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NICE demands more data for Sanofi's oral MS drug

UK body won't recommend Aubagio for NHS use based on current information

Sanofi Genzyme Aubagio teriflunomide MS 

Sanofi will need to provide more evidence supporting the effectiveness of its oral multiple sclerosis drug Aubagio if it wants the treatment to be recommended for use on the NHS in England and Wales.

The National Institute for Health and Care Excellence (NICE), which assesses the cost-effectiveness of treatments for NHS use, released initial draft guidance which requests several clarifications on the evidence submitted by Sanofi, which is looking to market Aubagio (teriflunomide) as a first-line treatment for relapsing remitting multiple sclerosis (RRMS).

“When reviewing the evidence for teriflunomide, the appraisal committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with RRMS,” said NICE's chief executive Sir Andrew Dillon.

This includes a revision of probabilistic analyses to include the waning of treatment effect and pairwise comparisons to evaluate the cost-effectiveness of plausible NHS practice in RRMS, such as a comparing the use of Aubagio and Rebif-44 to the use of Novartis' Gilenya (fingolimod) and Rebif-44.

Sanofi, which gained rights to the drug as part of its 2011 acquisition of US biotech Genzyme, has until October 8, 2013, to submit this extra information for further review and draft guidance.

Commenting to PMLiVE, a spokesperson from Sanofi/ Genzyme said: "The appraisal consultation document is a long and complex document and we will respond in detail to the questions raised by NICE before the consultation period closes."

The negative draft guidance mirrors a similarly troubled NICE pathway for Novartis' Gilenya, which was approved in 2011 as the first oral treatment available in Europe for the treatment of MS.

Novartis then faced two stages of draft guidance from NICE which deemed Gilenya in its approved RRMS indication was not a cost-effective enough use of NHS resources, despite being provided at an undisclosed discount through a patient access scheme.

NICE later reversed its decision after Novartis provided more data, but only for the use of Gilenya in a sub-group of RRMS patients who have an unchanged or increased relapse rates or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons.

As with Novartis and Gilenya, Sanofi has a patient access scheme in place for Aubagio to cover part of the drug's cost, which NICE estimates to come to £13,529 per patient per year.

This compares to the £19,196 per patient per year Gilenya is estimated to cost, although it is unclear what the NHS would pay for either medicine considering their respective undisclosed patient access schemes.

Article by
Thomas Meek

18th September 2013

From: Sales, Healthcare



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