NICE: we need more Aubagio data
pharmafile | September 18, 2013 | News story | Sales and Marketing | Aubagio, Genzyme, MS, NICE, Sanofi
NICE has demanded more information from Sanofi subsidiary Genzyme on its multiple sclerosis drug Aubagio before it authorises the immunomodulator for NHS use.
Draft guidance – which is now out for consultation – from the watchdog asks for a series of clarifications to be given by 8 October.
“The appraisal committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with relapsing-remitting MS,” said NICE’s chief executive Sir Andrew Dillon.
“This is why we have requested more details from the manufacturer: we want to ensure that we have as much information as possible to make an informed final recommendation,” he added.
Final guidance is expected next January: until then the NHS will decide locally whether to use the once-daily pill, which was approved in the European Union earlier this month, for adults with relapsing remitting MS.
Aubagio (teriflunomide) has already been launched in the US but faces stiff competition from Biogen Idec’s MS pill Tecfidera (dimethyl fumarate), which has been recommended in the EU and approved by the FDA.
EC approval was based on the Phase III TEMSO and TOWER trials, which significantly reduced relapse rate and time to disability progression at two years versus placebo.
However, NICE is concerned about some of the financial details: Genzyme has agreed to a patient access scheme, although both parties are tightlipped about the details. At list price, the manufacturer says Aubagio would cost £13,529 per patient per year.
Part of the problem is uncertainty over the most plausible ICER, which NICE at present has put in the range of £6,000 to £107,000 per QALY gained compared with glatiramer.
The committee wants Genzyme to do some more analysis on the evidence it has presented, such as revising figures by using ‘all years’ mixed treatment comparison data adjusted for baseline annualised relapse rates.
It has also asked for figures which include the waning of treatment effect, with 75% treatment effect after two years and 50% after five years.
Even if Aubagio gets over these obstacles, it will be in a competitive market: Tecfidera is still the only known drug to have demonstrated activation of the Nrf-2 pathway, which provides a way for cells to defend themselves against the inflammation caused by the chronic, disabling disease.
Injectable therapies such as Biogen’s existing Avonex and Merck Serono’s Rebif still make up the majority of the MS therapy area, although this is changing.
Other competitors in tablet form include Novartis’ Gilenya (fingolimod) – the first once-daily tablet approved to treat relapsing forms of MS – with two large Phase III studies suggesting Gilenya has a positive effect on relapses and MRI outcomes if used early.
Adam Hill
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