OBJECTIVES

: Within the EU there are multiple payer scientific advice options pharmaceutical companies can take to understand payers’ clinical and economic HTA evidence requirements. The aim of this study is to compare the key aspects companies must consider when seeking payer scientific advice.

METHODS

: Secondary research was conducted to identify the payer scientific advice processes at NICE, G-BA, HAS, AIFA and the parallel consultation with the EMA and HTA bodies. The timelines, submission requirements, scope of advice and fees for each procedure were then compared and contrasted.

RESULTS

: Major differences between payer scientific advice procedures were identified. The G-BA and NICE’s Office of Market Access have the shortest timelines, providing advice within 10 – 14 weeks, whilst NICE’s scientific advice and EMA’s parallel consultation take 24 – 34 weeks. The G-BA require the fewest submission materials; in contrast, the EMA, NICE, HAS and AIFA require a comprehensive briefing book, list of questions and company position for each question to be submitted prior to the meetings. The G-BA provides relatively defined feedback, such as likely comparators or patient populations, whereas NICE also provides feedback on statistical analysis and health economic considerations. The EMA parallel consultation also offers regulatory guidance, but may not provide the depth of feedback compared with individual HTA consultations. The cost of seeking advice varies considerably; HAS does not request fees, whereas the EMA parallel consultation incorporates fees from the EMA and each HTA involved in the parallel consultation, can exceed €50,000.

CONCLUSIONS

: This research highlights the variability regarding the scientific advice submission processes and scope of advice provided across the EU. Pharmaceutical companies should give careful consideration as to which procedure is most appropriate for their needs, taking into account their timelines and resources and the type of payer insights required to optimise their clinical trial designs from an HTA perspective.