Novartis's multiple sclerosis treatment Gilenya has not been recommended for reimbursement in draft guidelines from NICE, which cited concerns over the drug's cost-effectiveness, based on the evidence submitted. Novartis hopes to satisfy these concerns by submitting further data from comparator trials, but the challenge will be to convince NICE that Avonex is the most suitable comparator.
In a draft guidance subject to consultation, the National Institute for Health and Clinical Excellence (NICE) has rejected the use of Gilenya (fingolimod) on the National Health Service (NHS), based on uncertainties regarding its cost-benefit ratio from the data submitted by Novartis. Gilenya treatment is priced at GBP19,000 per year in the UK, and was launched in the country in April 2011.
NICE's stance on multiple sclerosis drugs has historically been strict, with interferons and Copaxone (glatiramer acetate; Teva) all rejected for NHS reimbursement. These drugs are currently only available in the UK through a risk-sharing scheme, which is designed to determine long-term cost benefit. Only Tysabri (natalizumab; Biogen Idec/Elan) is available on the NHS, due to its high efficacy.
NICE's rejection comes as a surprise, given that Gilenya's Phase II and III multiple sclerosis clinical trial programs were the most comprehensive in history, involving over 4,000 patients and showing excellent efficacy. However, NICE argued that Avonex was not the most appropriate active comparator and that Novartis should have submitted studies comparing it against Tysabri instead.
A rejection from NICE is not only a huge setback for future UK market uptake, but also has ramifications in the rest of Europe, as many countries use NICE recommendations to guide their own national formularies. However, Datamonitor is optimistic that Novartis will be able to convince NICE to recommend Gilenya. While the company has not conducted any head-to-head trials against Tysabri, Novartis intends to submit further data from its TRANSFORMS study, which showed that Gilenya is much more efficacious than Avonex. The company has until August 26 to submit any new data to argue its case.