In a recent news release, Genzyme, a Sanofi company, reports that Québec’s “Institut national d’excellence en santé et services sociaux” (INESSS) has recommended the inclusion of AUBAGIO (teriflunomide) 14 mg on the provincial drug formulary as a first-line oral agent for patients in the province with relapsing remitting multiple sclerosis (RRMS). The decision mirrors others made by international Health Technology Assessment Agencies in Europe, including NICE in January and Australia at the end of 2013.
The release states that AUBAGIO is designed as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Louis Adam, general manager, Multiple Sclerosis Society of Canada, Québec, says in the release that the organization welcomes the INESS’ recommendation, “We are delighted with this news since access to treatments for people with MS is paramount.”
The INESSS recommendation reportedly stemmed from efficacy data yielding from two Phase III clinical trials known as TEriflunomide Multiple Sclerosis Oral (TEMSO) and Teriflunomide Oral in people With relapsing remitting multiple scleRosis (TOWER).
The release notes that in the TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate and time to disability progression at 2 years when compared to the placebo in RRMS patients. TOWER trials results suggested that AUGBAGIO 14 mg significantly reduced the annualized relapse rate and the time to disability progression was statistically sustained when compared to the placebo in RRMS patients.
Peter Brenders, general manager, Genzyme Canada, articulates the organization’s excitement regarding AUBAGIO’s availability in Québec. “We congratulate Québec on its leadership in recognizing the value brought by this important new treatment, not only as an oral alternative to injectables, but as a first line agent for newly diagnosed patients.”
Additionally, to further its commitment to serving MS patients, Genzyme says it had developed the MS One to One program, which provides comprehensive information services and ongoing education as well as reimbursement navigation.
Source(s) Genzyme, Sanofi