1.5.3. Drugs affecting the immune response
Restrictions:
Restricted to specialist use in accordance with local protocols (see prescribing notes for detailed information the Formulary status of indications relating to inflammatory bowel disease).
Prescribing Notes:
Adalimumab should be prescribed by brand name. Amgevita® is the preferred biosimilar.
The licensed indications and Formulary status and restrictions are as outlined below (subject to restriction)
Crohn's disease:
Adalimumab is formulary for the treatment of severe active Crohn's disease in adults whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy, in line with the NICE (Multiple) Technology Appraisal Guidance No 187. It is restricted to specialist use in accordance with local protocol.
The treatment of moderately active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies is not recommended by SMC and is non-Formulary.
Treatment of moderately active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies is not recommended by SMC and is non-Formulary
Ulcerative colitis:
Use in the treatment of moderately to severely active ulcerative colitis in adults is restricted to those patients whose disease has responded inadequately to conventional therapy, including corticosteroids, mercaptopurine and azathioprine, or who cannot tolerate, or have medical contraindications for such therapies.
For the use in other indications, see sections 10.1.3, 11.8 and 13.5.3
Restrictions:
Restricted to specialist use for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Prescribing Notes:
More cost-effective sphingosine 1-phosphate receptor modulator choice than ozanimod
Restrictions:
Restricted to specialist use for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
Prescribing Notes:
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.
Restrictions:
Use in the treatment of moderately to severely active ulcerative colitis in adults is restricted to those patients whose disease has responded inadequately to conventional therapy, including corticosteroids, mercaptopurine and azathioprine, or who cannot tolerate, or have medical contraindications for such therapies. See NHSGGC clinical guideline here
Prescribing Notes:
See section 10.1.3 for other indications of golimumab
Restrictions:
Restricted to specialist use as outlined in the prescribing notes below
Prescribing Notes:
Infliximab should be prescribed by brand name. Remsima® is the preferred biosimilar.
Crohn's disease:
- Use in severe active Crohn's disease is restricted to patients whose disease has not responded to, or who are intolerant of or have contraindications to conventional therapy (including immunosuppressive and/or corticosteroid treatment).
- Use in active fistulating Crohn's disease is restricted to patients whose disease has not responded to, or who are intolerant of or have contraindications to conventional therapy (including antibiotics, drainage and immunosuppressive treatments).
- Use in the treatment of severe, active Crohn’s disease in paediatric patients aged 6 to 17 years of age is restricted to specialist use in patients who have not responded to conventional therapy.
Ulcerative colitis:
Use in the treatment of moderately to severely active ulcerative colitis in adults is restricted to those patients whose disease has responded inadequately to conventional therapy, including corticosteroids, mercaptopurine and azathioprine, or who cannot tolerate, or have medical contraindications for such therapies.
Restrictions:
Oral mercaptapurine for use in inflammatory bowel disease (unlicensed indication) is restricted to specialist initiation for patients unable to tolerate azathoprine. In cases where GPs continue the prescribing, associated monitoring will continue to be the responsibility of the acute sector.
Prescribing Notes:
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions:
Restricted to specialist use only as an alternative to ustekinumab/vedolizumab. The most cost-effective choice to be considered 1st line.
Prescribing Notes:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
To be used as per GGC guideline.
Restrictions:
Restricted to specialist use for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
Restrictions:
Restricted to specialist use in moderate to severely active Crohn's disease in patients 16 year of age and older, who have an inadequate response to, lost response to, or where intolerant to conventional therapy, or if such therapies are not advisable.
Restrictions:
Use for the treatment of adults with moderately to severely active ulcerative colitis is restricted to specialist use in patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent according to local guideline.
Prescribing Notes:
For other uses of tofacitinib, see section 10.1.5
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.
Restrictions:
Restricted to specialist use for the following indications:
- Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
- Treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent, or for whom such therapies are not advisable.
Prescribing Notes:
Following a MHRA review in April 2023, the risk of increased incidence of malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality, when compared to those treated with tumour necrosis factor (TNF)-alpha inhibitors, were are considered a class effects across JAK inhibitors used for chronic inflammatory disorders and therefore it is advised to avoid prescribing these medicines unless there are no suitable alternatives in patients with the following risk factors:
- age 65 years or older
- current or past long-time smoking
- other risk factors for cardiovascular disease or malignancy
Please see further details of the review here.
Restrictions:
Crohn's disease:
- The treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or where intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies is restricted to specialist use in accordance with NHSGGC protocol.
Ulcerative Colitis:
- The treatment of adults with moderately to severely active ulcerative colitis who have had a inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies is restricted to specialist use.
Link to relevant NHSGGC clinical guidelines
Prescribing Notes:
For uses in rheumatology, see section 10.1.3 and for use in dermatology see section 13.5.3
Restrictions:
Restricted to specialist use in accordance with local protocols for the indications detailed below:
- Ulcerative colitis: Use in patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist is restricted to specialist use in accordance with regional protocol.
- Crohn's disease: Restricted to specialist use in accordance with local protocol for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a TNFα antagonist.
Link to relevant NHSGGC clinical guidelines
Prescribing Notes:
The treatment of patients with moderately to severely active chronic pouchitis is not recommended for use by the SMC and remain non-Formulary.