Early Advice

Early Advice refers to the initial, often informal or semi-formal, guidance provided to manufacturers or developers of health technologies (such as pharmaceuticals, medical devices, or diagnostics) at the early stages of product development. This advice helps shape clinical development strategies, evidence generation plans, and regulatory pathways before pivotal trials or formal regulatory submissions. The goal is to identify potential challenges and align development plans with the expectations of health technology assessment (HTA) bodies, regulators, and payers to improve the likelihood of successful market access and reimbursement.

• Early advice typically occurs during Phase I or early Phase II of development, focusing on broad scientific, clinical, and regulatory considerations.

• It may include general guidance on study design, comparator selection, endpoints, patient populations, and data requirements.

• Early advice processes vary by country and agency, with some offering joint consultations with regulators and HTA bodies.

• It is generally non-binding but provides valuable insights to manufacturers to optimize development strategies and reduce risks later in the product lifecycle.

Comparison with Scientific Advice

Importance and Benefits

• Early advice aim to reduce uncertainty in clinical and economic evidence requirements, thereby increasing the chances of successful market access and reimbursement.

• Early advice allows manufacturers to adapt their development plans proactively, potentially saving time and resources.

In summary, Early Advice is a preliminary, often broader guidance process at the start of development, while Scientific Advice is a formalized, detailed consultation focused on optimizing evidence generation for regulatory and reimbursement success. Both are complementary and critical to efficient health technology development and market access.

Reference

• Papagiannopoulos C et al., ISPOR 2023: Overview of Early Scientific Advice processes across European HTA bodies, highlighting timelines, costs, and stakeholder involvement. https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3669/126270

• European Medicines Agency (EMA): Scientific advice focuses on how medicines should be tested to generate robust evidence for regulatory approval. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance

• Systematic review (PMC, 2022): Early and scientific advice frameworks help manufacturers focus product development on disease management needs and reduce evidence uncertainty. https://pmc.ncbi.nlm.nih.gov/articles/PMC9583828/

• ISPOR Value & Outcomes Spotlight: Early HTA scientific advice is a formal process providing feedback on clinical trial design and evidence generation to support market access. https://www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/unlocking-the-promise-of-real-world-evidence/early-health-technology-assessment-advice-opportunities-to-achieve-collaborative-and-efficient-dialogue

• Paul-Ehrlich-Institut Innovation Office: Differentiates between pre-advice (very early guidance) and scientific advice (specific project-related guidance). https://www.pei.de/EN/regulation/advice/advice-concept/advice-concept-node.html

• Remap Consulting (2025): Early HTA scientific advice reduces risks of negative reimbursement decisions by aligning clinical and economic evidence with payer expectations. https://remapconsulting.com/hta/early-hta-scientific-advice-market-access/

• SAPEA Report (2024): Discusses challenges for early- and mid-career researchers in providing scientific advice, emphasizing the importance of evidence-informed policymaking. https://scientificadvice.eu/reports/report-on-challenges-for-early-and-mid-career-researchers-in-the-provision-of-science-advice/

• Parexel Insights: Early scientific advice in cost-effectiveness markets helps create evidence packages meeting regulatory and payer requirements. https://www.parexel.com/insights/blog/early-scientific-advice-in-cost-effectiveness-markets-how-to-navigate-it-and-is-it-worth-it