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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  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
 
Mirikizumab (Omvoh®)
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Formulary
Red
High Cost Medicine
  • 100mg/1ml solution for injection pre-filled pens & 300mg/15ml concentrate for solution for infusion
  • Approved for treating moderately to severely active ulcerative colitis in adults in line with NICE 
 
Link  NICE TA925: Mirikizumab for treating moderately to severely active ulcerative colitis
 
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
    • Approved for treating moderately to severely active ulcerative colitis in adults in line with NICE
 
Link  NICE TA888: Risankizumab for previously treated moderately to severely active Crohn’s disease
Link  NICE TA998: Risankizumab for treating moderately to severely active ulcerative colitis
 
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
 
 ....
 Non Formulary Items
Dupilumab  (Dupixent®)

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Non Formulary
Red
  • 200mg/1.14ml & 300mg/2ml solution for injection
  • Not recommended for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal).
Link  NICE TA938: Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal)
  
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
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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
ICB
Green Low Carbon

Low carbon footprint

Amber Medium Carbon

Medium carbon footprint

Red High carbon footprint

High carbon footprint

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. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.   

Green plus

Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.  

Green

Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.  

Brown

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

Not Recomended

Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.  

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