Off-label prescribing. Is it justified? #ClinicSpeak #MSBlog #MSResearch #OffLabel
"After last week's post on off-label prescribing, I contacted our health policy unit about formally addressing this issue in the UK with the aim of producing a policy document. Surprisingly, I have got a lot of push back from the unit. Their position is that there is too much inappropriate off-label prescribing in the world and that we should really stick to the policy of only prescribing on-label. If their position is correct then we should not be investigating and promoting off-label DMT usage for MSers in resource-poor healthcare environments. Do you agree?"
"I don't agree. The incentives for licensing a drug from the Big Pharma perspective are financial. In comparison the incentives for academia are usually because of an unmet need in a particular patient group. The problem is that without a financial case academics, and the NHS for that matter, don't have the resources for licensing a drug or to maintain a license once one is granted. This then creates a Catch-22. I personally think there is a massive unmet need for off-label prescribing in MS. This is particularly pertinent that we have now changed our therapeutic aim in MS to treat-2-target of NEDA. We now have something to aim for regardless of which DMT we prescribe. Clearly the issue of off-label prescribing is not relevant in developed markets where there are laws to protect Big Pharma investment in novel innovative therapies. What we are trying to address is the unmet needs in environments where MSers simply can't afford innovator brands. Would you rather be on an off-label DMT or no DMT at all?"
Proposed essential off-label DMT list