Stakeholders' experiences with a clinician-led access programme linking evidence generation and reimbursement for precision cancer treatments: the drug access protocol in the Netherlands.

BACKGROUND AND PURPOSE: In the current landscape of tumour-agnostic oncology drugs receiving European Medicines Agency (EMA) authorisation, Health Technology Assessment (HTA) bodies face challenges in assessing these innovative drugs. Due to these products' non-randomised, single-arm nature, uncertainty exists regarding their real-world benefit. In the Netherlands, the Drug Access Protocol (DAP), a programme developed by oncologists, insurers and the healthcare public institute, aims to provide an innovative solution to address this uncertainty. This study aims to investigate the key characteristics, enablers and challenges of the programme by exploring stakeholders' perceptions. Patient/material and methods: A qualitative, semi-structured interview study was conducted. A supporting interview guide was drafted using available literature and a flowchart figure to illustrate the process. Interviews were conducted with market authorisation holders (MAHs) who participated in the programme, the insurer, the DAP study management and the DAP's governance committee. Recorded interviews were transcribed, pseudonymised and subsequently coded using NVivo software. Inductive thematic analysis was used to identify common themes, enablers and challenges for participating in the programme.

RESULTS: In total, eight organisations were interviewed. Although MAHs indicated several enablers (e.g. providing patient access, collecting real-world data), several challenges (e.g. the lack of transparency) lead to questions regarding the feasibility of the programme. Health insurers acknowledge these outcomes and expect products that obtain regular reimbursement to serve as an example.

INTERPRETATION: As the Drug Access Protocol may be a promising solution to mitigate uncertainties for healthcare decision-makers, implementation challenges can hamper its feasibility. Addressing these challenges could realise the potential of such programmes.