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Market Research Report
Innovation, Health Technology Assessment, and Comparative Effectiveness Research: The Obstacle Course to Market Access
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Innovation, Health Technology Assessment, and Comparative Effectiveness Research: The Obstacle Course to Market Access published by Decision Resources, Inc. in September, 2009. This report consists of 53 Pages and the price starts from US $ 4600.
Abstract
Introduction:
The use of health technology assessment (HTA) is growing steadily in Europe,
and the U.S. government has recently announced $1.1 billion in funding for
comparative effectiveness research (CER) as part of its planned overhaul of
the U.S. healthcare system. Payers in all markets will increasingly compare
new drugs with established therapies and offer the most favorable pricing and
reimbursement terms only to drugs that are deemed innovative.
Questions Answered in This Report:
- HTA has become a major focus of attention in healthcare systems around the
world in recent years. What are the key elements of HTA? What approaches
have the authorities in leading pharmaceutical markets taken to the use of
HTA?
- European governments have used various forms of HTA for many years. How
do HTA strategies vary from one European country to another? What common
trends can be observed in Europe?
- The United States has been much slower than other mature pharmaceutical
markets to embrace HTA. Which U.S. organizations have practiced HTA in the
past? What action has the U.S. government recently taken to stimulate greater
use of CER in the United States?
Scope:
- Increasing focus on HTA: defi nitions of HTA; role of health
economic evaluation; strategies in major markets.
- Use of HTA in leading markets: France; Germany; Italy; Spain;
United Kingdom; United States; international collaborations.
- Outlook and implications for the pharmaceutical industry: European
industry' s key principles for HTA; challenges presented by the adoption of CER
in the United States; key message to payers.
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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