Ocrevus

Drug - Ocrevus™ (ocrelizumab) [Genentech, Inc.]

October 2017

Therapeutic area - Multiple Sclerosis (MS)

Initial approval criteria

Patient must be at least 18 years old AND
Must be prescribed by a provider specializing in neurology AND
Prescriber’s specialty must be provided at time of request
Patient must have a diagnosis of primary progressive multiple sclerosis (PPMS) as documented by objective findings (e.g., MRI) OR
Patient must have a diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS [RRMS], secondary progressive MS [SPMS] with relapses or progressive relapsing MS [PRMS]) as documented by objective findings (e.g. MRI) AND
- Patient with relapsing forms of MS has documented prior trial and failure (or contraindication) of 2-year trial of continuous use of Copaxone 20 mg/mL
Patient has been screened for the presence of Hepatitis B virus (HBV) prior to initiating treatment AND patient does not have active disease (i.e., positive for HBsAg and anti-HBV tests) AND
Ocrevus is to be used as single agent therapy for MS (not to be used in combination with another MS disease modifying agent) AND
Patient must not have any ONE of the following:
- Active hepatitis B virus infection OR
- Concurrent administration of Ocrevus with live vaccine AND
Prescriber must provide baseline assessment using at least one of the following:
- increase in annualized relapse rate [ARR]
- development of new brain lesions on MRI
- onset or progression of sustained disability as evidenced by Expanded Disability Status Scale [EDSS]
- 25-foot walk test
- 9-hole peg test (9-HPT)

Patient continues to meet criteria defined for initial approval AND
Patient has not had a life-threatening infusion-related reaction with prior use AND
Absence of unacceptable toxicity from the drug (e.g., recurrent severe infections, severe immunosuppressive effectives, documented neutralizing antibodies) AND
Patient with relapsing forms of MS has demonstrated improvement or lack of progression from baseline in at least one of the following:
- increase in annualized relapse rate [ARR]
- development of new brain lesions on MRI
- onset or progression of sustained disability as evidenced by Expanded Disability Status Scale [EDSS]
- 25-foot walk test
- 9-hole peg test (9-HPT)
Patient with PPMS diagnosis has demonstrated a lack of meaningful progression

Start dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion
Subsequent doses: 600 mg intravenous infusion every 6 months

Ocrevus is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

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