MS: Busting the Myths
On 7 October, 2019, Pharmac announced the public funding for Ocrelizumab for Relapsing Remitting MS under the existing access criteria from 1 December, 2019.
To read the outcomes of the consultation process see here: https://www.pharmac.govt.nz/news/notification-2019-10-07-various/#Ocrelizumab
MSNZ is please that the treatment is now available in New Zealand particularly for those who have an urgent need to switch from their current treatment, and a further step in the direction of making a full range of therapies available. However, we are still concerned that the access criteria is not wide enough and people with RRMS and PPMS are missing out. See here for our full response: https://www.msnz.org.nz/ocrelizumab-approved-for-funding/
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.
On the 21 December 2017 Ocrelizumab was approved by Medsafe for RRMS and PPMS indications.
Read our submission for RRMS here
Read our submission for PPMS here
At the February and November 2018 PTAC (Pharmaceutical Technical Advisory Comittee) Meeting Ocrelizumab was reviewed following recommendations provided by the Neurological Subcommittee and MSTAC.
PTAC provided the following recommendations:
RRMS
PPMS
MSNZ is committeed to continuing to advocate for Ocrelizumab for PPMS and is currently gathering further evidence and support.
In April 2019 MSNZ wrote to Pharmac to advocate for the urgent funding of Ocrelizumab for RRMS as there is a imminent need for many patients who are on Tysabri and JCV positive.
Letter to Pharmac urging urgent approval of Ocrelizumab for RRMS – 23 April 2019
In May 2019 MSNZ again wrote to Pharmac asking when the cost negotiation process would begin and querying what was causing the delay.
Ocrelizumab – Letter to Pharmac urging urgent approval – 27 May 2019
On the 7th August 2019 Pharmac announced they were beginning public consultation for the funding of Ocrelizumab for RRMS.
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.
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)
Read our initial submission for RRMS here – 22 May 2017
Read our letter to Pharmac urging urgent approval – 23 April 2019
New clinical trial for those with Primary Progressive – recruiting now. June 2021
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.
Read our submission for PPMS here – 8 September 2017
For more information about Ocrelizumab contact the Roche NZ Medical Information Line:
Phone: 0800 276 243 (8.30am-4.30pm)
Email: auckland.medinfonz@roche.com
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/