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Early dialogue with NICE and EUnetHTA: a UK perspective in a politically uncertain ERA
Heyes A, Millar L
We have conducted a review of publicly available information on scientific advice services offered by HTA bodies – EUnetHTA in Europe and NICE in the UK. These services are designed to guide the manufacturer’s approach to reimbursement support activities for a new product.
Manufacturers under the purview of EUnetHTA submit a briefing book with information on their product and disease, along with specific questions on clinical and economic issues for HTA for up to 3 specific markets. NICE has a similar process and has introduced a shorter express service and some price flexibility with the choice of a more limited expert review. Recently, NICE has communicated that there are opportunities for joint HTA consultations with Canada, the US, Norway, Sweden and Finland. In the event that the UK does leave the EU, NICE has published a plan to ensure that their services will continue.
We found that the best time for manufacturers to seek advice is before finalizing the protocols for the main registration studies. This helps in implementing appropriate study design for both regulatory and HTA purposes. However, advice that is sought later in product development will also be useful for the manufacturer in informing the approach to economic analysis.
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