Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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Chapter Links... |
Crohns Disease Treatment Algorithm for High Cost Drugs |
Ulcerative Colitis Treatment Algorithm for High Cost Drugs |
Details... |
01.05.03 |
Drugs affecting the immune response |
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Azathioprine (Gastroenterology)
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Formulary
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Tablets
- Maintenance of remission of acute ulcerative colitis and Crohn’s disease in adults.
- Amber 1: For use in adults with Inflammatory Bowel Disease as per shared care protocol- see below
- Amber 1: For use in Inflammatory Bowel disease for children >12 years old as per shared care protocol - see below
- Oral suspension (expensive) available as an unlicensed special - recommended strength is 50mg/5mL as per RCPCH guidance. At SFH send patients to SFH pharmacy for supplies
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COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Nottinghamshire APC Shared Care Protocol: Azathioprine for IBD info sheet
Nottinghamshire APC Shared Care Protocol: IBD overarching document
Notts APC Shared Care Protocol: Azathioprine for IBD in children >12 years old
UKMI Q and A: Can mothers breast feed while taking azathioprine?
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Azathioprine (Autoimmune Hepatitis)
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Formulary
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Tablets
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COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Notts APC Shared Care Protocol: Azathioprine for Auto-Immune Hepatitis info sheet
Notts APC Shared Care Protocol: Azathioprine for Auto-Immune Hepatitis overarching document
UKMI Q and A: Can mothers breast feed while taking azathioprine?
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Ciclosporin (Gastroenterology)
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Formulary
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Injection, Capsules- Secondary Care only
- Treatment of ulcerative colitis
- MHRA specify that ciclosporin must be prescribed and dispensed by brand as bioavailability differences exist between brands.
- Capimune® is preferred brand for new patients at SFH. For advice on switching see BNF.
- Relative prices of different brands [Hospital price][GP price]
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SFH: Prescribing guideline for ciclosporin for ulcerative colitis
NUH Lite Bite: Importance of maintining brand for certain medicines
SFH only: IV autoprescription
SFH: IV drugs which need special giving sets
SPS: Which medicines should be considered for brand name prescribing in primary care?
SFH info on branded prescribing
Crohn’s and Colitis UK: Patient information leaflets
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Mercaptopurine (Gastroenterology)
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Formulary
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Tablets, suspension.
- Maintenance of remission of acute ulcerative colitis and Crohn’s disease in adults – unlicensed but in line with national guidelines
- Suspension (Xaluprine®) (expensive) only for patients where tablets are not suitable (i.e. small doses in paediatrics).
- Note that mercaptopurine use in children (under 18 years) is excluded from shared care and can be considered as
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- Amber 1: For use in Inflammatory Bowel Disease as per shared care protocol
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COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Nottinghamshire APC Shared Care Protocol: IBD overarching document
Nottinghamshire APC Shared Care Protocol: Mercaptopurine for IBD info sheet
UKMI Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
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Methotrexate (Gastroenterology)
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Formulary
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Tablets
- The day(s) of the week the patient takes their methotrexate should be highlighted on the prescription and the medication packaging see MHRA Alert
- 2.5mg tablets preferred as per NPSA alert
- Cytotoxic, do not crush and disperse in water, liquid may be available if required.
- Amber 1 for adults (>18yrs) with inflammatory bowel disease as per the shared care protocol below
- NUH: Metoject® injection available for paediatric patients - routinely supplied via homecare (prescribe by brand and generic name)
- Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
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COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Inflammatory bowel disease shared care protocol
Methotrexate information sheet
NUH Lite Bite: Methotrexate for non-cancer use
NUH Lite Bite: Safer use of weekly oral methotrexate
NUH: Medicines Matters Bulletin: Safer Use of Weekly oral Methotrexate
SFH: Methotrexate policy (medicines policy section 4.5.1)
UKMI Q&A: Alcohol and low dose methotrexate information
UKMI Q&A: Interaction between methotrexate and penicillins info.
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Vedolizumab (Entyvio®) (Gastroenterology)
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Restricted

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Concentrate for intravenous infusion Pre-filled syringe/pre-filled pen for subcutaneous injection
- For use in line with NICE guidance in ulcerative colitis (TA342) and Crohn's disease (TA352)
- Subcutaneous injection available through homecare for SFH, NUH and Treatment Centre patients. Please contact pharmacy medicines homecare team for further information.
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Vedolizumab in Gastroenterology patients (SFHT)
NICE TA352: Vedolizumab for Crohn’s disease
NICE TA342: Vedolizumab for ulcerative colitis
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01.05.03 |
Cytokine inhibitors |
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Adalimumab (Gastroenterology)
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Restricted

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Injection
- Approved in accordance with NICE TA187 for the treatment of Crohn's disease.
- Approved in accordance with NICE TA329 for treating moderately to severely active ulcerative colitis after the failure of conventional therapy.
- Approved for treating lymphocytic/microscopic colitis uncontrolled by conservative treatment in adult patients. (Unlicensed indication - named patient only)
- Approved for treating pouchitis uncontrolled by conservative treatment in adult patients. (Unlicensed indication - named patient use only)
- Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
- Biosimilar Imraldi® is the first line option for new patients
- Biosimilar Amgevita® can be used second line in those who are unable to tolerate Imraldi®
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Link to reviews
NICE TA187: Crohn’s disease - infliximab and adalimumab
NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
SFH: Homecare information
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Golimumab (Simponi®) (Ulcerative Colitis)
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Restricted

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Injection
SFH: Approved for treating moderately to severely active ulcerative colitis after the failure of conventional therapy as per NICE TA329.
NUH: Approved for treating moderately to severely active ulcerative colitis after the failure of conventional therapy as per NICE TA329. Prior approval with pharmacy required pending full assessment of local implementation.
Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
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NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
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Infliximab (Remicade®) (Gastroenterology)
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Restricted
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Infusion For use in line with NICE guidance-see below Use 1.2 micron filter when administering. SFH - Remsima® brand biosimilar to be used for all new patients. See entry below.
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SFH: Infliximab protocol in inflammatory bowel disease patients
Link to reviews
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
SFH: Information about IV filters
UKMI: Biosimilars - New Developments
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Infliximab (Remsima®) (Gastroenterology)
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Restricted
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Infusion (Infliximab biosimilar)
- SFH - Remsima® brand biosimilar to be used for all new patients.
- Approved for treating lymphocytic/microscopic colitis uncontrolled by conservative treatment in adult patients. (Unlicensed indication - named patient only)
- Approved for treating pouchitis uncontrolled by conservative treatment in adult patients. (Unlicensed indication - named patient use only)
Available at NUH only:
- Approved in accordance with NICE TA163 for acute exacerbations of ulcerative colitis
- Approved in accordance with NICE TA187 for the treatment of Crohn's disease.
- Approved in accordance with NICE TA329 for treating moderately to severely active ulcerative colitis after the failure of conventional therapy.
- Approved for the treatment of Crohn’s disease and ulcerative colitis in paediatric patients.
- Approved for the treatment of immunotherapy induced colitis in oncology patients who fail to respond to high dose steroids.
Infliximab biosimilar
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NICE KTT15: Biosimilar medicines
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
SPS: Biosimilars of infliximab guidance (taken from LMEN)
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Infliximab (Remsima®) (Neurology)
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Restricted
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Infusion (Infliximab biosimilar)
- Available through NUH only: Approved as per clinical commissioning policy for refractory or progressive neurosarcoidosis (adults and post-pubescent children). Unlicensed indication.
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Clinical Commissioning Policy: Infliximab for Refractory or Progressive Neurosarcoidosis (Adults and Post-pubescent Children)
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01.05.03 |
Vedolizumab |
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Non Formulary Items |
Infliximab (Inflectra®) (All indications)

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Non Formulary
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Infusion No formal assessment (NUH DTC Mar 15) Infliximab biosimilar |
SPS: Biosimilars of infliximab guidance
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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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Traffic Light Status Information
Status |
Description |

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Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market. |

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Medicines which should normally be prescribed by specialists only. eg hospital only.
For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care. |

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Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the Nottinghamshire APC. |

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Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
*Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice |

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Primary care/ non specialist may initiate as per APC guideline.
The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC. |

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Medicines suitable for routine use within primary care.
Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing. |

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