PHARMACOECONOMICS AND OUTCOMES RESEARCH Learning Outcomes Matrix

Created by the ISPOR Learning Outcomes Task Force

ISPOR Learning Outcomes Task Force Co-Chairs:

Peter G. Davey MD, Professor in Pharmacoeconomics, Director, Health Informatics Centre, University of Dundee, Dundee, Scotland and

Lieven Annemans MSc, PhD, Mman, Health Economist Ghent University, Senior Consultant Global Health Economics HEDM-IMS, Meise, Belgium

Basic skill level

Audience	Technical Skills	Ethical/Social/Professional Skills
Minimum for all audiences	Identify and define Terminology Describe basics of economic evaluation: principles Evaluation grid: when is an economic evaluation necessary Explain the techniques of basic statistics Distinguish between clinical and statistical significance Evaluate the quality of a publication/report Describe methods for literature searches and reviews Identify the basics of QOL/PROs	Explain basics of regulatory/reimbursement issues in own country Describe one’s own health care system Identify and describe the different possible perspectives of health economic evaluations Explain the consequences of separate budgets for pharmacy, hospitals etc…
Pharmaceutical Industry Marketing & Sales; Managers, etc	Explain the basics of economic evaluation: principles and methods Compare and contrast QOL/PRO and Utilities; between costs and charges Explain decision tree-calculations and terminology Describe Markov chain analysis and calculation Describe the basics of Utilities	Describe regulatory issues in outcomes research marketing Explain the function of outcomes research within an organization/understanding organization politics Explain the role of health economic evaluations within a multi-factorial decision making process Describe the ethical use of economic evaluation and outcomes research in the marketing of pharmaceuticals Describe strategic planning of economic evaluation studies in clinical trial phases
Formulary Committee Members responsible for drug evaluations	Explain the basics of economic evaluation: principles and methods Identify and describe basic epidemiology Explain budget impact models	List and describe the local legal issues (requirements for coverage/denial) e.g. knowledge of state regulations on “medical necessity”.
Clinicians	Identify and describe basic epidemiology Explain the basics of economic evaluation: principles and methods	Define and describe the basics of rationing health care (Example: understanding of concrete examples of rationing)
Pharmacoeconomics & Outcomes Researchers	Explain the basics of economic evaluation: principles and methods Explain decision tree-calculations and terminology Describe Markov chain an alysis and calculation List and explain data collection methods (expert panel, chart abstraction, database research)	Identify and explain implications of rationing based on benchmarks/league tables Interpret outcome studies at the population level Interpret within a clinical context List and explain ethical issues around resource allocation Describe political aspects of functioning within an organization Explain the healthcare policy process
Health Policy-makers/funders	List and describe instruments to interpret economic data correctly	List the criteria that play a role in deciding on what is a relevant economic result

Medium skill level

Audience	Technical Skills	Ethical/Social/Professional Skills
Minimum for all audiences		Apply terminology of OR correctly in written and oral communication.
Pharmaceutical Industry Marketing & Sales; Managers, etc	Ability to adapt a study to an alternate setting Interpret the results of a study in the overall context of a products value Choose and use appropriate instruments to interpret economic data correctly	Prepare and present an unbiased presentation of a study Identify regulatory issues Identify ethical considerations in study designs Identify the strength and weakness of certain economic approaches Explain financial and service flow in the health system Address economic results to the right group(s)/person(s)
Formulary Committee Members responsible for drug evaluations	Interpret the results of an evaluation in terms of internal and external validity Critically evaluate a study Make findings of a study generalizable to other populations through designing a study or providing access to data Prepare a summary report of findings	Adhere to legal requirements and in the absence of legal requirements be able to understand the ethics of denying coverage Participate in a roundtable discussion on an OR study Explain financial and service flow in the health system
Clinicians	Critically (and correctly) evaluate a study Possess an understanding of sources of bias in OR studies Interpret decision tree-calculations and terminology Describe Markov chain analysis and calculation	Identify regulatory issues Act as a spokesmen for physicians with regard to pharmacoeconomic issues (reimbursement decisions, etc…) Participate in a roundtable discussion on an OR study
Pharmacoeconomics & Outcomes Researchers	Design, implement and analyze a study and to adapt an evaluation to a specific setting Act as a co-author or sole author on a manuscript Develop, design, and carryout pharmacoeconomic and outcome studies Develop decision trees (modeling studies including Monte Carlo simulation, Markov modeling, sensitivity analysis) Describe advanced research methods & design Critique internal and external validity of research designs and measuring instruments Design and implement budget impact analysis Conduct probabilistic sensitivity analysis Conduct survival analyses	Evaluate issues for more than one reimbursement setting Coordinate pharmacoeconomic and outcome studies Identify and evaluate ethical issues on a global basis Compare & contrast different approaches to the distribution of resources (e.g., utilitarianism, Rawlsian, etc.) Address economic results to the right group(s)/person(s)
Health Policy-makers/funders	Critically evaluate a study Interpret the results of a budget impact analysis Challenge clinical and economic data assumptions	Interpret outcome studies at the population level Interpret study results within a clinical context Address ethical issues concerning resource allocation and priority setting Identify strengths and weaknesses of different economic approaches Differentiate between allocative and technical efficiency goals from a policy perspective

High skill level

Audience	Technical Skills	Ethical/Social/Professional Skills
Minimum for all audiences	Propose alternative study designs	Address economic results to the right group(s)/person(s) Negotiate with pharmacoeconomic results
Pharmaceutical Industry Marketing & Sales; Managers, etc	Interpret findings so they are applicable to a specific population Translate findings into alternative policy proposals Suggest alternative approaches to a given pharmacoeconomic problem	Identify and explain regulatory issues in different countries Develop internal standards Lead a roundtable or act as an internal expert in OR
Formulary Committee Members responsible for drug evaluations	Calculate the specific budget impact, in terms of total costs, of the introduction of a new agent to a new formulary Evaluate and verify the quality of a probabilistic sensitivity analysis	Communicate strength and weakness of different economic approaches
Clinicians	Ability to design a valid and relevant study for use in medical decision making Conceive/apply state-of-the-art methods Differentiate between generic and specific QOL instrument	Serve as a resource to other researchers
Pharmaco-economics & Outcomes Researchers	Design and conduct advanced analyses such as Willingness-to-Pay Develop and evaluate new QOL instruments	Teach others who have fewer capabilities
Health Policy-makers/funders	Describe limitations of pharmacoeconomic studies in the policy evaluation process	Communicate decisions, using an economic argument where necessary/appropriate

Technical Skills

Technical Skills

Technical Skills