Out-Law News 1 min. read
10 Feb 2023, 4:50 pm
Pharmaceutical companies active in the Netherlands should prepare for tough negotiations with the Dutch government on the pricing of innovative new treatments following a change in policy designed to curb healthcare costs in the country, according to experts in life sciences.
Amsterdam-based Judith Krens and Maud de Haas of Pinsent Masons were commenting after the Dutch health minister altered a financial threshold that determines whether medicines are automatically made available to patients in the Netherlands or not. The change will apply to decisions from 1 July 2023.
Since 2015, the Netherlands has applied a so-called ‘lock’ system whereby certain new medicines are withheld from general use until the Dutch Health Care Institute has examined their effectiveness relative to their price. There are two thresholds for entering the lock system – where the medicines would cost more than €40 million a year for one or more new treatments nationwide, or where the per-patient cost exceeds €50,000 a year and the total cost would exceed €10m annually. The Dutch government has estimated that it saved €383m in 2020 as a result of the lock system in place.
However, Dutch politicians have expressed concern about the rising cost of medicines and the potential impact on constrained healthcare budgets. As part of the coalition agreement drawn up when the multi-party government in the Netherlands was formed in early 2022, the government committed to tightening controls on the rising costs of medicines.
Initially the government considered amending the €40m threshold down to €10m, but researchers highlighted how this would severely impact on availability of medicines for patients in the Netherlands – academics last year highlighted how the existing lock system was impacting availability of so-called ‘orphan’ drugs, which are medicines earmarked for treating rare diseases.
Last month, health minister Ernst Kuipers wrote to the Dutch parliament (7-page / 376KB PDF) to confirm that a revised threshold limit of €20m would apply instead, beginning from 1 July 2023. No changes are being made to the second €50,000 per-patient / €10m total threshold.
Judith Krens said: “The lock has been introduced in order to keep healthcare costs low. With the reduction initially proposed, this would have meant that a lot more medicines would fall within the lock and would therefore not be automatically admitted to the basic healthcare package, which could have negative consequences for a lot of people. Even with the deviation of minister Kuipers, there’s still a risk that people will wait a long time for their new treatment.”
Maud de Haas said: “Minister Kuipers predicts there will be more price negotiations on new expensive drugs as a result of the policy change. In doing so, he hopes it will reduce the cost of new expensive medicines.”