Market Access and price and reimbursement application

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

Price and reimbursement applications require a variety of information

The sale and reimbursement of outpatient medicinal products are strictly regulated. Medicines require marketing authorisations (MA) in order to be sold. For this, a manufacturer must demonstrate that a product is efficient, safe, and of acceptable quality.  To bring the medicine within reach of most consumers, the marketing authorisation is not enough.  With an MA alone, consumers must pay the entire cost of the medicine. For wider access, most products also need to have a reimbursement status.

In Finland, the Pharmaceuticals Pricing Board (PPB) is the authority that makes reimbursement decisions. The PPB objectively determines the price level at which the medicinal product can be included in the reimbursement system with public funding. Preparation 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. When a new active substance or a significant extension of the reimbursement status is concerned, the application must be accompanied by a health economic assessment. 

A high-quality price and reimbursement application demonstrates value

The price and reimbursement application addresses the product’s impacts on treatment, the state budget, and the market. These aspects are meaningful for both individuals and society; 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 society. The evidence is compiled from numerous sources – national registers, clinical data, published data, and other sources of real-world data. It is analysed, studied, modelled, and interpreted.

There are important benefits to a successful application process: patients have access to medicinal products with demonstrated cost-effectiveness and positive societal impacts. This access to effective medications can have an enormous positive effect on patients’ quality of life. At ESiOR, this motivates us to do better every day.

ESiOR on your Team

Are you looking for expert assistance in navigating the complex world of market access and pricing for your healthcare product? At ESiOR, our team of seasoned professionals have a proven track record of successfully navigating the market access landscape and securing favorable pricing and reimbursement for our clients. With extensive experience in a wide range of therapeutic areas, ESiOR is your go-to partner for achieving commercial success in the healthcare sector.