FOI 2025/1223

Pursuant to the Freedom of Information Act 2000, I am writing to request information regarding the Greater Manchester Medicines Management Group’s policy on the use of high-cost drugs (HCD) in the field of immunology, particularly concerning the promotion of off-label usage outside the scope of NICE Technology Appraisals, which have focused on licensed indications.

It is my understanding that GMMMG is in the process of reviewing existing HCD pathways in immunology with a view to re publishing these pathways and promoting off-label (outside the scope of products market authorization) usage. I am keen to understand the rational and procedural framework surrounding this review.

Specifically, I seek information on the following points:

1. What is GMMMG’s rationale for potentially adding an additional criterion for off-license usage and preferential positioning of treatments?
2. What additional evidence-based analysis does GMMMG conduct (over and above the NICE TA process) prior to recommending off-license usage of medicines as preferential treatment options?
3. What safety and risk assessments are considered by GMMMG, and what safety advice is offered to local providers regarding promoting off-label usage?
4. How does GMMMG handle responsibility for adverse events experienced by patients and any consequent litigation related to off-license usage of treatments?
5. How does GMMMG ensure compliance with GIRFT recommendations, which aim to reduce care variation for patients with immunological conditions, while recommending off-label usage outside the scope of NICE TAs? Does such a practice create inequalities in treatment access for these patients?

The information requested will help clarify the implications and justifications for any proposed GMMMG’s decisions regarding off-license usage and their impact on patient care and treatment equity.

Please note that the information provided will be disseminated to the public via various media outlets, ensuring transparency and informed discussion regarding these healthcare decisions.

1. New uses of drugs must be proposed via the Greater Manchester Joint Formulary – GMMMG.  Applications must be submitted by an NHS clinician, supported by Greater Manchester-wide clinical consensus and body of acceptable evidence for efficacy and safety. Where appropriate, preference in positioning or off-label use recommendation would be based on clinical evidence and cost-effectiveness of the proposed intervention.
2. Literature search and review of the evidence, considered by the relevant subgroup of the Greater Manchester Medicines Management Group (GMMMG).
3. Any available relevant published safety and risk assessments and /or alerts would be considered for all treatment options, including off label recommendations. Safety advice and consideration would be tailored to the proposed off label use and documented in the pathways as appropriate.
4. The responsibility for prescribing lies with the prescriber who signs the prescription. Management of adverse events should be done by all healthcare professionals involved in patient care and patients themselves, in line with established best practice, MHRA, the yellow card scheme, etc. Each prescriber has responsibility to ensure indemnity cover.
5. GMMMG is committed to promote reduction of unwarranted variation and use of cost-effective of medicines through standardisation of pathways and access to high-cost drugs.