WIREDGOV

Scotland’s systems for approving and accessing new medicines for use in the NHS is to see a step change later this year.

From May 2014 patients and clinicians will be given a greater say on what new medicines are approved by the Scottish Medicines Consortium (SMC) for use in the NHS for end of life care and treating very rare conditions.

The Peer Approved Clinical System (PACS), which replaces the Individual Patient treatment Request (IPTR) for using medicines not approved for regular use in the NHS, will also come into full force in May 2014.

The SMC has outlined how they plan to transform their drug approval through the introduction of a new Patient and Clinician Engagement (PACE) meeting to give patient groups and clinicians a stronger voice in SMC decisions for life-limiting and rare conditions.

For medicines used to treat very rare conditions, those affecting around 100 people in Scotland, in addition to PACE, the SMC will consider more than just the direct health impact on the patient beyond its conventional assessments.

Pharmaceutical companies will also have an additional opportunity in the new process to put forward a Patient Access Scheme, which makes their medicines more affordable.

The SMC believe that these changes could benefit up to 1,500 patients by getting access to newly licensed medicines in the first year of their operation.

Health Secretary Alex Neil has welcomed the changes proposed by SMC to give patients substantially improved access to medicines.

Mr Neil said:

“Last year both the Scottish Parliament and Scottish Government made clear our wish to improved access to new medicines for patients at the end of life, or with rare conditions.

“I tasked the SMC with outlining how they could further enhance the new medicines approval process in Scotland to ensure that this improved access became a reality for patients.

“I know I’m not alone in welcoming their proposals, which are anticipated to help patients get new medicines quicker as they are more likely to be approved the first time they are submitted to the SMC, avoiding unnecessary time consuming resubmissions.

“I am particularly pleased that SMC decisions will better reflect the views of patients and the doctors who treat them. I firmly believe that such important decisions can only be made by those living with these conditions and our clinical experts.

“This is a major step that will revolutionise access to new medicines and make the system better for patients and I believe it will lead to Scotland having a world-leading process.

“To ensure the process does this, we will closely monitor the changes as they come into force and carry out a full review in one year.

“I also outlined last year that the IPTR system was to be replaced and I’m pleased to confirm that from May 2014 both the new SMC process and the new Peer Approved Clinical System will be in place.”

Professor Angela Timoney, Chair of the Scottish Medicines Consortium, said:

"These changes will mean that patients in need of end of life care or who have very rare conditions will be able to access more new medicines. We will actively engage with patient interest groups and clinicians to put these changes into practice and work with stakeholders to put resources in place to introduce these new changes as quickly as possible.

“These medicines have previously not been viewed as cost-effective by conventional measures and we have worked hard to find a way to enable access in Scotland. We look forward to putting our proposals in place.”

James Jopling, Director for Scotland at Breakthrough Breast Cancer said:

“Breakthrough Breast Cancer welcomes the enhanced role that patients and patients groups will now have in SMC decisions. By giving more weight to the value and benefit offered to patients by new medicines, we believe more drugs will be made available to those in their time of need.

"Last year, two very clinically effective medicines for secondary breast cancer were rejected for use on the grounds of cost, despite being highly valued by patients. These medicines would have given women precious additional quality time with their families and loved ones. We hope that the new system will allow drugs like these to be approved, giving hope to secondary breast cancer patients in Scotland."

Andrew Powrie-Smith, Director of the Association of British Pharmaceutical Industry (ABPI) in Scotland said: “We welcome the Scottish Government’s intent to ensure that patients in Scotland living with rare diseases or life limiting illness get access to the new, innovative treatments they need.

“SMC has taken a collaborative approach to developing proposals and as an industry, we look forward to continuing to work with SMC, NHS Scotland and the Scottish Government to ensure patients see a real difference in the speed and availability of the treatments they need.”

The changes will be supported by a package of measures, including extension of the Rare Medicines Drug Fund and additional £1 million investment in SMC, announced last year and will be subject to a full review in one year.