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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 1 - Gastro-intestinal system 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
01.05.03 Drugs affecting the immune response
Bedfordshire & Luton JPC Crohn’s Disease Biologic Treatment Pathway BLMK APC Ulcerative Colitis (Moderate to Severe) Biologic Treatment Pathway

Azathioprine tablets
(Therapy in Inflammatory Bowel Disease (IBD) and Autoimmune Hepatitis (SCG))

SCG
Formulary

25mg, 50mg tablets

10mg/ml oral suspension. Restricted to paediatric patients or patients with swallowing difficulties.

NB: 75mg and 100mg tablets were rejected for use Feb 2024 due to safety concerns relating to dosing errors and disproportionate cost. Do not prescribe these strengths. 

Note:

  • Avoid concomitant use of azathioprine with allopurinol, unless supervised by an appropriate specialist.
  • See Shared Care prescribing guideline for azathioprine therapy in inflammatory bowel disease (IBD) and Autoimmune Hepatitis.

Entry reviewed: August 2024

BNF BNFc SPC
BLMK ICB Azathioprine & mercaptopurine Shared Care Guidance for IBD and AIH Drug Safety Update Thiopurines and intrahepatic cholestasis of pregnancy

Etrasimod (Velsipity®)
(2mg film-coated tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or High cost drug form required - see link from Formulary homepage.

For use in accordance with the following NICE TA:

BNF BNFc SPC BlueTeq
NICE TA956: Etrasimod for treating moderately to severely active ulcerative colitis in people aged 16 and over

Filgotinib (Jyseleca®)
(100mg and 200mg film-coated tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or High cost drug form required - see link from Formulary homepage.

For use in accordance with the following NICE TA:

BNF BNFc SPC
MHRA DSU 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

Mercaptopurine

SCG
Formulary

50mg tablets

Do not crush or break tablets.

Shared Care Guidelines for inflammatory bowel disease

BNF BNFc SPC
Drug Safety Update Thiopurines and intrahepatic cholestasis of pregnancy

Methotrexate
(For GI Indications)

Amber SPIS
Formulary

For preparations see section 10.01.03 

 

Important: Metoject new pen device (available from March 2024): Manufacturer is updating the pen device to a button free autoinjector. Please ensure patients are aware and counselled appropriately on how to use the new device. Further details can be found here.

BNF BNFc SPC
MHRA Drug Safety Update: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (Sept 2020) MHRA DSU Aug 2023 Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

Ozanimod (Zeposia®)
(0.23mg, 0.46mg and 0.92mg hard capsules)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or High cost drug form required - see link from Formulary homepage.

For use in accordance with the following NICE TA:

BNF BNFc SPC BlueTeq
NICE TA828: Ozanimod for treating moderately to severely active ulcerative colitis

Tofacitinib 5mg, 10mg (Xeljanz®)
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted to prescribing by Consultant Gastroenterologist in accordance with NICE TA547.

BNF BNFc SPC
MHRA DSU April 2023 - Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis

Ustekinumab 45mg, 90mg, 130mg (Pyzchiva® Wezenla®)
(Pre-filled syringe, vials or IV infusion)

RED
Restricted Drug Restricted

Pyzchiva® or Wezenla® (biosimilar brands) preferred for new patients within licensed indications.

Stelara® for existing patients only (originator brand)

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted to prescribing by Consultant Gastroenterologist for the treatment of active Crohn's disease or moderately to severely active Ulcerative Colitis  in accordance with the following NICE TA(s):

Entry reviewed: October 2024

BNF BNFc SPC
NICE TA 633 Ustekinumab for treating moderately to severely active ulcerative colitis NICE TA456:Ustekinumab for moderately to severely active Crohn’s disease after previous treatment MHRA Drug Safety Update (Jan 15): (Stelara®) - risk of exfoliative dermatitis

Vedolizumab (Entyvio®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

300mg Injection
108mg pre-filled syringe for SC injection
Restricted Item 

BNF SPC
NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
01.05.03 Cytokine inhibitors
01.05.03 Vedolizumab
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.