After a few quiet decades we are now in the middle of a wave of the introduction onto the market of innovative - often expensive - medicinal products intended to treat serious diseases based on new techniques and insights.  Such medicinal products are often expensive and intended for small patient groups and are likely to have an enormous cost impact on societies. This provides for a challenge: making sure that fast access to such products is guaranteed for a socially accepted price. This challenge calls for an integrated approach both on a national and on an EU level. The Dutch Minister of Health (MoH) has presented her vision on medicinal products with a variety of measures to cope with this challenge.
 
The MoH recognizes that European cooperation is required to achieve the goal of fast access for acceptable prices in the EU Member States. The MoH will therefore use the opportunities during the EU presidency to put this topic on the agenda and to try and get many countries involved in joint negotiation strategies and information sharing - on a voluntary basis though, in order to avoid less willing EU Member States from slowing things down and recognizing that pricing and reimbursement are the exclusive competence of the EU Member States rather than of the EU itself. The MoH's ambitions go even further as she also wants to place topics on the agenda as orphan exclusivity, SPCs and other exclusivity rights that are arranged for on an EU level.
 
On a national level the MoH will introduce enhanced options for cooperation and information sharing between healthcare insurers and healthcare providers in order to create better purchasing power. Grants related to development of medicinal products will be made conditional on e.g. profit sharing or pricing structure of such new medicinal products. The MoH will recalculate reimbursement limits and introduce additional co-payments on top of those reimbursement limits. The use of biosimilars should be stimulated; if unsuccessful the MoH will consider limiting reimbursement of biologicals. The MoH will continue and further detail her policy regarding financial arrangements for expensive medicinal products with a focus on temporary exclusion of certain expensive products from hospital reimbursement.
 
We expect that the proposed measures will impact pricing and reimbursement of expensive innovative medicinal products in the Netherlands and more broadly in the European Union.
 
The MoH vision is built around the following 6 themes as summarized below:

1. New business models

It is time for new business models that also provide room for developing medicinal products that are commercially less attractive, e.g. antibiotics. An existing business model that the MoH wants to amend is the following. The Dutch government provides various grants to startup companies that develop promising new medicinal products. If such startup company is acquired by an established pharmaceutical company and the related product is successfully marketed, the government is generally not compensated for the success and subsequently has to pay for the product when provided to patients as part of the healthcare coverage. The MoH refers to this as double payment. The MoH wants to change that by imposing conditions when a grant is provided, e.g. profit sharing if a product is commercially successful or imposing a pricing structure if a product is marketed. Acquiring a biotech startup company may therefore in the future be subject to certain conditions.
 
2. Battle against high prices

The MoH does not intend to reform the dual reimbursement system (split between outpatient or extramural on the one hand and inpatient or intramural on the other hand) to one integrated system. The focus for the coming years will be mainly on intramural expensive medicinal products whereby the option to temporarily exclude a new medicinal product from intramural reimbursement will be further detailed. This option was first introduced last year for nivolumab (please see our previous newsletter). It is the intention of the MoH to use this option more frequently to ensure better prices for expensive medicinal products used in hospitals. Finally the MoH aims to improve the affordability of orphan medicinal products where an indication committee may be introduced to advice on initiating and stopping treatment with orphan medicinal products for individual patients.

The MoH announced that the current reimbursement limits in the reimbursement system for outpatient supply (GVS) per group of interchangeable medicinal products will be recalculated. It is the MoH's intention to introduce a further co-payment mechanism for patients on top of the reimbursement limit if more interchangeable medicinal products enter the reimbursement group. The MoH believes this will create sufficient price pressure so it will not be necessary to change the current regulations for maximum prices.
 
The MoH stresses the importance of international cooperation to be able to make the difference. Information sharing and joint negotiations between Member States can lead to better results. Cooperation will take place between countries on a voluntary basis. A pilot where the Netherlands, Belgium and Luxembourg jointly negotiate on prices is currently ongoing.

The MoH takes the view that healthcare insurers and healthcare providers must improve their purchasing power. The MoH believes this can be achieved by ensuring better information sharing and intensified cooperation, while staying within competition law boundaries. This is reflected in the following proposed measures:

  • A 'Platform Purchase Expertise Medicinal Products' will be incorporated where stakeholders can share information and expertise and where purchasing associations can be formed.
  • A 'horizontal scan', which provides information on new medicinal products, extensions of indications of approved products and patent expiry dates, will be further developed by the MoH together with healthcare insurers and healthcare providers;
  • The Dutch competition authority (Netherlands Authority for Consumers & Markets) will publish a guidance document on the permissibility of setting up purchasing associations, joint negotiations and financial arrangements;
  • A 'Monitor Expensive Medicinal Products' will be initiated that will provide an overview of spending on expensive medicinal products and arrangements between healthcare insurers and healthcare providers. This monitor should also provide insights in prescription behavior and local differences.
  • The MoH stimulates that each hospital will incorporate a 'medicinal products committee' in which the policy of such hospital regarding expensive medicinal products is discussed.
  • The MoH notes that some hospitals experiment with a therapeutic preference policy whereby a preferred medicinal product is designated from a group of 'similar' medicinal products. The MoH indicates that she welcomes such initiatives.

3. Appropriate use and use of biosimilars

Diagnostic tests and research regarding appropriate use are of importance to ensure that expensive medicinal products are used appropriately, e.g. for the right patient, in the right dosage, etc.  In order to stimulate developments in this area, an amount of EUR 10 million will be made available in the coming 5 years.

The MoH further intends to stimulate the use of biosimilars. If stimulating measures prove to be insufficient to increase the use of biosimilars the MoH will consider limiting reimbursement of biological medicinal products.

Measures will also be taken to improve medication monitoring by the pharmacist and in the transfer from hospital to pharmacy.

4. Create balance in pharmaceutical market structures

The vision and intended measures in this area focus on exclusivity rights on an EU level. The MoH would welcome a debate around additional exclusivity rights, e.g. supplementary protection certificates (SPCs - which provide for an extension of the patent term) and market exclusivity for orphan medicinal products. The MoH mainly focusses on orphan exclusivity and stresses that this type of exclusivity leads to undesirable effects as indications of medicinal products are 'cut into pieces' which leads to additional, smaller, orphan designations and corresponding separate exclusivity rights resulting in high prices.

5. Accessibility innovative products

Market access may lead to lengthy processes before a product is marketed. The time-to-patient can be accelerated by introducing more flexible forms of market access. The MoH intends – as part of the current Dutch EU presidency - to focus on ways to improve faster market access and to bring market access requirements more in line with reimbursement requirements. On a national level the Dutch reimbursement advising authority (Healthcare Institute or ZIN) and the Dutch Medicines Evaluation Board (CBG-MEB) will cooperate to better align the market access and reimbursement criteria. 
 
The MoH also points out that pharmacy compounded products that are prepared on a large scale may be of importance for individual patients and that the possibility for large scale preparations should be facilitated based on strict conditions. In light hereof the MoH will further review recent European case law (C544/13 and C545/13 - the Abcur/Apoteket case) which provided for strict conditions for pharmacy preparations.

6. Better information service

There is growing need for up-to-date information on efficacy and side effects of new medicinal products by using e.g. patient or disease related registries. In light of the growing amount of registries and the risk of fragmented information provision, the MoH will set up an action plan for information services. This plan should ensure clear rules for registries on targets, work plans, roles, responsibilities and financing.