For LUHFT and LWH, Drug and Therapeutics Group:
- Approves Trust wide or cross-Trust medicines-related documents (e.g. guidelines, patient information leaflets).
- Approves all prescription charts
- Approves and monitors the introduction of new medicines/new indications for approved medicines.
- Approves new medicine and formulary update requests for onward submission to Cheshire & Merseyside Area Prescribing Group (CMAPG).
- Approves the onward submission of individual funding requests (IFRs) to the relevant commissioner and follow up those which are approved.
When preparing a document for submission ensure that:
It is on the correct Trust template:
- LUHFT Clinical Guideline Template
- LUHFT SOP Template
- LUHFT Clinical Pathway Template
- LUHFT Policy Template
- Patient Information Leaflet (PIL) search 'template'
- Prescription Chart Template.
It adheres to Trust document standards:
More information
Documents for DTG approval should be submitted to jennifer.
Book in to DTG’s document clinic if you need further information or support with your document.
Guides
Check existing approvals
The new medicine (or use of an approved medicine for a new indication) may already be approved at Integrated Care Board (ICB) level, national level or Trust level. Make sure any existing approval matches exactly how you plan to use the medicine.
ICB approvals can be checked in the Cheshire and Merseyside Formulary.
National approvals can be checked here: https://
Check NHSE clinical commissioning policies Some NHSE approved medicines are only mentioned in clinical commissioning policies (e.g. icatibant is only mentioned here: Treatment-of-acute-attacks-in-hereditary-angiodema-adult.pdf, there is no corresponding NICE TA).
If in doubt or to check:
- Whether there are any existing organisation approvals
- The process for the approval of new medicines (including unlicensed equivalents) when there is a supply issue
- The process for the approval of a new formulation of an existing medicine for a single patient (e.g. needs liquid for administration via a tube).
Contact fatimah.akbar@liverpoolft.nhs.uk or jennifer.bellis@liverpoolft.nhs.uk
If you still think you need to make a new medicine application
Consider who will fund the medicine – ICB, NHSE or directorate. For high-cost drugs always consider submitting an individual funding request (IFR) to Cheshire & Mersey ICB or NHSE. To find out whether a NICE approved medicine is ICB or NHSE commissioned, go to the ‘Tools and resources’ section of the relevant TA webpage, select ‘Resource impact summary report’ and head to the ‘Key information’ table.
ICB Individual Funding Request
Read the clinical exceptionality criteria before starting the application: Forms and applications - NHS Cheshire and Merseyside.
The completed form must be submitted to jennifer.
NHSE Individual Funding Request
Read the clinical exceptionality criteria before starting the application: NHS England » Individual requests for funding
The application must be completed by the lead consultant via the Apollo portal apollo.ardengemcsu.nhs.uk/
Trust Individual Funding Request
Apply to DTG; the application must be accompanied by HOO and CD approvals https://
Check existing approvals
The new medicine (or use of an approved medicine for a new indication) may already be approved at Integrated Care Board (ICB) level, national level or Trust level. Make sure any existing approval matches exactly how you plan to use the medicine.
ICB approvals can be checked in the Cheshire and Merseyside Formulary.
National approvals can be checked here: https://
Check NHSE clinical commissioning policies Some NHSE approved medicines are only mentioned in clinical commissioning policies (e.g. icatibant is only mentioned here: Treatment-of-acute-attacks-in-hereditary-angiodema-adult.pdf, there is no corresponding NICE TA).
If in doubt or to check:
- Whether there are any existing organisation approvals
-
The process for the approval of new medicines (including unlicensed equivalents) when there is a supply issue
Contact fatimah.akbar@liverpoolft.nhs.uk or jennifer.bellis@liverpoolft.nhs.uk
If you still think you need to make a new medicine application
Consider who will fund the medicine – ICB, NHSE or directorate. For high-cost drugs always consider ICB or NHSE. To find out whether a NICE approved medicine is ICB or NHSE commissioned, go to the ‘Tools and resources’ section of the relevant TA webpage, select ‘Resource impact summary report’ and head to the ‘Key information’ table.
ICB Cohort Request (sometimes referred to as a business case)
Forms and applications - NHS Cheshire and Merseyside
Collaboration with other providers in Cheshire & Merseyside is essential – find out if they support the application and how many of their patients they predict will be eligible if it is approved
The completed ‘Application for New Medicines’ form must be submitted to jennifer.
NHSE Cohort Request
An NHSE clinical commissioning policy would need to be developed see NHS commissioning » Clinical Priorities Advisory Group (CPAG). Contact the jennifer.
Trust Cohort Request
Apply to DTG; the application must be accompanied by HOO and CD approvals https://
DTG Clinical Document Receipt & Approval Timelines 26/27
|
Target DTG meeting |
Deadline for document to enter DTG Review Process |
Comments back to author |
Deadline for submission |
|
3rd April |
30th January |
20th February |
20th March |
|
1st May |
27th February |
20th March |
17th April |
|
5th June |
3rd April |
24th April |
22nd May |
|
3rd July |
1st May |
22nd May |
19th June |
|
7th August |
5th June |
26th June |
24th July |
|
4th September |
3rd July |
24th July |
21st August |
|
2nd October |
31st July |
21st August |
18th September |
|
6th November |
4th September |
25th September |
23rd October |
|
4th December |
2nd October |
23rd October |
20th November |
|
1st January |
30th October |
20th November |
18th December |
|
5th February |
4th December |
24th December |
22nd January |
|
5th March |
1st January |
22nd January |
19th February |
DTG New Drug Application & Follow Up Report Timelines 26/27
|
Target DTG meeting |
Deadline for submission |
|
3rd April |
25th March |
|
1st May |
22nd April |
|
5th June |
27th May |
|
3rd July |
24th June |
|
7th August |
29th July |
|
4th September |
26th August |
|
2nd October |
23rd September |
|
6th November |
28th October |
|
4th December |
25th November |
|
1st January |
23rd December |
|
5th February |
27th January |
|
5th March |
24th February |