At the beginning of August 2019, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) has published an overview of the procedures for the conditional entry into the Basic Insurance Package – the instrument introduced by the Minister of Health, Welfare, and Sport (Volksgezondheid, Welzijn en Sport, VWS). Conditional entry applies to new and existing forms of health care, whereby the condition is that data must be collected on effectiveness and cost-effectiveness. These data can eventually be used to decide on permanent entry into the package, termination of the – conditional – entry, or advising the Minister on removal from the package.
The process consists of the following phases:
- Phase 0 – The opportunity to submit a dossier for the conditional admission
- Phase 1 – The assessment of the dossier by ZIN and the Dutch Organisation for Health Research and Development (De Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie, ZonMw). The preliminary approval is not given by the Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport, VWS) yet
- Phase 2 – The agreement development process is initiated; the assessment of the agreement by ZIN is conducted. The request for final approval is sent to VWS
- Phase 3 – Start of the main effectiveness and cost-effectiveness study for the conditionally authorized intervention, that approximately lasts about 3.5 years
- Phase 4 - Before the end of the conditional entry process, ZIN decides whether the intervention meets 'the state of science and practice' or not. Based on this, further information regarding its inclusion into the basic package is provided
Finally, the forms of health care included in the Basic Insurance Package in a framework of the conditional are reimbursed for a certain period in the basic package.
The applications for procedures and medical devices are in the following phases:
- Heated intraperitoneal chemotherapy (HIPEC) added to primary debulking surgery in patients with stage III ovarian cancer is in phase 2
- GAG therapy in patients with bladder pain syndrome (BPD) with Hunnian lesions is in phase 1
The overview is available in Dutch here.
Find the details about the scheme in Dutch here.
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