Concerns have been raised about the relative effectiveness of an increasing number of new medicines at the time of their market authorisation, a spokesperson for outgoing Dutch Medical Care Minister Pia Dijkstra told Euractiv.
The spokesperson was responding to questions about a letter Dijkstra sent to the Dutch House of Representatives in April in which she outlined her plans to reform the system for the reimbursem*nt of new high-cost medicines.
The minister said patients, doctors, and health insurers have questions about the value of new medicines while facing increasing pharmaceutical expenditure.
“The phased assessment still needs to be elaborated, and the minister will inform the House of Representatives about this in due course,” the spokesperson said.
In the letter, outgoing Medical Care Minister Pia Dijkstra (D66) said the current package management of expensive innovative medicines must be adapted to meet the challenges of the future. She said if nothing is done about the issue, patients and healthcare workers will suffer consequences.
Dijkstra said she aims to create a future-proof system for the reimbursem*nt of new expensive drugs together with the parties of the National Council on Expensive Medicines (LODG).
New system assesses medicines in phases
Dijkstra explained she is now working on a system in which more new high-cost medicines are assessed in phases, and stakeholders are involved in the reimbursem*nt process.
“To this end, I want to set up a process in which parties, including patient organisations and the professional group, consider the risks of possible package inclusion of medicines,” she added.
The Medical Care Minister also outlined each phase of the new system. First, the Horizon Scan for new medicines will be used to identify which risks may arise when reimbursing a medicine, such as uncertainty about its relative effectiveness.
Next, the Minister said there will be a risk identification phase that will look into relative effectiveness, uncertainty about the correct use of a medicine, and any major financial impact. If there are no or limited risks, a medicine will proceed to the basic package.
If risks are identified, the medicine will move to the next phase, which involves a rapid review to identify further risks requiring follow-up. The final phase will then consider which identified risks can be managed. Medicines found not to be cost-effective can then only be reimbursed if financial agreements are made with a company.
Three main goals
According to the minister, the LODG parties have three main goals for such a future system: controlled access to medicines, insights on the actual value of new expensive medicines, and expenditure control.
The parties within the LODG want as many new effective medicines and indication extensions of existing medicines as possible to become available to Dutch patients as quickly as possible.
“Currently, assessing and negotiating a socially acceptable price for a new expensive drug takes considerable time. The parties want to shorten the time patients wait for the group of medicines that actually have added value as much as possible,” Dijkstra said.
She also said parties want to collect information that provides more insight into the quality, effectiveness, and efficiency of new drugs to influence their use and price.
Lastly, on budget control, the minister said it has been agreed in the Integrated Care Agreement (IZA) that the growth in expenditure on expensive medicines from the basic package should be proportional to the total spending on curative care.
In 2025 and 2026, the annual expenditure growth in the budgetary framework for Medical Specialist Care that can be absorbed is at most 5%.
Orphan drugs
The Dutch National Patient Alliance for Rare and Genetic Diseases (VSOP), one of the LODG parties, confirmed to Euractiv that, along with several other organisations, it’s been pleading for faster access to promising orphan drugs in the Netherlands.
“It seems that despite all the statements on patient involvement in the government letter, VOSP’s concerns are not transferred to Parliament,” the director of the VSOP, Cor Oosterwijk, remarked.
Some of the issues Oosterwijk highlighted included conditional reimbursem*nt strategies being applied scarily and no national registry infrastructure for the follow-up of promising medicines, despite the urgent and repeated advice of the National HTA Appraisal Committee of the National Healthcare Institute, in which VSOP, until recently, was represented.
“Nevertheless, the Dutch government refuses to fund this widely respected patient umbrella organisation, despite its impressive track record of responsible end effective patient advocacy in the Netherlands and Europe,” Oosterwijk said.
Efficacy vs Effectiveness
With the European Medicines Agency (EMA) expected to assess almost 250 new medicines for admission to the European market and approve new indications for nearly 200 existing medicines, Dijkstra raised the issue of uncertainty about their relative effectiveness at the time of market approval.
“This means that it is not sufficiently clear whether a new medicine has comparable or better outcomes than existing therapies. For example, whether a medicine ensures that a patient lives longer or has fewer long-term side effects compared to existing therapies,” Dijkstra said.
On reimbursem*nts, the minister said that while the EMA assesses drugs for their efficacy, the national health authorities look for effectiveness to determine whether the costs of a new drug are in proportion to its effectiveness.
Beneluxa negotiations
Dijkstra said she is actively looking to collaborate with Belgium, Luxembourg, Austria, and Ireland in the so-called Beneluxa Initiative to learn from the other countries “and to be better prepared for the arrival of new medicines”.
“In general, in price negotiations, you stand stronger as a negotiating party when you have more purchasing power. This principle also applies in the case of Beneluxa,” the spokesperson for the Minister told Euractiv.
“Virtually all European governments are also struggling with the sharply increasing expenditure on expensive medicines and the great pressure this places on the sustainability of healthcare as a whole,” Dijkstra said.
Dijkstra said she also wants more control over the development of medicines at a European level.
“I think it is important that the supply of medicines meets the needs of patients as closely as possible and that innovation focuses primarily on the greatest unmet medical needs,” she said, adding that this is one of the goals of the ongoing revision of the European pharmaceutical legislation.
[By Christoph Schwaiger, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]
Read more with Euractiv
Bulgaria extends ban on exports of insulin, antibiotics for children
Bulgaria continues to experience serious medicine supply problems, leading caretaker Health Minister Galya Kondeva to extend the export ban on antibiotics for children, insulin and blood sugar-lowering drugs until mid-July.
