On the 21 December 2017 Ocrelizumab was approved by Medsafe for RRMS and PPMS indications. The treatment is not currently funded as the review by PHARMAC is expected in early 2018.
In March 2017 the FDA in America approved Ocrelizumab as a treatment for RRMS and PPMS. MSNZ has reviewed the positive research and been in discussions with the pharmaceutical company Roche regarding the treatment since 2016. In August 2016 Roche submitted Ocrelizumab for Medsafe approval which can take over 12 months in most cases. This is still under review and we hope to receive further information by October 2017.
On 22nd May 2017 Roche applied to PHARMAC for Ocrelizumab to be listed on the Pharmaceutical Schedule for RRMS under the pre-existing MS Treatments Special Authority Criteria for review at the August meeting. Despite not yet having Medsafe approval this decision was made to speed the process along and have the treatment available in NZ at the earliest opportunity. MSNZ wrote to PHARMAC in support of this application on Monday 22nd May.
In August 2017 Roche made a submission to PHARMAC for Ocrelizumab to be indicated for PPMS use. On 8 September MSNZ wrote in support of the funding for Ocrelizumab for PPMS. Our request for funding focussed on meeting the unmet medical need of those with PPMS who have no alternative option for treatment currently available.
OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.
OCREVUS is administered by intravenous infusion.
First & second infusions (day 1 and day 15):
Subsequent infusions (every 6 months)
Patients most commonly experienced mild to moderate infusion reactions and upper respiratory tract infections. There were also slight increased risks of oral herpes reactivation and neoplasms which should be considered when assessing treatment appropriateness.
Read more: Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis – poster presented at the 69th American Academy of Neurology (AAN) Annual Meeting; April 22–28, 2017; Boston, MA, USA
No cases of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal viral brain disease were found during the trials. Since then one case in Germany has been found in an Ocrelizumab patient however causality has been assigned to the earlier use of Natalizumab (Tysabri). Read more here about switching patients at high risk of PML .
Two identical trials involving 1656 people with RRMS, 821 of which received the proposed treatment, showed clear demonstrable evidence that relapses were reduced, the volume of brain lesions were significantly decreased and the reduction in disability progression. Trials OPERA 1 and OPERA 2 clearly showed in comparison to its Rebif (interferon beta-1a) trial comparator:
Read more on the OPERA 1 and OPERA 2 trials:
Hauser, S. L., et al, Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N ENGL J MED (2016).
Calabresi, P. A., B-Cell Depletion — A Frontier in Monoclonal Antibodies for Multiple Sclerosis. N ENGL J MED (2016)
There has been a lot of media interest since Ocrelizumab was approved by the FDA as it is the first treatment in the world that has shown proven benefits for people with Primary Progressive MS.
A Phase III study (ORATORIO) involving 732 participants with PPMS was undertaken which showed evidence of reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. The results showed that at 120-weeks:
Read more on the ORATORIO trial: Montalban, X, et al, Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N ENGL J MED (2016).
Should Ocrelizumab for PPMS be funded in NZ it will have its own special authority criteria developed. Roche has consulted with MSNZ and an Advisory Board around the potential criteria. We foresee that there will be special authority criteria based on the research findings. Roche made a submission to PHARMAC in August 2017 for the funding of Ocrelizumab for PPMS.
MSNZ is continuing to work with those involved to ensure people receive access based on the research evidence and made a submission in September 2017 to PHARMAC for funding for PPMS.
Applications for the Global Compassionate Programme are now closed. PwMS who are successfully registered on the programme will continue to receive fully funded access to Ocrelizumab until either:
For more information about Ocrelizumab contact the Roche NZ Medical Information Line:
Phone: 0800 276 243 (8.30am-4.30pm)
Further information: http://www.roche.com/media/store/releases/med-cor-2017-03-29.htm
Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).
For instructions and further information https://nzphvc.otago.ac.nz/reporting/