Gilenya

Drug - Gilenya (fingolimod) [Novartis]

October 2013

Therapeutic area - Multiple Sclerosis

FDA approved indication

Gilenya (fingolimod) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Approval criteria

Gilenya is being used as monotherapy for relapsing forms of multiple sclerosis AND

After documented compliance of at least 6 months of therapy unless contraindicated, has had an inadequate response to Copaxone 

Inadequate response is defined as meeting two of the following three criteria during treatment with another Disease Modifying Drug:

• Unchanged or increase relapse rate or ongoing severe relapses compared with the previous year despite treatment
• The patient continues to have CNS lesion progression as measured by MRI
• The patient continues to have worsening disability. Examples of worsening disability include, but are not limited to, decreased mobility or decreased ability to perform activities of daily living due to disease progression.

Quantity limit

34 capsules per 34-day supply

Gilenya is supplied as a carton of 28 capsules containing 2 folded blister cards of 14 capsules per blister card [NDC 0078-0607-51] and as a carton of 7 capsules containing 1 blister card of 7 capsules per blister card [NDC 0078-0607-89].

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411