Operation is not the problem. A new drug against an aggressive form of breast cancer is “certainly of added value” concluded the Zorginstituut. But the drug (Trodelvy) is not reimbursed anyway, Minister Ernst Kuipers (Public Health, D66) made known at the end of March. It is too expensive.
The result is unique when it comes to cancer drugs. The breast cancer association is outraged: “It is the patient who pays the price for this failing system.” How did this decision come about?
Medicines travel a long way before reaching the patient. First, the European Medicines Agency determines whether a medicine can enter the European market: does a medicine do what it should do? The Zorginstituut then determines whether the medicine will be included in the basic package. Lydia de Heij, head of the team that draws up those recommendations: “We are looking at the Dutch situation: what resources are already available? Does this add anything? And if a comparable drug exists, then a new drug should not cost more.”
The institute consults studies, specialists and patients. A scientific council of experts tests the findings in the meantime.
In essence, such ‘package advice’ revolves around hard facts: health benefits, years of life, side effects and costs. “For example, we discuss clinical relevance: whether a medicine really improves patients’ lives,” says De Heij. She gives obesity drugs as an example. “If someone loses a few kilos, but gains it back just as quickly when he stops taking a substance, then discussions are about that threshold: is that relevant enough?”
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Young women
In addition to the hard facts, there is also room for social input. Trodelvy is intended for patients with triple negative breast cancer. In the advice on the substance, it is important that they are often young women with children. Women who are currently out of treatment. Then a few extra months (an average of 5.4 months in this case) can be of great value, is the thought.
Trodelvy, according to the Zorginstituut last year, is of added value. But there are “great concerns” about the price – that’s what models are for. In order to include it in the basic package, the price of 69,000 euros per patient per year would have to be reduced by 75 percent.
The Zorginstituut has come to this conclusion more often in the past five years. “The prices that manufacturers ask for resources are getting higher and higher. Five years ago we were still surprised at 200,000 euros per patient. Now you see that it can also be 500,000 euros,” says De Heij. “It seems that manufacturers are more often anticipating the negotiations. That they add a shovel on top of the price in advance.”
For the time being, the minister always came to an agreement with the industry. The price negotiations are secret, so whether manufacturers actually drop to the recommended price, we do not know. De Heij: “Perhaps a previous minister was more inclined to accept a higher price?”
Kuipers is now drawing a line, the care budget is under “increasing pressure”, he writes a letter to Parliament. And it is “not inconceivable” that this will happen more often in the future.
Internist-oncologist Gabe Sonke, who works at the Antoni van Leeuwenhoek hospital, calls this a necessary development. “It is a sad story for patients that we like a medicine, but the manufacturer asks so much money for it that we cannot reimburse it” – he also has patients who qualify for this drug. “But if you don’t say ‘no’ once, then the boundaries are gone.”
‘Smarter admission’
Sonke is in favor of “a smarter admission” of expensive cancer drugs. Out a study of the Comprehensive Cancer Center showed again last week that many of these resources hardly yield any health benefits in practice. How is it possible that these resources still end up in the basic package?
Sonke, who is also a member of the Medicines Evaluation Board, says that the data on which those decisions are made are “less and less robust”. What you would like to know, he says, is whether someone lives longer on a drug and whether their quality of life improves. “But studies on medicines are less and less often focusing on such questions, and much more on, for example, whether the tumor is getting smaller. That does not always appear to be a good predictor for a longer life.”
The lack of such data is related to the urge for speed: no time is taken to wait for the results. “Patients and doctors do not want to wait. Manufacturers are in a hurry. The development of new medicines is accelerating. They fear that something new will be available soon.”
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In exchange for that speed, says Sonke, we accept more and more uncertainty about the effect of a drug. “You can see that in the new study by the Cancer Center.”
There is more rattling about the clinical studies, he says. For example, many medicines are tested on fit people in their forties and fifties, while there are often people in their seventies and eighties in the consulting room.
Sonke advocates a temporary admission to the basic package, at ‘entry rate’. “Then go and test in practice what the best way is to give such a remedy. Can the dose be lower? Can you prescribe it shorter? What has the fewest side effects? And does it work just as well in practice? Based on that information, you can decide whether or not you want to keep it in that basic package and for what price.”