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Before a new drug reaches Swedish patients, it goes through the so-called NT Council (Council for New Therapies). It is a group of experts, with representatives from the regions, who have the mandate to give recommendations on what new drugs to use in hospital care.
Since the council was formed in 2015, they have more and more to do, says its chairman Gerd Lärfars:
– When we started with an orderly introduction at the national level, we expected TLV (Pharmaceutical and Dental Benefits Agency) to do 5 to 6 drug evaluations per year. Last year they got 11-12, and this year they got the same number only in the first half, she says.
The reason for the increase is that the development of new drugs has taken off during the same period. These include immunotherapies and combination treatments in the field of cancer, gene and stem cell therapies, as well as orphan drugs for people with rare diagnoses.
In the category of drugs for rare hereditary diseases, domestic costs have risen significantly over the past ten years, from 200 million SEK in 2010 to more than 1.1 billion SEK this year.
– When you invest in certain areas, a lot can happen in a short time. For example, the field of gene and stem cell therapies has been very successful. There has been a will through legislation, facilities to develop this type of drug, and there is a lot of money. All of these things together have made it a great development, says Gerd Lärfars.
When the NT Council is going to assess the cost for a drug, they are based on the economic health analysis that TLV performs for them. On two occasions, most recently this summer, they have recommended against using Vimizim, a drug that could help the roughly ten people in Sweden who have the rare genetic disease MPS 4, Morquio’s disease.
– It turned out that the effect of the drug is very uncertain. We don’t know for sure what benefit Vimizim brings and how well it slows the course of the disease, and it comes at a very high price, says Gerd Lärfars.
To assess the cost of different drugs, the quality-adjusted life years (QALY) measure is used, which combines two dimensions of health: quality of life and longevity compared with current disease treatment. For each year in full health, TLV estimates that Vimizim would cost between 12.8 and 14.5 million SEK.
What would be a reasonable price?
– For very rare diseases where it has a good effect from drugs, the TLV has come to a reasonable cost of around two million crowns per quality-adjusted life year.
However, the QALY measure is not the same as the cost of drugs per patient. For Vimizim, on the other hand, it is estimated between 3.3 and 6.6 million SEK.
