MS: Busting the Myths
May 23, 2018 | Advocacy, Treatments
In May the minutes were released from PHARMACs Pharmacology and Therapeutics Advisory Committee (PTAC) meeting held in February 2018. At this meeting applications for funding from Roche and supporting submissions from Multiple Sclerosis New Zealand (MSNZ) were reviewed calling for the inclusion of Ocrevus® (Ocrelizumab) on the Pharmaceutical Schedule for both Relapsing Remitting (RRMS) and Primary Progressive MS (PPMS).
The Minutes have concluded that PTAC support the funding of Ocrelizumab for Relapsing Remitting MS on the guarantee that this will be cost neutral to other currently available MS Treatments. They are also requesting further information from the Neurological Subcommittee and MS Technical Advisory Committee (MSTAC) on the risks of using Ocrelizumab in patients who are JCV positive, potential fiscal (financial) risks of adding an additional therapy, and views of sequencing options of ocrelizumab. Further information is being provided to PTAC on these matters and we expect these to be considered by PTAC in the near future (dates TBC) once this information has been provided. MSNZ is very pleased with this result and hope to see Ocrelizumab on the Pharmaceutical Schedule for RRMS soon as a first-line treatment option.
MSNZ is highlighting to PHARMAC that further delays put people with MS at risk of disease and disability progression, particularly for those patients who are JCV positive, or not responding to current treatment options available. International consensus of the MS Brain Health experts[1], recommend early intervention to minimise potential damage and increase chances of protecting neurological reserve and maximising lifelong brain health as well as ensuring a range of therapies be available to optimise the chances of finding the best option for each person.
MSNZ is also continuing to advocate to widen the access criteria for RRMS treatments which we see as currently too restrictive and not in line with increasing international evidence and consensus. Earlier access will give better chances of treatment success and reducing the unnecessary risk of increased and potentially irreversible neurological damage.
PTAC unfortunately declined the recommendation to fund Ocrelizumab for PPMS patients. Ocrelizumab is the first FDA approved treatment for PPMS and is the only approved disease modifying treatment to slow the progression of the condition in clinical trials. MSNZ is disappointed with this outcome and will be meeting with PHARMAC to contest this decision. Whilst some may consider the successes “modest”, for those New Zealanders living with PPMS, the most aggressive, disabling and life altering form of the condition these results provide hope that Ocrelizumab may potentially slow or halt the progression of disability, reduce their fatigue and improve their mental quality of life.
While PTAC accepted that there is a high unmet need for those with PPMS, PTAC have questioned the evidence and outcomes[2] of the ORATORIO clinical trial as well as its use in combination with other immunosuppressive treatments. Several other papers by leading international neurologists and researchers have been supportive of the evidence.[3] [4] [5] Roche have refuted the comments made by PTAC and the position of this paper and provided updated documentation of safety and efficacy of Ocrelizumab to PHARMAC for further review. It is important to note that Medsafe along with other regulating bodies globally including the FDA have reviewed and approved the same information and found this valid. Ocrelizumab is still available privately for PPMS as it has Medsafe approval for use in New Zealand and those on the Compassionate Programme, applications for which are now closed, will continue to be provided access.
We will continue to update as further developments come to light. Over 40,000 people worldwide are currently using Ocrelizumab and MSNZ is committed to continuing to advocate for Ocrelizumab being made available for both people with RRMS and PPMS in New Zealand.
MSNZ is committed to advocating for people with MS in New Zealand to have access to first world treatment, resources and services to improve their well-being and quality of life. However, to do this we must annually raise over 90% of our income through the generosity of the community through donations, fundraisers, grants and bequests. Please consider making a donation to help us continue on in our mission of improving the lives of the 4000 people diagnosed with MS, and those yet to be. Can you help us? Donate here to support our Advocacy Programme.
Read our submission for RRMS here
Read our submission for PPMS here
[1] https://www.msbrainhealth.org/
[2] Filippini, G. – Ocrelizumab appears to reduce relapse and disability in multiple sclerosis but quality of evidence is moderate. Evid Based Med. December 2017, volume 22, number 6, 215-216.
[3] Montalban, X. et al. Evaluation of No Evidence of Progression Using Composite Disability Outcome Measures in Patients With Primary Progressive Multiple Sclerosis In ORATORIO Trial. Presented at ECTRIMS 2016: Platform Number 167.
[4] Miller, D. M. et al. The Association Between Confirmed Disability Progression and Patient-Reported Fatigues in PPMS Patients in the ORATORIO Study. NCT01194570. Presentation
[5] De Seze, J. et al. Patient-Reported Outcomes in the Phase III Double-Blind, Placebo-controlled ORATORIO Study of Ocrelizumab in Primary Progressive Multiple Sclerosis. Poster Presented at ECTRIMS 2016: 14-17 September.