In Sweden, we have the value-based approach, which means that the TLV uses health technology assessment as an important tool on which to base our decisions. When we assess a new drug, we take into account both therapeutic effects and, of course, the cost of using this drug in clinical practice. We also take into account the severity of the disease and if there are any available alternatives already.
The development, where the new pharmaceuticals come to market with more uncertain data, is really a challenge when it comes to making these assessments in early phases. That's why we have developed this national platform together with the pharma companies and the county councils. Within these so-called three-party negotiations, we develop tools in order to make an early assessment, reimburse the product to a small patient group, and link that to a data collection, real-world data, as a complement to RCTs, randomized control trials.
Our ambition, with this real-world data as a basis, is to make a follow-up, and hopefully the drug delivers as much as it promises and we can take that data as a basis for expanding the patient population and making the product available and reimbursed for a larger patient group. I wouldn't say that we have solved this problem, but I think we have started work that tries to meet these challenges in the collaborative framework.