Anti-TNF approved for moderate-to-severe UC by NICE

Earlier this week, NICE issued their final guidance for their multi-technology appraisal of infliximab, adalimumab and golimumab for the treatment of moderate-to-severe ulcerative colitis. The summary guidance is:

1.1 Infliximab, adalimumab and golimumab are recommended, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.

Golimumab is recommended only if the company provides the 100 mg dose of golimumab at the same cost as the 50 mg dose, as agreed in the patient access scheme.

1.2 The choice of treatment between infliximab, adalimumab or golimumab should be made on an individual basis after discussion between the responsible clinician and the patient about the advantages and disadvantages of the treatments available. This should take into consideration therapeutic need and whether or not the patient is likely to adhere to treatment. If more than 1 treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose).

1.3 Infliximab is recommended, within its marketing authorisation, as an option for treating severely active ulcerative colitis in children and young people aged 6–17 years whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.

1.4 Infliximab, adalimumab or golimumab should be given as a planned course of treatment until treatment fails (including the need for surgery) or until 12 months after starting treatment, whichever is shorter. Specialists should then discuss the risks and benefits of continued treatment with the patient, and their parent or carer if appropriate:

  • They should continue treatment only if there is clear evidence of response as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. People who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate.

  • They should consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People whose disease relapses after treatment is stopped should have the option to start treatment again.

For Scotland, Healthcare Improvement Scotland has issued its own statement in which they advise that 'the recommendations are as valid for Scotland as for England and Wales'.

This important new guidance expands the possibilities for medical therapy of ulcerative colitis across Scotland and the rest of the UK.