Market Report Source

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