Tag: #OffLabel

GROLDI hits a wall

To help with our #OffLabel campaign to help HCPs treat pwMS in resource-poor environments I asked Gisela Kobelt, a health economist, who I have worked with for many years for help. What she said to me made me realise that the hurdles we face are much higher than I expected. 

These are her relevant comments:

“The economic case for any treatment in resource-poor countries is difficult, simply because not treating is cheaper than treating, and as no one seems to take care of disabled people in these countries they are left in the charge of their families. Therefore, the usual health economic arguments do not apply. As the economic arguments have been wasted in Europe and the USA, how could we expect them to work in these countries?”

“You need something bigger, in fact, something at the strategy level where the main message is that any health care system, even in poor countries, has been designed to help people with the means available. You need to make humanitarian arguments more than economic ones. Politicians that actually have a heart and a brain (rare birds these days!!) can promote the right arguments. Maybe an economic component would be that currently, even the things that are being done are pretty useless, hence resources are being wasted, and some could be switched to interventions that have some utility.”

The bottom line is that we need to shift the emphasis away from the economic arguments to the humanitarian ones. So if you have any stories to highlight the plight of people with MS living in resource-poor countries to share with us please come forward; you can use the Barts-MS blog as a soap-box.  We need to make politicians in these countries and the WHO sit-up and listen.

  1. Azathioprine*
  2. Cladribine
  3. Cyclophosphamide*
  4. Fludarabine*
  5. Leflunomide
  6. Methotrexate*
  7. Mitoxantrone
  8. Rituximab*
  9. Generic dimethyl fumarate (Skilarence)
  10. Compounded dimethyl fumarate
  11. HSCT

*on the 19th WHO Model List of Essential Medicines (April 2015)

If you are interested in helping address the issue of lack of access to MS DMTs in resource-poor countries and environments please sign-up to our Grass Roots Off-Label DMT Initiative (GROLDI). 

CoI: multiple

#OffLabel

I am speaking at the Multiple Sclerosis International Federation (MSIF) Access to Treatment and Healthcare meeting next week in London. My talk is on “Off-label opportunities, barriers and risks in availability and affordability”.

My journey to this point goes back 5-years and started when I was on sabbatical and was visiting countries all over the world and seeing how MS was managed. I soon realised that MSers living in resource-poor environments had poor access to MS disease-modifying therapies and other MS services. This led us to formulate an Essential Off-Label DMT list and to start a social media campaign using the hashtag #OffLabel to get people to adopt off-label prescribing of DMTs. We also developed a protocol for off-label cladribine use and have distributed it widely. 

These activities and other factors nudged the MSIF to make ‘access to treatment’ one of their priorities and led to the MSIF submitting an application to the WHO to get three DMTs, albeit licensed DMTs, onto the essential medicines list (EML). If successful (hopefully we will hear next week – fingers-crossed) we will be able to use this as a springboard to raise awareness of untreated or under-treated MS across the world. It will also raise awareness about MS in low prevalence areas and challenge the prevailing dogma that MS is a rich-world problem. 

Please note our essential off-label DMT list is ‘evidence-based’ or at least anchored to licensed DMTs. The following is a new version of the list.

  1. Azathioprine*
  2. Dimethyl fumarate (generic, licensed for psoriasis)
  3. Cladribine
  4. Cyclophosphamide*
  5. Fludarabine*
  6. Leflunomide
  7. Methotrexate*
  8. Mitoxantrone
  9. Rituximab* 
  10. HSCT

*drugs that are on the 19th WHO Model List of Essential Medicines (April 2015)

I am particularly interested to hear stories about off-label treatments in your countries and if any of you are receiving off-label treatments.

Apart from rituximab use, particularly in Sweden, off-label prescribing is simply not being adopted. Why? I think it takes more than a few people standing on a soap-box to make it happen; what is required is a systems change and a whole lot of nudges to get HCPs to start doing it. This is why I have become so interested in behavioural psychology and behavioural economics, which teaches us why information is simply not enough to change HCP behaviour.

CoI: multiple

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