FOI2026/2114

1. Does the ICB have a process to ensure that a positive NICE TA is considered by the APC, formulary committee or equivalent decision-making body in sufficient time for a final local formulary and/or traffic light decision to be made within the applicable NICE funding/implementation period? 

• Yes / No
• If Yes, please provide a copy of, or link to, the relevant process and state who is responsible for preparing the paper or submission for committee consideration.

2. Is preparation of an APC/formulary paper or equivalent assessment routinely required for positive NICE TAs before a final traffic light classification is agreed?

• Yes / No
• If Yes, please provide any template, terms of reference, procedure or other document setting out the information, approvals or governance required.

3. Does the ICB assign an interim or temporary traffic light/RAG (red, amber, green) classification to a medicine following publication of a positive NICE TA while awaiting a final local formulary/APC decision?

• Yes / No
• If Yes, please state the classification used and provide the definition of that classification, including what it means in practice for initiation, prescribing responsibility, funding and patient access.
• Please also provide any policy, procedure or guidance governing the use of the temporary classification and explain how the interim position is communicated to prescribers and providers.

4. Where a temporary classification is used, is it time-limited or subject to a specified review date?

• Yes / No
• If Yes, please state the usual timeframe and review arrangements.

5. (If applicable) Has the ICB’s use of a temporary/interim traffic light classification for a NICE-recommended medicine ever been subject to a formal challenge?

• Yes / No
• If Yes, please state whether the challenge took the form of judicial review or other legal proceedings, a pre-action protocol letter, formal complaint, Freedom of Information request, patient or clinician challenge, commissioner/provider challenge, or another formal route. Please provide the number of such challenges recorded and, where held, copies of any final decisions, findings or resulting policy/process changes, subject to any applicable exemptions.

6. Where no temporary classification is used, does the ICB routinely classify a medicine recommended by a positive NICE TA as Red/specialist-only pending a final formulary/APC decision?

• Yes / No
• If Yes, please provide the relevant policy or procedure and explain whether this permits prescribing and access through specialist services during the interim period.

7. (If applicable) Has the ICB’s approach of assigning a Red/specialist-only classification, or leaving a NICE-recommended medicine unclassified pending local review, ever been subject to a formal challenge of the types described in question 8?

• Yes / No
• If Yes, please provide the equivalent information requested in question 8.

8. Does the ICB ever leave a medicine recommended in a positive NICE TA unclassified pending local review?

• Yes / No
• If Yes, please explain what this means for prescribing, funding and patient access during that period.

1. NHS Greater Manchester formally take all NICE TAs through the medicine’s governance process.

The GMMMG Clinical Reference Group manages formulary updates, including monthly NICE guidance and technology appraisals. The GMMMG process documents are available on the GMMMG website and can be accessed via: https://gmmmg.nhs.uk/meetings/membership-and-tor/gmmmg-process-documents/

The CRG secretariat is responsible for ensuring that governance processes are followed. The CRG terms of reference are available on the GMMMG website and can be accessed via: https://gmmmg.nhs.uk/wp-content/uploads/2023/01/Clinical-Reference-Subgroup-ToR-Jan-23-approved.pdf

2. Yes – See question 1, GMMMG process documents are publicly available
3. No
4. Not applicable
5. Not applicable
6. No
7. Not applicable
8. Yes – Following publication of a final positive NICE Technology Appraisal (TA), the medicine is subject to the local governance and approval process before being formally adopted onto the GMMMG formulary. During this interim period, the medicine remains unclassified locally, and prescribing should not commence until the formulary adoption process has been completed. Consequently, routine prescribing and patient access may be delayed pending local approval and confirmation of the relevant funding arrangements if applicable.