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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Guidelines for the Management of Adults with Asymptomatic Liver Blood Test Abnormalities

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

NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

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

NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

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

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

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. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.