CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 4
CHAPTER 2 BRIEF OVERVIEW OF UK PRICING & REIMBURSEMENT ENVIRONMENT 8
Introduction 8
The UK uses a range of P&R tools to regulate drug costs and usage 9
Potential future changes to the UK P&R system 10
Additional cost containment tools are used in conjunction with P&R tools 11
The PPRS is the primary mechanism used to control drug prices in the UK 12
Introduction to the PPRS 12
Has the PPRS worked? 13
The future of the PPRS system: is it going to be replaced with value-based pricing? 14
A number of bodies and policies impact drug prescription and spending in the UK 15
CHAPTER 3 NICE: ITS ROLE, EFFECTIVENESS AND ISSUES 17
NICE plays a key role in UK drug reimbursement 17
Introduction: what does NICE do? 17
NICE and pharmacoeconomics 19
How does NICE determine which drugs to assess? 20
A number of issues have been raised with NICE's appraisal process prompting several reviews 24
Time delays caused by NICE are a significant issue 26
But are time delays a significant issue for drug developers? 27
The solution: there are two key ways to accelerate drug access through improving NICE 27
Earlier guidance can be provided by starting standard appraisals earlier 28
Using STAs should also help to accelerate drug approvals in the future, although they have had limited success so far 28
NICE assessments have created significant controversy 30
NICE has faced significant controversy over its assessment of oncology and Alzheimer's disease drugs 30
NICE's controversial decisions over oncology drugs 30
NICE's guidance over Alzheimer's disease drugs has also been highly contentious 31
NICE needs to become more responsive 32
NICE has historically faced significant criticism that it is not responsive enough 32
NICE is becoming increasingly responsive to stakeholder activism and consultations 33
NICE changes its mind following consultation 33
Patient, physician and charity activism can help to change NICE responses 34
NICE needs to use assessment factors other than QALYs to make decisions 35
NICE has an over-reliance on QALYs to the detriment of other assessment factors 35
NICE becomes more flexible by offering risk-sharing agreements: the Velcade story 36
Future changes in the influence of NICE 38
Going forward, there is set to be a greater interaction between NICE and other HTA bodies 38
Potential future changes to NICE function and influence 39
Is there a possible role for NICE in drug pricing? 39
NICE guidance set to continue to guide drug provision decisions, yet the government shows greater flexibility in providing access to cheaper drugs 39
CHAPTER 4 BIBLIOGRAPHY 41
Publications and online articles 41
Datamonitor resources 46
APPENDICES 47
Appendix A: Glossary of terms 47
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 9
Figure 2: Regional differences in NICE influence 19
Figure 3: NICE published technology appraisal guidance for drugs has focused heavily on oncology drugs to date 21
Figure 4: NICE topic selection process 23
Figure 5: Datamonitor has identified four key issues that NICE will need to address going forward 26