#ClinicSpeak & #PoliticalSpeak: why should people with primary progressive MS be treated as 2nd-class citizens?

Will pwPPMS be forced to pay for ocrelizumab privately? #ClinicSpeak #PoliticalSpeak

My blog post yesterday regarding equitable access to healthcare and HSCT generated some lively discussion. One reader asked: Any idea when ocrelizumab will be available in Europe for PPMS? It isn’t fair that the FDA has approved the drug and we are still waiting and losing brain’. Interestingly, I was asked the same question at the EAN meeting after one of my talks and one of the Roche delegates at the meeting was able to answer the question for me and said it will be available soon.

Even if it ocrelizumab gets licensed ‘soon’ there will still be many hurdles to get over before it can be used in clinical practice. In the UK it will need to go via NICE and then it has to be vetted by NHS England. I have major concerns that the cost-effective model that will be used for PPMS will not be the same as RRMS, where the comparator is current DMTs and the model is based on incremental costs. For PPMS ocrelizumab will be compared to best supportive care. I therefore anticipate ocrelizumab being available for PPMS in other countries and not the UK. The latter worries me even more; why should English patients be disadvantaged? This discussion also raises the possibility of the worst case scenario, i.e. the EMA deciding not to license ocrelizumab for PPMS. What will happen then? This will mean the the product will be on the market for RRMS and pwPPMS who can afford to pay for it; i.e. the wealthy will get ocrelizumab privately and those who can’t afford to pay for it won’t be treated. The latter already happens in the NHS with some of the high-cost cancer drugs that have not been NICE-approved. Most HCPs, patients and even politicians find this sort of healthcare inequity abhorrent. This is why the NHS and other socialist healthcare systems are meant to exist; to stop a healthcare lottery based on wealth. 

One of my patients with PPMS who was in the fingolimod PPMS trial has already said to me he can’t wait any longer. He asked me about starting rituximab and paying for it privately. He had no idea of the cost of rituximab and so we are now having to explore the possibility of using off-label cladribine. The use of cladribine for the treatment of PPMS is not really backed-up with much data, is really a shot in the dark and is based on the scientific principle that suppressing inflammation will help. 

I have also recently become aware that Roche may be launching a compassionate early access programme for PPMS, which is something I will explore for him and other patients in a similar situation. 

What do you think we should do to make sure pwPPMS get access to ocrelizumab ASAP? Can you please complete the following survey to explore some ideas. If you have any suggestions please don’t hesitate to contact me. 

CoI: multiple

13 thoughts on “#ClinicSpeak & #PoliticalSpeak: why should people with primary progressive MS be treated as 2nd-class citizens?”

    1. I suspect not. Rituximab is not licensed for PPMS and in fact the rituximab PPMS trial was negative. In short the NHS won't allow us to use it to treat PPMS. Generic rituximab will not be cheap; biosimilars only bring down the price of a drug by ~30%.

    1. NHS England only rules on England. The other home countries have their own rules and access schemes.

    2. Imagine of Scotland says yes and England no? This has happened with some cancer drugs. I am aware of some cancer patients moving from Wales to England to access certain therapies. This cross-border migration is an extreme form of the post-code lottery playing out.

  1. How can the FDA accept the results as real and clinically meaningful, and not the EMA and other regulators?

    1. The EMA and other regulators have yet to announce their assessments. I am expecting the EMA and other regulators to license ocrelizumab for PPMS; I only raised the issue on the off chance that they don't license the drug. My worry is more to do with the NHS and NICE.

    2. An important question. Why is there no reciprocity between countries' assessments and clinical trials for MS drugs? Japan recently finished phase 2, safety profile for Natalizumab. The FDA approves Ocrelizumab yet the EMA is still pending. Why not develop an international agency for drug licensing in countries that meet stringent and comparable standards? It sounds like the only discrepancy is monetary.

    3. Far too sensible but it ensures that pharma greases the cogs in each region.Some countries want to ensure that they are biologically different but if you really wanted to stream line the process you would sort the patents out. These have to be filed in each country and translated, £20,000 to translate a patent into Japanese, you don't see a poor patent lawyer…win ker-ching lose ker-ching

    4. lawyers are as poor as doctors…. and yes patent lawyers are as poor as neurologists 🙂

  2. I am PPMS (also particiapated in the Fingolimod trial), can my neurologist reclassify me as RRMS? It would b a lie but i wouldn't care. However i wouldn't want him to get into trouble and ruin his career. But if MS is one disease then it wouldn't be a lie …. and i could get ocrelizumab!

    1. The other idea is to see a new neuro (or 10) and try to get yourself rediagnosed with RRMS… I am fairly sure all you need is a relapse or 2… which you can prove by presenting yourself at an ER with a self diagnosed relapse 😀 If the neuro insists that you haven't had a relapse because it's not showing up on the MRI, then you know that neuro is either stupid or doesn't believe you… and move on to the new neuro.:)

  3. Here in US, Kaiser Permanente only provides Rituximab to its spms patients. UC San Francisco docs. are prescribing ocreliumab to people with MS at all levels of progression. Roughly household income of $150,000 or less qualifies pwms for Genentech supported ocrelizumab treatment at UCSF…Would you please clarify / expand upon / provide sources for per May 23, 2017 – ThinkSpeak & ClinicSpeak: do PPMSers need a DMT? “…I have recently learnt that ocrelizumab is a much more potent B-cell depleter than Rituximab, i.e. – 10 x as potent… A 600mg dose of ocrelizumab is therefore – 6x more potent than 1,000mg dose of rituximab…”Great thanks.US pw spms

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