Limited coverage criteria – siponimod

siponimod

0.25 mg/2 mg tablet

Initial

Treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability, only if ALL of the following conditions¹ are met:

• A history of relapsing-remitting multiple sclerosis (RRMS) and current active SPMS
• An expanded disability status scale (EDSS) score of 3.0 to 6.5
• Documented EDSS progression during the two years prior to initiating treatment with siponimod (≥ 1 point if EDSS < 6.0; ≥ 0.5 points if EDSS ≥ 6.0 at screening)
• A Special Authority request is submitted by a neurologist from a designated multiple sclerosis clinic and the request is received within 90 days of a recent neurological examination

1 year

Patients should be assessed for a response to siponimod every six months

Renewal 

Siponimod may be renewed for patients who do not exhibit evidence of disease progression since the previous assessment. Disease progression is defined as an increase in the EDSS score of ≥ 1 point if the EDSS score was 3.0 to 5.0 at siponimod initiations, or an increase of ≥ 0.5 points if the EDSS score was 5.5 to 6.5 at siponimod initiation.

A Special Authority request is submitted by a neurologist from a designated multiple sclerosis clinic and the request is received within 90 days of a recent neurological examination.

1 year

Patients should be assessed for a response to siponimod every six months

Discontinuation criteria

In patients who exhibit either of the following:

• Progression to an EDSS score of ≥ 7.0 at any time during siponimod treatment
• Confirmed worsening of at least 20% on the timed 25-foot walk since initiating siponimod treatment