Pharmacoeconomic and Outcomes Fellowship Guidelines

1. Pharmacoeconomic and Outcomes Fellowship Guidelines ISPOR and ACCP Joint Statement ISPOR Annual Meeting May 22, 2007

2. Task Force Group Leaders • Alan Bakst,Pharm.D., MBA • Senior Director, Health Economics and Reimbursement • Baxter International • Employer Group Leader • Sandra Kane-Gill, Pharm.D., M.S. • Asst. Prof., U. of Pittsburgh School of Pharmacy • Educator Group Leader • Prabashni Reddy, Pharm.D., M.S. • Director, Clinical Outcomes Research • ABT Associates • Consulting/Consumer Group Leader • Shiraz Gupta, Pharm.D., M.P.H. • Fellow, HEOR-UIC/TAP Pharmacoeconomic Fellowship • Survey Manager and Analyst

3. Program Agenda • Introduction and History of PE Guidelines • Preparation of Survey and Survey Method • Training Program Requirements, Qualifications of Training Site, Fellowship Applicant Criteria • Fellowship Experience, Evaluation of Fellow, Preceptor and Program • Concluding Remarks and open discussion

4. Why PEOR Fellowship Guidelines? • Field of pharmacoeconomics and health outcomes research is growing rapidly. • Researchers and consumers of PEOR data require skills to perform PEOR research and interpret results for decision making about adaptation of new health technologies.

5. Why PEOR Fellowship Guidelines? • Candidates interested in the PEOR field come from multiple disciplines. Providing a recommended framework for core didactic coursework and experiential training may be valuable for people seeking entry to the field.

6. Why PEOR Fellowship Guidelines? • Organizations and sponsors interested in providing training in PEOR can utilize guidelines to develop their programs • Professional organizations may utilize guidelines to accredit PEOR fellowships • Employers in field can feel comfortable in the expertise provided by person completing a fellowship.

7. Why PEOR Fellowship Guidelines? • Assists candidates in evaluating and comparing training programs

8. History of PEOR Fellowship Guidelines • 1999 Am. College of Clinical Pharmacy issues a Position Statement on Guidelines for PE Research Fellowships • Pharmacotherapy 1999;19(9):1105-1109 • May 1998 ISPOR position statement on Standards for fellowship training in pharmacoeconomics and outcomes research. • Vittorio Maio, Jennifer Lofland, Tammy Girts, David Nash, and others who have surveyed PE fellowship programs, preceptors and fellows, and described their findings in publications (Am. J. Pharm.Ed. 2003;67 (3) )

9. Task Force Survey Objectives • 1) Understand how current PEOR researchers and consumers of health outcomes information valued PEOR fellowship programs in terms of: • qualifications of the training site, program, and preceptor(s), • fellowship applicant requirements, • research commitment, • didactic coursework • evaluation of fellow’s research skills • 2) Develop PEOR fellowship guidelines based on information attained from the survey.

10. Survey Development Timeline • October 2006 • Task Force Leader Group Draft Survey Preparation • November 2006 • Discussions of Draft Survey with Working Groups • December 2006 • Finalization of Survey and Dissemination via Survey Monkey • January 2007 • Reminders sent to Survey Respondents and non-Respondents mid month • Survey Closed at end of month • February 2007 • Tabulation and Preparation of Results • March 2007 • Manuscript Preparation

11. Survey Design • Responder Information (organization membership and practice area) • 6 Sections, 28 questions • Qualifications of the Training Site • Qualifications of the Program • Qualifications of the Preceptor(s) • Requirements of Fellowship Applicants • Research Experience Criteria • Evaluation of Fellows Research Skills

12. Survey Availability • Email link to SurveyMonkey.com • Open from Dec. 31, 2006 – Jan. 31, 2007 • Respondents and non-respondents were sent 2 reminders: • Jan. 15, 2007 • Jan. 29, 2007

13. Survey Respondents • ISPOR Fellowship Task Force • ACCP Outcomes and Economics Practice Research Network (PRN) • 280 Total Survey Recipients • 117 Total Survey Respondents • 42% Response Rate

14. Analysis of Data • Response frequencies calculated as percentage of total responses per question • Free-text response data incorporated in discussion sections of guidelines

15. Training Program Requirements • A minimum of 3,000 hours (approximately 75%) of the fellowship training time should be devoted to PEOR research-related activities over a minimum period of two years. • Develop a documented training plan with goals and objectives prior to starting the fellowship.

16. Training Program Requirements • Availability of advanced educational opportunities in research-related topics. • Ready access to personnel that teach and use research skills. • Have a team of preceptors however fellow assigned one preceptor to be an advisor to oversee the fellow’s training and fellowship experience.

17. Qualifications of Site • Demonstrate capabilities in performing PEOR through publications, presentation at scientific meetings or through known collaboration with organizations producing PEOR. • Direct or indirect access to healthcare information providing fellow with data to perform PEOR. • Appropriate facilities to conduct research

18. Qualifications of Site • Administrative support for the preceptor’s research program and the fellowship training program. • Ready access to a medical library or electronic access to medical literature as well as computing facilities. • Access to other sites to provide fellow with experience in multiple practice environments

19. Preceptor Qualifications • Established and ongoing record of independent research accomplishments and expertise in the area of PEOR through • Fellowship training, a graduate degree and/or equivalent experience • Principal or primary investigator on research grants and/or projects • Published research papers in the peer-reviewed scientific literature on which the preceptor is the primary or senior author

20. Preceptor Qualifications • Didactic training in research methods and PEOR. • Prior experience training fellows and/or other individuals in PEOR. • Active collaborative research relationship with other health outcomes researchers or organizations.

21. Fellowship Experience • The fellow should demonstrate proficiency in multiple aspects of a PEOR fellowship through participation in one or multiple studies during their training. These may include: • Literature reviews • Dossier development • Prospective studies • Retrospective studies • Economic modeling • Patient reported outcomes • The fellow should actively participate in all aspects of research through a combination of didactic and on the job training including: • Study design • Study implementation • Data collection • Data analysis • Research program management • Reporting

22. Fellowship Experience • The fellow should develop an understanding of multiple aspects of clinical outcomes through a combination of didactic and on the job training that includes: • Clinical markers (e.g., BP, LDL, glucose) of disease • Impact of disease on patients • Impact of drug on patients • Patient safety (e.g., adverse events) • Adherence/Compliance/Persistence • Process and delivery of care • The fellow should demonstrate proficiency in multiple aspects of economic outcomes through a combination of didactic and on the job training that includes • Costing • Direct medical costs e.g., drug, office visit, hospitalizations, etc. • Direct non-medical costs e.g., caregiver costs • Indirect costs e.g., loss of work, productivity outcomes (e.g., absenteeism, presenteeism) • Economic analyses e.g., cost-benefit, cost-effectiveness, cost-minimization, or cost-utility

23. Fellowship Experience • The fellow should demonstrate proficiency in multiple aspects of patient-reported outcomes through a combination of didactic and on the job training that includes: • Health-related quality of life • Patient satisfaction • Patient preference • The fellow should develop an understanding of multiple aspects of the healthcare delivery system and the implications on PEOR within these systems through a combination of didactic and on the job training that includes: • Healthcare financing • Payors/managed care and integrated delivery systems • Health technology assessment • Clinical practice guideline development and use, • Disease management, • Medication use policy analysis

24. Fellowship Experience • The fellow should attain the following grantsmanship skills during the fellowship through a combination of didactic and on the job training that includes: • Identification of sources of funding, • Grant and/or proposal development • Conception of research ideas • Literature retrieval and evaluation • Biomedical science ethics • Identification of issues related to quality/integrity of HEOR data • The fellow should develop oral communication skills as well as written communication skills, for example through: • Participation in professional and or public communication of PEOR • Preparation of reports, abstracts, and manuscripts • The fellow should be encouraged to participate in journal clubs, research workshops and/or seminar series

25. Evaluation of Fellow, Preceptor and Program • An evaluation of the fellow should ideally occur at 6-month intervals • The fellow should be evaluated based on the goals and objectives set at the beginning of the fellowship. • Objective criteria include: • Poster and/or oral presentation at a national meeting • Seminar on PEOR related topic • Manuscript submission/publication • Research project executed in full • Subjective criteria include: • Motivation • Professionalism • Communication skills (verbal, e-mail, formal writing) • Presentation skills (research ideas and findings) • Collaboration/team work skills • Ability to evaluate clinical, economic, and PRO literature • Research skills (question development, process, management, analysis, etc) • Time management

26. Evaluation of Fellow, Preceptor and Program • In addition, the fellow should perform a preceptor and program evaluation every six months • The fellow should use the goals and learning objectives developed at the beginning of the fellowship to determine if the program is progressing as planned • This is an optimal time to discuss modification of the goals and objectives incase the fellow has developed additional interests or altered their original interests • It is recommended that the fellow be able to express their assessment of the primary preceptor and contributing preceptors’ abilities to support/accomplish the outlined goals and objectives

27. Employer Working Group Members • Alan Bakst Baxter International • Alexander Chernavin Sanofi-Aventis • Zeba Khan Novartis Pharmaceuticals • Connie Mclaughlin-Miley Abbott Laboratories • Jenny Sung Novartis Pharmaceuticals • Shiraz Gupta TAP Pharmaceuticals • Concetta Crivera Ortho-McNeil Neurologics • Izhar Hussain Abbott Laboratories • Tracy Li Bristol-Myers Squibb • Liviu Niculescu Pfizer • Vanja Sikirica Ortho-McNeil Janssen

28. Academia Members • Sandra Kane U. of Pittsburgh • John Bridges Johns Hopkins U. • Johanita Burger North-West University • Jeff Guo U. of Cincinnati Medical • Jackie Kwong U. of Georgia • Jeffrey McCombs USC College of Pharmacy • Lisa Prosser Harvard Med School • Vittorio Maio Jefferson Medical College • Glen Schumock U of Illinois at Chicago • Marianne Mccollum U of Colorado • Kim Coley U. of Pittsburgh • Craig Currie Cardiff University • Scott Strassels U of Texas Austin • Dennis Raisch VA Coop Studies Program • Gonzalo Garcia-Donato U of Castilla-La Mancha

29. Consulting and Health Outcomes Customers • Prabashni Reddy ABT Associates • Ljubica Besker-Ivasovic Clinica S. Anna • Healther Campbell VA Cooperative • Alex Fu Cleveland Clinic • Emma Guitierrez DeMesa European Commision • Lisa Mucha Thomson Medstat • Jens Rathemann PAION Deutschland • Anita Varghese CMS/DHHS • Krista Yokoyama Wellpoint Pharmacy • Vladimir Zah ZRX Outcomes Res. • Michael Iskedjian PharmIdeas • John Doyle Analytica Int.

30. Next Steps • Draft PEOR Fellowship Guidelines to be placed on ISPOR website for comments • PEOR Guidelines to be published in Pharmacotherapy and on ISPOR and ACCP Websites