Access to EU-Authorized Nonreimbursed Anticancer Medicines: An Explorative Survey Among Dutch Medical Oncologists.

Abstract

Purpose: Timelines for market authorization and reimbursement for anticancer medicines differ across European countries. Therefore, medical oncologists may face periods when promising anticancer medicines are not reimbursed, prompting ethical concerns about equitable access, particularly in publicly funded healthcare systems, such as the Netherlands. This study explores Dutch medical oncologists' experiences and moral perspectives regarding access to EU-authorized nonreimbursed anticancer medicines and assesses practice variation.

Methods: A survey targeted 378 Dutch medical oncologists from all hospitals to explore their experiences, perspectives, and perceived responsibilities, as well as hospital policies regarding nonreimbursed EU-authorized anticancer medicines and their opinions on out-of-pocket payments and information provision.

Findings: Responses were provided by 132 medical oncologists (response rate of 34.9%), with 104 (78.8%) reporting that they sought access to nonreimbursed medicines in the past three years for one or more patients, primarily through manufacturer-funded "free-of-charge" programs (n = 77/104; 74,0%), clinical trials referral (n = 46/104; 44.2%) or clinical trials at their own hospital (n = 45/104; 43.3%), insurance leniency (n = 45/104; 43.3%), or the Dutch Drug Access Protocol (n = 42/104; 40.4%). While 48.5% felt responsible for seeking access to nonreimbursed medicines, 40.9% did not. Respondents mentioned different hospital policies on drug access. In the past three years, 69.5% (n = 91/131) of respondents had received patient inquiries about out-of-pocket (OOP) payment, but only 3.1% (n = 4/131) had actually prescribed OOP financed medicines. Fewer than half of the respondents (44.7%; n = 59/132) informed patients about nonreimbursed treatment options. Oncologists expressed strong concerns about financial toxicity, inequities in access, and threats to solidarity-based health care.

Implications: The majority of Dutch medical oncologists encounter EU-authorized, nonreimbursed anticancer medicines and report substantial variation in related practices and ethical views. In the absence of a national access framework, availability often depends on individual physicians, leading to potential inequities. National regulation is recommended to ensure consistent and equitable access for all patients.