More price negotiations on new expensive drugs in the Netherlands

On the 24th of January 2023, the Dutch Minister of Health, Welfare and Sport Ernst Kuipers has decided to adapt the rules for admission of expensive (intramural) medicines to the basic health insurance package as from 1st July 2023. He is doing this by tightening the so-called lock criteria.

Since 2015, the Netherlands has had a ‘lock procedure’ for expensive (intramural) medicines. Since 1 July 2018, the criteria for using the lock procedure have been legally enshrined by an amendment to the Healthcare Insurance Decree. Zorginstituut Nederland (ZIN) advises the Minister of Health, Welfare and Sport not to allow an expensive intramural medicine to automatically enter the insured package after approval by the EMA but to place it ‘in the lock’ if the estimated expenditure for the treatment of one or more new indications with the medicine in question exceeds € 40 million per year throughout the Netherlands.  

The second lock criterium is based on the costs per patient per year. Drugs where the expected cost of dispensing the medicine to treat a new indication is €50,000 or more per patient per year and the expected total cost of the dispensations is €10 million or more per year are also considered as lock candidates. 

The Healthcare institute evaluates every 6 months the drugs that may fulfil the lock criteria. It has identified the following drugs for the first half of 2023 to potentially be placed into the lock: etranacogenic dezaparvovec (severe haemophilia B), ublituximab/Ublyxi (recurrent multiple sclerosis), tislelizumab (first-line non-small cell lung cancer; second-line non-small cell lung cancer second-line oesophageal cancer), mirikizumab (moderate to severe ulcerative colitis), pegunigalsidase alfa (Fabry disease), tremelimumab/Imjudo (metastatic non-small-cell lung cancer liver cancer), glofitamab (third-line relapsing/refractory B-cell non-Hodgkin’s lymphoma/lymphoma), niraparib/abiraterone (metastatic castration-resistant prostate cancer), belantamab mafodotin/Blenrep (third-line multiple myeloma/Kahler’s disease) cabozantinib/Cabometyx (second- or third-line metastatic non-small cell lung cancer in combination with atezolizumab) and dostarlimab/Jemperli (stage 3 or 4 ovarian cancer). This list of therapies will increase because of the implementation of new criteria. 

As from July 1st 2023, Minister Kuipers has decided to lower the expenditure threshold to € 20 million or more. The other lock criterion remains unchanged. This new criterium will be applied to all new intramural medicines or new indications of existing intramural medicines for which from 5 June 2023 onwards, a marketing authorisation will be issued by the European Commission or a protocol for use ‘off-label’ will be established . 

Important note 

In his letter to the Second chamber, the minister also announced that he is in discussion with ZIN on how the inclusion of expensive” extramural drugs in the basic health insurance benefit package can be better aligned with the criteria of intramural drugs. This would mean using the macro cost impact instead of the currently used budget impact. The macro cost impact looks at the expected gross expenditure on a drug, while budget impact only looks at the additional costs and includes, for example, substitution with other drugs. Although changes on these criteria have not been decided yet, it seems likely to become reality in the course of 2023. 

More information can be found on the following link: 


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