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The General Health Insurance Fund of the Czech Republic (VZP) has published a new Methodology for the Managed Entry of Innovations, Version 1.0, effective from 21 September 2026. Its aim is to establish a uniform and structured process for assessing innovations for which their clinical or system-level value, safety, economic impact, operational feasibility and an appropriate pathway for potential future funding or reimbursement need to be evaluated.

The process is intended primarily for:

• medical devices and equipment-based technologies with a digital component,
• software as a medical device,
• digital health technologies,
• telemedicine and remote monitoring,
• AI and algorithmic tools with a clinical or operational impact.

Proposals may be prepared primarily by:

• manufacturers and suppliers of health technologies,
• research and academic institutions,
• consortia comprising multiple entities, where applicable.

VZP accepts innovation proposals through two pathways:

1. Continuous submission of innovations with exceptional benefits
   VZP has already launched continuous submission of proposals for innovations with a significant impact on the economic efficiency of the public health insurance system.
   A key requirement is a demonstrable reduction in direct public health insurance costs of at least 5% within one year compared with the current situation, while maintaining or improving clinical outcomes, safety, accessibility and quality of healthcare.
   The savings must be supported by an economic analysis conducted using the Budget Impact Analysis (BIA) methodology.
   
   
2. Thematic calls
   In addition to continuous submission, VZP will also launch calls focusing on specific areas corresponding to its strategic priorities and healthcare policy.
   The areas specified include, in particular, oncological and cardiovascular diseases, diabetes and related metabolic diseases, and neurodegenerative diseases.
   Submission of proposals will generally be open for a period of three months, after which proposals submitted under the respective call will be assessed together.

What will VZP assess?

The scope of the assessment will depend on the nature and risk associated with the particular innovation. The assessment will focus primarily on clinical value and safety, value for patients, economic impact, impact on the organisation of care, regulatory, data and security readiness, and the ability to measure the outcomes of the innovation.

The process may result in direct inclusion in the reimbursement system, conditional entry, pilot testing, or rejection of the proposal. In the case of pilot testing or temporary reimbursement, the target population, measurable indicators (KPIs), data sources, financial framework and rules for continuation or termination, among other aspects, should be defined in advance.

The managed entry of innovations does not replace statutory pricing and reimbursement procedures, regulatory approval or conformity assessment, nor does it establish an automatic entitlement to reimbursement.

Description of the process according to the VZP website:

Do you need assistance in preparing supporting documentation for VZP's assessment of an innovative technology? Do not hesitate to contact us.

Pharmeca a.s. has extensive experience in health technology assessment, clinical evidence and economic analyses. Drawing on this expertise, we can assist you in preparing the supporting documentation required for the assessment of an innovation under VZP's new process.

Our knowledge, your opportunity.

The English translation was prepared using the latest available ChatGPT model.