HOT & NOT

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Arvelle Therapeutics’ Ontozry (cenobamate), for the treatment of focal-onset seizures in adults with uncontrolled epilepsy in England and Wales. Cenobamate is recommended as an add-on treatment, after at least one other add-on treatment has not controlled seizures. Epilepsy affects over 600,000 people in the UK, which is approximately one in every 100 people.

Eli Lilly and partner Incyte have revealed that their JAK inhibitor Olumiant (baricitinib) maintained a consistent safety profile in a long-term analysis of patients with rheumatoid arthritis (RA). A pooled analysis from across nine randomised studies, plus a long-term extension study, evaluated the safety of Olumiant 4mg and 2mg over time in 3,770 patients with RA. Patients treated with Olumiant had an overall incidence rate of adverse events per 100 patient years of exposure was 22.6.

Janssen has announced that the Scottish Medicines Consortium (SMC) have accepted Ponvory (ponesimod) within NHS Scotland, as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS). MS currently affects over 15,000 people in Scotland. The SMC’s advice is based on data from the Phase III OPTIMUM trial, a multicenter, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 patients with relapsing multiple sclerosis (RMS) aged 18-55 years, in 28 countries.

The EMA has stopped a rolling review of the marketing authorisation application for the antibodies bamlanivimab and etesevimab by Eli Lilly Netherlands, to treat COVID-19. This follows the company withdrawing from the process, citing a lack of demand from EU member states. The company has stated that “At this point Lilly is not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorisation application.”

NICE has published draft guidance in which it has decided not to recommend BioMarin’s rare disease med Vimizin (elosulfase alfa). NICE’s independent committee has concluded that BioMarin’s cost-effectiveness modelling is ‘not robust or plausible’ – in particular because it does not adequately capture disease progression. The committee was also ‘concerned’ about how the real-world data was used to model long-term wheelchair use.

NICE has published draft guidance for public consultation which does not recommend tucatinib, in combination with trastuzumab and capecitabine, for some types of breast cancer. NICE concludes that, based on comparisons of the tucatinib combination with standard care such as chemotherapy, people taking the tucatinib combination have longer before their disease progresses, and they live longer overall. However, it is still uncertain how much longer patients live.