To understand the implementation and impact of the Netherland’s lock system on high-cost drug pricing and patient access in the oncology space.

The analysis plans to employ a pragmatic secondary research methodology to assess eligible lock candidates and drugs locked since the introduction of the system, and the effect on oncology drugs in particular. Additionally, an in-depth case study analysis has been performed to illustrate lock process considerations, decision drivers, pricing, and patient access impact.

Historically, if a hospital drug complied with “established medical science and medical practice,” it was automatically reimbursed by the Ministry of Health, Welfare and Sports, resulting in almost all hospital drugs being publicly funded regardless of cost. Since the introduction of the lock system in mid-2018, the Dutch National Health Care Institute (ZIN) has directed for 21 oncology treatments to be put on lock (i.e., not receive reimbursement until the completion of the lock assessment). ZIN will often ask manufacturers for additional information to determine budget impact more accurately, such as economic model assumptions, methodology, and epidemiology data. Lock products tended to achieve broad patient access through full reimbursement after mandatory public and confidential price discounts, while some are funded as “add-ons” by a separate fund outside of the general hospital budget, including alectinib, binimetinib, and encorafenib. Separately, several oncology products were indicated for lock and were exempt from the process after providing more accurate patient population estimations to demonstrate a lower budget impact below the lock threshold.

Since the Netherlands introduced the lock system, the policy is adding scrutiny on drugs with high budget impacts that exceed >€40 million a year or >€10 million a year and treatment costs per patient >€50,000. ZIN started to extract mandatory and confidential discounts, at the trade-off of delayed broad patient access for the duration of the lock.