Managed Entry Agreement

The cost of hospital treatment has increased rapidly in Finland. In 2017, medaffcon conducted a survey to understand what methods other than flat-rate rebates are used to facilitate access to hospital care. The survey focused on entry-level manague agreements, which provide access to patented drugs made over the past two years (2015-2017). During the interviews, manufacturers indicated that they were routinely invited by the EMA to collect additional data on TCR, safety studies or patient registries as part of conditional marketing authorizations. However, these studies did not necessarily provide the specific data that HTA`s national agencies and payers are looking for. A closer reconciliation of evidence-based requirements after approval between HTA services and regulators could involve improved data development in flexible pricing agreements. If there were an opportunity to do so, many companies would like to explore these opportunities, as they could allow value-based pricing. The entry-level agreements administered – taxonomy, which was used during interviews. Despite these challenges, there are also examples of a successful and comprehensive use of results-based entry-level agreements. Italy has invested in comprehensive data collection systems on pharmaceutical use in clinical practices facilitating post-market surveillance and in different types of payment models (Pani, 2016).

Several payers stated in interviews that they were considering or had begun to use paid models (a subtype of a results-based market entry agreement) for certain products that have been introduced in recent years or have begun to use performance payment models (a subtype of the results-based entry agreement agreement). In interviews, producers indicated that they were willing to also consider the use of results-based agreements. In the Netherlands, since 2012, financial arrangements have been in place for extramural care under adverse conditions or where the budgetary impact is above average and the market situation is unable to cope with high prices or high expenditures, for example due to the absence of competing drugs.