Sanofi and its Genzyme unit has been boosted after the National Institute for Health and Care Excellence issued final guidance recommending that the multiple sclerosis pill Aubagio be reimbursed by the National Health Service.
Specifically, NICE has backed Aubagio (teriflunomide) for patients who do not have highly active or rapidly evolving severe relapsing–remitting MS, making it the first oral, once- daily, first-line therapy. Novartis' pill Gilenya (fingolimod) is already available but only as second-line for patients whose MS remains active despite treatment with one of the beta interferon drugs.
Brendan Martin, general manager for Genzyme UK and Ireland, told PharmaTimes that Aubagio will be in the mix with those interferons - Biogen Idec's Avonex, Merck Serono's Rebif and Bayer's Betaferon, as well as Teva's Copaxone (glatiramer acetate). These disease-modifying drugs are all injectables but interestingly he notes that none of them have been recommended by NICE but have been made available through the Department of Health's risk-sharing scheme launched in 2002.
First 1st-line MS drug to have formal NICE assent
The fact that these injectables have not had the formal assent of NICE, having been rejected for not being cost-effective, may have contributed to the mixed uptake of disease-modifying drugs for MS in the UK, Mr Martin adds. It remains to be seen how much difference "having the imprimatur of NICE behind this drug, which is something unique and novel", will make to this problem, he said, noting that only 20% of patients in the UK have access to a disease-modifying therapy. The NHS now has a legal obligation to begin funding Aubagio for eligible patients within the next three months.
Mr Martin is confident Aubagio will make major in-roads into the market, noting that the firm's sales force hopes to have another MS drug to promote - the injectable Lemtrada (alemtuzumab) which is being appraised by NICE. More important than the size of the field force is "the work you do in advance of launch to secure market access", he told PharmaTimes.
Aubagio will have a significant head-start on Biogen's much-touted MS pill Tecfidera (dimethyl fumarate) which still has not been launched. The list price is £1037.84 per 28-tablet pack (excluding VAT) and Sanofi has estimated the annual cost of Aubagio will be £13,529 per patient per year. The company has agreed a patient access scheme with the Department of Health regarding a discount, the level of which is confidential.
The news has gone down well with doctors and patients. Benjamin Turner at Barts Health NHS Trust said this approval "is great news for UK patients and especially those who cannot tolerate injections, as until now there have been limited treatment options open to them". His stance was echoed by Nick Rijke, director for policy and research at the MS Society, who added that "we’ve been waiting a long time for a tablet to be available for early-stage MS, so this is excellent news. As well as making another valuable treatment available…many people will be delighted to have the option of a tablet rather than regular injections, which can be difficult to manage".