Market Access requires a holistic approach

Jan 15, 2021
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Obtaining a price and reimbursement is often quite a challenge for innovative medicines. This requires a holistic approach by a cross-functional team and an open dialogue with all relevant stakeholders.

More explanation by Sven Tops and Frank Vanderdonck, Managing Partners at AxTalis

Complex reimbursement process

Tops: “The decision-making on the price and reimbursement of innovative medicines is often complicated by a lack of mature data, the correct comparator in the clinical trials and uncertainty about patient numbers. As a consequence, it is a challenge for authorities to determine the added value and budget impact. We therefore speak of clinical and economic uncertainties. In Belgium, this is solved by allowing temporary reimbursements pending confirmation of clinical value in real life."

Vanderdonck: “Companies also have to deal with an increasing complexity in research and development. There are multiple challenges like finding enough patients with the right profile to include in the studies, or endpoints that are difficult to measure in a short amount of time. In parallel, there is a high budget pressure and a great urgency for the patient. "

Additional cross-functional team

Tops: “We believe pharmaceutical companies should engage in a dialogue with the government from the early stages of development to discuss the identified uncertainties and agree on solutions. Companies may be confronted with high workload and a lack of personnel or resources, preventing them to approach this appropriately, making external help necessary. Axtalis was specifically established to provide companies with this support by providing a "dedicated cross-functional team".

Vanderdonck: “This team, which holds both medical/scientific and economic expertise, tackles the preparation, implementation and aftercare of the entire reimbursement process, including early access programs, real-world evidence data collection and complete support for the dossiers."