International Trends in the Use of Health Technology Assessment

Introduction
Health technology assessment (HTA)—which typically involves the use of cost-effectiveness studies to evaluate the relative value of a new drug or medical technology—can play a key role in helping reimbursement authorities determine which medical treatments to reimburse. Authorities in Australia, Canada, and much of Europe have used elements of HTA as a factor in their reimbursement decisions for several years, and many other countries are now following suit. Most significantly, payers in the United States are increasingly interested in the potential that HTA holds in reimbursement decision making.

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- Reimbursement authorities largely agree on the main methods of economic evaluation for new drugs
and medical technologies. However, the increasing use of health economic data in decision making has
highlighted several important issues. What are these issues, and what consequences do they hold for medical health companies?
- In light of the use of HTA and economic assessment to help reimbursement authorities determine which medical treatments to include in their formularies, drug manufacturers must seek to make the most of their limited influence over the HTA process. What strategies can manufacturers pursue to ensure they maintain a role in the reimbursement decision-making process?
- In recent years, leading pharmaceutical companies—including Janssen-Cilag and GlaxoSmithKline have responded to increasing cost-containment pressures in Europe by negotiating risk-sharing agreements with reimbursement authorities. Why did Janssen-Cilag and GlaxoSmithKline in particular pursue risksharing agreements? Under what circumstances can risk-sharing agreements prove benefi cial for drug manufacturers?
- At present, relatively few reimbursement authorities require the use of quality-adjusted life-years (QALYs) in economic evaluations of new drugs and medical technologies. However, use of this measure is increasing.
Why are objections being raised to the use of this statistic?
- A reimbursement authority’s cost-effectiveness threshold is important because it indicates the maximum amount the authority is willing to pay for a unit of health gain. However, very few reimbursement authorities have set explicit cost-effectiveness thresholds. Which European country is an exception to this rule?

Scope
- Health technology assessment: European and American definitions; the role of health economics and pharmacoeconomic studies in HTA; how HTA is currently used by reimbursement authorities in Australasia, Europe, Asia, Latin America, Canada, and the United States.
- Methodological developments in HTA: synthesis of clinical comparisons for new medical drugs and technologies; cost-effectiveness of new techniques for subgroups; QALY; incorporating equity issues in reimbursement decisions; characterizing uncertainty in economic estimates.
- Procedural developments in HTA: priority-setting; stakeholder involvement; defi ning the costeffectiveness threshold; the advent of conditional reimbursement.
- Risk-sharing agreements: Janssen-Cilag’s pricing agreement for Velcade; the U.K. Department
of Health’s pricing agreement with manufacturers of multiple sclerosis drugs; GlaxoSmithKline’s flexible pricing agreements in Europe.
- Outlook and implications: the world’s embrace of HTA; Europe in the vanguard; the United States
begins to join the party; drug manufacturers challenged by varied postmarketing data requirements across the world; pharmaceutical companies’ adjustment to new reimbursement negotiations; the prominence of value-based reimbursement and the ascent of risk-sharing agreements.
- Appendices: a detailed examination of key reimbursement and clinical assessment issues in each of four countries (England, Germany, the United States, and the Netherlands). SHOW LESS READ MORE >

Executive Summary 3
Strategic Considerations 3
Stakeholder Implications 3
Introduction 4
What Is Health Technology Assessment? 4
Use of Health Technology Assessment by Reimbursement Authorities 5
Australasia 5
Europe 5
Asia 9
Latin America 9
North America 9
Methodological Developments in HTA 11
Synthesis of Clinical Comparisons 11
Analysis by Patient Subgroup 12
Estimation of Quality-Adjusted Life-Years Gained 12
Incorporation of Equity Considerations 13
Characterizing Uncertainty in Estimates 13
Procedural Developments in HTA 14
Topic Selection and Priority Setting 14
Stakeholder Involvement 15
The Cost-Effectiveness Threshold 16
Conditional Reimbursement Linked to Further Research 17
Outlook and Implications for the Pharmaceutical Industry 18
Appendix A The National Institute for Health and Clinical Excellence—An International Role
Model for HTA? 21
Appendix B IQWiG—Anything but NICE? 25
Appendix C Slow Adoption of Health Technology Assessment in the United States 28
Academy of Managed Care Pharmacy 28
Agency for Healthcare Research and Quality 29
Drug Effectiveness Review Project 29
Medicare 30
Outlook 30
Appendix D Going Dutch—HTA and Reference Pricing in the Netherlands 34

Sidebars
International Cooperation on Health Technology Assessment 10
Risk-Sharing Agreements Present New Opportunities—and Threats—for the
Pharmaceutical Industry 18

Tables
1 Key Features of Pharmacoeconomic Guidelines in Selected Countries 6

Figures
1 Components of Health Economic Evaluation 5
2 Quality-Adjusted Life-Years Added by Treatment 13

Companies
- Abbott
- American Pharmaceutical Group
- Amgen
- AstraZeneca
- Bristol-Myers Squibb
- Eli Lilly
- GlaxoSmithKline
- Janssen-Cilag
- Johnson & Johnson
- Merck Serono
- Novartis
- Pfizer
- Roche
- Sanofi -Aventis
- Schering Health Care
- Servier
- Velcade
- Wyeth

Organizations
- Academy of Managed Care Pharmacy
- American Pharmaceutical Group
- Association of British Neurologists
- Association of the British Pharmaceutical Industry
- Bioindustry Association
- Centers for Education and Research on Therapeutics
- European Federation of Pharmaceutical Industries and Associations
- European Network for Health Technology Assessment (EUnetHTA)
- Japanese Medical Association
- Pharmaceutical Research and Manufacturers of America
- U.S. National Library of Medicine
- Verband Forschender Arznei-mittelhersteller (VFA; German Association of Research-Based Pharmaceutical Companies)
- World Health Organization