A national protocol to facilitate access to new targeted anti-cancer drugs that are not yet eligible for reimbursement in the Netherlands pending additional data, and in doing so to collect data on the effectiveness and safety of these drugs.
The primary aim of the study is to give cancer patients access to promising drugs that have already been studied for their specific tumour type in several research phases and have shown positive results, but which for various reasons are not yet available on the Dutch market. Giving patients access to these new drugs makes it possible to collect data on the effect and safety of the treatment at the same time. These additional data can support the eventual admission of the drug to the Dutch market.
Target group: patients with cancer for whom no satisfactory treatment options are available within the Dutch healthcare system and who, based on tumour type or specific characteristics in the tumour DNA, are eligible for a drug available within the Drug Access Protocol.
Patients with solid tumours and a predefined, potentially actionable tumour profile (histological or molecular) are treated within the protocol with a drug that is not yet available to patients in the Netherlands but for which the registration process is under way. Drugs for which FDA/EMA registration has been requested, or which are awaiting a positive reimbursement decision from the Dutch government, are included in the protocol. As soon as the treating doctor registers a patient with the study team, their data are collected systematically, together with data from other patients treated by their own doctors with the same not-yet-reimbursed drug. Donating a pre-treatment tumour biopsy is optional; it can be used later for biomarker analysis. If the patient consents to take part, they are followed for standard toxicity and efficacy outcomes, including tumour response, progression-free and overall survival and duration of study treatment.
In this study we treat patients with targeted anti-cancer drugs based on the characteristics of their cancer cells. These drugs are in principle not yet approved, but have already been studied extensively. Several Dutch hospitals take part. When a patient wishes to take part, the treating doctor first checks (through physical and additional examinations) whether they meet all conditions for safe treatment with a specific drug. If so, treatment can start. What it looks like depends on which drug has been selected based on the tumour-cell characteristics. The effect is checked regularly during treatment. Patients can in principle continue the study drugs for as long as they appear to benefit from them.
Overview of the drugs within the Drug Access Protocol, with the reimbursement route and the participating centres and their local principal investigators for each drug (as of April 2023). Download the overview (pdf, Dutch)
Reimbursement: Individualised reimbursement
Reimbursement: Free of charge (no reimbursement agreement with Dutch Health Insurers for this drug)
Reimbursement: Individualised reimbursement
Reimbursement: Conditional admission (VT)
Reimbursement: Individualised reimbursement; for the correct indication, consult the specific DAP indication code in the G-Standaard
Reimbursement: Individualised reimbursement
DAP is a broadly supported initiative of NVMO, Antoni van Leeuwenhoek, the Dutch National Health Care Institute (ZiNL) and Dutch Health Insurers (ZN). Nine hospitals take part: Amsterdam UMC, Antoni van Leeuwenhoek, Erasmus MC, LUMC, Maastricht UMC+, Prinses Máxima Centrum, Radboudumc, UMC Groningen and UMC Utrecht.
The DAP design is described by Zeverijn LJ, et al. in The Lancet Oncology (2022). See also the official NVMO/NVALT protocol document.
See also the Drug Rediscovery Protocol (DRUP).
