Around The World in HTAs: The Netherlands – 5 Routes for New Tech

The Dutch health system

Three separate coverage schemes form the basis of the Dutch health system that together provide broad universal coverage. First, competing health insurers administer a social health insurance system for curative care. This scheme mandates all residents to purchase insurance policies that cover a defined benefits package set by the government. The set covers primary care, all specialist care, pharmaceuticals, medical devices, adult mental health care, some allied care services, and community nursing. In addition to statutory coverage, most (>80%) of the population purchases supplementary voluntary insurance covering a range of services, incl. dental care, eyeglasses and lenses, and physiotherapy.

The second scheme is a single-payer social insurance scheme for long-term care, carried out by special long-term care administrators at the behest of the central government.

The third scheme is a tax-funded social care scheme implemented by the approximately 400 municipalities and includes social support services, youth care, and public health services. The out-of-pocket spending in the Netherlands stands well below the EU average. A large share of the out-of-pocket expenditure comes from the mandatory deductible, which requires patients to pay a minimum amount (€385 in 2023) before the insurer begins to cover services. In addition, consumers may pay a voluntary deductible (max. €500 in 2023) on top of the mandatory deductible, in exchange for a lower monthly premium. For more details, please see State of Health in the EU: The Netherlands, Country Health Profile 2021.

Assessment of pharmaceuticals in the Netherlands

There are two assessment procedures for outpatient pharmaceuticals in the Netherlands:

• Procedures to allow entry onto the Dutch market: these procedures take place via the Medicines Evaluation Board (MEB). In doing so, the MEB primarily looks at the balance between efficacy and risks;
• Procedures to become eligible for reimbursement within the framework of the insured standard health care benefits package. Whether a pharmaceutical product is eligible for reimbursement is determined by four criteria: necessity, effectiveness, cost-effectiveness, and feasibility. All relevant facts, positions and interests are collected and weighted through a deliberative process. The decision on inclusion is made by the Minister of Health, Welfare and Sports, who can ask the National Health Care Institute for advice.

These are separate procedures that each have their own assessment criteria.

Roadmaps for new health technologies in the Netherlands

As part of the value chain of MedTech in the Netherlands, five roadmaps have been identified. Each of the roadmaps is characterised by its main actor:

1. Consumer route

The consumer route is applicable for technologies directly offered to and paid for by the public (i.e., consumer or patient). There is no reimbursement required since the technology is financially affordable. Healthcare insurers may be interested in including the technology as part of the supplementary insurance.

The technology is valued by the public for its solution capability of a recognisable health problem. Typically, these technologies focus on wellness or ease/ comfort. It Is important for producers of these technologies to collect and share experiences from users, opinions from experts, and certificates which confirm the technology meets certain standards.

The most important actors are consumer/ patient; care provider, patient association (for promotion of technology); and pharmacy or drugstore (for distribution of technology).

2. Provider route

The provider route is applicable when a technology delivers direct value to the healthcare provider, for example because it improves the efficiency of healthcare delivery, creates a competitive advantage, or enhances a desired image. Healthcare providers will invest or pay for such technology, leaving the health insurer out of this route.

To convince a healthcare provider to buy the technology, they have to be convinced by means of a powerful vision on how to solve recognisable problems, preferably in combination with a well-founded business case for the proposed solution. It is advised to co-create these kinds of technologies since this will promote recognition and acceptance among the target group. (1)

The most important actors are healthcare organisations; healthcare providers; supporting services; and patients.

3. Municipality route

The municipality route is relevant for technologies that support the self-reliance of clients, enable clients to stay longer at home, improve the well-being of clients, support informal caregivers, or control costs for municipalities.

Each municipality divides tasks in its own way, making different choices, from direct procurement by the municipality, procurement through one or more care providers, to facilitating procurement through welfare organisations. It is important to consider beforehand how a technology will be purchased. Municipalities often want to provide as much customisation as possible and cooperate with local parties.

To convince a municipality to buy the technology, robust and convincing user research preferably in combination with a well-founded business case is needed.

The most important actors are healthcare provider; patients and patient associations; municipalities; and welfare organisations.

4. Insurer route

The insurer route is applicable when the technology replaces existing care and will lead to cost savings.  The content of health care remains unchanged by the technology, only the form in which health care is provided will change. By adopting the new technology, health care becomes, for example, easier to access or is offered in a more efficient way.

Health insurers will request data that shows a reduction of the loss ratio by substituting high-cost health care with lower cost technology and/or by a lower volume of health care services within a period of less than 3 years.

If an innovation or application does not fit within existing healthcare performances (for example due to limitations in the description or tariffs), the healthcare provider and healthcare insurer can submit an application to the Dutch Healthcare Authority (NZa). NZa can adjust a performance or draw up a temporary performance (innovation policy rules). If necessary, an application then receives time to prove itself.

For technologies under this route, the important actors are the health care provider; patient and patient association; professional associations; health care insurer, and NZa.

5. Government route

This route applies for technologies that result in the provision of health care that so far has been non-existing or not reimbursed. This route shows similarities with the insurer route (#4). However, in the government route, a new performance will almost always have to be requested from NZa. The technology then receives a certain period of time to prove itself before it will be considered for inclusion in the basic insurance package. This route is often complex, costly, and time-consuming.

In addition to the information required in route #4, information will need to meet the criteria of the Healthcare Institute (ZIN), including safety, (cost-) effectiveness, and societal business case.

The most important actors under this route are healthcare providers; professional associations; patient and patient associations; health insurers; NZa and ZIN.

Current challenges

An interesting development between Belgium, the Netherlands, Luxembourg, Austria and Ireland is the BeNeLuxA initiative, which aims to improve collaboration on pharmaceutical policy and procurement by means of horizon scanning, HTA, information sharing and policy exchange, and pricing and reimbursement.

Following a feasibility study ‘Horizonscan MedTech’, a study is being performed to explore the application of horizon scanning as an instrument for obtaining up-to-date information on new technologies. It is interesting to see whether and how the Dutch horizon scanning will exchange information with EUDAMED.

From 2021 to 2024, the Netherlands Organisation for Health Research and Development (ZonMw) supports research to further develop and make available HTA research designs, analytical techniques, and outcomes measures for existing and new technologies to collect data for decision-making regarding appropriate use, efficient procurement, and management of the insurance package.

Next steps for the Dutch HTA

The Dutch government aspires to broaden the systematic application of full HTA towards other types of health care than outpatient pharmaceuticals to optimise the content of the basic insurance package. Where the current use of HTA fits outpatient pharmaceuticals well, this will be different for other kind of health technologies. Broadening the systematic application of HTA in the Netherlands requires creating a suitable regulatory and policy framework as well as developing specific methodologies to be able to perform HTA in particular circumstances.