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Medical Device Reimbursement in the Netherlands.

Identification and application for the relevant codes in the Dutch Healthcare Authority's Policy for of the Performance and Tariffs for Specialist Medical Care and inclusion in the Dutch DOT case mix system.

Reimbursement Landscape in the Netherlands

The purpose of this step is to understand the current reimbursement environment in the Netherlands, relevant for your medical device. To do so, we will:

  • Clarify the relevant type of coding systems, such as the Dutch Healthcare Authority's (Nederlandse Zorgautoriteit) Policy for of the Performance and Tariffs for Specialist Medical Care or the DRG like DOT case mix system. Identify relevant coverage policies, under the mandatory national health insurance scheme (Zorgverzekeringswet, Zvw) and supplementary benefits packages. Indicate the assigned payment rates in different reimbursement catalogs and Segment A/B payment rates of DOT Care Products, applicable for the specific device or to any comparable products.
  • Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms (e.g., an application for an adjustment to the DTC system or an application for conditional reimbursement from the Dutch Healthcare Authority.
  • Identify the main decision makers, lay out the typical path towards obtaining reimbursement under the national health insurance scheme (Zvw) or supplementary benefits packages, including milestones and typical timelines and provide an initial reimbursement strategy for the device in the Netherlands.

Reimbursement Planning for Dutch Decision Makers

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for Dutch decision makers, such as the Minister of Health, Welfare and Sport (VWS), the Dutch Healthcare Authority, The Netherlands Organization for Health Research and Development (ZonMw) or the Netherlands Health Insurers Association (ZN). This includes the development of:

  • Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers (healthcare providers, Dutch health insurance companies) and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of Dutch decision makers. May identify specific outcomes data that should be added to future clinical study protocols.
  • Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
  • Decision Makers' Feedback: Conduct interviews with the identified Dutch decision makers, utilizing Mediclever's network of local clinicians, payer representatives and other stakeholders, to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.

Implementation

Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:

  • Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
  • Reimbursement Applications: Work with the relevant medical societies to apply for new reimbursement mechanisms, such as an application for an adjustment to the DTC system or an application for inclusion in the Policy for of the Performance and Tariffs for Specialist Medical Care.
  • Pilot Projects: Collaborate with healthcare providers and insurers to apply to the NZa for a pilot project of up to 3 years, in accordance with the Innovation Policy of the Dutch Healthcare Authority.
  • Other Funding Options: Commission a health technology assessment from the Institute for Medical Technology Assessment (iMTA) or other reputable entities, or apply to the Dutch Healthcare Authority for conditional reimbursement (provided an approval by the Ministry of Health).

Flat fees, concrete timelines, and support through your entire reimbursement process

Local Presence and Experience in:

  • Sweden
  • Austria
  • Denmark
  • Other
  • Australia
  • Israel