Market access is not written. It is built.

A reimbursement dossier is an important output of market access work. It is not the whole process. For a life sciences launch, evidence, local relevance and practical adoption need attention well before the submission is written.

A dossier can be robust and coherent while important questions remain unanswered: does the product address the clinical need as local clinicians see it? Is the comparator relevant? Can hospitals incorporate the treatment into their existing pathway? Which budget pays, and who needs to make the operational decisions?

Separate authorisation, reimbursement and adoption

These are connected but distinct steps. EMA explains that, after a European marketing authorisation, pricing and reimbursement decisions take place at national and regional level. EMA itself does not decide pricing or reimbursement.

Even where funding is available, a launch team still needs to understand how patients will reach the treatment, how clinicians will use it and which organisational changes are needed. A market access strategy should therefore follow the patient pathway as well as the formal assessment route.

Build the evidence story while choices are open

Late writing cannot change the comparator used in a completed trial or add a missing outcome retrospectively. That is why access questions should inform development discussions while there is still scope to act.

• Test whether endpoints address the outcomes relevant to the intended assessment and clinical decisions.
• Examine comparator choices against local standards of care and likely changes before launch.
• Identify patient subgroups and uncertainties that could influence the interpretation of value.
• Check economic assumptions against the relevant care setting and resource use.
• Plan how genuine evidence gaps could be addressed, rather than hiding them behind a stronger narrative.

Understand the people behind the pathway

Stakeholder understanding is more specific than a list of influential names. Clinicians, pharmacists, hospital management, payers, budget holders, professional groups and patient organisations may each see a different part of the problem.

Purposeful, appropriate engagement can reveal practical questions that desk research misses. A team might discover that an administration requirement affects staffing, that a referral pathway is poorly defined, or that the perceived target population differs from its original forecast. These insights should improve the plan, not merely decorate a stakeholder map.

Turn local insight into a working access plan

Assign each important assumption an owner and a clear next step. Distinguish confirmed requirements from interpretation, and record where stakeholders disagree. Connect medical, access, regulatory and commercial work so that new information changes the launch plan when it needs to.

For the Benelux, that means testing the relevant country and care setting. A regional strategy can coordinate the work, but it should not erase differences between national systems or local implementation.

What should be ready before the dossier?

The team should be able to explain the intended place in therapy, the evidence supporting it, the unresolved uncertainties and the practical route to patient access. The dossier then expresses a strategy that has already been examined, rather than becoming the first moment at which those questions are considered together.

At Health Devotion, we believe market access is built through early preparation, credible evidence and local understanding. Read about our life sciences services or discuss your access questions with us.

About the author: Ivo Vink, Health Devotion.

Source: EMA: authorisation of medicines and patient access.