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

SUMMARY

Overview

Introduction

NICE is one of the most advanced cost effectiveness assessment bodies operating in the major pharmaceutical markets. Since it was established it has had an increasing impact on the availability of new drugs in England and Wales, but has also generated considerable attention globally.

Scope

• Overview of the UK pricing and reimbursement system and the role NICE plays in it
• Analysis of the key issues facing NICE and the measures being taken to rectify them
• Discussion of case studies to illustrate the effect of and response to key NICE rulings

Highlights

NICE plays a key role in the UK healthcare system although it does not currently assess all new drug approvals. It's impact is also felt outside the UK as organizations and indeed individual physicians in other countries also monitor its conclusions.

A variety of stakeholders have input into the NICE topic selection process including patients, physicians and the pharmaceutical industry. To date cancer drugs have accounted for the largest number of completed assessments.

Reasons to Purchase

• Understand how NICE assessments impact the pricing and reimbursement environment in England and Wales
• Gain insight into the key issues with NICE assessments and the changes which are being used to tackle them
• Benchmark the impact and response to the outcome of key NICE assessments

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