Health Board Chief Executives in Wales have approved advice for two medicines, infliximab and vedolizumab (Entyvio®), after assessing them through the One Wales Medicines process.
Infliximab can be used for the treatment of immune checkpoint inhibitor induced grade 3-4 enterocolitis, where symptoms have not responded to first line immunosuppression with corticosteroids. Similarly, vedolizumab (Entyvio®) can be used for the treatment of immune checkpoint inhibitor induced grade 3-4 enterocolitis, where symptoms have not responded to first line immunosuppression with corticosteroids and infliximab, or when infliximab is unsuitable.
Immune Checkpoint Inhibitor (ICI) immunotherapy is a recent advancement in cancer treatment which activates the patient’s immune system to attack the tumour. However, one common and severe side-effect of treatment with ICIs is enterocolitis which can include nausea, vomiting, diarrhoea, abdominal pain, and blood and mucous in the stool. These symptoms are the most common reason for disrupting or stopping treatment with ICIs.
After reviewing the evidence summary reports (ESR) compiled by AWTTC, the One Wales Medicines Advisory Group (OWMAG) recommended that both infliximab and vedolizumab (Entyvio®) should be made available to help treat ICI induced enterocolitis where symptoms have not responded to treatment with corticosteroids. Being able to manage this side-effect will make the use of ICIs to treat some cancers a more viable option for some patients.
The use of infliximab and vedolizumab in the patient groups considered is unlicensed. Prescribers are reminded that the risks and benefits for each medicine should be clearly stated and discussed with patients or their carers to allow informed consent, and prescribers should consult the guidelines on prescribing unlicensed medicines.
AWTTC will review the advice for each medicine after 12 months or earlier if new evidence becomes available.
More about the One Wales Medicines process, including a new video explaining how the process works is available at https://awttc.nhs.wales/one-wales