The District Court of The Hague (Rechtbank Den Haag) has rejected Novartis's attempt to force the Dutch government to reopen price negotiations for lutetium (177Lu) vipivotide tetraxetan, Pluvicto. More broadly, the judgment supports the government's ability to set its own view of a societally acceptable price when deciding whether a high-cost medicine should enter statutory insurance.
Pluvicto is authorised for adults with progressive PSMA-positive metastatic castration-resistant prostate cancer previously treated with androgen-receptor pathway inhibition and taxane chemotherapy. It has remained in the Dutch ‘sluis’ since December 2022. The sluis temporarily excludes selected high-cost hospital medicines from the basic insurance package while the National Health Care Institute (Zorginstituut Nederland, ZIN) assesses their clinical value, cost-effectiveness and budget impact and the government can negotiate financial terms.
ZIN recommended reimbursement after a sufficient price reduction. Negotiations nevertheless ended without agreement in April 2026. Novartis then argued that the Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport, VWS) had placed excessive weight on cost-effectiveness and insufficient weight on the price already paid for an unlicensed pharmacy-prepared alternative.
The court disagreed. It found that VWS had used ZIN's advice appropriately and was entitled to decide that a higher price would create an unacceptable risk of non-cost-effective expenditure. The existing price of the pharmacy preparation did not create a price floor that the government had to recognise.
Novartis also pointed to reimbursement of Pluvicto at higher prices in neighbouring European countries. The court rejected that argument explicitly. Medicine reimbursement remains a national responsibility, it said, and countries use different criteria, healthcare systems and access arrangements. Foreign reimbursement prices therefore did not constrain the Dutch negotiating position.
The judgment fits a longer Dutch policy direction. The sluis was introduced in 2015 specifically to prevent expensive hospital medicines entering reimbursement automatically before assessment and negotiation. In November 2025, the government kept Xenpozyme, Carvykti and one Enhertu indication outside the package after negotiations failed to produce what it considered acceptable prices. Dutch authorities have also developed formal principles for determining societally acceptable expenditure on medicines.
The Netherlands has gone further in exceptional cases. The Authority for Consumers and Markets (Autoriteit Consument & Markt, ACM) fined Leadiant for abusing a dominant position by charging an excessive price for CDCA-Leadiant. The price had risen from about €46 to almost €14,000 per pack. After appeal procedures, a €17.044 million fine was upheld by the District Court of Rotterdam in 2025. That was competition-law enforcement rather than reimbursement negotiation, but it illustrates the broader willingness of Dutch authorities to challenge pharmaceutical prices.
The Netherlands is not alone in taking a firm value-based position. Denmark and Norway regularly decline or defer medicines where negotiated prices remain disproportionate to expected benefit, while England uses NICE cost-effectiveness assessment and NHS commercial negotiation to achieve a price compatible with reimbursement. Italy and the UK have also brought competition-law cases concerning excessive pharmaceutical pricing.
The Dutch judgment nevertheless provides unusually clear judicial support for payer discretion. It indicates that a manufacturer cannot require the state to converge on prices accepted elsewhere in Europe, or treat another reimbursed treatment as a binding price benchmark.
Source: District Court of The Hague
Link: Vonnis in kort geding van 30 juli 2026 (Judgment in summary proceedings of 30 July 2026)
Date: 30 July 2026
Source: National Health Care Institute
Link: Naar maatschappelijk aanvaardbare prijzen voor dure medicijnen (Towards societally acceptable prices for expensive medicines)
Date: 15 October 2025
Source: Authority for Consumers and Markets
Link: Rechtbank bevestigt boete ACM aan Leadiant voor excessieve prijs CDCA (Court upholds ACM fine on Leadiant for excessive CDCA price)
Date: 13 February 2025
