Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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Chapter Links... |
County Durham and Tees Valley Guidance for Prescribing and Monitoring in Post Bariatric Surgery in Primary Care |
Guidelines for the Management of Adults with Asymptomatic Liver Blood Test Abnormalities |
North of Tyne, Gateshead and North Cumbria - Management of patients, post-bariatric surgery in primary care |
NTAG: Transanal irrigation (TAI) systems (Peristeen Plus®, Aquaflush®, and QuFora®) for neurogenic bowel dysfunction, chronic constipation and chronic faecal incontinence |
Details... |
01.05.03 |
Drugs affecting the immune response |
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Azathioprine
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Formulary
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North Cumbria SCG - Azathioprine & Mercaptopurine
South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine and Mercaptopurine in Gastroenterology
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Ciclosporin
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Formulary
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- Capsules: 10mg, 25mg, 50mg, 100mg
- Oral solution: 100mg/ml
- Must be prescribed by brand name
- Brands include Capimune, Capsorin, Deximune, Neoral, Sandimmun, Vanquoral
- 50mg/1ml continuous infusion
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County Durham and Darlington Shared Care Guideline: Ciclosporin
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Etrasimod (Velsipity®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 2mg tablet
- Approved for treating moderately to severely active ulcerative colitis in people aged 16 and over in line with NICE
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NICE TA956: Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over
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Filgotinib (Jyseleca®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 100mg and 200mg tablets
- Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
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MHRA Drug Safety Update April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA792: Filgotinib for treating moderately to severely active ulcerative colitis
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Mercaptopurine
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Formulary
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County Durham and Darlington Shared Care Guideline: 6-Mercaptopurine
North Cumbria SCG - Azathioprine & Mercaptopurine
South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine and Mercaptopurine in Gastroenterology
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Tofacitinib (Xeljanz®) (See 10.01.03 Drugs which suppress the rheumatic disease process)
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Formulary
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- 5mg and 10mg tablets.
- Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
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MHRA Drug Safety Alert Oct 2021: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
MHRA Drug Safety Alert March 2020: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
MHRA Drug Safety Update (April 2023): Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
MHRA Drug Safety Update May 2019: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis
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Upadacitinib (Rinvoq®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 15 and 30mg tablets
- Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
- Approved for previously treated moderately to severely active Crohn's disease in line with NICE
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MHRA Drug Safety Update April 2023: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA856: Upadacitinib for treating moderately to severely active ulcerative colitis
NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease
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Methotrexate
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Formulary
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- See section 8.1.3
- NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL
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County Durham and Darlington Shared Care Guideline: Methotrexate
MHRA Drug Safety Update (Sept 2020): Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
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Vedolizumab
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis
NICE TA826: Vedolizumab for treating chronic refractory pouchitis after surgery for ulcerative colitis (terminated appraisal)
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01.05.03 |
Cytokine inhibitors |
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Adalimumab
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA187: Crohn’s disease - infliximab and adalimumab
NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
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Golimumab
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
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Infliximab (Remicade®, Inflectra®, Remsima®)
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Formulary
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- Only approved for use in accordance with NICE guidance.
- Prescribe by brand only.
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NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
NICE TA187: Crohns disease - infliximab & adalimumab
NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
NTAG recommends the use of infliximab biosimilars as an option where the originator product (Remicade®) would normally be prescribed
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Mirikizumab (Omvoh®)
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Formulary
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- 100mg/1ml solution for injection pre-filled pens & 300mg/15ml concentrate for solution for infusion
- Approved for treating moderately to severely active ulcerative colitis in adults in line with NICE
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NICE TA925: Mirikizumab for treating moderately to severely active ulcerative colitis
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Risankizumab (Skyrizi®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 150mg/1ml solution for injection (pre-filled devices)
- Approved for previously treated moderately to severely active Crohn's disease in people 16 years and over in line with NICE
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NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease
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Ustekinumab (Stelara® )
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Formulary
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- 130 mg concentrate for solution for infusion
- Approved for previously treated moderately to severely active Crohn’s disease in adults in line with NICE
- Approved for treating moderately to severely active ulcerative colitis in line with NICE
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MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis
NICE TA456 Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
NICE TA633: Ustekinumab for treating moderately to severely active ulcerative colitis
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Ozanimod (Zeposia®)
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Formulary
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- Approved for moderately to severely active ulcerative colitis in adults in line with NICE.
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NICE TA 828: Ozanimod for treating moderately to severely active ulcerative colitis
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Non Formulary Items |
Dupilumab (Dupixent®)
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Non Formulary
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- 200mg/1.14ml & 300mg/2ml solution for injection
- Not recommended for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal).
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NICE TA938: Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal)
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
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