Glatiramer Acetate Injection

As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) meeting ALL the following criteria:

• Recent neurological examination consistent with the diagnosis of RRMS; AND

• Lesions typical of multiple sclerosis on brain magnetic resonance imaging (MRI); AND

• Experienced at least 2 clinical attacks in their lifetime with one attack occurring within the prior year; AND

• EDSS score less than or equal to 6.0 prior to start of treatment; AND

• Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis.

Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.

As monotherapy for the treatment of patients who have experienced a single demyelinating event/ Clinically Isolated Syndrome (CIS) meeting ALL the following criteria:

• CIS occurred within the prior 12 months; AND

• Recent neurological examination; AND

• Lesions typical of CIS confirmed on brain magnetic resonance imaging (MRI); AND

• EDSS score less than or equal to 6.0 prior to start of treatment; AND

• Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis

Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.

Renewal of therapy for patients diagnosed with relapsing remitting multiple sclerosis (RRMS) or a single demyelinating event /Clinically Isolated Syndrome (CIS) who meet ALL the following criteria:

• Used as monotherapy for the treatment of RRMS or CIS; AND

• EDSS score less than or equal to 6.0; AND

• Disease activity is stabilized as determined by a neurological exam and the number of clinical relapses experienced while on treatment; AND

• Prescribed by a neurologist experienced in the treatment of Multiple Sclerosis (MS) OR a prescriber in consultation with a neurologist overseeing the patient's MS.