Market Access requires a holistic approachJan 15, 2021
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 AxTalix
Complex reimbursement process
Tops: “The decision-making on the price and reimbursement of innovative medicines is often complicated by a lack of mature data or the correct comparator in the studies and uncertainty about patient numbers. This makes it difficult for the government 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 production and development. The challenges are manifold: finding the right and enough patients to include in the studies and endpoints that are difficult to establish in the short term. At the same time, 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 upon solutions. Due to the high workload, companies might be confronted with a lack of personnel and resources to carry out this properly in critical moments, 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 medical / scientific and economic expertise, is deployed on both the preparation, implementation and aftercare of the entire repayment process, including early access programs, real-world evidence data collection and complete file support.
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