Could oral cladribine steal alemtuzumab’s thunder? #ClinicSpeak #MSBlog #MSResearch
I naively discovered yesterday that NHS England will only be allowing us to use two courses of alemtuzumb in our patients with active relapsing MS. If these patients breakthrough and need a third, fourth or additional course of alemtuzumab we will have to apply for additional funding via an IFR (individual funding request). The problem with the latter is that as soon as there are more than 5 patients in England requiring an IFR for the same indication this triggers the requirement for a business case. Making a business case stack-up for additional courses of alemtuzumab, when it costs so much, will be difficult outside of formal NICE guidance. At present ~40-50% of patients treated with alemtuzumab will require additional courses. Based on my previous experience with NHS England, and their dire financial predicament, I suspect getting a green-light for additional courses of alemtuzumab is going to be an uphill battle. In short we have been truly NICED. The question is whether or not Genzyme-Sanofi will come to the table with additional courses at a lowered price? If not we are going to need a plan B. What DMT will we use in patients who breakthrough post-alemtuzumab?”
I am now going to have to take this information into account when counselling patients. I suspect that this may turn many patients off alemtuzumab as a treatment option. Does this also mean we should be routinely be offering our patients, who want an induction therapy, off-label cladribine or in those with highly-active disease HSCT? This new information also means that if oral cladribine gets a license it is going to disrupt alemtuzumab’s market. The following is my ECTRIMS poster showing you the effect of oral cladribine. The difference with oral cladribine is that we have access to the much cheaper generic oncology version that could be used for subsequent courses if NICE, and NHS England, say no to additional courses of cladribine. Unfortunately, at present we don’t have this option with alemtuzumab.