Wolters Kluwer Lippincott Williams & Wilkins Health Philadelphia Baltimore New York«London Buenos Aires Hong Kong Sydney Tokyo

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1 Essentials of Pharmacoeconomics SECOND EDITION Karen L. Rascati, PhD Eckerd/Turley Centennial Professor of Health Outcomes and Pharmacy Practice University of Texas College of Pharmacy Austin, Texas Wolters Kluwer Lippincott Williams & Wilkins Health Philadelphia Baltimore New York«London Buenos Aires Hong Kong Sydney Tokyo

2 Contents PART I BASIC TOPICS CHAPTER 1 Introduction 1 Pharmacoeconomics What Is It? 1 Why Is Pharmacoeconomics Important? 2 Relationship of Pharmacoeconomics to Other Research 3 Types of Pharmacoeconomic Studies 4 SUMMARY 8 QUESTIONS/EXERCISES 8 REFERENCES 8 SUGGESTED READINGS 9 CHAPTER 2 Measuring and Estimating Costs 10 Costing Terms 10 Cost Categorization 11 Alternative Method of Categorization 13 Perspective 13 Timing Adjustments for Costs 14 Resources for Cost Estimations 18 SUMMARY 21 QUESTIONS/EXERCISES 24 REFERENCES 24 SUGGESTED READINGS 25 CHAPTER 3 Critiquing Research Articles 26 Appropriateness of Methods of Analysis 26 Questions to Use When Critiquing Research Articles 26 SUMMARY 32 QUESTIONS/EXERCISES 32 REFERENCES 33 SUGGESTED READINGS 34 CHAPTER 4 Cost-Minimization Analysis 35 Overview 35 SUMMARY 36 Composite Article: CMA Anti-nausea 37 QUESTIONS/EXERCISES 42 REFERENCES 44 SUGGESTED READINGS 44 xiii

3 xiv CONTENTS CHAPTERS Cost-Effectiveness Analysis 45 Overview 45 Presentation of Costs and Effectiveness 46 Cost-Effectiveness Grid 47 Cost-Effectiveness Plane 49 Intermediate Outcomes versus Primary Outcomes 50 Efficacy versus Effectiveness S3 Consensus and Debate 54 SUMMARY 55 Composite Article 1: CEA Asthma 55 Composite Article 2: CEA Post-Myocardial Infarction Heart Failure 63 QUESTIONS/EXERCISES 70 REFERENCES 71 SUGGESTED READINGS 71 CHAPTER 6 Cost-Utility Analysis 72 Overview 72 Steps in Calculating QALYs 73 Trends in CUA Analyses 80 SUMMARY 85 Composite Article 1: CUA Oncology 85 Composite Article 2: CUA Immunosuppression 92 QUESTIONS/EXERCISES 99 REFERENCES 101 SUGGESTED READINGS 102 CHAPTER? Cost-Benefit Analysis 103 Definition and History 103 Advantages and Disadvantages of Cost-Benefit Analysis 104 Conducting a CBA 105 Difference between Costs and Benefits 106 Measuring Indirect and Intangible Benefits 106 Calculating Results of Costs and Benefits 112 SUMMARY 114 Composite Article 1: CBA Vaccination 117 Composite Article 2: CBA Alzheimer's Disease 123 QUESTIONS/EXERCISES 128 REFERENCES 129 SUGGESTED READINGS 130 CHAPTER 8 Health-Related Quality of Life: Health Status Measures 131 Definitions 132 HRQoL Measures versus Utility Measures 132 Domains of Health Status 136 Assessing HRQoL Instruments 138 Pharmacoeconomics and HRQoL Measures 141

4 Contents XV Preference-Based Classification Systems 141 Patient-Reported Outcomes 143 SUMMARY 144 Composite Article 1: HRQoL Rheumatoid Arthritis 144 Composite Article 2: HRQoL Chronic Low Back Pain 152 QUESTIONS/EXERCISES 161 REFERENCES 165 SUGGESTED READINGS 166 PART II ADVANCED TOPICS CHAPTER 9 Decision Analysis 169 What Is Decision Analysis? 169 Steps in Decision Analysis 169 Threshold Analysis 175 SUMMARY 177 Composite Article 1: Decision Analysis Migraine 178 Composite Article 2: Decision Analysis Erectile Dysfunction 185 QUESTIONS/EXERCISES 191 REFERENCES 192 SUGGESTED READINGS 192 CHAPTER 10 Markov Modeling 193 Overview 193 Steps in Markov Modeling 193 Disadvantages of Markov Modeling 200 Advanced Issues 201 Other Advanced Topics 202 SUMMARY 203 Composite Article 1: Markov Modeling Initiation of HIV Therapy 204 ANSWERS 212 Composite Article 2: Markov Modeling Phosphate Binders 213 ANSWERS 220 QUESTIONS/EXERCISES 221 REFERENCES 223 SUGGESTED READINGS 224 CHAPTER 11 Retrospective Databases 225 Overview of Retrospective Databases 225 Randomized, Controlled Trials 225 Observational Studies 226 Advantages and Disadvantages ofrcts 226 Advantages and Disadvantages of Observational Studies 227 Types of Retrospective Databases 228 Insurance and Claims Records 230 Critiquing Retrospective Database Studies 230

5 xvi CONTENTS SUMMARY 232 Composite Article 1: Retrospective Database COPD 232 Composite Article 2: Retrospective Database Bisphosphonates 240 QUESTIONS/EXERCISES 244 REFERENCES 244 SUGGESTED READINGS 245 CHAPTER 12 Pharmacy Services 246 What Are Pharmacy Services? 246 History of Pharmacy Services 247 Review of the Research 247 Issues in Valuing Pharmacy Services 249 Medicare Medication Therapy Management 250 SUMMARY 252 Composite Article: Pharmacy Services 253 QUESTIONS/EXERCISES 260 REFERENCES 262 SUGGESTED READINGS 263 CHAPTER 13 International Perspective 264 Health Care Expenditures 264 Comparability of Pharmacoeconomic Results between Countries 266 History of Pharmacoeconomic Guideline Development 266 SUMMARY 271 QUESTIONS/EXERCISES 271 REFERENCES 273 SUGGESTED READINGS 274 CHAPTER M Future Issues 275 Application of Pharmacoeconomics in the United States 275 Federal Agencies 275 Private Health Care Plans 276 Barriers to Pharmacoeconomics in the United States 277 Other Future Issues 278 SUMMARY 279 QUESTIONS/EXERCISES 280 REFERENCES 280 SUGGESTED READINGS 282 Glossary 283 Index 289