Infographic - What is the lock procedure for expensive medicinal products?
The lock procedure for expensive medicinal products is for medicines and treatments that cost a great deal for each patient. Or that will cost a lot per year in total because many patients need them. Moreover, it is often unclear how well the medicines work and for exactly whom they work. Using the lock procedure lets the governmental authorities ensure that medicines are only reimbursed, and then only at a reasonable price, when used in patients for whom they genuinely work.
The lock procedure: what is it and how does it work?
What is the lock procedure for expensive medicinal products?
New hospital medicines are sometimes very expensive…
…and it is often unclear how well they work and for whom.
In the lock procedure, the government assesses whether these medicinal products are worth their price and can be reimbursed.
Medicines will only be reimbursed…
…if they work better than or as well as those that are already reimbursed
...and if they are reasonably priced
When are medicinal products placed in the lock procedure?
The minister of Health, Welfare and Sport may decide to place a medicinal product in the lock procedure if:
…the medicinal product is part of a course of hospital treatment
…and the expected costs are very high
More than €20 million per year for society as a whole
or: more than €50,000 per patient per year and more than €10 million for society.
What are the steps in the lock procedure?
After a medicinal product is licensed for admission to the market:
The manufacturer must submit a complete file to the National Health Care Institute
only then can the National Health Care Institute start assessing the medicinal product
The National Health Care Institute asks patients’ associations, professional groups and health insurance companies for input
With an assessment, the minister of Health, Welfare and Sport can negotiate with the manufacturer about the price and decide whether or not the medicinal product should be reimbursed.
What does the National Health Care Institute assess?
Does the medicinal product work better than or equally well as medicines that are already being reimbursed? And for which patients?
Is the price of the medicinal product reasonable, given what it brings for the patient and society as a whole?
Are the effects of the disease so great that medicinal products are needed?
How can the medicinal product be used appropriately in practice?
The National Health Care Institute receives advice from: the Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP)
Using the lock procedure means:
…medicines are only used for patients for whom they genuinely work
…patients do not suffer unnecessary severe side effects of medicines that do not work for them
…more money is left over for other appropriate care;
…a greater amount of appropriate care can be provided within society as a whole.
