Clinicians can propose medicines for review that:
• are within our remit
• have support from cancer specialists across Scotland
What we can consider
Off-label uses of licensed cancer medicines
Off-label medicines can be:
- branded
- generic
- biosimilar
We can consider off-label uses for:
- an illness or patient population not specified within the marketing authorisation
- administration by a different route, dose, frequency or duration
On-label uses of licensed generic or biosimilar cancer medicines
This is also known as off-patent use.
This category can include medicines uses which are not recommended by Scottish Medicine Consortium (SMC):
- if the patent has expired since SMC advice was published
- with generic or biosimilar medicines now available at lower cost and where current cost-effectiveness is unknown
What we cannot consider
- medicines without any marketing authorisation in the UK (unlicensed medicines)
- situations where a marketing authorisation is likely to be sought for the proposed medicine in the off-label use within 24 months
- established off-label uses which have already become standard of care nationally
- paediatric indications
We will consider on a case by case basis situations where a regulatory decision on marketing authorisation (licencing) is:
- pending for a competitor product
- in the same off-label use as a proposal received by NCMAG
The process
We have guidance to help you follow the submission process.
Remit check request form
Before submitting a proposal, please complete a remit check request form and send to us at his.ncmag@nhs.scot
Proposal cut-off dates for rounds of scheduling
- 25 July 2024
- 24 October 2024
The NCMAG council meets quarterly to review proposal submissions.
Updating on progress
After NCMAG executive team prioritise and schedule submissions, proposers will be updated on the review timeline.
Once a medicine proposal is accepted onto the workplan, the NCMAG team will find and evaluate the clinical and health economic evidence for its use.
This evidence is then reviewed and decisions are made by our council at their quarterly meetings. The decisions are shared with NHS boards and published.
Resources to support you
| Resource name | What it is and what it is for |
|---|---|
| Resource name | What it is and what it is for Guidance on what we can and can’t consider. Completing the form reduces the risk of clinical teams working up full proposals that may be outside our remit |
| Resource name | What it is and what it is for Form for proposing a medicine. Use this form to make sure the medicine you are proposing meets our remit |
| Resource name | What it is and what it is for Booklet with advice on how to complete the proposal form |