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Nottinghamshire Area Prescribing Committee
Joint Formulary
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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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01.05.03  Expand sub section  Drugs affecting the immune response
Cytotoxic Drug Azathioprine
(Gastroenterology)
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Formulary
Amber 1

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
 
Link  COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Link  Nottinghamshire APC Shared Care Protocol: Azathioprine for IBD info sheet
Link  Nottinghamshire APC Shared Care Protocol: IBD overarching document
Link  Notts APC Shared Care Protocol: Azathioprine for IBD in children >12 years old
Link  UKMI Q and A: Can mothers breast feed while taking azathioprine?
   
Cytotoxic Drug Azathioprine
(Autoimmune Hepatitis)
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Formulary
Amber 1

Tablets

 
Link  COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Link  Notts APC Shared Care Protocol: Azathioprine for Auto-Immune Hepatitis info sheet
Link  Notts APC Shared Care Protocol: Azathioprine for Auto-Immune Hepatitis overarching document
Link  UKMI Q and A: Can mothers breast feed while taking azathioprine?
   
Ciclosporin
(Gastroenterology)
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Formulary
Red

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]
 
Link  SFH: Prescribing guideline for ciclosporin for ulcerative colitis
Link  NUH Lite Bite: Importance of maintining brand for certain medicines
Link  SFH only: IV autoprescription
Link  SFH: IV drugs which need special giving sets
Link  SPS: Which medicines should be considered for brand name prescribing in primary care?
Link  SFH info on branded prescribing
Link  Crohn’s and Colitis UK: Patient information leaflets
   
Cytotoxic Drug Mercaptopurine
(Gastroenterology)
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Formulary
Amber 1

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 Red.
  • Amber 1: For use in Inflammatory Bowel Disease as per shared care protocol
 
Link  COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Link  Nottinghamshire APC Shared Care Protocol: IBD overarching document
Link  Nottinghamshire APC Shared Care Protocol: Mercaptopurine for IBD info sheet
Link  UKMI Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
   
Cytotoxic Drug Methotrexate
(Gastroenterology)
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Formulary
Amber 1
Homecare

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
 
Link  COVID19: DMARD shared care monitoring during COVID19 (Notts CCG)
Link  Inflammatory bowel disease shared care protocol
Link  Methotrexate information sheet
Link  NUH Lite Bite: Methotrexate for non-cancer use
Link  NUH Lite Bite: Safer use of weekly oral methotrexate
Link  NUH: Medicines Matters Bulletin: Safer Use of Weekly oral Methotrexate
Link  SFH: Methotrexate policy (medicines policy section 4.5.1)
Link  UKMI Q&A: Alcohol and low dose methotrexate information
Link  UKMI Q&A: Interaction between methotrexate and penicillins info.
   
Vedolizumab (Entyvio®)
(Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

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.
 
Link  Vedolizumab in Gastroenterology patients (SFHT)
Link  NICE TA352: Vedolizumab for Crohn’s disease
Link  NICE TA342: Vedolizumab for ulcerative colitis
   
01.05.03  Expand sub section  Cytokine inhibitors
Adalimumab
(Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

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®

 

 
Link  Link to reviews
Link  NICE TA187: Crohn’s disease - infliximab and adalimumab
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
Link  SFH: Homecare information
   
Golimumab (Simponi®)
(Ulcerative Colitis)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

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

 
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
   
Infliximab (Remicade®)
(Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
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. 
  • Link  SFH: Infliximab protocol in inflammatory bowel disease patients
    Link  Link to reviews
    Link  NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
    Link  NICE TA187: Crohns disease - infliximab & adalimumab
    Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
    Link  SFH: Information about IV filters
    Link  UKMI: Biosimilars - New Developments
       
    Infliximab (Remsima®)
    (Gastroenterology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    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
     
    Link  NICE KTT15: Biosimilar medicines
    Link  NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
    Link  NICE TA187: Crohns disease - infliximab & adalimumab
    Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
    Link  SPS: Biosimilars of infliximab guidance (taken from LMEN)
       
    Infliximab (Remsima®)
    (Neurology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    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.
     
    Link  Clinical Commissioning Policy: Infliximab for Refractory or Progressive Neurosarcoidosis (Adults and Post-pubescent Children)
       
    01.05.03  Expand sub section  Vedolizumab
     ....
     Non Formulary Items
    Infliximab  (Inflectra®)
    (All indications)

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    Non Formulary
    Grey
    High Cost Medicine
    Infusion
    No formal assessment (NUH DTC Mar 15)
    Infliximab biosimilar
    Link  SPS: Biosimilars of infliximab guidance
     
      
    Key
    note Notes
    Section Title Section Title (top level)
    Section Title Section Title (sub level)
    First Choice Item First Choice item
    Non Formulary Item Non Formulary section
    Restricted Drug
    Restricted Drug
    Unlicensed Drug
    Unlicensed
    Track Changes
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to children's BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    Cytotoxic Drug
    Cytotoxic Drug
    CD
    Controlled Drug
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Grey

    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.
      

    Red

    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.
      

    Amber 1

    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.
      

    Amber 2

    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
      

    Amber 3

    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.
      

    Green

    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.   

    OTC

      

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