Drug Information Update- Ocrevus (ocrelizumab)
New Drug Approval:
On March 28th, 2017 the FDA approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
Prescribing information is available here.
Drug Overview & Place in Therapy:
Ocrevus (ocrelizumab) is anticipated to fill two unmet needs in the MS population; it is the first drug approved for the treatment of PPMS and an effective option for patients with relapsing MS who are refractory to current standard of care therapies. Analysts predict Ocrevus will be a blockbuster product with sales predictions of over $4 billion in 2022.
Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that manifests as muscle weakness, fatigue and vision problems. MS is estimated to affect 400,000 patients in the United States and is the leading cause of disability in patients age 20 to 40 years old. The majority of patients, over 85%, have relapsing-remitting MS (RRMS) which is characterized by episodes of worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 15% of patients are diagnosed with PPMS and experience steadily worsening symptoms without distinct periods of relapse or remission.
Ocrevus is a monoclonal antibody that inhibits the CD20-positive B cells of the immune system and is administered as an intravenous infusion every six months. Ocrevus was approved based on data from three phase 3 studies in which Ocrevus improved annual relapse rate compared to Rebif (interferon beta-1a) in patients with RRMS and reduced disability progression compared to placebo in patients with PPMS. The most common side effects associated with Ocrevus were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. According to the manufacturer, Ocrevus will be priced at $65,000 per year.
Utilization Management Strategies:
The manufacturer has stated that it will launch within the next two weeks. A full clinical review of Ocrevus (ocrelizumab) was conducted during the MedImpact 1st Quarter 2017 Pharmacy & Therapeutics (P&T) Committee Meeting on Friday, January 27th.