Category: Archive

CD20 depletion seems an obvious choice when you look at the real-life data.

The Swedish neurologists are walking-the-talk. It looks as if the majority of people with MS are being treated with rituximab off-label? How come? I was under the impression that this was illegal under EU law. EU law is meant to protect Pharma’s interests, i.e. healthcare systems are meant to support licensed drugs. This issue is a hot potato in England. Bayer has brought a legal case against NHS England about the off-label use of bevacizumab (Avastin, Roche) to treat wet macular degeneration instead of the licensed products aflibercept (Eyelea, Bayer) and ranibizumab (Lucentis, Novartis). Maybe Britain’s gift to the EU as it exits the EU is the halting of off-label rituximab use for MS across Europe. If Bayer wins their case in Britain, a legal precedent will be set and the ruling will ripple across Europe. 

ProfG    
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If you have PPMS, and live in Europe, you are one step closer to having a disease-modifying therapy for your MS.

If you have PPMS and live in England you have to wait for NICE to determine whether or not ocrelizumab is a cost-effective treatment to slow down your disease progression.  To help manage expectations I anticipate NICE saying no for the PPMS indication. Ocrelizumab will be priced for the RRMS indication and not PPMS. The impact of ocrelizumab on disease progression is less in PPMS compared to RRMS and because it will be compared to ‘best supportive care’ for PPMS it is unlikely to be deemed cost-effective. One solution to this impasse is for differential pricing, i.e. for Roche to charge the NHS much less for PPMS compared to RRMS. Is Roche and the NHS ready for differential pricing? I am not sure. However, the NHS accounting mechanisms are in place to do this. It will be interesting to see how the NICE negotiations play out.


EMA information on ocrelizumab.

ProfG    
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How quickly should we treat MS? As soon as possible. 

I made the case on behalf of DrK last month for a natalizumab Brain Attack Trial? I now have a personal clinical anecdote why we should not delay things any longer.

I saw a new referral in my MS clinic about 6 weeks ago. She was from an ethnic minority (red flag) with highly-active disease. Her imaging was very active but slightly atypical; she had a confluent lesion around the aqueduct that has been described in anti-aquaporin-4 positive patients with NMO spectrum disorder. I, therefore, delayed making the diagnosis to repeat her imaging, do a lumbar puncture and check her anti-AQU-4 results. As this, all occurred over the Christmas period it took 6 weeks for her to come back to me with all the results. In this period she has gone onto to have a very disabling brainstem attack. All her tests are back and confirm the original diagnosis of MS. If only I had started her on natalizumab whilst I was doing all the tests we would probably have prevented her having this attack. 

She is now coming into hospital as an urgent admission for a course of intravenous steroids and to be started on natalizumab. Please note we have decided to start natalizumab without knowing her JCV serostatus. If she is JCV-ve we will leave her on natalizumab and if she comes back JCV+ve we will then decide on what DMT to transition her onto after a 12 month period of treatment. 

What this patient illustrates is that MS activity tends to be clustered. A powerful predictor of a relapse is a recent relapse. The case for putting patients with possible early active MS at risk from having to wait is well illustrated in this example. Why don’t we to treat all patients like this with natalizumab to protect their brains and spinal cords while we complete their diagnostic work-up? This is analogous to treating stroke.

Why natalizumab? (1) It is one of our most effective DMTs, (2) it works very quickly, (3) it is given as an IV infusion, hence there is no problem with adherence and (4) it is very safe for up to 12 months. (5) It is also relatively safe in pregnancy. During this 12 month period, the neurologist and the patient can then decide what strategy they want to pursue in the long-term. This could be to continue natalizumab long-term or to switch to another DMT, or in the case of an alternative diagnosis the drug can be stopped.

To make the Brain Attack Trial a reality we need the EMA to license natalizumab as a 1st-line treatment. This will probably require data. Hence we are proposing that Biogen sponsor a ‘Brain Attack Trial’. This would become even more important if you can derisk the PML problem associated with natalizumab. Imagine if we can reduce the risk of PML to zero? Who wouldn’t want to start on natalizumab as a first-line therapy? Natalizumab will become the one and only platform therapy. The problem with this is that Biogen has other DMTs in the MS space and the Brain Attack Trial will potentially result in natalizumab cannibalizing their other DMT market. How bold is Biogen?

ProfG    
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Prof G’s rose-tinted view of the world!

The following are 10 of my highlights, and a few lowlights, from 2017.

ProfG    
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Thank you for completing our recent survey on coffee consumption amongst pwMS and the reasons for drinking coffee. The results are quite interesting. What do you think? 

The following are the results of the coffee survey in pwMS. Is clear that you find coffee helpful. 

ProfG    
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For more information on this research, please read the participant information and leave any questions in the comments field.


Jonsdottir et al. Serious games for arm rehabilitation of persons with multiple sclerosis. A randomized controlled pilot study. Mult Scler Relat Disord. 2017 Oct 28;19:25-29


OBJECTIVES: The feasibility and preliminary evidence for the efficacy of a serious games platform compared to exergame using the Wii for arm rehabilitation in persons with multiple sclerosis (MS) was investigated.


METHODS: A pilot single-blind randomized (2:1) controlled in clinical trial was carried out. Sixteen persons with MS participated (age years 56.8 (SD 12.3), MS-onset years 19.4 (SD 12.3), EDSS 6.5). Ten participants used a serious games platform (Rehab@Home) while 6 participants played with the commercial Wii platform, for four weeks (40min, 12 sessions/4 weeks). Feasibility and user experience measures were collected. Primary outcomes were the 9 Hole Peg Test (9HPT) and the Box and Block test (BBT). Secondary outcomes were the EQ-5D visual analogue scale (EQ-VAS) and the SF-12. Nonparametric analysis was used to verify changes from pre to post-rehabilitation within group and treatment effect was verified with Mann-Whitney U test. P value was set at 0.10 and clinical improvement was set at 20% improvement from baseline.


RESULTS: Serious games were perceived positively in terms of user experience and motivation. There were clinically significant improvements in arm function in the serious games group as measured by 9HPT (38-29.5s, P = 0.046, > 20%) and BBT 32-42 cubes, P = 0.19, > 20%) following the 12 gaming sessions while the exergame group did not improve on either test (9HPT 34.5-41.5s, P = 0.34; BBT 38,5 to 42 cubes, P = 0.34). Only the exergame group perceived themselves as having improved their health. There was a significant between groups treatment effect only in the perception of health (EQ-VAS) (Z = 1.93, P = 0.06) favouring the exergame group.


CONCLUSIONS: Virtual reality in a serious gaming approach was feasible and beneficial to arm function of persons with MS but motivational aspects of the approach may need further attention.

ProfG    
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‘‘Before the Internet, when first diagnosed, I depended on my neurologist. His opinion was the final say about everything from use of steroids to physical therapy to which disease-modifying medicine I would use. The Internet empowered me as a patient to become informed about my condition, to consider my options and the opinions of others, and to take charge of managing my disease in the best possible way for me.’’

ProfG    
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Time is Brain, even in MS! 


How quickly should we treat MS? 

DrK makes the case for treating everyone as quickly as possible. Do you agree? Can you help us convince Biogen about the case for a Brain Attack Trial?

When we were at the ECF meeting in Baveno DrK came up with a very important trial design to maximise the protection of the brain in MS. We all know that ‘Time is Brain’ and most MSologists will have patients who have had catastrophic relapses whilst waiting for a diagnostic workup and/or DMTs. We also know that MS activity tends to be clustered, i.e. one of the best predictors of a relapse is a recent relapse. Instead of putting patients with possible early symptomatic MS at risk from having to wait why don’t we to treat them all with natalizumab to protect their brains and spinal cords? This is analogous to treating stroke.

Why natalizumab? It is one of our most effective DMTs, it works very quickly, it is given as an IV infusion, hence there is no problem with adherence and is very safe for up to 12 months. It is also relatively safe in pregnancy. During this 12 month period, the neurologist and the patient can then decide what strategy they want to pursue in the long-term. This could be to continue natalizumab long-term or to switch to another DMT, or in the case of an alternative diagnosis the drug can be stopped.

To make the Brain Attack Trial a reality we would have to get Biogen to ask the EMA to license natalizumab as a 1st-line treatment. This may require data. Hence we are proposing that Biogen sponsor a ‘Brain Attack Trial’. This would become even more important if you can derisk the PML problem associated with natalizumab. Imagine if we can reduce the risk of PML to zero? Who wouldn’t want to start on natalizumab as a first-line therapy? Natalizumab will become the one and only platform therapy. The problem with this is that Biogen has other DMTs in the MS space and the Brain Attack Trial will potentially result in natalizumab cannibalizing their other DMT market. How bold is Biogen?

I can’t resist a business anecdote. Sony invented the Walkman, which transformed the way we listen to music. Sony then developed a digital version of the Walkman, i.e. their version of iPod. This was done a decade before Apple launched the iPod. However, Sony blinked and you should never blink in business. The issue was that Sony also produced content via Sony Music and other record labels (e.g. Columbia Records) and as a result of this Sony Executives decided it was too risky to launch the digital Walkman and decided to keep it under wraps and mothball it. Sony was worried that a digital Walkman would fuel digital piracy and cannibalize the music industry. Fast-forward a decade an Apple launches the iPod, which transforms the music industry, kills the Sony Walkman, revitalises Apple and the rest is history. 

Sony was the one company, outside of Apple, Steve Jobs admired and feared most. Have you compared the recent fortunes of Apple and Sony? Joseph Schumpeter, the famous economist, calls this creative destruction. 

The moral of this story is that if Biogen doesn’t do this study another company will and Biogen will run the risk of becoming the Sony of the MS world; first admired, then envied and finally irrelevant.

ProfG    
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The Australian state of Victoria has become became the country’s first to legalise assisted dying or suicide. Is dying a better euphemism? 

ProfG    
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I have just returned from the European Charcot Foundation meeting in Baveno, Italy. The meeting is small (< 500 attendees) with no parallel sessions and ample time to mix with attendees and chew the cud. I did a plenary presentation on “dealing with increasing economic constraints”.  The feedback I received after my talk, and subsequently via email, has been extraordinary. An eminent neurologist said he was glad that someone was thinking about these issues and taking it on. I have also been contacted by a health economist and have been urged to write up the talk.

I started the talk by focusing on microeconomic factors around treating and managing individuals with MS. The arguments are well rehearsed; most of the costs of treating MS are linked to disability. Treat-early and effectively to prevent disability and you lower treatment costs. To achieve this I asked the audience to read and adopt the “Brain Health: Time Matters” policy initiative. I used the recent cost of MS study done by Gisela Kobelt to strengthen my arguments.


I then briefly mentioned how innovation in the design of healthcare systems and service delivery could also save money. Due to time constraints, I didn’t go into details; this is a talk in itself. In short, new ways of managing patients using digital and asynchronous tools will change the way we run our MS services. Not to forget the revolution in self-monitoring and self-management that is about to transform clinical practice.


In terms of the high costs of DMTs, the major disruptor would be the small molecule DMTs when they come off-patent. When I was a trainee medical registrar in South Africa, Simvastatin had just been launched and it triggered a national debate about whether or not the country could afford statins. South Africa has one of the highest rates of cardiovascular diseases in the world, particularly in the Afrikaaners. Please note since statins have come off patent and generics have arrived the price of Simvastatin has almost plummeted to zero.  When fingolimod, teriflunomide, and oral cladribine come off-patent it will have the same effect.


I then made the case for using off-label therapies that are cheap, or relatively cheap, to treat MS in resource-poor environments. I mentioned the trials and tribulations of trying to get support for this list from the two largest MS Societies. Both the societies were supportive in principle but for various reasons are unable to endorse ‘off-label prescribing’ in the DMT space. I mentioned that I have had support from the MSIF (MS International Federation) who represent MS Societies from across the globe. Interestingly, the large MS Societies are prepared to support compassionate use or low-cost access programmes in resource-poor countries. With this advice in hand, I did contact several Pharma companies and Tim McCormick from Biogen stepped up to the plate. However, because I don’t work on the ground in one of these countries it was difficult for me to stay engaged with this initiative. In short, I have handed the baton to the MSIF. However, the experience has taught me that making high-cost innovator drugs available to patients in resource-poor environments has many legal, political and logistical hurdles they are highlighted in the slides.


I then went on to discuss some low hanging fruit, i.e. unplanned hospital admissions. A good proportion of these admissions are preventable by running a responsive and proactive MS service and targeting high-risk subjects. The potential savings for the healthcare system is quite large. I did some back of envelope calculations to show that by investing in trained staff, i.e. MS clinical nurse specialists, that you can make savings. I used data from Barts Health NHS Trust Hospitals and the local boroughs.


I then moved onto high-cost drugs and showed how effective NICE is at keeping down costs for the NHS. The downside of this strategy is the parallel observation on the rising costs of DMTs in the USA. I mentioned that as a consequence the USA is now subsidizing drug development for the world; a situation that is unsustainable in the long-term.


I briefly touched on the issue of off-label prescribing and the legal case that is currently being assessed under EU law between Bayer and the NHS. Bayer markets aflibercept (Eylea) and is challenging the rights of the NHS to allow the off-label prescribing of bevacizumab (Avastin) for wet macular degeneration. If Bayer wins then this will have implications for the use of rituximab to treat MS, an off-label indication.


I then discussed politics and the link between poverty and poor health outcomes and the need for us to address inequality. The UK has one of the greatest inequality gaps in Europe and may explain the disparity of DMT prescribing in the UK. Inequality is certainly one of the reasons why certain segments of the UK population voted to leave Europe. Inequality is a problem and Society needs to tackle it rather than ignoring it. 


How I could not resist presenting the threats and advantages of automation (robots) and artificial intelligence (AI) on the care of MS. I suspect algorithms are coming sooner than we realise to the management of MS.


I closed my presentation on the subject of MS prevention. I can imagine a world in which an EBV vaccine is licensed to prevent MS and other diseases caused by this virus. Wouldn’t that be wonderful? A low cost vaccine would be the most effective way to deal with the economic burden of MS. 


Read this post from last year for a further debate on high-cost drugs in the US.


Here’s my talk, please leave your comments below:

ProfG    
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