If you live in the UK and have MS you may receive a letter from the NHS stating that you are potentially in the ‘extremely vulnerable group’ in relation to COVID-19. The reason for that is they are using GP databases and other sources of information to identify patients who may be on immunosuppressive therapy. If you receive one of these letters don’t be alarmed and please contact your MS Team for specific advice.
In my opinion, the only pwMS who should be classified as ‘extremely vulnerable group’ are those who have had HSCT and alemtuzumab in the last 3-6 months and are still immunodepleted or patients with severe disability who have swallowing problems and/or a history of recurrent chest infections.
You will have seen the UK Government have updated its guidance and is now “classifying people on immunosuppression as being extremely vulnerable, which probably includes pwMS on immunosuppressive DMTs. There are three reasons for this. (1) To protect you from potentially getting infected with SARS-CoV2 and (2) potentially getting more severe COVID-19 that needs hospitalisation and a potential ITU bed and ventilation. (3) There is also a potential risk of creating a population of super spreaders, which increases the risks to the general population. Immunosuppressed people may not be able to clear the virus quickly and hence shed more virus and for longer.
The current list of what is an immunosuppressive therapy is incomplete and was not drafted from an MS perspective. This is despite being a member of the subcommittee that was meant to help draft this guidance. I think it important to liaise with your own MS team about your own situation.
What about if you have MS and are an essential worker? If you can work from home, please work from home. If your job involves no contact with people then you may be able to continue working; however, please clear this with your organisation. If your job entails coming into contact with people and particularly people infected with SARS-CoV2 then you are going to have to self-isolate. This advice may seem harsh, but this is a war, a war against a virus, and it demands extraordinary sacrifices at an individual level for the good of society. This is not only about looking after your own health, but the health of the country.
The above may be relevant today and may change by tomorrow. If we don’t adhere to the Government’s advice, it will become a diktat tomorrow.
I have put together some slides to show how we think immunosuppression may affect the disease severity curve of COVID-19. Please note it is a may and not a definite as we don’t have evidence to back up these claims. I hope this is self-explanatory.
I predict that NHS letters will create a lot of anxiety so this is a warning not to panic. I am still collating this information on my COVID-19 & MS microsite.
“I love deadlines. I like the whooshing sound they make as they fly by” Douglas Adams, Hitchhikers Guide to the Galaxy.
There is one deadline that happened quitely earlier this month. NHS England turned on the blueteq form ocrelizumab treatment for PPMSers living in England; they did at the last possible timepoint dictated by the law. The good news is that the requirements for someone with PPMS to be treated are relatively simple. All that is required from us is the following:
1. Confirmation the patient has a diagnosis of early PPMS with active disease, defined by the appearance of new lesions confirmed by two MRI studies taken at least 6 months apart OR one or more gadolinium enhancing lesions on one MRI over the last three years.
2. EDSS score <= 6.5
3. A decision agreed at an MS multi-disciplinary team (MDT) meeting.
4. Recording of all the above in the patient’s records (for audit purposes).
This has been a long time coming and I want to thank all my colleagues who signed-up to the open letter we sent to the Chief Medical Officer (see below). I suspect the letter may have helped find a funding solution. It is clear that when there is a will there is a way.
I am also beginning to realise that NHSE is actually on the side of the patient and contrary to my previous perceptions NHSE want patients to access effective treatments. The problem is they have limited budgets and are beholden to the Department of Health and the political system of the day.
We may have won one battle, but the war continues. PPMSers in Scotland still have no access to ocrelizumab. How can we live in a country, with a socialist healthcare system, that allows your place of abode to dictate your access to treatment? If there is anything we can do to help PPMSers living in Scotland please let us know.
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 were rightly criticised last year for holding a meeting that highlighted the problem of variance in the provision of MS services, in the NHS. without a plan and vision about how to change things. I hope we have listened to you. The follow on meeting that we are hosting next month (8th-9th July) has a more ambitious agenda; it will even come with a 3-year action plan.
I have always made the argument that variance, when it comes to the provision of healthcare services, is a euphemism for inequality and that simply represents the haves and have-nots in society and the world. Why should someone with MS who lives in place B, or country Y, get a different service to someone with lives in place A or country X? On the other side of the coin, variability creates the engine for change; it is the catalyst for people to do something about the poor services they are providing or receiving; that is assuming they know about the quality of their service and are willing to do something about it.
My colleagues have told me that I shouldn’t beat myself up too much over the problems and criticisms of our first meeting; after all, it was very instructive in that it:
Brought us together as a wider MS community and allowed us to recognise and reflect on the challenges we face in addressing the variance in the NHS.
The meeting was inclusive in that there was no hierarchy in terms of the importance of the people who deliver MS services. We identified ourselves as equals, or partners, and included people with MS.
The meeting made us realise that we have cognitive biases that need to be addressed to make the community inclusive and more diverse. Diversity of ideas is going to be the catalyst for the next phase of our project.
We also realised that variance is not necessarily bad. We need some variance and ways to measure it so that the outliers at the upper end stimulate change. The next meeting is called ‘Raising the Bar’ and refers to improving services across the board.
The meeting also allowed us to get away from the NHS rat race and provided quality thinking time, i.e. time to reflect on the task at hand. This has allowed us to set priorities or specific work streams that will allow us to set key objectives for the programmes of work going forward.
As the chair of the committee, I have been asked to set out my vision for the initiative and define what success will look like for this initiative. To make it tangible I have defined targets at year 1, 2 and 3 and beyond.
YEAR 1
At the end of next year, I would expect all participating centres to actively engage in a national quality audit. This will include providing metrics on the NICE quality standards and several other new metrics that will allow us to assess how good or bad we are at achieving what we have set out to achieve.
My vision is 4×4, i.e. for 75% of patients with uncomplicated MS to be diagnosed within 4 weeks of the specialist MS team receiving a referral letter with a diagnosis of suggestive of MS and for 75% of pwMS, eligible for DMTs under the NHSE guidelines, to be have been offered, counselled and given a date for starting a DMT. Is this too much to expect? These time frames are compatible with our International Brain Health standards so why wouldn’t we aspire to meet them?
YEAR 2
At the end of year 2, all participating centres will have a patient partner programme in place to upskill pwMS on how to navigate their local MS services and how to self-monitor and self-manage their MS. This programme will be developed in partnership with patient organisations and will depend on local champions to make it happen. We are in an era in which knowledge has been democratised. Why shouldn’t people with MS participate in providing their own healthcare and contributing to their own healthcare?
YEAR 3
Participating centres will be working differently and managing MS holistically. This will include programmes to screen and manage comorbidities and to promote lifestyle interventions. Participating centres will collect data on these new activities as part of the annual national audit. As part of this holistic management of MS, there will be a ‘no patient left behind’ philosophy embedded in all MS services. This will require systems to make sure that all people with MS, who are covered by a particular service, will have access to that service. We don’t want vulnerable, less educated or less well off patients to be disadvantaged by the service.
LEADERSHIP
It was clear to us at last year’s meeting that for our vision to be realised we need a new generation of leaders to make things happen. We are therefore proposing putting in place a leadership training programme to equip people with the skills to make things happen. The leadership programme will be small and selective and will focus on doing, i.e. as part of the programme delegates will be expected to participate in and complete a national project. This will be run by Gabriele De Luca who is a shining example of what good leaders can do. Gabriele has experience from the AAN young leadership programme and is passionate about the field himself. It may be worthwhile coming to, and participating in, our meeting just to access the leadership training programme.
SHARING BEST PRACTICE
As always the wheel has usually been invented. Most ideas are not new, but how they have been tested and implemented may be new. We are proposing to use the Variance platform to share best practice. Why reinvent something if it already exists? We expect all centres to share their successes and failures so that others can learn from them. This will hopefully allow MS centres to share their materials and experiences with other centres so as to raise the bar for everyone and to create a collegiate atmosphere. The advantage the MS Academy has is that we already have the infrastructure to make sharing relatively easy.
So if you are reading this post and are attending this year’s meeting don’t be shy; please submit a poster to the meeting on something in your service that you are proud of, or even something you are not so proud of. We will select 3 or 4 posters for a platform presentation to allow wider discussion.
If you have not registered already please do so now there are a few remaining places.
Why don’t you support private prescribing and HSCT abroad?
The social media response to yesterday’s Barts-MS Hangout on HSCT has been rather mixed. A lot of commentators are being critical of us for creating too many hurdles regarding the access to HSCT and that we shouldn’t stop our patients going abroad for treatment. From my perspective, going abroad or to private units in the UK for HSCT is private healthcare at its worst. The countries who offer private HSCT, on a fee-for-service basis, are some of the countries with the largest health inequities in the world. These private HSCT units are in it for the money and hence are not that selective in whom they will treat. Can you pay? If you say yes, then you can be treated next week, but only after you put down a large deposit.
The founding principles of the NHS and other socialist healthcare systems are that healthcare is a basic human right, therefore it should be free at the point of access and it must be equitable. Private HSCT, private prescribing and even off-label prescribing undermine these principles and this worries me a lot. This is why I can’t and won’t openly support my patients travelling abroad for HSCT; you need to understand that when it comes to access to healthcare I am card-carrying socialist.
We at Barts-MS have been pushing our Essential Off-Label list to improve access to treatments in resource-poor environments. The problem with this is that adoption of off-label prescribing is patchy at best and creates pockets of prescribing in a desert of limited access. The latter creates massive variances in prescribing and inequity. This is why we decided a few years ago to hand the baton of promoting an Essential DMT List, including HSCT, which is on our list, to the MSIF (Multiple Sclerosis International Federation).
The MSIF is an umbrella organisation representing all of the MS Charities from across the world and is therefore in the best position to endorse and promote an Essential DMT list. The MSIF made the strategic decision to go via the WHO Essential Medicines List (WHO-EML). Over the last 2 years, we have actively been working on this and I have had the privilege of co-chairing the MSIF WHO-EML Taskforce with Professor Brenda Banwell. We managed to get an international consensus on three DMTs (glatiramer acetate, fingolimod and ocrelizumab) to be considered for the WHO-EML. Please note HSCT did not make the shortlist mainly because we are trying to address the unmet need in resource-poor countries. Our application is now online and we hope the wider MS community get behind our application. Our application is more than about these three DMTs, it is a political campaign to get the WHO and the world to realise that MS is a problem across the globe; MS is not just a rich world disease. For example, did you know that there are more people with MS in India than there are in the UK?
So to our critics out there, we at Barts-MS have a wider responsibility to the MS community and to support the NHS and the pwMS living in the UK by trying as best we can to uphold the founding principles of the NHS.
