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Review of Access to New Medicines

DescriptionThis independent review was undertaken by Dr Brian Montgomery to assess the impact of the new approach introduced in 2014 by SMC.
Official Print Publication Date
Website Publication DateDecember 14, 2016


ISBN 978 1 78652 693 9 (Web only publication)
PPDAS 85068

This document is also available in pdf format (660KB)
Responses are available in pdf format (5.7MB)


1 Preface

2 Executive Summary

3 Introduction

4 Engagement Process

5 Data

6.1 How the agreed definitions for end of life, orphan and ultra-orphan medicines are working in practice;

6.2 How the views from the Patient and Clinician Engagement process are taken into account in decision making;

6.3 How the new approach to assessment of ultra-orphan medicines is operating in practice;

6.4 How the acceptance rates for end of life, orphan and ultra-orphan medicines have changed as a result of the new approach;

6.5 How the transparency of SMC has improved and what further opportunities there are for patient and clinician engagement;

6.6 How NHS Boards are implementing SMC decisions under the new approach (both accepted and not recommended) including utilisation of the New Medicines Fund;

6.7 How the new approach has had an impact on reliance on access to medicines on an individual patient basis (through individual patient treatment requests and peer approved clinical system);

6.8 Whether there are further opportunities to take a 'once for Scotland' approach in any aspect of access to newly licensed medicines;

6.9 How the SMC process should be adapted to include commercial negotiation with the aim of (1) ensuring best value for the NHSS and (2) getting to a pharmaceutical companies' best offering on price earlier;

6.10 Whether there have been unintended consequences of any aspect of the new approach, the potential of which was noted by the Task and Finish Group Report;

6.11 How the new approach will accommodate advances in new medicines and a developing regulatory framework;

6.12 Whether the progress made to date provides a solid basis for developing further a Scottish Model of Value.

7 Conclusions

8 Discussion

9 Summary of Recommendations

10 Glossary

Appendix 1: Task & Finish Group Recommendations

Appendix 2: Task & Finish Group Definitions for end-of-life, orphan and ultra- orphan medicines

Appendix 3: Remit and Scope of the Review

Appendix 4: References