NICE Scientific Advice Program May Seek Broader Application Through Boosting Regulator Link-Up
This article was originally published in The Pink Sheet Daily
NICE’s scientific advice program, now in its third year, may need refocusing and increased co-operation with regulators to appeal to small and medium-sized companies.
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Roche’s Perjeta suffered a knock-back in Europe when NICE said the clinical trial population was not wholly relevant to the patient population in the UK.
Sanofi’s failure to align its comparator selection with that of Germany’s reimbursement authorities has resulted in dismissal of Lyxumia for diabetes type 2, although the company will have an opportunity to challenge the decision.
Sweden has been offering joint scientific advice to drug developers via a collaborative project between the country's reimbursement authority (TLV) and the Medical Products Agency (MPA).