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07/18/18 8:22 PM

#183222 RE: Lykiri #183220

– A PIM [UK's Promising Innovative Medicine] designation gives an early signal that, based on the evidence to date, the medicine may be a possible candidate for the Early Access to Medicines Scheme and thus has the potential to be of value in areas of unmet medical need. The MHRA operates the process resulting in a PIM designation.”



Excellent point

exwannabe

07/19/18 7:33 AM

#183245 RE: Lykiri #183220

We discussed this topic in the past few months! For clarity :first you have PIM (Promising Innovative Medicine) designation. At the end you have NICE Technology Appraisal.


The PIM is the first step in getting the EAMS designation which allows the drug to be used while waiting approval.

In your document it lists 6 steps. The second never happened because that is the scientific opinion whee NWBO would have to provide data.

The NICE TA is for reimbursement. It would happen concurrent with EAMS, but would also happen for drugs not in EAMS, as is the case here.