In many companies, Market Access is brought in once the registration file is approved. The team is handed a price corridor, a launch date and an expectation of fast uptake. By then, several decisions that will shape access are already fixed.
What is already decided by registration
- The evidence. The trials are finished. If the comparator, endpoints or population do not match what local payers fund and care about, there is little time to fill the gap.
- The label. The approved indication defines the population you can argue for. A label broader than the population that benefits most can make the budget conversation harder, not easier.
- The price logic. External reference pricing means prices set in other countries can follow the product into the region. A launch sequence decided globally may have already set a ceiling.
What starting early makes possible
When Access is involved one to two years before registration, the team can do the slow work that determines speed later.
- Map the healthcare system and the funding routes the product will need, sector by sector.
- Understand the patient flow, including where patients are diagnosed and treated today.
- Identify the evidence gaps payers will raise and plan how to address them, including local real-world data.
- Build relationships with the clinical and payer stakeholders who will shape the decision.
- Prepare a budget impact estimate grounded in local epidemiology rather than global assumptions.
The fastest access is usually the result of the earliest preparation.
A change of role
Starting early also changes what the Access function is. It stops being the team that negotiates a listing after launch and becomes the team that tells the business, before launch, what it will take for patients to receive the medicine. That is a more strategic seat at the table, and it is the one ambitious Access professionals should aim for.