Two new medicines have been cleared for routine use by the NHS in England and Wales – Eli Lilly’s Omvoh for Crohn’s disease and BeOne Medicine’s Brukinsa for mantle cell lymphoma.
Health technology assessment (HTA) agency NICE has published final draft guidance for IL-23 inhibitor Omvoh (mirikizumab), making it an option for moderately to severely active Crohn’s disease if an earlier biologic therapy for the inflammatory bowel disease stops working or cannot be tolerated, or if TNF inhibitors are not suitable.
The decision comes just three months after Omvoh’s approval by the UK medicines regulator, the MHRA, and means that Omvoh will become an option for adult patients in England within the next 30 days and in Wales within 60 days. It is already being used to treat patients with ulcerative colitis, having been recommended by NICE for that use in 2023.
Omvoh now joins a range of biologics in the NHS armamentarium for moderately to severely active Crohn’s, alongside older TNF drugs, AbbVie’s Skyrizi (risankizumab) and Johnson & Johnson’s Stelara (ustekinumab) – also IL-23 inhibitors – and Takeda’s integrin inhibitor Entyvio (vedolizumab). NICE guidance is that the cheapest option be prescribed for a patient from the suitable treatments.
“Many patients with Crohn’s disease have explored several of the currently available therapies, but are still seeking a treatment option that effectively helps manage their symptoms and reduces the long-term inflammatory burden of the condition,” said Prof James Lindsay, an IBD specialist at Barts Health NHS Trust in London.
“The recent authorisation of mirikizumab is positive news for those living with Crohn’s disease, as well as the gastroenterologists and specialists who care for them, as it gives a new option for treatment.”
In Scotland, NICE’s counterpart, the SMC, is due to deliver a decision on Omvoh for Crohn’s in August.
Turning to Brukinsa (zanubrutinib), NICE’s appraisal committee has backed use of the BTK inhibitor for relapsed or refractory MCL after one earlier line of treatment, becoming the first reimbursement authority in Europe to do so.
The drug is already recommended by NICE for NHS treatment of some patients with Waldenstrom’s macroglobulinaemia, chronic lymphocytic leukaemia (CLL), and marginal zone lymphoma (MZL).
BeOne (formerly Beigene) estimates that there are around 600 people in the UK diagnosed with MCL every year. The SMC is also reviewing the new indication for Brukinsa with a decision due in August.
“While initial treatments are usually effective at controlling the lymphoma, they do not work in every patient, and many patients with mantle cell lymphoma will eventually relapse,” commented Dr David Lewis, consultant haematologist at University Hospitals Plymouth NHS Trust.
“Zanubrutinib offers a welcome addition to our therapeutic toolkit, with data showing high response rates and a manageable safety profile,” he added.