Charlie Hewitt from Remap Consulting initiated today’s session by providing a description of the challenges that early scientific advice seek to solve, and its function for manufacturers, playing a crucial role in identifying and mitigating uncertainties early in the development process to optimise pricing and reimbursement outcomes. As misalignment between payer expectations of clinical trial design and actual implemented design can lead to uncertainties, restricted reimbursement, and suboptimal price outcomes, engaging in scientific advice after Phase 2 or early in Phase 3 allows manufacturers to refine trial design and mitigate potential uncertainties that may be highlighted in HTA.
This session provided insight into how best to navigate early payer scientific advice to ensure optimal outcomes for an asset, the variations between different advice processes, and the commonalities which manufacturers should consider.
Key Thoughts:
Scientific advice processes seek to cover a number of factors, including defining reimbursable patient populations, selecting appropriate comparators, assessing relevant clinical endpoints, and addressing clinical and economic uncertainties. Various options exist for seeking advice, including Joint Scientific Consultations (JSC), national scientific advice (e.g., in France, Germany, Italy, the UK, Australia, and Canada), and informal HTA input through advisory boards or triad interviews. Choosing the appropriate route requires consideration of depth of advice, timelines, resource requirements, and eligibility. JSC is the most resource-intensive but valuable especially when questions arise regarding PICOs, the SA process takes around six months from briefing package development to final advice.
Charlie presented a strategic BRAVE approach that manufacturers should follow to enhance the effectiveness of scientific advice:
- Be Bold with questions – Ask specific, forward-thinking questions early to gain actionable insights, and ensure that challenging questions are not shied away from to gain the most useful insights
- Recognise red lines – Identify areas of flexibility and non-negotiable aspects of trial design to help prioritise key questions
- Align internally – Secure cross-functional buy-in, particularly from the clinical team, to ensure a structured, efficient scientific advice process
- Validate your argument – Use data and expert input to craft well-supported strategic narratives, utilising workshopping of company positionings and identification of support for rationale
- Engage proactively – Conduct thorough preparation, rehearse discussions, be open to alternate team perspectives, and seek clarification post-report to maximize the benefits of scientific advice
The Takeaways
- Early scientific advice facilitates the optimisation of pricing and reimbursement through alignment with payer expectations and reduction of uncertainties in trial design
- The choice of scientific advice processes requires strategic selection based on the depth of advice required, forecasted timelines, resource availability, and eligibility to maximise the utility of output
- The BRAVE approach should be utilised to prepare and undertake the scientific advice process to ensure manufacturers have the most opportunity to gain beneficial advice