It's good to have that bit of extra confirmation that DCVax-L is
being used to treat a few patients in the UK.
It is the UK Specials programme that allows this to happen.
It has to be at the request of a physician directly responsible for the individual patient concerned. And to meet the special needs of that individual patient that cannot be met with a licensed product.
The supplier cannot 'solicit' orders.
The supplier is able to set a price and be reimbursed.
The manufacturer has to have a UK Specials Licence.
And our manufacturer is Advent, operating out of CCGTT (who have the appropriate licence) in London, where Mark Lowdell is the Director.
One assumes that numbers are very small. Maybe 1 or 2 a month, though that's just a guess.
Clearly, it will be UK neuro-oncologists/surgeons with an awareness of DCVax-L, who will be doing the prescribing.
And most likely Dr Ashkan does some of these. But not necessarily all of them.
Suspected or actual adverse events must be reported.
I don't think the patient has to be a UK citizen necessarily.
And the UK Special drug can be exported for use on a patient in a different EU state.
What is not entirely clear to me is who pays
I think it is
down to the patient (hence the online funding appeals), but the guidance document doesn't actually say that the NHS doesn't do the funding.
So NWBO can certainly cover all their costs in relation to supply under UK Specials, and there is nothing to preclude a profit element. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf