Category: Politics, campaigns and information

Chief Energy Officer, or not

The MS Academy held our first #MSVariance meeting on 1st and 2nd of November in Birmingham. We were oversubscribed, which would indicate that there is an appetite for change in the way we practice MSology in the UK. I learnt a lot from the meeting and had several of my assumptions challenged.



Lesson 1: Be more proactive about including women and other under-represented groups in the meeting from the beginning. Our apologies for not including women on the steering committee; it was my mistake. The steering committee self-selected each other based on a discussion we had about #MSVariance following a debate on this topic at the ABN earlier this year in Birmingham. We have already made amends and have approached some women to help taking things forward so that this initiative gains momentum.


Lesson 2: Variance does not imply inequality. I thought variance, in the context of MS services, as being a euphemism for inequality. It is not. The variance in MS services and their provision may arise at the top due to improvements in access and the rapid adoption of innovations. This then could act as a stimulus or other centres and individuals to up their game and to improve things. In other words, variance acts like an evolutionary selection pressure; i.e as a driver for improvement. The question is that we need to make this variation transparent so all can see it and respond to it. For this to happen we are going to need to set-up a rolling national audit.


Lesson 3: Don’t be too hard on ourselves and celebrate the successes. We were very fortunate to have Stephen Bleach a Times Editor and Journalist who has MS attend and speak at the meeting. He had written a personal account of having MS in the preceding week’s Sunday Times. He compared his journey with the disease to that of his late father’s. His father developed MS in the pre-DMT era when MS services were poorly developed and he tragically had a very poor outcome. At the end of the meeting he got up and reminded us to celebrate his success; his MS was diagnosed and treated rapidly and he is now doing very well and working full time. His future with MS may still be uncertain, but it promises to be a much better future than what his father had at the same stage. Stephen’s perspective is important, but his experience is what we need to replicate across the country. Time is brain and there are simply too many people with MS outside the system, with unacceptable delays getting into the system to be assessed for treatment. In addition, access to MS services is highly variable with some people having to travel long distances to be assessed.


Lesson 4: Don’t reinvent the wheel. There are a lot of initiatives that are currently running to address some of the issues that underpin #MSVariance. NHSE are reviewing the configuration and implementation of neuroscience services, which includes MS. GIRFT (get it right the first time) is also looking into what it can do to raise neurological standards across the country. What we clearly need are well-defined channels to disseminate information accurately and timely. It is clear that there are pockets of excellence across the country and that we need to celebrate these and get them to share best practice. The MS Trust has a mechanism to do this, with several cases studies that have been published on the MS Trust’s website. There is clearly an appetite for centres to be able to access each other’s protocols and this is something we can do relatively easily and effectively using the MS Academy.


Lesson 5: This initiative goes beyond DMTs. At the start of the meeting, there was some discussion about the focus of the initiative. Many attendees felt strongly that it should not only be about reducing variation in the prescribing of DMTs, but it should include the needs of all MSers, in particular, those with more advanced or progressive MS. I couldn’t agree more.


Lesson 6:  Expanding the brief to look at the social determinants of health. These are clearly important for health in general and almost certainly play a role in MS outcomes. However, data presented on this specific topic show that more research is needed. On a similar note, there was some discussion about social capital and lifestyle and wellness. Therefore, we will need to think carefully about how we incorporate these components into any metrics we develop and specific programmes to improve social capital and wellness.


Lesson 7: Chief Energy Officer. As I left for the meeting on the first morning of the meeting my wife mentioned to me that the main role of a CEO is being changed to that Chief Energy Officer. She said that my role at the meeting was to create the necessary energy and to inspire people to make change happen and to take control. In fact, Ben Bridgewater, one of the external speakers, implored us to #TakeControl and #ToMakeItHappen. If we didn’t make it happen then no one else would. I must admit my energy levels have been rather low; too MSed out, which is why I have taken so long to pen this post. However, I am just back from a very special holiday and feel rested and energised.


Lesson 8: Patient Activation. There is a difference between ‘patient engagement’ and ‘patient activation’. George Pepper, from shift.ms, gave a brilliant talk on what true patient activation should look like. It was clear that we need to define it and to make it happen. Patients who are actively engaged in their care are the true change agents. What we need now need to do it create the environment both inside and outside the NHS. In fact, we are planning to do this for our #BrainHealth #TimeMatters initiative and the following is a draft programme to train MSers to become #MSActivists. Please note this initiative is global, but will also include MSers from the UK. If you have any ideas to add to the programme below please do not hesitate to contact me.  


Draft BrainHealth Training Course for People with MS
(2-day course)


  1. Pre-reading and online content review, a needs analysis (online survey) and to prepare a short 2 min presentation on who you are and what delegates want to achieve as a Brain Health Champion / Ambassador


  1. Introduction – Gavin Giovannoni
    1. What is the MS Brain Health initiative and why is it important for people with MS?
    2. Introductions – each person does a 2-minute presentation
  2. Objectives of the BrainHealth Champions Programme – Gavin Giovannoni
    1. Why do we need Brain Health champions?
    2. How can you help?
    3. What is your role locally, nationally and internationally?
  3. Patient activation and empowerment – TBA
    1. This component will define what we mean about patient activation and how to empower yourself with knowledge. This will cover the essential components of what should be in a patient bill of rights and/or patient charter. It will also cover shared decision-making and what constitutes best practice in terms of shared-decision making.
  4. Health Policy and how it applies to the treatment of MS – External Speaker who is an expert on policy
    1. In this section, you will learn about health policy and how to use it to promote better MS services and ultimately better outcomes for people with MS.
  5. Personal branding, how to create an online profile and to use social media effectively – External Speaker who is an expert on branding and social media
    1. This will component of the training programme will cover (1) personal branding, (2) your online presence, (3) how to use social media and (4) how to use tools to automate your online activity.


  1. Brain Health Tools – OHPF
    1. This component will review the available Brain Health tools, patient check-list and future plans
    2. Breakout sessions to come up with new ideas for tools and initiatives to drive innovation and its adoption.
  2. Social Capital – TBA
    1. How important are the social determinants on MS outcomes?
    2. How to measure social capital?
    3. How to create or expand social capital?
  3. Review of the competitive space
    1. Lessons from other disease areas, e.g. dementia, type 1 diabetes
    2. Partnerships: setting-up partnerships with other groups
    3. How to share best practice
  4. Projects and mentoring scheme
    1. A session on potential projects to kick-start Brain Health initiatives locally
    2. How to get funding for projects
    3. Buddy up with a national mentor to help participants implement their Brain Health projects
  5. Follow-up webinars to review projects
    1. This will include online presentations of the specific Brain Health projects
        
  6. Conclusion
    1. Certificate of attendance and confirmation of being a Brain Health Champion
    2. Award for the best project
    3. Potential publications of best projects
    4. The inclusion of projects on Brain Health website
CoI: multiple

Why is Prof G dissatisfied?

I have been espousing the message that time is Brain in the treatment of MS, but the NHS makes it difficult to practice what you preach. MS services in the NHS are not configured at present to react quickly in terms of new referrals and as a result, MSers pay the price. In the last few months, two MSers have lost brain and spinal cord because of how long it has taken them to get into the Barts-MS system. This upsets me and leaves me feeling very dissatisfied with my NHS practice. 



The first is a patient with quite advanced MS who was reasonably well controlled on fingolimod. She moved to London to join her husband from a European country. She, unfortunately, ran out of fingolimod tablets before seeing me and by the time she arrived in our service she had rebound disease activity with severe brainstem and spinal cord disease activity. She was off her feet with the loss of bowel and bladder function. 


The second case was also a European who has been living in the UK for 10 years. His first attack was a brainstem attack that occurred almost 2 years ago. He was initially seen in accident and emergency department of a district hospital. It took him almost a year to see a neurologist and then 6 months for a diagnostic workup to be completed before being referred to me. It took me just shy of 3 months to see him in my new patient MS clinic. By the time I saw him it was 21 months since he had his initial attack. His EDSS was 4.5. He now has bladder and bowel problems, unsteadiness of gait, double vision, weakness in his legs, incoordination in his limbs and depression. He has also lost his job and is unlikely to be able to resume work. His MRI is a full house of poor prognostic factors; high lesion load, Gd-enhancing lesions, posterior fossa and spinal cord lesions, black holes on T1 imaging and some early brain atrophy. 


What did we do? We have put both these patients on natalizumab as part of our #BrainAttack paradigm, i.e. to get on top of the MS disease activity before we even have their JCV serostatus back. If they turn out to be JCV positive we can derisk their PML risk, by switching their treatment or offering them extended interval dosing (EID). 


All MSologists 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.

At Barts-MS we want to promote the #BrainAttack strategy and to potentially do a trial. Please note that if you adopt the #BrainAttack paradigm you need to commit to at least 6 months, and potentially 12 months, of natalizumab treatment, to prevent patients from developing anti-natalizumab or anti-drug antibodies. We rely on the continued administration of natalizumab to trigger high-zone tolerance and to switch off NAB development. We learnt about this when natalizumab was initially pulled from the market in the US after the initial PML scare. Those patients have 1, 2, 3 or 4 infusions were much more likely to become persistently NAB-positive and if this occurs they can never be treated with natalizumab again.

Please note that another issue with these two MSers is that they were both foreigners who grew up outside the UK and simply did not know how to navigate the NHS systems. I think everyone who lives in the UK knows how to navigate the NHS and to be more demanding. I am sure if these MSers had been native to the UK they would have found a way to expedite their appointments. This is no excuse. The tragedy for me is that both these MSers have acquired significant disabilities as a result of NHS systems. I now going to explore the possibility of setting-up an urgent DMT assessment clinic to try an avoid this from happening again.  


ProfG    

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Is it time to reunify MS as one disease?

I am just about to leave Berlin tired but content that the MS world is finally beginning to acknowledge that #MS_is_1_and_not_2_or_3_diseases. We have covered this topic extensively over the last 4-5 years and I did so again in my talk as part of the Roche satellite symposium.



I have also uploaded all my other ECTRIMS-related slides and posters to my new SlideShare site for download.



CoI: multiple

ECTRIMS 2018: will MS become one again?

I arrived in Berlin yesterday and already I am seeing ECTRIMS 2018 turning into a battle between the lumpers and splitters, i.e. is MS one, two or three diseases. 
Making Berlin one again

Roche, who has ocrelizumab licensed for relapsing and primary progressive MS want MS to be one disease. On the other hand, Novartis who have just submitted siponimod to the FDA for SPMS want it to be at least two diseases. This new battle helps nobody. We have been running the #MS-is-1-not-2-or-3-diseases for several years on this blog and I am not going to change my position on this.

Our MS as a length-dependent axonopathy hypothesis makes a strong case of MS being one disease, which is why we are arguing that advanced MS (formerly known as progressive MS) is modifiable. This principle underpins our #Chariot-MS and the #Oratorio-Hand studies and explains the positive low-dose oral methotrexate and ASCEND (natalizumab) trials. If we had interpreted the results of the low-dose oral methotrexate progressive trial from over 20 years ago correctly we would have had licensed therapies for progressive MS decades ago; yes, decades ago.

In reality, the salami slicing-up of MS into relapsing and non-relapsing forms, and of chronic progressive MS into primary and secondary progressive MS, was driven by money. When the interferon trials started it was important to make MS an orphan disease, i.e. to having fewer than 200,000 patients classified as having the disease. Being an orphan disease allowed Pharma (Bayer-Schering) to access the market with one pivotal trial, gave them market exclusivity and allowed them to charge much more for their product. The consequences of this is that we have divided MS into being many diseases, which is to the detriment of people with MS. The consequences of this are not trivial. Being diagnosed as having MS is bad enough, but then being diagnosed as having secondary-progressive disease is like getting another disease. The latter is still interpreted by most people with MS as now having a disease that is not modifiable. For example, in the NHS we are meant to stop DMTs in patients who develop SPMS. There are also many other reasons to avoid a diagnosis of SPMS.

An analogy to the RRMS vs. SPMS dichotomy is being diagnosed with a low-grade tumour, that on average is quite indolent and slow growing, however, after time the tumour mutates to become highly-malignant, life-threatening and often terminal. Just as people fear their tumour mutating, and becoming ‘terminal’, people with relapsing MS live in fear of developing progressive MS.

Recruitment for our PROXIMUS trial, which is now closed and being analysed, has been a victim of MS being two and not one disease. We made the mistake of calling it a secondary progressive trial. Very few of my colleagues referred patients for this trial simply because it meant diagnosing their patients as having early SPMS. Almost every neurologist I know avoids making a diagnosis of SPMS as long as possible because of the repercussions it has for their patients.

I think we need to turn the clock back and get rid of arbitrary, non-science, based definitions of MS. They don’t help us clinically. MS begins long before the first clinical attack. Similarly, progressive MS is present from the start of the disease. There is simply no magic point in time when you become SPMS. Dividing MS into relapsing and progressive phases may have helped Pharma get interferons licensed under the orphan-drug act, made them lots of money, but it is now doing the field of MS a major disservice. 


Now that there are marketing reasons to keep MS sliced-up as multiple diseases I can only imagine the Pharma shenanigans that will emerge. ECTRIMS-BERLIN 2018 is witnessing the first shots of this epic battle. Who will win? At least this new battle buries the dogma that advanced, or progressive, MS is not modifiable. We have won one battle only to replace it with another one. 

I am determined to remain an optimist and view this change in perspective as being positive for the field; at least both sides believe progressive MS is now modifiable.  

CoI: multiple 

ProfG’s MS-related Twitter activity: week 1st-7th October 2018


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CoI: multiple

ProfG are you walking-your-talk or just huffing-and-puffing?

I was asked after my ‘ProfG is fuming‘ blog post from a few weeks ago, if I was walking-my-talk and doing something about NICE’s decision about ocrelizumab for PPMS? Or was I just huffing-and-puffing and doing nothing about it? 


My response was yes; I am walking-my-talk. The following is a summary of some of my activities.

  1. I signed the MS Society’s petition. Did you? 
  2. I penned and managed to get over 90 HCPs to sign an open letter to Professor Dame Sally Davies in the Department of Health  (see below). 
  3. I did an MS Reporters interview with Rachel Horne from Shift.MS. Amazingly these have had more than 10K views in just three weeks (see below). It is the first interview/video I have done that has gone viral. It shows you the power of social networks.
  4. I have helped set-up an MS Academy meeting in early November to discuss variance and inequality in relation to MS Service provision in the NHS. I have little doubt the plight of PPMSers will high on the agenda. The meeting is now fully subscribed.
  5. I am putting to together a group of activated PPMSers to brain-storm, what to do next. I think we need to personalise it, i.e. to get individual stories out there about PPMSers who have been and will be disadvantaged by not having access to treatment. If you want to get involved please drop me an email (bartsmsblog(at)gmail.com). 

Prof G: The problem with off-label prescriptions in multiple sclerosis.

Why should Ocrelizumab cost more for Relapse Remitting MS than for Primary Progressive?

Prof G disagrees with NICE: Ocrelizumab is value for money
Ocrelizumab has been turned down for primary progressive MS in the UK. Why?


 Open Letter

 Professor Dame Sally Davies
Chief Medical Officer
Department of Health
Room 114, Richmond House
79 Whitehall
London SW1A 2NS
Email:CMOweb@dh.gsi.gov.uk

 24 September 2018

 Dear Dame Sally

 Ocrelizumab for the Treatment of Primary Progressive Multiple Sclerosis

 We are writing to you as concerned healthcare professionals for help. We are neurologists, nurse specialists and allied healthcare professionals who specialise in multiple sclerosis (MS). Although patients with the relapsing-remitting type of MS have access to many disease-modifying treatments no treatments until now have been licensed for those with the primary progressive type of MS (PPMS). In its final appraisal document [FAD ID938] NICE has not recommended the first available licensed treatment ocrelizumab, for treating early PPMS.

 The problem with NICE’s appraisal determination (FAD) is that the price for ocrelizumab had already been set for treating relapsing-remitting MS (RRMS, FAD TA533), but this price was considered not cost-effective for the treatment of PPMS based on its efficacy in the PPMS trial. As there are currently no licensed treatments for PPMS ocrelizumab had to be compared with best supportive care or no treatment. In comparison, when NICE appraised ocrelizumab for RRMS it was compared to all the other licensed disease-modifying therapies (DMTs).

 We have been told that Roche had then agreed to lower the price for ocrelizumab so that it would be cost-effective for the PPMS indication. If this was accepted it would mean ocrelizumab having two NHS prices, a higher price for the treatment of RRMS and a lower price for the treatment of PPMS. Apparently, the Department of Health is not prepared to support differential pricing, despite having a mechanism with the blueteq system for tracking prescribing for the PPMS and RRMS indications.

 NICE’s decision in association with the Department of Health’s Rules means an irrational decision has been made. It also creates inequity. People with PPMS who are prepared to pay for ocrelizumab privately will be able to receive the therapy, potentially in an NHS institution. Similarly, those who are fortunate may be able to move and be treated with ocrelizumab in another country where ocrelizumab is covered for the PPMS indication as other UK and EU countries have different decision-making processes.

 We would appreciate it if you could review the Department of Health’s position on differential pricing as a solution for people with PPMS being treated with ocrelizumab? We are convinced that there must be a solution that will allow our patients with PPMS to be appropriately treated under the NHS.

 Despite the pharmaceutical company conceding to the NICE target and the drug receiving a European license, it is now the government who is preventing patients receiving appropriate treatment for their MS simply due to a rule, arguably an irrational rule, created by the Department of Health.

 We look forward to hearing from you.

 Yours sincerely

 Concerned NHS HCPs.

 CoI: multiple

Shame on Barts Health NHS Trust

 

In our patch of East London if you have MS and live in Newham you get a very poor service; for example, you are 3-4 times more likely to require an emergency or non-elective hospital admission compared to if you live in Tower Hamlets or Hackney (our local London boroughs).

Why? 

We think the main reason is that there are no community-based MS clinical nurse specialists in Newham. We have been trying to progress a business case for a nurse post at Newham. The business case was due to be primed by the MS Trust and partly covered by the Newham CCG (clinical commissioning group), but as Barts Health is essentially bankrupt they won’t sign off on their part of the deal, i.e. to continue to fund our contribution to the post after two years. 
 
Our Trust is in special measures which mean external bean counters (consultants) come in and block all non-essential services or spend. This is all part of our CIPs (cost improvement plans) to make our NHS Trust financially viable. They don’t really care about MSers living in Newham who will continue to need admission for UTIs, falls, fractures, faecal impaction, pneumonia, pressure sores, etc. The MS Trust has data that shows that within the first year of specialist nurse appointment unplanned or emergency MS-related hospital admission fall by over 40%. In other words, MS clinical nurse specialists pay for themselves and at the same time improve the quality of life of their patients and families. Barts Health NHS don’t care. It is shameful that we such local variation in MS services.


Variations like these in local and regional MS services is one of the reasons why we are holding a meeting on ‘MS Service Provision in the UK; the Way Forward‘ in Birmingham on the 1st and 2nd of November. We will hopefully tackle thorny issues such as the above. Another issue is why do MSers in socioeconomic groups 4 & 5 not get the same services compared to MSers in socioeconomic groups 1, 2 & 3? Why can’t MSers who are referred into specialist services from DGHs (district general hospitals) get a more prompt service? Why are they worse off than MSers who are managed directly by the specialist centre? Why do MSers with relapsing-MS get a better deal than those with more advanced or progressive MS? These are just a few of the questions we will attempt to answer at this meeting. 

 
The good news is that the response to our meeting has been overwhelming with representatives from all over the UK. I sincerely hope we can come up with some common sense solutions to the issues raised. At the end of the day, we simply want to get rid of post-code prescribing and inequity in MS service provision across the UK. 
 
UK Centres signed-up to attend the variation in MS Services Meeting
 
We plan to record the talks and some of the discussions from the meeting and put them online. We will let you know when this happens as well as the outcome of the meeting. 
 
We need a wider debate about how we want the NHS to evolve and how MS services are delivered. 
 
CoI: multiple
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