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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
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Formulary
Red
High Cost Medicine

  • Only approved for use in accordance with NICE guidance. 

 
Link  NICE TA187: Crohn’s disease - infliximab and adalimumab
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
 
Golimumab
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA329: Infliximab, adalimumab and golimumab for moderately to severely active ulcerative colitis
 
Infliximab (Remicade®, Inflectra®, Remsima®)
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Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance.
  • Prescribe by brand only.  

 

 
Link  Infliximab subcutaneous injection (Remsima SC ®) - interim COVID-19 guidance
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  NTAG recommends the use of infliximab biosimilars as an option where the originator product (Remicade®) would normally be prescribed
 
Risankizumab (Skyrizi®)
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Formulary
Red
High Cost Medicine
NHS England
CCG
  • 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
 
Link  NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease
 
Ustekinumab (Stelara® )
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Formulary
Red
High Cost Medicine
  • 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

 

 
Link  MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis
Link  NICE TA456 Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
Link  NICE TA633: Ustekinumab for treating moderately to severely active ulcerative colitis
 
OzanimodBlack Triangle (Zeposia®)
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Formulary
Red
  • Approved for moderately to severely active ulcerative colitis in adults in line with NICE.
 
Link  NICE TA 828: Ozanimod for treating moderately to severely active ulcerative colitis
 
 ....
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
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

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.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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