Yes to clarify one more thing: the NHS is *not* the FDA. The MHRA is the closest equivalent of the FDA. This part of the NHS is closest to Medicare’s CMMS This institution decides what part of the England National Health Sevice will allow be used to sometimes treat and reimbursed by government funds.
Now you say, why would NHS England decide to pay for and use something that MHRA hasn’t approved? Well,
1. To provide access to experimental treatments that are essential to treating effectively life limiting disease where there are few good other treatments (EAMS)
2. To front run the MHRA when their process is just slow approving something that other regulators have already signed off on in other countries
3. To allow pharma companies to offer free of charge medicines in pre-commissioning before MHRA or NICE decisions are complete (FOC)
My guess is we got in on EAMS originally (this was the old entry thaf was deleted that was GBM-only). My guess is that they have enough confidence that uk clinicians are or will be asking to use the treatment - and use it in cancers beyond GBM - that they updated the entry, changed to the new INN name, and updated indications all cancers.
I’ve never seen the direct interplay between this body and MHRA. It’s even more uncertain now given the turmoil in NHS England with the PM’s restructuring. However, speculating, I can’t imagine they’d do all the work on the HCL entries to have the MHRA just reject the MAA in the coming days/weeks/months.
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