Hi manibiotech,
That is a fair question, and the distinction lies in sequencing and regulatory mechanics, not contradiction.
You are right that NICE often aims to publish their final recommendation close to or even concurrently with MHRA approval. But that refers to timing of publication, not the timing of submission.
The NICE process cannot formally begin, meaning the sponsor cannot submit an evidence package, until the MHRA has finalized the SmPC (Summary of Product Characteristics). That document defines the approved indication, dosing, target population, and safety profile. NICE cannot perform a health economic evaluation or model cost-effectiveness without it.
This is exactly what the July 15 NICE letter confirms:
“The company are not yet in a position to provide their evidence submission with us…”
That is not about delay or unwillingness. It is a procedural block. The SmPC is not final yet, so the evidence cannot be submitted. Once it is, NICE can begin its appraisal and aim for rapid alignment with the public announcement of MHRA approval.
So your memory about NICE’s goal of near-simultaneous publication is correct, but it depends on early coordination after MHRA approval in principle, not evidence submission before that milestone.
Happy to clarify further if needed.
Bullish
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