In this update, we describe a number of developments relating to pricing and reimbursement in the Netherlands, including the Belgian-Dutch cooperation on price negotiations and a judgment of the European Court of Justice.

  • Belgian and Netherlands Ministers of Health have announced joint price negotiations for expensive medicinal products
  • Health insurance companies do not fall within the scope of the public procurement law
  • Reimbursement of dietary foods for medical purposes: no preference policy allowed
  • EU Transparency Directive: obligation to state reasons also applicable to a decision by which reimbursement of medicinal product is reduced or restricted
  • Reimbursement of off-label use in exceptional case where such off-label use is not included in statutory health insurance package
  • Court confirms that HTA authority does not need to separately address lower evidence if Evidence Based Medicine (EBM) method entails the assessment of such lower evidence

1. Belgian and Netherlands Ministers of Health have announced joint price negotiations for expensive medicinal products
 
In 2016 a pilot project will start where Belgium and the Netherlands will jointly negotiate prices of expensive medicinal products, especially of orphan medicinal products. It is intended to negotiate lower prices in the interests of patients. In addition hereto Belgium and the Netherlands will assess how both countries can cooperate more broadly, e.g. regarding the exchange of data, setting up registers and coordinating methods of evaluation.

2. Health insurance companies do not fall within the scope of the public procurement law

A Dutch health insurance company (CZ) appealed a preliminary proceedings judgment where this health insurance company was considered a contracting authority for the purchase of colostomy products for its insured patients. The appeal is successful; in its judgment of 12 May 2015 the court of appeal in 's-Hertogenbosch decided that a health insurance company should not be considered as a contracting authority.

The court of appeal considered that a health insurance company should be considered as an authority established for the specific purpose of meeting needs in the general interests that does have commercial character. It is because of this commercial character that the court of appeal finds that a health insurance company should not be considered a contracting authority. The court of appeal determined the commercial character based on 3 criteria in accordance with established case law from the Court of Justice of the European Union: a health insurance company (i) has a profit motive, (ii) operates under normal market conditions and (iii) bears economic risks. After considering the specifics of the regulation of the Dutch health insurance system the court of appeal concluded that health insurance companies in the Netherlands meet these 3 criteria and thus have a commercial character.

3. Reimbursement of dietary foods for medical purposes: no preference policy allowed

In the Netherlands, health insurance companies are not allowed to apply a preference policy for dietary foods whereby as a general rule only generic and low-cost dietary food products are reimbursed, unless there is a medical need. Health insurance companies apply a similar preference policy for medicinal products whereby a health insurance company may designate one or more medicinal products for reimbursement from a group of medicinal products with the same active substance. Reimbursement is then limited to such designated medicinal products, unless there is a medical need. There is a legal basis pursuant to the Dutch Health Insurance Act that allows health insurance companies to limit the reimbursement of medicinal products with a certain active substance to one designated (typically generic) medicinal product with that active substance. Dutch laws and regulations do not provide for the possibility to apply a preference policy for dietary food products. In its judgment of 24 February 2015, the Gelderland district court confirmed previous decisions that a preference policy is not allowed for dietary foods. Health insurance companies should reimburse the dietary food products conform the prescription of the physician or dietitian.

4. EU Transparency Directive: obligation to state reasons also applicable to a decision by which reimbursement of medicinal product is reduced or restricted

In its judgment of 16 April 2015, the European Court of Justice decided that the obligation to state reasons as provided for in article 6(3) and (5) of the EU Transparency Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (Directive 89/105/EEC) must be interpreted as follows. The obligation to state reasons does not only apply to decisions by which a medicinal product is excluded from the reimbursement list, but also applies to a decision that restricts the conditions of reimbursement or reduces the level of coverage of a medicinal product by excluding it from the list of proprietary medicinal products covered by compulsory health insurance schemes in addition to services relating to hospital treatment covered by fixed payments in respect of period of hospitalization and hospital care.

5. Reimbursement of off-label use in exceptional case where such off-label use is not included in statutory health insurance package

In its judgment of 19 December 2014, the Dutch Supreme Court considered that in exceptional circumstances the general principles of reasonableness and fairness of Dutch contract law can overrule regulatory decisions made by the Minister of Health on the basis of statutory health insurance law. More specifically the Supreme Court provides guidance as to the circumstances under which a healthcare insurance company has an obligation to reimburse the cost of a medicinal product to insured patients a) even if there is an exhaustive and mandatory statutory government reimbursement list that does not provide for the option of reimbursement of that medicinal product in a specific case and b) a health insurance company is in general - based on statutory provisions - not allowed to reimburse medicinal products outside the statutory health insurance package. Such circumstances could, in particular, include instances where the medicinal product involved is not included in the insured package for the relevant group of insured persons or when the medicinal product is included in the insured package, but for reasons that do not fully correspond with what the legislator had in mind with regard to the composition of that package. In such cases, a claim to reimbursement of that medicinal product is allowed if (i) the costs are so high that the insured patient cannot provide for it itself, (ii) there is a lack of alternatives, (iii) the required medicinal product is associated with a serious medical condition that is life-threatening or leads to severe suffering and (iv) it can be assumed that the medicinal product will be eligible or included in the package in the near future because of its efficacy, necessity and efficiency.

The case is about the off-label reimbursement of the medicinal product Bosentan for an 11 year old girl that suffers from limited scleroderma. Bosentan is included in the positive list of reimbursed medicinal products that forms part of the Health Insurance Regulation and reimbursement is subject to the fulfillment of certain criteria. One of these criteria is that the patient should be 18 years of age or older. In this case the health insurance company refused reimbursement of the medicinal product referring to this reimbursement condition. The Supreme Court considered that - although the list of reimbursed products and reimbursement conditions is intended to be mandatory and exhaustive by the legislator – in this exceptional case there was room for leniency based on fairness and reasonableness. The Supreme Court took into consideration the severity of the paediatric patients' condition, the circumstance that there are indications that Bosentan would be just as effective with paediatric patients as with adults and the fact that Bosentan is not authorised for pediatric patients is attributable to the rarity of the condition. The Supreme Court therefore upheld the preliminary relief courts' ruling that the costs of the use of Bosentan should be reimbursed by the health insurance company.

6. Court confirms that HTA authority does not need to separately address lower evidence if Evidence Based Medicine (EBM) method entails the assessment of such lower evidence

It follows from a judgment of the Amsterdam district court of 19 November 2014 that the current EBM model used by the Dutch reimbursement authority ZIN, which it uses in health technology assessment and to advise the Dutch Minister of Health on reimbursement issues is valid and in line with statutory provisions. Healthcare (including medicinal products) that form part of the statutory health insurance package must comply with the state of the art criterion. ZIN is the authority that advises the Minister of Health on reimbursement decisions. ZIN has developed an EBM method to assess whether or not a form of healthcare complies with the state of the art criterion. This EBM method consists of a systematic search and review of several levels of evidence, e.g. systematic reviews, randomized clinical trials, other trials/research, expert opinions, whereby more importance is attached to higher evidence. If available, higher evidence can push out lower evidence within the EBM method: the assessment will be based on the higher evidence and not on the lower evidence.

In this case ZIN issued an opinion stating that certain bladder fluids do not comply with the state of the art criterion. A patient organisation had successfully initiated preliminary injunction proceedings against this opinion. However, in the proceedings on the merits of the case the court has now decided differently. The court decides that the opinion of ZIN which is based on the EBM model is not contrary to statutory provisions and ZIN policies. ZIN has sufficiently addressed expert opinions and other forms of lower evidence in its assessment as such opinions form part of the EBM method which was used by ZIN for its opinion. Because higher evidence was available on the use of bladder fluids ZIN did not have to base its opinion on expert opinions and other lower evidence brought forward by the patient organisation.