North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 1: Gastro-intestinal system - Full Chapter

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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

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01.05.03

Drugs affecting the immune response

Azathioprine

Formulary

North Cumbria SCG - Azathioprine & Mercaptopurine

South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine and Mercaptopurine in Gastroenterology

Ciclosporin

Formulary

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

County Durham and Darlington Shared Care Guideline: Ciclosporin

Etrasimod (Velsipity^®)

Formulary

2mg tablet
Approved for treating moderately to severely active ulcerative colitis in people aged 16 and over in line with NICE

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

Filgotinib

(Jyseleca^®)

Formulary

100mg and 200mg tablets
Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE

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

Mercaptopurine

Formulary

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

Tofacitinib

(Xeljanz^®)
(See 10.01.03 Drugs which suppress the rheumatic disease process)

Formulary

5mg and 10mg tablets.
Approved for the treatment of moderate to severe active ulcerative colitis in line with NICE

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

Upadacitinib

(Rinvoq^®)

Formulary

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

NICE TA856: Upadacitinib for treating moderately to severely active ulcerative colitis

NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease

Methotrexate

Formulary

See section 8.1.3
NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL

County Durham and Darlington Shared Care Guideline: Methotrexate

MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

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

Formulary

Only approved for use in accordance with NICE guidance.

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)

Newcastle, North Tyneside, Northumberland & Gateshead - Guidelines for Monitoring of Immune Modifying Drugs (IMDs) in Stable Adult Patients (excluding post transplantation) in Primary and Secondary Care

NICE CG61: Irritable bowel syndrome in adults: diagnosis and management

NICE NG129: Crohn’s disease: management

NICE NG130: Ulcerative colitis: management

NICE NG147: Diverticular disease: diagnosis and management

01.05.03

Cytokine inhibitors

Adalimumab

Formulary

Only approved for use in accordance with NICE guidance.

NICE TA187: Crohn’s disease - infliximab and adalimumab

NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis

Golimumab

Formulary

Only approved for use in accordance with NICE guidance.

NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis

Infliximab (Remicade^®, Inflectra^®, Remsima^®)

Formulary

Only approved for use in accordance with NICE guidance.
Prescribe by brand only.

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

Mirikizumab (Omvoh^®)

Formulary

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

NICE TA925: Mirikizumab for treating moderately to severely active ulcerative colitis

Risankizumab (Skyrizi^®)

Formulary

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
- Approved for treating moderately to severely active ulcerative colitis in adults in line with NICE

NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease

NICE TA998: Risankizumab for treating moderately to severely active ulcerative colitis

Ustekinumab (Stelara^® )

Formulary

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

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

Ozanimod

(Zeposia^®)

Formulary

Approved for moderately to severely active ulcerative colitis in adults in line with NICE.

NICE TA 828: Ozanimod for treating moderately to severely active ulcerative colitis

....

Non Formulary Items

Dupilumab (Dupixent^®)

Non Formulary

200mg/1.14ml & 300mg/2ml solution for injection
Not recommended for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal).

NICE TA938: Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal)

Key

	Notes
	Section Title (top level)
	Section Title (sub level)
	First Choice item
	Non Formulary section
	Restricted Drug
	Unlicensed
	Display tracking information
	Link to adult BNF
	Link to children's BNF
	Link to SPCs

	Cytotoxic Drug
	Controlled Drug
	High Cost Medicine
	NHS England
	Homecare
	CCG

Traffic Light Status Information

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