Market access

The market access process is a crucial and essential component in the development of your health products. Our team of experts supports and advises you to ensure the best pricing and reimbursement criteria for your health products, with regard to your clinical studies and public health issues.

Development and implementation of the market access strategy.

Preparation and submission
for derogaroty accesses.

Market access strategies, reimbursement and pricing

Our support for your market access strategies includes developing and validating pricing strategies, and highlighting the innovation and therapeutic interest of your health products. We help you define the recommended therapeutic strategy and advise you on the choice of comparator, optimizing strategies in collaboration with recognized experts when the complexities of the case so require.

Collaboration with stakeholders & interactions with health authorities

We take care of the preparation and drafting of Transparency files for registration, renewal and/or extension of indication (Note of Technical Interest, NIT), as well as price files (Note of Interest Economic). The submission of these files to the competent authorities and the interaction with the various stakeholders are also managed by our team, ensuring an integrated and efficient approach.

By working in close collaboration with all stakeholders – healthcare professionals, patient associations and regulatory authorities – we ensure market access strategies aligned with the needs of the market. We negotiate pricing and reimbursement conditions, highlighting the clinical, economic and public health benefits of your products.

Derogatory access

In the context of derogatory access strategies, such as Early Access Authorization and Compassionate Access Authorization, we offer our expertise in drafting and submitting your files to the competent authorities. Our team handles the technical aspects of early access application, including PUT-RD drafting, data collection and analysis. We also provide ongoing support to your teams on market access strategies and the latest regulations, to help you manage market challenges effectively.

Economic and clinical impact assessment

We help you optimize your products’ market positioning. This includes competitive analysis and assessment of potential barriers to market entry.

When necessary, Axelys Santé also carries out assessments of the economic and clinical impact of your products to argue for the added value of your healthcare products.

By choosing Axelys Santé for your market access needs, you are opting for an expert partner who not only understands the regulatory and commercial challenges of the healthcare sector but also helps you successfully overcome them.

To learn more about how we can help your business successfully achieve its marketing goals, feel free to view our services and contact our team of experts directly.