Achieving national market access for hospital pharmaceuticals
Market access for hospital pharmaceuticals has been driven by local decision-makers and tender processes. In recent years, however, a number of new national decision-making processes for hospital products have emerged in the Nordic markets.
In Denmark, all product for hospital use need to be assessed by the Medicine Council (MC). The Council assesses the added clinical value of a product in a Danish context taking advice from a panel of clinical experts and from the national procurement organization. As a company you will need to apply to the MC to initiate the assessment and will asked to provide clinical documentation and economic analyses. In Denmark no established criteria are defined for orphan/ultra-orphan diseases and no clear willingness to pay is defined for these diseases.
In Sweden, TLV is responsible for establishing health economic documentation but does not have decision-making authority for hospital products. The decision on which hospital products TLV should evaluate is made by NT rådet - a council appointed by the County Councils’ directors for Health and Health Care. This council is also responsible for making the final national recommendation based on the TLV assessment and health economic evaluation. In Sweden, a higher willingness to pay (WTP) is accepted for orphan/ultra-orphan diseases.
Since 2017 all new products within specialist health services should be assessed before they can be prescribed in Norway. Manufacturers of the relevant technology will be asked to submit documentation in the form of a single technology assessment (STA). For pharmaceuticals the STA is evaluated by the Norwegian Medicines Agency. Based on the STA, the forum of regional health authority directors (Beslutningsforum) will make the national recommendation on use of a technology in the Norwegian specialist health services. There is a higher willingness to pay (WTP) for products meeting prespecified criteria (the criteria define that the disease should be very severe and ultra-orphan and that the product should be highly effective).
In Finland there is no national market access process for hospital products. FIMEA, however, will select technologies for assessment as a guidance for local decision makers.
When launching a product in Norway, Sweden and Finland, an option is available to apply for a joint assessment in all three markets via FINOSE – a joint project across SLV, TLV and FIMEA.
From the start we have supported manufactures of new hospital products in compiling the documentation and performing economic analyses to meet the requirements defined for these different market access processes. We are in the best possible position to support you in finding with best way forward for your product.