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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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01.05.03  Expand sub section  Drugs affecting the immune response
Cytotoxic Drug Azathioprine
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Formulary
Amber
 
Link  North Cumbria SCG - Azathioprine & Mercaptopurine
Link  South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine and Mercaptopurine in Gastroenterology
 
Ciclosporin
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Formulary
Amber
  • 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 Red
 
Link  County Durham and Darlington Shared Care Guideline: Ciclosporin
 
Etrasimod (Velsipity®)
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Formulary
Red
High Cost Medicine
CCG
  • 2mg tablet
  • Approved for treating moderately to severely active ulcerative colitis in people aged 16 and over in line with NICE
 
Link  NICE TA956: Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over
 
FilgotinibBlack Triangle (Jyseleca®)
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Formulary
Red
High Cost Medicine
CCG
  • 100mg and 200mg tablets
  • Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
 
Link  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
Link  NICE TA792: Filgotinib for treating moderately to severely active ulcerative colitis
 
Cytotoxic Drug Mercaptopurine
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Formulary
Amber
 
Link  County Durham and Darlington Shared Care Guideline: 6-Mercaptopurine
Link  North Cumbria SCG - Azathioprine & Mercaptopurine
Link  South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine and Mercaptopurine in Gastroenterology
 
TofacitinibBlack Triangle (Xeljanz®)
(See 10.01.03 Drugs which suppress the rheumatic disease process)
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Formulary
Red
  • 5mg and 10mg tablets.
  • Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE
 
Link  MHRA Drug Safety Alert Oct 2021: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Link  MHRA Drug Safety Alert March 2020: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Link  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
Link  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
Link  NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis
 
UpadacitinibBlack Triangle (Rinvoq®)
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Formulary
Red
High Cost Medicine
CCG
  • 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
 
Link  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
Link  NICE TA856: Upadacitinib for treating moderately to severely active ulcerative colitis
Link  NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease
 
Cytotoxic Drug Methotrexate
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Formulary
  • See section 8.1.3
  • NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL Red

 

 
Link  County Durham and Darlington Shared Care Guideline: Methotrexate
Link  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
 
Vedolizumab
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
Link  NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis
Link  NICE TA826: Vedolizumab for treating chronic refractory pouchitis after surgery for ulcerative colitis (terminated appraisal)
 
01.05.03  Expand sub section  Cytokine inhibitors
Adalimumab
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Formulary
Red
High Cost Medicine

  • Only approved for use in accordance with NICE guidance. 

 
Link  NICE TA187: Crohn’s disease - infliximab and adalimumab
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
 
Golimumab
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
 
Infliximab (Remicade®, Inflectra®, Remsima®)
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance.
  • Prescribe by brand only.  

 

 
Link  NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
Link  NICE TA187: Crohns disease - infliximab & adalimumab
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
Link  NTAG recommends the use of infliximab biosimilars as an option where the originator product (Remicade®) would normally be prescribed
 
Mirikizumab (Omvoh®)
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Formulary
Red
High Cost Medicine
  • 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 
 
Link  NICE TA925: Mirikizumab for treating moderately to severely active ulcerative colitis
 
Ustekinumab (Stelara® )
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Formulary
Red
High Cost Medicine
  • 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

 

 
Link  MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis
Link  NICE TA456 Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
Link  NICE TA633: Ustekinumab for treating moderately to severely active ulcerative colitis
 
OzanimodBlack Triangle (Zeposia®)
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Formulary
Red
  • Approved for moderately to severely active ulcerative colitis in adults in line with NICE.
 
Link  NICE TA 828: Ozanimod for treating moderately to severely active ulcerative colitis
 
 ....
 Non Formulary Items
Dupilumab  (Dupixent®)

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Non Formulary
Red
  • 200mg/1.14ml & 300mg/2ml solution for injection
  • Not recommended for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal).
Link  NICE TA938: Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal)
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

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.  

Amber

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.  

Green plus

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.  

Green

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.  

Black

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.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

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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