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. This overview document and factsheet provides 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. The submissions received in May and June 2014 have been prioritised for assessment on the basis of feedback from Area Drug and Therapeutics Committees and Regional Cancer Networks on patient need. We have agreed with the service and 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.
- PACE statement for pharmaceutical companies
- PACE statement for clinical experts
- PACE statement for patient groups
Update to the New Product Assessment Form
The New Product Assessment Form (NPAF) has been updated to reflect the changes to the SMC process for assessment of medicines for end of life care and very rare conditions. The most recent NPAF update (June 2014) covers end of life and orphan medicines. There is also a Supplement to the Manufacturers Guidance for these groups of medicines. When completing the NPAF please ensure that you are using the most recent version. The updated NPAF and Guidance to Manufacturers can be downloaded here.
Resubmissions of medicines not recommended after PACE
Please see link to SMC process for resubmissions for medicines that have not been recommended after a PACE meeting.