aHUSUK’s patient evidence has now been submitted to the SMC, following Alexion’s joint application for approval of Eculizumab for aHUS and PNH patients in Scotland.
We expect the date for the New Drugs Committee evaluation to be announced soon, As their advice will almost certainly have to be “not recommended” because of the cost of Eculizumab, a date will also be set for a PACE (Patient and Clinician Engagement) meeting.
The PACE process is very important because it gives patient groups and clinicians a stronger voice in the SMC decision making process and will be a major factor in the SMC decision. It allows us to describe the added benefits of Eculizumab, and its impact on quality of life for patients and their families. We expect to make a strong case and provide the SMC with the evidence they need to grant approval of Eculizumab.
We expect the dates for the meetings to be set for sometime in the first quarter of 2016. More information about the PACE process can be found here