Monoclonal Antibodies Report Part II: Companies - Holding mAbs in portfolio promises protection against the looming 2011-12 patent cliff

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
  • Key findings
• CHAPTER 2 BRIEF OVERVIEW OF UK PRICING & REIMBURSEMENT ENVIRONMENT
  • Introduction
  • The UK uses a range of P&R tools to regulate drug costs and usage
    • Potential future changes to the UK P&R system
    • Additional cost containment tools are used in conjunction with P&R tools
    • The PPRS is the primary mechanism used to control drug prices in the UK
      • Introduction to the PPRS
      • Has the PPRS worked?
      • The future of the PPRS system: is it going to be replaced with value-based pricing?
  • A number of bodies and policies impact drug prescription and spending in the UK
• CHAPTER 3 NICE: ITS ROLE, EFFECTIVENESS AND ISSUES
  • NICE plays a key role in UK drug reimbursement
    • Introduction: what does NICE do?
    • NICE and pharmacoeconomics
    • How does NICE determine which drugs to assess?
  • A number of issues have been raised with NICE' s appraisal process prompting several reviews
  • Time delays caused by NICE are a significant issue
    • But are time delays a significant issue for drug developers?
    • The solution: there are two key ways to accelerate drug access through improving NICE
      • Earlier guidance can be provided by starting standard appraisals earlier
      • Using STAs should also help to accelerate drug approvals in the future, although they have had limited success so far
  • NICE assessments have created significant controversy
    • NICE has faced significant controversy over its assessment of oncology and Alzheimer' s disease drugs
      • NICE' s controversial decisions over oncology drugs
      • NICE' s guidance over Alzheimer' s disease drugs has also been highly contentious
  • NICE needs to become more responsive
    • NICE has historically faced significant criticism that it is not responsive enough
    • NICE is becoming increasingly responsive to stakeholder activism and consultations
      • NICE changes its mind following consultation
      • Patient, physician and charity activism can help to change NICE responses
  • NICE needs to use assessment factors other than QALYs to make decisions
    • NICE has an over-reliance on QALYs to the detriment of other assessment factors
    • NICE becomes more flexible by offering risk-sharing agreements: the Velcade story
  • Future changes in the influence of NICE
    • Going forward, there is set to be a greater interaction between NICE and other HTA bodies
    • Potential future changes to NICE function and influence
      • Is there a possible role for NICE in drug pricing?
      • NICE guidance set to continue to guide drug provision decisions, yet the government shows greater flexibility in providing access to cheaper drugs
• CHAPTER 4 BIBLIOGRAPHY
  • Publications and online articles
  • Datamonitor resources
• APPENDICES
  • Appendix A: Glossary of terms
  • List of Figures
    • Figure 1: A range of P&R tools are in use across 5EU markets, with many of these being used in the UK
    • Figure 2: Regional differences in NICE influence
    • Figure 3: NICE published technology appraisal guidance for drugs has focused heavily on oncology drugs to date
    • Figure 4: NICE topic selection process
    • Figure 5: Datamonitor has identified four key issues that NICE will need to address going forward