Multiple Sclerosis: Gilenya (fingolimod) Step Edit Policy

Description: MS is a chronic disabling disease of the CNS which impacts the brain, spinal cord and the optic nerves. It is believed to be an autoimmune disease that involves the degeneration of myelin, the insulating material that surrounds the nerve fibers in the CNS. When the myelin sheath is damaged, nerve impulses are not transmitted or are distorted, leading to a wide variety of symptoms. Most people are diagnosed with MS between the ages of 20 to 50 years.

Four specific disease courses have been identified in MS.  Relapsing-remitting MS: the most common form, episodes of acute worsening of neurologic function occur with some amount of recovery and no progression in between.  Progressive-relapsing MS: occurs as progressive disease at onset. Occasional acute relapses occur but with continuing disease progression.  Primary-progressive MS: involves a continued worsening course from onset without specific relapses.  Secondary-progressive MS: involves an initial relapsing-remitting course, but the disease transitions to a steadily progressive form with a loss of function.

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator approved by the Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. Gilenya is the first oral disease-modifying MS therapy.

Guidelines: An expert opinion paper published in 2007 from the National MS Society states that initiation of treatment should be considered as soon as possible after a definitive diagnosis of MS with an active, relapsing disease, and may be considered for selected patients with a first attack who are at high risk of MS with:  interferon beta medication (Avonex, Betaseron, Extavia, Rebif) or glatiramer acetate (Copaxone)

Therapy with the agents should continue indefinitely, except if there is a clear lack of benefit, intolerable side effects, or a better therapy becomes available.

Dosing: The recommended dose for Gilenya is 0.5 mg once daily (QD).

Purpose: To encourage the appropriate use of Gilenya to treat Multiple Sclerosis.

Criteria: rd Gilenya will be paid as a covered benefit at the 3 tier for members who meet the following criteria: 1. Member has been on requested product in the previous 180 days; OR 2. Member has tried and failed therapy with one (1) of the preferred drug(s) in the previous 180 days.

Preferred drugs to be tried: Avonex OR Rebif

If deemed an emergency situation and the prescriber is NOT available, Prior Authorization of Benefits Center can authorize an override for 72 hours or until the next full business day following a holiday weekend upon request from the dispensing pharmacist.