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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
01.05.03  Expand sub section  Cytokine inhibitors
Adalimumab
(Gastroenterology)
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Restricted Drug Restricted
Red
High Cost Medicine
Homecare

Injection

  • For use in line with NICE guidance below
  • 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)
    View adult BNF View SPC online
    Restricted Drug Restricted
    High Cost Medicine
    Infusion (Infliximab biosimilar)
  • SFH - Remsima® brand biosimilar to be used for all new patients.
    Red Traffic Light NUH and Nottingham Treatment Centre:
  • Approved for the treatment of Crohn’s disease and ulcerative colitis in adult in line with NICE approved indications.
    Red Traffic Light NUH:
  • 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.
    Grey Traffic Light For other indications and specialities, no formal assessment (NUH DTC Mar 15)
    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)
    View adult BNF View SPC online
    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)

    View adult BNF View SPC online View childrens BNF
    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

      

    netFormulary