Did you know that 3rd, and subsequent courses, of alemtuzumab are off-label? #OffLabel #ClinicSpeak #MSBlog
My post on NHS England not funding 3rd, 4th and other additional courses of alemtuzumab has caused a great stir. Apologies for causing anxiety; in future I won't do these sorts of posts. However, since then I have learnt a lot.
The situation we find ourselves in is because of the conditions of the licensing authorisation, or label, the EMA have given alemtuzumab. If you read the Summary of Product characteristics below you will notice that alemtuzumab is only licensed for two cycles of treatment. The document does not mention 3rd, 4th or subsequent courses. It is because of this that the NICE STA only mentions two cycles of treatment. NICE is not in the business of approving, or supporting, off-label prescribing. The good news, however, is that NICE took a third course of treatment into account in their cost-effective analysis of alemtuzumab. Based on this NICE approved alemtuzumab for active relapsing MS in England. Therefore, a third a course of treatment is cost-effective and it is highly likely it will be funded by NHS England under an exemption. There is a precedent for this in the MS space and it will require us, the MS community, to make the case in writing to NHS England for the need to use additional courses. The latter however will not necessarily cover 4th and subsequent courses; for this we will probably need more detailed cost-effectiveness data.
Please note that Genzyme-Sanofi have been very quite on this issue. Why? They as a company are not allowed to promote off-label prescribing so it will be up to us to make the case to NHS England.
After speaking to NHS England I am now confident that we will be able to at least offer our patients a third course.
CoI: multiple
My post on NHS England not funding 3rd, 4th and other additional courses of alemtuzumab has caused a great stir. Apologies for causing anxiety; in future I won't do these sorts of posts. However, since then I have learnt a lot.
The situation we find ourselves in is because of the conditions of the licensing authorisation, or label, the EMA have given alemtuzumab. If you read the Summary of Product characteristics below you will notice that alemtuzumab is only licensed for two cycles of treatment. The document does not mention 3rd, 4th or subsequent courses. It is because of this that the NICE STA only mentions two cycles of treatment. NICE is not in the business of approving, or supporting, off-label prescribing. The good news, however, is that NICE took a third course of treatment into account in their cost-effective analysis of alemtuzumab. Based on this NICE approved alemtuzumab for active relapsing MS in England. Therefore, a third a course of treatment is cost-effective and it is highly likely it will be funded by NHS England under an exemption. There is a precedent for this in the MS space and it will require us, the MS community, to make the case in writing to NHS England for the need to use additional courses. The latter however will not necessarily cover 4th and subsequent courses; for this we will probably need more detailed cost-effectiveness data.
Please note that Genzyme-Sanofi have been very quite on this issue. Why? They as a company are not allowed to promote off-label prescribing so it will be up to us to make the case to NHS England.
After speaking to NHS England I am now confident that we will be able to at least offer our patients a third course.