Lock procedure for expensive medicinal products

Expensive medicinal products temporarily in the lock procedure

Medicinal products that are used in hospitals are referred to as ‘intramural’ or ‘inpatient’ medicines. These are mostly admitted to the basic health insurance package without any special agreements about usage and pricing. However, if new medicines are extremely expensive, the Ministry of Health, Welfare and Sport (VWS) can decide to keep them outside the basic health insurance package temporarily. The minister then places the medicines in the ‘lock procedure’. The National Health Care Institute advises the minister on which medicines should be in the lock. We base our recommendation on information from the Horizon Scan for Medicinal Products.

Why are medicines placed in the lock procedure?

The lock procedure is for medicines and treatments that are very expensive per patient or that will cost a lot per year in total because many patients need them. It is often unclear how well the medicines work and for exactly whom they work. Using the lock lets the governmental authorities ensure that medicines are only used in patients for whom they genuinely work. This means that patients do not suffer unnecessary severe side effects of medicines that do not work for them. It also leaves more money for other suitable care and allows more appropriate care for society as a whole.

When are medicines placed in the lock procedure?

The criteria for using the lock procedure are laid down by law. A medicine can be a candidate for the lock procedure if: 

• It costs € 20 million a year or more throughout the Netherlands to use the medicinal product for one or more new indications. The medicine then enters the lock procedure for each new indication. 
• The cost of a medicine for one indication is € 10 million or more per year and the cost of using it per patient per year is € 50,000 or more. 

An ‘indication’ means stating for which disease or condition the medicine is used. Only the cost of the medicinal product itself is included in these criteria; other aspects of the treatment are excluded. For example, this could be the cost of hospital admission.

What are the steps in the lock procedure?

The marketing authorisation holder (usually the manufacturer) must first get its medicine or treatment licensed for admission to the European or Dutch market. The European Medicines Agency (EMA) and the Medicines Evaluation Board (CBG) assess that, looking inter alia at a medicine's efficacy and safety. A medicine can only be sold when it meets all the requirements. The minister then decides whether the medicine will be placed definitively in the lock procedure. 

The marketing authorisation holder must submit a complete file to the National Health Care Institute

After definitive placement in the lock procedure, the marketing authorisation holder must submit a complete file to the National Health Care Institute. Only then can the National Health Care Institute start assessing the medicinal product.  

Assessment by the National Health Care Institute

We carry out the assessment based on the 4package criteria: 

• Necessity: are the effects of the disease so great that medicines are needed?  
• Effectiveness: how well does the medicine work compared to those already being reimbursed in the Netherlands? 
• Cost-effectiveness: is the price of the medicine reasonable, given what it brings for the patient and society?  
• Feasibility: can inclusion in the basic insured package be implemented in practice? 

The National Health Care Institute gets advice for its assessment from 2 independent committees: 

• The Scientific Advisory Board (WAR) reviews the data against ‘established medical science and medical practice’, in other words looking at what the effect of the medicine is for the patient and how large the effect is, whether the medicine works better than or as well as medicines that are already reimbursed, and which patients it works for. In addition, the Scientific Advisory Council looks are the cost-effectiveness: how the costs of the treatment relate to what it brings for the patient and society. 
• The Insured Package Advisory Committee (ACP) handles the social deliberations. The ACP looks at the interests of the patients who are eligible for the medicinal product. The ACP also considers the interests of patients with other conditions, because they will want the medicine to be reimbursed for their condition too. In addition, the committee looks at the interests of all premium payers: the basic health insurance package should maximise the health gains for the entire population.

In the assessment, the National Health Care Institute asks patients’ associations, professional groups and health insurance companies for input.  

Recommendations from the National Health Care Institute to the minister

Based on the input from the WAR, ACP and stakeholders, the Executive Board of the National Health Care Institute issues an advisory report to the minister. If the advisory report about inclusion in the basic healthcare package is positive, the National Health Care Institute will indicate whether the minister should negotiate a price reduction with the marketing authorisation holder. In addition, the National Health Care Institute indicates what constitutes appropriate use of the medicine, i.e. which patients the medicinal product or treatment is suitable for and which not, and what agreements have been made about that with the professional group. Over the years that follow, the National Health Care Institute monitors and evaluates whether the agreements are being observed in practice. 

Definitive decision by the minister

The medicinal product will only be released from the lock procedure and be reimbursed from the basic package when it is determined that it is worth its price. The minister of VWS will take the final decision on this, doing so after successful price negotiations and once agreements on appropriateness of use are in place. Based on the evaluation by the National Health Care Institute, the minister may revise their decision.