Canada


Now Aubagio® and Lemtrada® are reimbursed by the RAMQ in Quebec.

Date: October 27, 2014

Mississauga, ON - October 27, 2014 - Genzyme, a Sanofi company, announces that Aubagio® (teriflunomide) and Lemtrada® (alemtuzumab) have be included on the provincial drug formulary under “Médicaments d’exception”.

Aubagio®: as first-line for people living with relapsing-remitting multiple sclerosis (RRMS). The decision is effective since June 2nd 2014. This is the only oral treatment once-daily medication to be reimbursed for first-line use.

The reimbursement criteria are:

• “For treatment of persons suffering from remitting multiple sclerosis, diagnosed according to the McDonald criteria (2010), who have had one relapse in the last year and whose EDSS score is less than 7;

• Authorization for an initial request is granted for a maximum of one year. The same duration applies to requests for continuation of treatment. In these latter cases, however, the physician must provide evidence of a beneficial effect defined by the absence of deterioration. The EDSS score must remain under 7.”

Aubagio® is reimbursed under the criteria defined by INESSS and under Médicaments d’exception process with the codification: SN 134

Lemtrada®: as second-line for people living with relapsing-remitting multiple sclerosis (RRMS). The decision is effective since October 1st 2014. This is the only second-line treatment to be given intravenously once a year for 2 years.

The reimbursement criteria are:

• “For treatment, as monotherapy, of persons suffering from remitting multiple sclerosis,

-diagnosed according to the McDonald criteria (2010),

- who have had at least two relapses in the last two years, one of which must have occurred in the last year. In addition, one of the relapse must have occurred while the person was taking a disease modifying drug included on the list of medications for the treatment of MS under certain conditions for at least six months,.

- The EDSS score must be equal to or less than 5.

• Authorization of the initial request is for a cycle of five consecutive days of treatment at a daily dose of 12 mg to cover the first year of treatment.

• For treatment continuation after the first year, the physician must provide proof of a beneficial effect on the annual frequency of relapses, combined to, a stabilization of the EDSS score or to an increase of less than 2 points, without exceeding a score of 5.

• Authorization of the second request is for a cycle of three consecutive days of treatment at a daily dose of 12 mg administered 12 months after the first cycle. The total duration of treatment allowed is 24 months.”

Lemtrada® is reimbursed under the criteria defined by INESSS and under Médicaments d’exception process by using the specific form #8120 – Lemtrada or the general form.

Genzyme is pleased that transformative drugs like Aubagio® and Lemtrada® are available to all Quebecers living with relapsing MS.

Last Updated: 12/3/2015
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