Common Drug Review Recommends Listing Fingolimod (Gilenya™) Under Public Drug Programs

Summary
On November 16, 2011, the Canadian Agency for Drugs and Technologies in Health announced the Common Drug Review (CDR) recommendation that fingolimod (Gilenya), the first oral disease modifying therapy, be reimbursed through provincial and territorial public drug programs. Health Canada approved Gilenya in March 2011 as a “second line” therapy for people with relapsing-remitting MS who have had inadequate response to, or are unable to tolerate, other approved MS therapies.

Details
Gilenya is the first oral disease modifying therapy for relapsing-remitting MS to be approved in Canada. It is manufactured by Novartis Pharmaceuticals Canada Inc. On November 16, 2011, Gilenya received the CDR recommendation that it be available for reimbursement through provincial and territorial public drug programs in people who meet the following criteria:

• “Failure to respond to full and adequate course of at least one interferon beta formulation and glatiramer acetate, or contraindications to these therapies.
• Two or more disabling relapses in the previous year.
• Significant increases in T2 lesion load compared with that from a previous MRI scan, or at least one gadolinium-enhancing lesion.”

In addition, the CDR recommendation is to discontinue treatment with fingolimod in patients with relapsing-remitting whereby:

• “Failure to achieve at least a 50% reduction from baseline in the average annual relapse rate after two years.
• Attainment of an EDSS score of greater than 5.0.”

While issuing a positive recommendation, the CDR noted the cost of Gilenya is high and that a lower price similar to that of the interferon beta products would increase the likelihood of a recommendation with less restrictive criteria. The yearly base price of Gilenya is $30,992, which is similar to natalizumab (Tysabri) at $33,020, and higher than glatiramer acetate (Copaxone) at $15,704, interferon beta-1a (Avonex and Rebif) at $18,928 to $23,036 and interferon beta-1b (Betaseron and Extavia) at $18,096, according to the CDR document.

With the exception of Quebec, all provinces use the CDR

recommendations in their decisions about drug listing and

reimbursement. In October 2011, the Quebec drug review

committee recommended that Gilenya not be added to the list of

drugs for reimbursement based on a high cost versus treatment

benefit rationale.

Most people with MS who have private or employer paid drug plans

have had access to Gilenya since it was approved by Health

Canada. Criteria for reimbursement under those plans vary,

and individuals should check with their benefit providers.

The MS Society of Canada is working closely with the provincial and

territorial governments, urging them to make quick and positive

decisions to include Gilenya in their list of drugs for

reimbursement under their public drug plans.

office at 1-268-7582. The MS Society of Canada will continue

to provide updates as provincial and territorial decisions

regarding Gilenya become available.