Product Details

Ocrevus

Ocrelizumab
30 mg/mL
Concentrate for solution for infusion
Single-Use 10-mL Vial Pack (Preservative-Free)

DIN/PIN/NPN

02467224

Manufacturer

Hoffmann-La Roche Limited

Formulary Listing Date

2019-09-12

Unit Price

8150.0000

Amount MOH Pays

8150.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

92:20:00 Biologic Response Modifiers

Therapeutic Note

NO

ATC Code

L04AA36

Interchangeable Products

NO

LU Clinical Criteria

NO

EAP Criteria

Therapeutic Class	Reimbursement Criteria
Multiple Sclerosis Drugs	Ocrelizumab Brand(s): Ocrevus Dosage Form/Strength: 300 mg Injection Initiation Criteria: For treatment of Early Primary Progressive Multiple Sclerosis (PPMS) in adult patients who meet ALL of the following criteria: 18 years of age or older; Diagnosis of early PPMS is confirmed based on McDonald 2017 diagnostic criteria meeting the following: i) Patient has had one year of disability progression (retrospectively or prospectively determined) independent of clinical relapse; AND ii) Two or more of the following: • One or more T2-hyperintense lesions (symptomatic or asymptomatic) characteristic of multiple sclerosis in one of more of the following brain regions periventricular, cortical, juxtacortical or infratentorial • Two or more T2-hyperintense lesions (symptomatic or asymptomatic) in the spinal cord • Presence of CSF-specific oligoclonal bands Level of disability from disease meeting the below: i) A recent Expanded Disability Status Scale (EDSS)¹ score between 3.0 and 6.5 prior to initiation of ocrelizumab; AND ii) A Functional Systems Scale (FSS) score of at least 2.0 for the pyramidal system due to lower extremity findings (Note that FSS scores associated with disability in other systems such as brainstem or cerebellar can be considered); Disease duration from onset of multiple sclerosis meeting one of the below: i) Less than 15 years for those with an EDSS score greater than 5.0 ii) Less than 10 years for those with an EDSS score equal to or less than 5.0 iii) PPMS has been progressive in the last 3 years in the absence of activity The drug request is from a neurologist experienced in the management of PPMS from one of the MS Society recognized Ontario MS clinics² or includes a consult note from a neurologist from one of these clinics supporting the diagnosis and the treatment with ocrelizumab. ¹A “recent” score is an EDSS evaluated within the prior 6 months. Consideration will be provided for results from a neurological exam within the prior 12 months upon confirmation that the patient’s clinical status has not deteriorated. ²MS Society recognized Ontario MS clinics:* Hamilton MS Clinic HHS, McMaster University Kingston MS Clinic, Kingston General Hospital London MS Clinic, London Health Sciences Centre Ottawa MS Research clinic, Ottawa Hospital General Campus Ottawa Pediatric MS Clinic, CHEO Toronto MS Clinic, St Michael’s Hospital Toronto Pediatric MS Clinic, The Hospital for Sick Children Sunnybrook Health Sciences Centre Note: Requests for patients who are under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Exclusion Criteria:* Patients with an EDSS score equal to or greater than 7.0 Dosage: - Initial dose of 300 mg intravenous infusion, followed 2 weeks later by a second 300 mg intravenous infusion. - Subsequent doses of single 600 mg intravenous infusion every 6 months after the first initial dose. Renewal Criteria: Ongoing funding will be provided for those who continue to benefit from treatment and who have an Expanded Disability Status Scale (EDSS) score less than 7.0 Duration of Approval of Initials and Renewals: 18 months Initiation Criteria: For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 18 years of age or older Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following: i) 2 or more attacks¹ and clinical evidence of 2 or more lesions²; OR ii) 2 or more attacks and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location; ¹If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: a) Additional clinical attack b) Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan) c) Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands ²If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: a) additional clinical attack implicating different CNS site b) 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND Patient has an EDSS score less than 6.0 before start of therapy; AND Ocrelizumab is used as monotherapy; AND The drug request is from a neurologist experienced in the management of RRMS from one of the MS Society recognized Ontario MS clinics³ or includes a consult note from a neurologist from one of these clinics supporting the diagnosis. ³MS Society recognized Ontario MS clinics:* Hamilton MS Clinic HHS, McMaster University Kingston MS Clinic, Kingston General Hospital London MS Clinic, London Health Sciences Centre Ottawa MS Research clinic, Ottawa Hospital General Campus Ottawa Pediatric MS Clinic, CHEO Toronto MS Clinic, St Michael’s Hospital Toronto Pediatric MS Clinic, The Hospital for Sick Children Sunnybrook Health Sciences Centre Note: Requests for patients who are under the care of a community neurologist working outside of one of the MS Society recognized Ontario MS clinics can be considered on a case-by-case basis. Exclusion criteria:* Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. Patients with an EDSS score equal to or greater than 7.0 Dosage: - Initial dose of 300 mg intravenous infusion, followed 2 weeks later by a second 300 mg intravenous infusion. - Subsequent doses of single 600 mg intravenous infusion every 6 months after the first dose. Renewal Criteria: Ongoing funding will be provided for those who continue to benefit from treatment and who have an Expanded Disability Status Scale (EDSS) score less than 7.0 When requesting renewal of funding, information that should be provided should include: Date and details of the most recent neurological examination and EDSS scores to support ongoing benefit from therapy. Clinical details of the date and onset of clinical attacks/relapses Information to support that the patient is stable/not demonstrating a sub-optimal response Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed. Approval Duration of Initial and Renewals: 18 months EAP Drug Request Form: Standard Form for EAP Drug Requests
Renewals of Multiple Sclerosis Drugs – Telephone Request Service (TRS) Drugs	Ocrelizumab Brand(s): Ocrevus Dosage Form/Strength: 14mg tablet EAP will renew coverage of ocrelizumab for patients with Relapsed Refractory Multiple Sclerosis (RRMS) who are stable and experienced no more than one disabling attack/relapse in the past year and have an EDSS score less than or equal to 6.5. Prescriber must provide the following information: Description of the patient’s clinical course in the last year, including details of all attacks; Date and details of the most recent neurological examination (within the last 90 days); AND EDSS score Exclusion criteria: Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. Patients with an EDSS score equal to or greater than 7.0 Standard Approval Duration: 18 months Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed. EAP will renew coverage of ocrelizumab for patients with Primary Progressive Multiple Sclerosis (PPMS) who continue to benefit from treatment and who have an Expanded Disability Status Scale (EDSS) score less than 7.0 Prescriber must provide the following information: Description of the patient’s clinical status in the past year Date and details of the most recent neurological examination; AND EDSS score Exclusion Criteria: Patients with an EDSS score equal to or greater than 7.0 Dosage: - Initial dose of 300 mg intravenous infusion, followed 2 weeks later by a second 300 mg intravenous infusion. - Subsequent doses of single 600 mg intravenous infusion every 6 months after the first initial dose. Standard Approval Duration: 18 months

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