News item | 12-04-2023 | 2:45 pm
The medicine Libmeldy is not admitted to the insured package of the health insurance. Minister Ernst Kuipers (Public Health, Welfare and Sport) has conducted negotiations with the supplier together with Belgium and Ireland, whereby the supplier has not met the conditions set by the three countries.
Libmeldy is a single gene therapy for metachromatic leukodystrophy, a rare inherited metabolic disease. In the Netherlands, five patients were expected to be treated with Libmeldy in the first three years. However, the price is extremely high, the long-term effects uncertain and the cost-effectiveness unfavorable. The negotiations have shown that the supplier is unwilling to reach acceptable agreements with the countries involved.
Minister Ernst Kuipers:
“I think it’s terribly hard for the patients and their loved ones. They suffer the adverse consequences of this outcome. I understand the desperation and I sympathize with them. I have also passed this message on to the patient association. It hurts, and especially from my former role as a doctor, I know the enormous impact care can have on the quality of someone’s life. On the other hand, difficult choices are inevitable and necessary. This is the only way we can keep our care available and accessible to everyone in the future.
A large number of new medicines come onto the market every year. That is good news for patients. But the flip side is that we see the prices for some of these drugs skyrocketing. Provided that I give each patient the best possible treatment, looking at the bigger picture, the amounts involved are enormous, which are increasing rapidly every year. With these very expensive treatments the efficacy is regularly based on limited clinical evidence and the list price charged is disproportionate to the demonstrated efficacy. This makes the cost-effectiveness unfavorable. These treatments displace other, effective care and the reimbursement is therefore at the expense of care provided to other patients.
In the case of Libmeldy, the Zorginstituut advised me on the conditions for admission. It was not possible to reach an agreement with this supplier in line with the advice. If the supplier is still willing to come to acceptable agreements, the compensation from Libmeldy can be reconsidered.”
Solidarity under pressure
Libmeldy costs € 2.9 million per patient based on the public list price. Such extremely high drug prices create a serious dilemma between the desire of patients, families and practitioners to make a drug available and the social acceptability of the price charged by the industry. This is not an exclusively Dutch phenomenon. Suppliers abroad also sometimes charge exorbitant prices. That is why the Netherlands seeks cooperation with other countries in negotiating the price of expensive medicines. In this case, this was done together with Ireland and Belgium, with whom the Netherlands has a permanent partnership.
To ensure solidarity in our reimbursement system now and in the future, it is necessary to curb drug prices and expenditure. This may mean that for a promising treatment it can be concluded that the expected health gain is not in proportion to the price asked for it. In this way there is no question of effective care.
With the conclusion of the integral care agreement, it has become all the more clear that sometimes sharp considerations have to be made about what our collective financial resources are used for.
Drug lock
Libmeldy was placed in the so-called lock for expensive medicines in January 2021. After the supplier submitted a request for reimbursement, the National Health Care Institute assessed Libmeldy. The Zorginstituut concludes that effectiveness has been demonstrated for children who do not yet have symptoms, but that the long-term effects are uncertain. For these patients, the Healthcare Institute advises the Minister to only include Libmeldy in the basic package on the condition that a price reduction is achieved and so-called pay-for-performance agreements are made, whereby payment is only made for patients for whom the medicine actually has health benefits. According to the Zorginstituut, the effectiveness of Libmeldy has not been demonstrated in children with clinical manifestations of the disease.
Libmeldy is not the only medicine that, after negotiation, does not flow into the insured package from the medicine lock. Previously this also happened with the drug Trodelvy. The Zorginstituut’s conclusion was that the demonstrated health gain was also disproportionate to the price asked by the supplier for this product. Minister Kuipers follows the advice of the Zorginstituut by not admitting the product to the basic package now that no agreement has been reached with the supplier.