Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- The Challenge of Assessing Innovation
- France
- HTA as an Element of the Standard Price-Setting Process
- HTA as an Element of the Price-Setting Process for Innovative Drugs
- Multiple Technology Assessments
- National Frame of Reference for the Appropriate Use of Expensive and
Innovative Drugs
- Expanded Role for the National Health Authority
- Pending Reforms
- Germany
- Coverage Offered by the Statutory Health Insurance System
- Introduction of Health Economic Evaluation
- Regulatory Framework
- Opposition from Health Economists and the Pharmaceutical Industry
- Response of the GBA and IQWiG to Criticism
- Draft Methodology for Health Economic Evaluation
- Future Focus on Costly New Therapies
- Government Plans for Stricter Limits on Access to Some New Therapies
- Italy
- HTA as an Element of Pricing and Reimbursement Decision Making
- Spain
- Pharmaceutical Price Setting
- Progress Toward a National HTA Strategy
- United Kingdom
- Creation of the National Institute for Health and Clinical Excellence
- Industry Criticisms of NICE
- Government Response to Parliamentary Review of NICE
- New Pharmaceutical Price Regulation Scheme
- Horizon Scanning
- Guaranteed Funding for NICE-Approved Therapies
- Guidance on the Funding of Therapies Not Appraised by NICE
- Promoting the Uptake of New Drugs
- Flexible Pricing
- Patient Access Schemes
- Improving Patient Access to Innovative Medicines
- Plans for NICE to Offer an Advisory Service to the Pharmaceutical
Industry
- Risk-Sharing and Cost-Sharing Agreements - Creative Responses to
Rejection by NICE
- Growing Industry Disillusionment with the U.K. Market
- United States
- Academy of Managed Care Pharmacy' s Format for Formulary Submissions
- Technology Evaluation Center
- Drug Effectiveness Review Project
- WellPoint Health Networks
- Agency for Healthcare Research and Quality
- Medicare
- New Government-Sponsored Comparative Effectiveness Research Initiative
- International Cooperation on Health Technology Assessment
- Outlook and Implications for the Pharmaceutical Industry
Tables
- 1. Relationship Between SMR Ratings and Reimbursement Rates by Disease
Severity
- 2. Proposed Topics for U.S. Comparative Effectiveness Research of
Particular Relevance to the Pharmaceutical Industry
Figures
- 1. Percentage of Drugs Awarded Various Medical Benefi t (SMR) Ratings in
France
- 2. Percentage of Drugs Awarded Various Improvement in Medical Benefi t
(ASMR) Ratings in France
- 3. U.S. Health Plans' Assessment of the Quality of Select Aspects of
Manufacturers' Formulary Submissions
- 4. U.S. Health Plans' Desired Improvements to Manufacturers' Formulary
Submissions
- 5. U.S. Health Plans' Assessment of the Utility of Manufacturers'
Formulary Submissions
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