| Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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| Chapter Links... |
 LSCMMG: Gastroenterology Biologics Pathway |
| LSCMMG: Primary Care Constipation Guidelines |
| MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review |
| NICE CG147: Diverticular disease: diagnosis and management |
| NICE CG184 Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management |
| NICE CG61: Irritable bowel syndrome in adults: diagnosis and management |
| NICE NG1: Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people |
| Details... |
| 01.05.03 |
Drugs affecting the immune response |
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Azathioprine
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Formulary
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Tablets 25mg, 50mg
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LSCMMG: Shared care guideline - Azathioprine
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Mercaptopurine
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Formulary
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Tablets 50mg
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LSCMMG: Shared care guideline - Mercaptopurine
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Methotrexate
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Formulary
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2.5mg tablets, Prefilled syringes and pens (various strengths)
Crohn's disease.
Methotrexate should be prescribed once weekly as a single dose on the same day each week.
If oral methotrexate is prescribed only use the 2.5 mg strength
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LSCMMG: Shared care guideline - Methotrexate
 MHRA: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
MHRA: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
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Ciclosporin
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Formulary
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Capsule
Severe ulcerative colitis
Specialist initiation only
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LSCMMG: Shared care guideline - Ciclosporin
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Ciclosporin injection
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Formulary
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Severe ulcerative colitis
Specialist initiation only
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| 01.05.03 |
Tumor necrosis factor alpha (TNF-a) inhibitors |
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Infliximab
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Formulary
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Intravenous infusion 100mg
Pre-filled pen 120 mg solution for injection
Pre-filled syringe 120 mg solution for injection
Use in high risk patients for prevention of recurrence or upon recurrence of Crohn's Disease following surgery.
Crohn's disease - NICE TA187
Acute exacerbations of Ulcerative Colitis - NICE TA163
Moderate to severe active ulcerative colitis - NICE TA329
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NICE TA163: Infliximab for acute exacerbations of ulcerative colitis
NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Adalimumab
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Formulary
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Pre-filled syringe or pen
Crohn's disease - NICE TA187
Ulcerative colitis - NICE TA329
High risk patients for prevention of recurrence or upon recurrence of Crohn's Disease following surgery
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NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Golimumab
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Formulary
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Pre-filled syringe or pen
Moderate to severe active ulcerative colitis
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NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
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Infliximab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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Adalimumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Adalimumab
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Certolizumab pegol
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Formulary
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Do not prescribed for Crohn's disease or ulcerative colitis
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LSCMMG: Certolizumab Pegol Crohn’s disease
LSCMMG: Certolizumab Pegol Ulcerative Colitis
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Golimumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Golimumab
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| 01.05.03 |
JAK inhibitors |
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Tofacitinib
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Formulary
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Tablets 5mg, 10mg, MR tablets 11mg
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NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis
MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
MHRA: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
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Upadacitinib (Rinvoq ®)
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Formulary
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Prolonged release tablets 15mg, 30mg, 45mg
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NICE TA905: Upadacitinib for previously treated moderately to severely active Crohn’s disease
MHRA: 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
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Filgotinib
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Formulary
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Tablet 100mg, 200mg
Moderately to severely active ulcerative colitis
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NICE TA792: Filgotinib for treating moderately to severely active ulcerative colitis
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| 01.05.03 |
Immunomodulating drugs |
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Etrasimod
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Formulary
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Tablets 2mg
For the treatment of ulcerative colitis in accordance with NICE TA956
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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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Ozanimod
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Formulary
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Capsules 230microgram, 460microgram, 920 microgram
Moderately to severely active ulcerative colitis
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NICE TA828: Ozanimod for treating moderately to severely active ulcerative colitis
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| 01.05.03 |
Interleukin inhibitors |
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Mirikizumab
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Formulary
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100mg/ml solution for injection pre-filled pen, 300mg/15ml concentrate for solution for infusion vials
For treatment of moderately to severely active ulcerative colitis
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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
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solution for injection pre-filled syringes, solution for injection pre-filled pen 150mg/mL
Crohn's disease - TA888
Moderately to severely active ulcerative colitis - TA998
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NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease
NICE TA998: Risankizumab for treating moderately to severely active ulcerative colitis
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Ustekinumab
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Formulary
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Concentrate for solution for infusion 130mg
Solution for injection 45mg
Pre-filled syringe 45mg, 90mg
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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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| 01.05.03 |
Monoclonal antibody, anti-lymphocyte |
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Vedolizumab (Entyvio®)
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Formulary
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intravenous infusion 300mg vial, pre-filled pen 108mg solution for injection, pre-filled syringe 108mg solution for injection
Use in high risk patients for prevention of recurrence or upon recurrance of Crohn's Disease following surgery.
Moderately to severely active Crohn's disease - NICE TA352
Moderately to severely active ulcerative colitis - NICE TA342
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LSCMMG: Vedolizumab SC
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
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Vedolizumab
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Formulary
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Prevention of recurrence of ulcerative colitis following surgery
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LSCMMG: Vedolizumab
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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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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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Traffic Light Status Information
| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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