Abstract
Introduction
The pharmaceutical industry has long criticized the slow uptake of new
medicines in the United Kingdom. Beginning January 1, 2009, the U.K.
government plans to implement measures to accelerate and widen access to
innovative drugs. However, the pharmaceutical industry will be expected to
adapt to a more fl exible pricing environment. In this report, we analyze the
potential impact of the changes unveiled in November 2008.
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- The United Kingdom is one of the most accessible of all European
pharmaceutical markets in terms of product registration, price setting, and
reimbursement. How do U.K. prices compare with prices in other major markets?
What are the procedures for price setting in the United Kingdom? How do
manufacturers secure reimbursement for their products?
- The U.K. government uses a more limited range of cost controls than most
of its European neighbors.
- How has the government used price cuts and freezes to curb spending? What
measures have been implemented to stimulate the use of generics? How are
prescribing budgets and audits used to modify physicians' prescribing behavior?
- The National Institute for Health and Clinical Excellence (NICE) has
become a very powerful infl uence on medical practice in England and Wales.
How has the institute' s activity evolved over the years? How does the
pharmaceutical industry view NICE? What measures have some companies adopted
to overcome NICE' s rejection of their drugs? What changes has the government
proposed to minimize any negative impact on access to medicines from NICE' s
activity?
- The government' s recently unveiled reform program includes some very
welcome developments for the pharmaceutical industry. What measures are
designed to accelerate the uptake of innovative therapies? What changes are
expected to improve the reimbursement prospects of end-of-life treatments?
What is the government doing to widen access to therapies not endorsed by NICE?
- In return for these concessions, how will the government require greater
pricing fl exibility from the pharmaceutical industry?
Scope
- Organization and funding of the U.K. healthcare system: history of the
National Health Service (NHS); healthcare spending in the United Kingdom;
funding of the NHS; role of private healthcare in the United Kingdom; recent
organizational changes to the NHS.
- Pharmaceutical prices: comparison of prices in the United Kingdom and
other major markets; pricing of branded prescription drugs based on new active
substances, branded prescription drugs based on established active substances,
and generic drugs; pricing in the hospital sector.
- Cost-containment measures: price cuts and freezes; reimbursement
restrictions; prescribing budgets and audits; local formularies; use of
generics; parallel imports; patient copayments.
- Health technology assessment: creation of the National Institute for
Health and Clinical Excellence (NICE); industry criticisms; government
response to parliamentary review of NICE; focus on oncology; risk-sharing and
cost-sharing agreements.
- Outlook for the U.K. pharmaceutical market: key trends; growing industry
disillusionment with the U.K. market; promise of reform in draft NHS
constitution; improving patient access to innovative medicines; implications
for the pharmaceutical industry.
Mentioned in This Spectrum Report
Organizations
- Advisory Committee on NHS Drugs (ACD)
- American Pharmaceutical Group
- Association of British Neurologists
- Association of the British Pharmaceutical Industry
- Bioindustry Association
- Confederation of British Industry (CBI)
- Department of Health
- House of Commons Health Committee
- National Health Service (NHS)
- National Institute for Health and Clinical Excellence (NICE)
- Organization for Economic Cooperation and Development (OECD)
- Prescription Pricing Authority (PPA)
- World Health Organization (WHO)
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Overview
- Challenging Times for the Drug Industry
- How Industry Can Meet the Challenge
- Blockbuster Model Versus Personalized Medicine Model
- Back to the Basics: Genes
- Mining the Genome for Pharmacogenomic Information
- The Human Genome Project.
- The HapMap Project
- Key Commercial Activity in Haplotype Testing
- Affymetrix
- Illumina
- Applied Biosystems
- Perlegen
- Clinical Data
- Celera Genomics
- Commercial Next-Generation Sequencing Systems
- Roche (454 Life Sciences)' s Platform
- Illumina (Solexa)' s Genome Analyzer
- Applied Biosystems' SOLiD Sequencer
- Helicos' s Helioscope
- Next-Next-Generation Sequencing Systems - the Future?
- NGS-Enabled Innovative Collaborations
- X Prize Foundation
- The 1000 Genomes Project
- The International Cancer Genome Organization
- The National Human Genome Research Institute
- Outlook
- Gaining Improvements in Sequencing Methodology
- Enhancing Drug Discovery Applications
- Strengthening Biological Knowledge
Tables
- 1. Blockbuster Model Versus Personalized Medicine Model for the Drug
Industry
- 2. Personalized Medicine Offers Key Opportunities to the Drug Industry
- 3. Key Challenges of Personalized Medicine for the Drug Industry
- 4. Properties of Select Commercial Next-Generation Sequencing Analyzers
- 5. Select Emerging Next-Generation Sequencing Technology Companies
- 6. NHGRI-Funded Next-Generation Sequencing Projects Announced in August
2008
Figures
- 1. FDA Approval of NMEs Compared with R&D Spending
- 2. Success Rates as Compounds Advance Through Stages of Development
- 3. Next-Generation Sequencing Workfl ows for Commercial Systems
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