Europe – Market Access: making the process easier and efficient
For innovative medical devices and medicines, in addition to clinical development, it is important that it is clear at an early stage of product development (1) what a possible selling price of a new technology can be and (2) whether for this price a reimbursement via regular health insurance policies or otherwise is possible. For start-up technology companies, the question of whether reimbursement is possible is all the more pressing, since such companies are often dependent on one or a few products, for which – often also for external financiers – it should be clear as quickly as possible what these products can « do in the market ». Indeed, often the value of such a company is the same as the value of the product under development.
We have developed a new service for starting technology companies as well as for bigger companies: “Early Market Access » of health technologies in order to gather an indication at an early stage of product development (pre-clinical and clinical) of (1) the possible price for a new innovative technology, (2) ) make an estimate of a possible reimbursement and (3) provide a strategy, plan and elaboration to realize a possible maximum price and reimbursement in the market.
For instance, in The Netherlands, if the new technology does not fit into an existing performance description with an appropriate remuneration (so always investigate), then apply for a new performance description and obtain a decision that reimbursement is possible. We need the NZa (Dutch Health Authority) for performance descriptions and the ZIN (Dutch Healthcare Institute) for a reimbursement decision. The ZIN states that reimbursement is possible if the new technology meets the State of Science and Practice (StWP). In the Netherlands, the shortest route for reimbursement of a new technology is to request an interpretation of the « State of Science and Practice » (StWP) by the Healthcare Institute (ZIN). If the ZIN has determined that a technology is StWP-compliant, health insurers cannot refuse reimbursement of the technology, since Dutch insured persons are entitled to treatments, the clinical effectiveness of which is established and which is endorsed by Dutch professional groups of doctors. To determine the StWP of a technology by the ZIN, it must be risk-bearing for the package and the clinical efficacy must be established. The latter is usually determined by randomized clinical trials. During this process, the application for the performance description must also be started with the NZA…