Down, but definitely not out!
The WHO rejected our application to get glatiramer acetate, fingolimod and ocrelizumab/rituximab onto the Essential Medicined List. Why?
The following is the relevant section from Executive Summary:
“The Expert Committee recognized the public health need for effective and affordable treatments for multiple sclerosis (MS) but did not recommend the addition to the EML and EMLc of glatiramer acetate, fingolimod and ocrelizumab at this time. The Committee acknowledged the application’s approach to increasing access to MS treatments by prioritizing selected treatment options. However, the Committee noted that some relevant therapeutic options for MS were not included in the application (azathioprine and natalizumab) or were not given full consideration (rituximab). The superiority of presented medicines over other therapeutic options in the outcomes considered (benefits, harms, affordability) did not clearly emerge. The Committee would, therefore, welcome a revised application which comprehensively reviews the relative roles of relevant available medicines for MS. “
For the committee to recommend we look at azathioprine again, when the WHO themselves rejected azathioprine in 2015, is odd. To the best of my knowledge, nothing has changed in terms of new data since 2015 to change Azathioprines position as a potential off-label treatment for MS.
As for natalizumab, we did not add it to the EML application because it is still on patent, i.e. expensive, it needs to be given as a monthly infusion, which adds to its expense, and is associated with a high monitoring burden for PML. The latter is would be very difficult in resource-poor environments. At the moment the PML JCV serology assay is controlled by Biogen so when natalizumab comes off-patent, and say natalizumab biosimilars emerge, what will happen to the international JCV serology monitoring system that currently exists? Would the WHO take it over from Biogen? Would it be distributed to national labs? Will resource-poor countries be able to incorporate this into their already over-stretched systems?
We went through all these factors in our deliberations and came to the conclusion that 6-monthly ocrelizumab, and rituximab if ocrelizumab is not available, would be a better alternative to natalizumab. Another factor was that ocrelizumab is now licensed to treat PPMS. If we excluded ocrelizumab from the list what message would this send out to PPMSers in the world? In addition, the monitoring requirements for anti-CD20 therapies are much less burdensome than natalizumab.
So we take the punch on the chin, get up and start working on the next application that will be due in 2021. We are a resilient group and we owe it to people with MS all over the world to get them access to effective DMTs.
The following is the MSIF’s press release and the agenda for their meeting in London this Thursday and Friday. Instead of a celebratory mood, I suspect the atmosphere will be more sombre.
We may have lost a battle, but we have not lost the war.