Medicines for end of life and very rare conditions
Following an extensive review, the SMC has changed the way it evaluates end of life medicines and medicines to treat very rare conditions. From May 2014 pharmaceutical companies will be able to request that SMC convenes a Patient and Clinician Engagement (PACE) group.
The PACE process gives patient groups and clinicians a stronger voice in SMC decision making. In addition, the assessment process for ultra-orphan medicines will involve a broad decision-making framework. Our overview document and factsheet provide more detail and helps explain what can be expected from the PACE process.
Since the new process was introduced SMC has received an increased number of submissions for these medicines.
We have agreed with NHSScotland and the Association of the British Pharmaceutical Industry (ABPI) that from July 2014:
- The monthly submission dates that SMC generally works to will be removed for medicines for end of life /orphan conditions
- Submissions for these medicines will be scheduled for assessment in order of date and time received
- For medicines where there is exceptionally high patient need, e.g. no other treatment available, SMC may schedule the submission earlier
This is a change to the SMC process to ensure that these submissions are considered as quickly as possible for the benefit of patients.
The main purpose of PACE is to gather detailed information which will allow a discussion on the benefits of a medicine, including how it can impact the quality of a patient’s life. This information may not always be fully captured within the conventional assessment process.
Pharmaceutical companies, clinical experts and patient groups are each required to provide a written statement, which will be used as part of the PACE meeting.
Resubmission of medicines not recommended after consideration through PACE 567kb (PDF)Download