Ocrelizumab (Ocrevus®) (NEW)

Current Status

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.

Ocrelizumab NZ Data Sheet

 

Background

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.

Read our submission for RRMS here

Read our submission for PPMS here

 

What is Ocrelizumab

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.

 

How is Ocrelizumab Administered?

OCREVUS is administered by intravenous infusion.

First & second infusions (day 1 and day 15):

  • Pre-medications 30-60 mins before infusion
  • Infusion 2.5 hours
  • Observe for at least one hour after infusion

Subsequent infusions (every 6 months)

  • Pre-medications 30-60 mins before infusion
  • Infusion 3.5 hours
  • Observe for at least one hour after infusion

 

Side Effects

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 .

 

Ocrelizumab for Relapsing Remitting MS

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:

  • 46% and 47% lower rate of relapses
  • 40% lowered the risk of disability progression
  • 33% higher disability improvement
  • between 47.9% and 47.5% of the Ocrelizumab recipients had no evidence of disease activity over the trial period compared to 29.2% and 25.1% of those on the interferon
  • 94% and 95% lower number of T1 gadolinium enhancing lesions in those patients MRIs who were being administered Ocrelizumab than the interferon recipients
  • 77% and 83% lower number of new or growing T2 hyperintense lesion
  • the longer the patients underwent treatment the number of new lesions decreased

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)

Read our submission for RRMS here

 

Ocrelizumab for Primary Progressive

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:

  • on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo
  • the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo
  • the percentage of brain-volume loss was 0.90% with ocrelizumab versus 1.09% with placebo

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.

Read our submission for PPMS here.

 

Ocrelizumab Global Compassionate Programme

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:

  1. PHARMAC agree to fund the treatment in NZ for PPMS, or if funding does not happen;
  2. until the patient chooses to discontinue or it is not clinically appropriate any longer on the advice of their neurologist

 

More information for Neurologists

For more information about Ocrelizumab contact the Roche NZ Medical Information Line:

Phone: 0800 276 243 (8.30am-4.30pm)
Email: aucklandmedinfonz@roche.com

 

How can you help our advocacy work?

  • MSNZ would be interested in speaking to people who join the Compassionate Programme. If you are successfully registered onto the Programme and would like to update us on your progress please contact info@msnz.org.nz.
  • Provide feedback to MSNZ about the impacts of our advocacy to help demonstrate the positive outcomes of our work. Information we are interested may include but is not limited to:
    • What has accessing treatments meant to you?
    • How has it improved your life?
  • MSNZ is also interested to understand the issues impacting and restricting access to services and treatments.

Further information: http://www.roche.com/media/store/releases/med-cor-2017-03-29.htm

 

What to do about a bad reaction to medication

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/