Market Access and price and reimbursement application

’Market Access’ can generally refer to a product’s access to market. In the health sector, however, Market Access usually refers to bringing and keeping medicinal or medical products or devices on the market and available for patients. Market Access in its entirety is vast and includes numerous aspects, such as whether the product is intended for outpatient or inpatient care. One of the most central tasks in a Market Access process of outpatient products is to determine a reasonable wholesale price and to apply for reimbursement status. Inpatient products’ Market Access procedures, on the other hand, require public tendering and possible risk-sharing agreements, for instance. Here we focus on the core of outpatient products’ Market Access: the price and reimbursement application.

Price and reimbursement application necessitates varied information

The sale and reimbursement of outpatient medicinal products are strictly regulated and thus a medicine needs a marketing authorisation in order to be sold. The product has to be efficient, safe, and of acceptable quality to meet the requirements of the marketing authorisation. The authorisation and taking the product to market are not enough to bring it within the reach of most consumers. If the medicine only had a marketing authorisation, its price would have to be paid solely by the consumer. For this reason, most products also need to have a reimbursement status.

In Finland, the Pharmaceuticals Pricing Board is the authority that objectively determines the price level at which the medicinal product can be included in the reimbursement system with public funding. The composition of the price and reimbursement application requires comprehensive information about the product: its therapeutic value, position in the national clinical practice, and its economic impacts. The application must be accompanied by a health economic assessment when it concerns a new active substance or a significant extension of the reimbursement status.

High quality price and reimbursement application demonstrates value

Price and reimbursement application addresses the product’s impacts in treatment, the state budget, and the market. These aspects are meaningful for both individuals and the society as the reimbursement decision can affect tens of thousands, even hundreds of thousands of people in Finland alone. Therefore, the application must demonstrate the value for patients, health, and the society. The evidence is compiled from numerous sources and it is analysed, studied, modelled, and interpreted.

A successful application process serves in many ways: the patients have access to examined medicinal products whose cost-effectiveness has been demonstrated and whose wider impacts on the society and its budget have been assessed. A successful process can have an enormous positive effect on patients’ quality of life. That motivates us at ESiOR to do better every day.


Further information: Taru Hallinen