will be recorded for students to view at a later date. Students may submit questions ahead of time to the instructor. Please email questions to kauf@cop.ufl.edu by noon the day of the session. Before joining an Elluminate session for the first time, please review this information. Point your browser to the UF Elluminate website at http://elm.elluminate.com/UniversityOfFlorida/index.html to sign in to meetings and view recorded meetings. Hint: use the search box to search for “PHA5267 Instructor Office Hours” to find the meeting. Or, you can point your browser directly to http://elm.elluminate.com/UniversityOfFlorida/join_meeting.html?meetingId=1247979228002. 2 Course Text and Resources: There is no required text for the course. No background knowledge of economics is necessary; however, some familiarity with basic economic principles such as supply and demand and marginal analysis will be helpful. If you are concerned about your preparation for this class, please contact the instructor. For those students who desire some background information prior to lecture, optional readings will be posted for each class. There are several introductory texts that cover the topics that will be discussed in the course; Essentials of Pharmacoeconomics, First Edition, by Karen L. Rascati (Philadelphia, PA: Wolters Kluwer, 2009) is recommended as a reference for students who would like additional practice. Relevant chapters from Rascati are listed in the Course Schedule but will NOT be posted to ELS due to copyright issues (with the exception of Chapter 3 which will be posted). If you are particularly interested in pharmacoeconomics and plan to take PHA6264 next year, you might consider purchasing a textbook for that class now. Although subject to change, the most recent textbook for the course is Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the Economic Evaluation of Health Care Programmes. Third Edition. Oxford University Press, 2005. There are a variety of other useful texts; please see the instructor to discuss which might best suit your needs. Some lectures will include content from published pharmacoeconomic analyses or related work, and these articles are required. In addition, a portion of the assignments for the class will rely on published articles. All required readings are listed in the Course Schedule and will be posted on ELS. Students without prior experience conducting literature searches in the area of pharmacoeconomics should read the module, “Searching the Published Economic Evaluation Literature,” and complete the exercise that follows it. Completion of the module and the associated exercise is completely voluntary and does not contribute directly to students’ grades. However, understanding where and how to look for pharmacoeconomic information may be helpful for completing course assignments. The module, the accompanying exercise, and an answer key are posted on the course website and can be completed at your leisure. Evaluation Techniques: Grades in this course will be based on weekly exercises, weekly current events discussion sessions (last 5 weeks of the semester only), a review paper, and a final exam as described below. All of the assignments will be posted on ELS. Weekly Exercises Weekly exercises will be posted on ELS after most lectures, for a total of five exercises. These individual assignments are designed to assess your understanding of the material covered in class and in the readings. At least some questions for each week’s assignment will draw upon a published pharmacoeconomic article. The exercises will be similar to those given to the professional students, but will be slightly more in-depth. Current Events Discussions Graduate students will meet with the instructor for an informal discussion of current events every Friday from 2 – 3pm, beginning on March 18 and ending on April 15, for a total of 5 sessions. The purpose of these sessions is to encourage students to consider the broader implications and applications of technology assessment. 3 Each graduate student shall identify a news item that is related to pharmacoeconomics and health technology assessment (either directly or indirectly). Items should be current (within the past 6 months) and should come from the general news media, not from scientific or professional journals. Students will provide a short (oral) introduction and then the implications of the piece will be discussed by the group. Finally, each student will submit a brief write-up summarizing the article and its implications. Detailed instructions are provided on ELS. Review Paper The final project for PHA5267 is a review paper that will build on the project proposals developed in the Intro to POP course, PHA6266. The objective of the paper is to establish the economic significance of your Intro to POP project by critically analyzing and interpreting the pharmacoeconomic literature related to it. For some topics, the economic implications will be relatively straightforward. In other cases, you may need to put some thought into it. Rest assured, if you can make a case that your topic is significant, that significance can be extrapolated into an economic argument. If you need help, come see me, and we’ll come up with something together. One purpose of this exercise is to practice describing the significance and value of your work. The other chief purpose of the project is to develop your critical appraisal skills. Your review of the existing pharmacoeconomic literature should recognize areas of general consensus or lack thereof and identify gaps in the literature. There are no page limits for this exercise. I imagine that most of your reports will be around 5 double-spaced pages, not counting references, tables, etc. Importantly, every statement in your paper should be written towards some purpose; that is, extraneous content that is not directly related to the exercise should be excluded. It may be useful to consult some general reviews of cost-effectiveness literature—even if outside your project area—to get a sense of how they are written and the types of information included in them. The journal, Pharmacoeconomics, publishes systematic reviews on a fairly regular basis. The review paper is due by 5pm on Friday, April 22. Final Exam Graduate students will take the same final exam as the professional students. The final exam will consist of multiple choice and true/false questions and will be held from 4 – 6pm on Thursday, 24 February 2011. The exam will cover all material presented in lecture, weekly exercises, and assigned readings. Grading Summary: Course grades will be determined as follows: Assignment Weekly Exercises Current Events Write-Up and Participation Review Paper Final Exam Total 4 Contribution 40% (5 exercises @ 8% each) 10% 25% 25% 100% Scores from each of the assignments will be combined to calculate the final grade. Letter grades will be assigned according to the following scheme*: A: B+: B: C+: C: D+: D: E: 90.0 – 100% 87.0 – 89.9 80.0 – 86.9 77.0 – 79.9 70.0 – 76.9 67.0 – 69.9 60.0 – 66.9 <60 * In accordance with the Faculty Senate resolution of December 14, 2006, the University of Florida’s grading scale will be changed to include minus grades effective the Summer 2009 term. To see the comparative chart depicting the changes to the official grading scale, see http://www.isis.ufl.edu/minusgrades.html or go to http://www.registrar.ufl.edu/catalog/policies/regulationgrades.html for more information. Late Assignment Policy All assignments are due by 5:00 pm Gainesville time on the due date specified in the course schedule. Late assignments that are submitted prior to the discussion of answers or publication of an answer key will receive one of the following: The class mean if the actual score is the mean or higher, or The actual score if the score is lower than the class mean.* Delays due to unforeseen and distressing events (e.g., serious illness, a death in the family, hardware/software failure) will be treated on a case-by-case basis by the instructor. Any assignment submitted after the publication of an answer key or discussion in class will receive a zero score, NO EXCEPTIONS. 5 Academic Honesty: The conduct of all students is expected to conform to the standards of academic integrity as described in the University of Florida Honor Code. In adopting this Honor Code, the students of the University of Florida recognize that academic honesty and integrity are fundamental values of the University community. Students who enroll at the University commit to holding themselves and their peers to the high standard of honor required by the Honor Code. Any individual who becomes aware of a violation of the Honor Code is bound by honor to take corrective action. Student and faculty support are crucial to the success of the Honor Code. The quality of a University of Florida education is dependent upon the community acceptance and enforcement of the Honor Code. The University of Florida Honor Code “We, the members of the University of Florida community, pledge to hold ourselves and our peers to the highest standards of honesty and integrity.” On all work submitted for credit by students at the University of Florida, the following pledge is either required or implied: “On my honor, I have neither given nor received unauthorized aid in doing this assignment.” Students should be aware that any use of resources other than those explicitly allowed on an assignment will be considered as academic dishonesty. Plagiarism, which occurs when another person’s work is used or copied without attribution, also will be considered academic dishonesty. All incidents of demonstrated or suspected academic dishonesty will be reported to the Associate Dean for Professional Affairs, and procedures regarding academic dishonesty will be enforced. Students who fail to apply a high level of academic integrity to all conduct related to this course risk receiving a failing grade. For more information about academic honesty and the University of Florida’s Honor Code, point your browser to the Dean of Students Office and Student Judicial Affairs at http://www.dso.ufl.edu/judicial/procedures/studenthonorcode.php. 6 Communication with Faculty: ELS will be used for most communications between the faculty and students. Check for new announcements at least once a day for any course updates. Email will also be used once in a while for mass communication to the class, so please check your email at least once a day as well. All emails sent out to the entire class will also be posted as an announcement on ELS. General questions about course content or policies should be posted to the discussion board. Students are expected to help each other track down answers as best as possible. When needed, the instructor and/or TAs will respond to posts. Just be sure you are not giving answers to any assignments as this is potential grounds for academic dishonesty. Read through all the other posts in the discussion board first before posting to make sure your question has not been addressed/answered already. Please include clear subjects for your post topics to make the subject your post pertains to clear to others. Discussion board postings and emails can easily be misinterpreted, so make sure your message is clear before sending it. Any posts/emails deemed inappropriate by the instructor and/or TAs will be dealt with on a case-by-case basis directly with the instructor or the Associate Dean for Professional Affairs. For personal issues/questions, please email the TA or the instructor directly. Be sure to include in the subject line the course number and a brief description (e.g., PHA5267 – Family emergency). This will allow coordinators to easily identify emails related to the course in amongst the plethora of junk and other emails that are received each day. Emails not properly addressed may get lost in the shuffle and unintentionally deleted or ignored, so be sure to follow the guidelines exactly. Accommodations for Students with Disabilities: Students requesting classroom accommodation must first register with the Dean of Students Office. The Dean of Students Office will provide documentation to the student who must then provide this documentation to the course instructor when requesting accommodation. Request for accommodation should be made at the beginning of the semester for exams or other assignments due during the semester. Faculty and Course Evaluations: Course and instructor evaluations are requirements for the successful completion of this course. Course and instructor evaluations must be completed, just as exams, papers, and assignments must be completed for you to receive credit for this course and all other courses in the College of Pharmacy. If you do not complete all required course and instructor evaluations by the last day of classes, you will receive an "I" or an incomplete grade for the semester because you have not completed all of the course requirements. See the College of Pharmacy Student/Faculty handbook and the UF undergraduate catalog in the Academic Regulations Section regarding policies and procedures for the conversion of "I" grades. 7 Course Schedule: Date Topic Readings Assignments* Course Overview & Introduction to Pharmacoeconomics Week 1 Jan 7 Required: Ubel & Goold (1998)—pp 209 – 210 only, Rascati Chapter 3 Optional: Rascati Chapter 1 or Bungay & Sanchez (2003) Measuring and Estimating Costs Week 2 Jan 14 Optional: Rascati Chapter 2 or Robertson et al (2003) Cost Effectiveness Analysis Week 3 Jan 21 Required: Doubilet et al (1986) Weekly Exercise 1: Costs Due Jan 20 Optional: Rascati Chapter 5 or Eisenberg (1989) Health-Related Quality of Life Week 4 Jan 28 Optional: Rascati Chapter 8 or Guyatt et al (1993) Weekly Exercise 2: CEA Due Jan 27 Cost Utility Analysis Week 5 Feb 4 Optional: Rascati Chapter 6 or Naglie et al (1997)—skip probabilities section Weekly Exercise 3: QOL Due Feb 3 Decision Analysis Week 6 Feb 11 Optional: Rascati Chapter 9 or Detsky et al (1997a, b)—just skim the second paper—or Briggs & Sculpher (1998)—skip sections 2.4 – 3) Weekly Exercise 4: CUA Due Feb 10 Cost Benefit Analysis, Net Monetary Benefit, and Sensitivity Analysis Week 7 Feb 18 Optional: Rascati Chapter 7 (skip bidding vehicles and IRR) or Hoch et al (2002)—just the introduction—or Briggs et al (1994) Week 8 Thurs, Feb 24 FINAL EXAM: 4 – 6:00pm. Rooms TBD. Week 11 Mar 18 Current Events Session Weekly Exercise 5: Dec Trees Due Feb 17 Evelyn, Jessica, Jean 8 Date Topic Readings Week 12 Mar 18 Current Events Session Xinyue, Monica, Hong Week 13 Mar 18 Current Events Session Salvatore, Amy, Danny Week 14 Mar 18 Current Events Session Wei, Hanah, Steven Week 15 Apr 15 Current Events Session Danijela, Irene, TBD Week 16 Apr 22 REVIEW PAPERS DUE: 5pm Assignments* * Weekly exercises are due by 5:00pm ET on the Thursday before class. Course Bibliography: Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy. Am J Health Syst Pharm. 2005 Aug 1;62(15):1596-605. Week 3 REQUIRED. Briggs A, Sculpher M, Buxton M. Uncertainty in the economic evaluation of health care technologies: The role of sensitivity analysis. Health Econ. 1994;3(2):95-104. Briggs A, Sculpher M. An introduction to Markov modeling for economic evaluation. PharmacoEconomics. 1998; 13(4): 397-409. Bungay KM, Sanchez LA. Types of economic and humanistic outcomes assessments. In: Pharmacoeconomics & Outcomes, 2nd Edition. 2003. Kansas City, MO: American College of Clinical Pharmacy. Detsky AS, Naglie G, Krahn MD, Naimark D, Redelmeier DA. Primer on medical decision analysis: Part 1—Getting started. Med Decis Making. 1997a Apr-Jun;17(2):123-5. Detsky AS, Naglie G, Krahn MD, Redelmeier DA, Naimark D. Primer on medical decision analysis: Part 2—Building a tree. Med Decis Making. 1997b Apr-Jun;17(2):126-35. Doubilet P, Weinstein MC, McNeil BJ. Use and misuse of the term “cost-effective” in medicine. New Eng J Med (1986); 314(4): 253-6. Eisenberg JM. Clinical economics: A guide to the economic analysis of clinical practices. JAMA 1989; 262(20):2879-86. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622-9. 9 Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: A framework for the marriage of health econometrics and cost-effectiveness Health Econ. 2002; 11 (5): 415-30. Hughes DA, Vilar FJ, Ward CC et al. Cost-effectiveness analysis of HLA B*5701 genotyping in preventing abacavir hypersensitivity. Pharmacogenetics. 2004 June;14(6):335-342. Week 6 REQUIRED. Khalid AN, Quraishi SA, Hollenbeak CS, Stack BC Jr. Fine-needle aspiration biopsy versus ultrasound-guided fine-needle aspiration biopsy: cost-effectiveness as a frontline diagnostic modality for solitary thyroid nodules. Head Neck. 2008 Aug;30(8):1035-9. Week 5 REQUIRED. Mark DB, Hlatky MA, Califf RM et al. Cost effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction. New Engl J Med. 1995; 332(21):1418-24. Week 4 REQUIRED. Naglie G, Krahn MD, Naimark D, Redelmeier DA, Detsky AS. Primer on medical decision analysis: Part 3—Estimating probabilities and utilities. Med Decis Making. 1997 AprJun;17(2):136-41. Robertson J, Lang D, Hill S. Use of pharmacoeconomics in prescribing research. Part 1: costs-moving beyond the acquisition price for drugs. J Clin Pharm Ther. 2003 Feb;28(1):73-9. Sullivan PW, Arant TW, Ellis SL, Ulrich H. The Cost Effectiveness of Anticoagulation Management Services for Patients with Atrial Fibrillation and at High Risk of Stroke in the US. Pharmacoeconomics. 2006;24(10):1021-33. Week 7 REQUIRED. Ubel PA, Goold SD. ‘Rationing’ health care: Not all definitions are created equal. Archives Int Med 1998; 158(3):209-14. 10