New Medicines Reviews 2013

FOREWORD

The human body's ability to fight disease and recover from illness is nothing short of remarkable, just as its fragility in the face of the ravages of many diseases and conditions can be heart-breaking. It is this fundamentally human desire to prevent these ravages and to save or extend life that is at the very core of the medical science of pharmacology.

Developing, understanding and utilising the complex chemicals or biological molecules calls on a range of expertise to ensure that right therapeutics are used effectively in the right clinical situation.

Building on the many years of collective experience of NHS clinicians the processes such as Area Drug and Therapeutic Committees (ADTCs) and the Scottish Medicines Consortium (SMC) have evolved to ensure that medicines both efficacious and represent value for money are recommended for use across NHSScotland so that people across Scotland can benefit as quickly as possible., Where clinicians believe there is a case to prescribe a medicine which has not been recommended, they are able to instigate an Individual Patient Treatment Request (IPTR).

However, following some concerns expressed by clinicians and patient representatives regarding some aspects of SMC, ADTC, IPTR processes, I was clear that it was time for a full expert review of every aspect of the assessment, introduction and availability of new medicines, to ensure that these processes enable medicines to make the maximum contribution to creating the safe, person-centred and effective healthcare we are committed to providing for everyone, as set out in my 2020 vision for health and care in Scotland.

Professor Routledge was commissioned to review the current new medicines assessment procedures of the SMC and make any recommendations to improve the process. Professor Charles Swainson was similarly commissioned to review how SMC accepted medicines as introduced into ADTC formularies, to review both the ADTC network and IPTR's and to make recommendations.

The reviews have now been received and their recommendations include:

• More public involvement within SMC.
• Increased flexibility in the consideration of new evidence on cost or effectiveness of a drug while it is being assessed.
• More public involvement in Health Board ADTCs and the IPTR processes.
• Health board decisions on IPTRs should be published making them more open and transparent.
• Increased scrutiny and standards should be put in place to continually review requests for drugs not recommended for routine use.

An interim recommendation from the review - a £21 million fund to cover the cost of medicines for patients with very rare conditions - has already been introduced.

I am grateful to Professor Routledge and Professor Swainson for the rigour, thought and time they have given to produce their reports. I will carefully consider their recommendations alongside the conclusions that the Health and Sport Committee will reach when it completes their report, and the responses from the external consultation process.

Alex Neil MSP
Cabinet Secretary for Health and Wellbeing etc.