PoliticalSpeak & OffLabel: New Year Resolution

Off-label prescribing; should it be one of our New Year's resolutions? #PoliticalSpeak #MSBlog #OffLabel

"On reflection one of the most important issues we have tried to address on this blog in 2015 is access to effective DMTs for people with MS (pwMS) who live in resource-poor settings. My personal experiences of what it is like to be a pwMS living in a resource-poor country remains the primary motivator for this policy initiative. Barts-MS plans to take this policy forward in 2016 with the help of several new partners."

"A part of the solution we have been promoting the use of off-label, cheaper, alternative DMTs to treat MS. The following is our Barts-MS essential off-label DMT list (click on each drug for more information):

  1. Azathioprine*
  2. Cladribine
  3. Cyclophosphamide*
  4. Fludarabine*
  5. Leflunomide
  6. Methotrexate*
  7. Mitoxantrone
  8. Rituximab*
*on the 19th WHO Model List of Essential Medicines (April 2015)

We think there is enough direct, or indirect, efficacy and safety data to support the use of these drugs as DMTs in MS."

"Interestingly, we have a lot of resistance to this policy from multiple sources; internally from within our University (Policy Unit), Pharma, colleagues (from both resource rich and poor countries),  and even several of the MS Charities. Our policy unit feels that there is far too much inappropriate off-label prescribing in the world and that we should really stick to the policy of only prescribing on-label. Pharma as it challenges their business model. Colleagues in resource-rich countries feel the medicolegal risks of prescribing off-label are too high and can't be justified. Clinicians in resource-poor settings don't like double-standards; why should they apply lower standards to treating pwMS in their countries? Surely, pwMS in resource-poor countries should have access to the same DMTs with appropriate risk:benefit assessments to those living in richer countries? The MS Charities favour lobbying Pharma to make available licensed DMTs at a cheaper price to pwMS in resource poor countries. The latter solution exists in many other disease areas; why not in MS? I suspect there is still a perception that MS is a 'rich-country' disease and is too rare in developing countries to warrant a sponsored drug-access scheme. Herein lies the problem. MS is not only a rich-country disease, we are seeing increasing incidence rates across the developing world. We mustn't forget pwMS who live in these countries, they need our help. If we want to reduce the burden of MS across the world we need workable policies so that MSers living in resource-poor countries get access to the same health care and treatments as MSers living in the developed world."

"The New Year will therefore see us launch a new initiative to focus on MS issues that are unique and pertinent to the pwMS living in developing countries and/or in resource poor settings; the latter includes refugees, illegal immigrant populations and possibly the medically uninsured living in developed countries. If you are a healthcare professional (HCP) looking after pwMS in these environments and want to help and be part of this initiative please do not hesitate to contact us. As will all policy initiatives the more people who get involved the better. We need volunteers!"

"We still have an open survey running to see how much support we have for the off-label prescribing component of our policy. When I last checked the results over 80% of you were supportive of our efforts. Do you still feel this way?"

"Let's make 2016 the year of hope and effective treatment options for all people living with MS. Happy New Year!"

CoI: multiple

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