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Review of Access to New Medicines

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)


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