By Maria Wouters Rentero, Senior Account Director, Incisive Health
“What is the cost of inaction when policy, access, and pricing are managed in silos?”
This is not just a theoretical question; it is something that we are facing every day across Europe. As we work supporting clients navigate the European policy landscape, we need to understand what these shifts mean for companies and patients, and how to act on them. New frameworks for pricing, reimbursement, and health technology assessment (HTA) are reshaping the policy landscape, and the choices we make now will determine how quickly and how widely patients can access the treatments they need and benefit from innovation.
Europe’s access landscape is moving fast
We are at the crossover of some of the biggest changes in years. The new EU HTA Regulation brings joint clinical assessments for oncology and advanced therapy medicinal products (ATMPs), directly impacting how soon patients across Europe can receive innovative treatments. For companies, this new framework means aligning evidence strategy earlier and across multiple markets; for patients, it translates into the potential for faster and fairer access across Europe.
At the same time, Member States are putting affordability and value under the spotlight: Spain has reshaped its HTA process with a new Royal Decree, France is expanding its early access framework, and Germany is debating the future of AMNOG.
Together, these changes clearly show that demonstrating the value of innovation is no longer enough: it must be showed earlier on and more clearly to the different stakeholders involved in the process. This will shape how quickly and widely patients can benefit from new therapies.
Policy as a lever, not just a constraint
Too often, policy is seen as something to “manage”. But when a step back is taken, policy can also be a powerful enabler.
It can open the door to earlier dialogue with decision-makers, align evidence requirements across countries, and create a space for new access models that give patients faster access while balancing affordability concerns.
Working strategically and holistically, can create a more predictable environment for companies, reduce duplication for regulators, and ultimately speed up patient access.
When policy, access, and value strategy are aligned, we can go beyond reacting to a legislation or a policy reform: we can work to create one that is predictable, innovation-friendly, and focused on improving patients’ lives.
Breaking the silos
One of the biggest opportunities we see is to look at policy, access, and pricing through a combined approach. When these considerations come together early, during clinical development and launch planning, the conversation shifts from “how do we adapt?” to “how do we lead?”.
Bringing policy intelligence into the development, evidence strategy, and launch planning early helps avoid surprises and paves the way to early and fair access to treatments. This approach turns policy from a constraint into a lever, allowing companies to anticipate requirements, engage with decision-makers proactively, and co-create solutions that benefit both health systems and patients.
An integrated approach is where the real value lies. This is how we move from firefighting to foresight: building bridges between science and health systems that are strong enough to carry innovation to patients in every market, and flexible enough to respond to future needs.
Looking ahead
Policy is not an obstacle to overcome. It is a tool we can use to shape faster, fairer, and more sustainable access for patients.
The organisations that will thrive will be the ones that connect policy, access, and evidence planning early, using that integration to shape the environment rather than waiting for it to shape them.
The real question is this: are companies, regulators, policymakers, and payers willing to connect the dots now, across policy, access, and evidence, to make faster, fairer patient access a reality? What we do today will decide whether tomorrow’s innovations reach the patients who need them most, and whether health systems can sustain it.
Interested in hearing more? Connect with us here.