Swedish Council for Novel Therapies sets a limit for cost of medication to preserve life

The Swedish Council for Novel Therapies (NT-rådet) has recommended that certain medicines should not be given to patients if they are too expensive – even if the alternative is death. The recommendation is to the Counties who run the hospitals on behalf of the country’s health service. Effectively it means that patients who have atypical hemolytic-uremic syndrome (a-HUS) can no longer be prescribed Eculizumab. There is no known cure for this quite rare (1:500,000) genetic condition  which attacks the kidneys:

Atypical hemolytic-uremic syndrome is a disease that primarily affects kidney function. This condition, which can occur at any age, causes abnormal blood clots (thrombi) to form in small blood vessels in the kidneys. These clots can cause serious medical problems if they restrict or block blood flow. Atypical hemolytic-uremic syndrome is characterized by three major features related to abnormal clotting: hemolytic anemia, thrombocytopenia, and kidney failure.

With a population of just under 10 million, Sweden may have about 20 individuals suffering from this genetic condition. Eculizumab (trade name Soliris) is a medication that has recently been approved for the treatment of aHUS, an ultra-rare genetic disease that causes abnormal blood clots to form in small blood vessels throughout the body, leading to kidney failure, damage to other vital organs and premature death. But it costs approximately €430,000 per year for ongoing treatment.

Clinical trials in patients with aHUS demonstrated inhibition of thrombotic microangiopathy (TMA), the formation of blood clots in small blood vessels throughout the body, including normalization of platelets and lactate dehydrogenase (LDH), as well as maintenance or improvement in renal function.

The medicine does not cure the condition but inhibits the expression of some its fatal effects. It gives a patient a chance to live on.

But as Swedish Radio reports, the Swedish Council for Novel Therapies has decided that this cost of keeping a patient living is too high. For this council, the value of the life of a patient suffering from a-HUS is clearly less than about SEK 4 million per year.

Clearly there is an economic cost benefit analysis to be made for all medical treatment. Clearly also an unlimited cost for keeping someone alive is also not possible. But what about the value of the life to be prolonged? Even assuming that there is some cost limit which is not be borne, the “forbidden” cost level cannot just be an absolute value which takes no note of the value of the life preserved. If cost-benefit is to be the guiding factor, then should not all health costs be balanced against the life or the quality of life to be preserved?

Swedish Radio:

The Swedish Counties’ council of experts, the Council on Novel Therapies, has decided to discourage counties from using a drug for a very rare and life-threatening blood disorder. The reason is that the medicine will cost 4.5 million kronor per patient annually – making it one of the most expensive in the world. A small group of patients could thus eventually die of the disease that brings inflammation, clots and kidney failure. 

“I think it is a completely unreasonable decision. One can not deny the patients with this difficult disease to receive treatment. Although there is plasma and dialysis treatment, survival is most certainly not so long as with this treatment. So I think that they have to change their decision”, says chief physician Ingela Fehmarn-Ekholm.

The disease is called aHUS (atypical hemolytic uremic syndrome), where the blood cells break down and patients become anemic and can get blood clots, stroke, and renal failure.

Ingela Fehrman Ekholm describes one of the patients she treated with the new drug. Before it came, he had donated a kidney to his daughter who suffered from the disease, but the girl did not survive.

A year later he  himself got aHUS. After several years of dialysis and three kidney transplants, he received the new medicine. “It is now almost three years, absolutely no side effects and kidney works great and he feels great”, says Fehmarn-Ekholm.

But it would seem that for this patient, Stefan Persson, the treatment will not be able to continue if this recommendation is followed.

However the statement from the Chairman of the Council almost reads as if it is just a game – a price negotiation with the manufacturer with the death of patients being played out as one card in the game.

Stefan Back is the Chairman of the Council of Novel Therapies that has taken the decision stop using the medicine Soliris.

He believes that the responsibility lies with the manufacturer, who failed to show why the drug has such a high price.

“It is regrettable that it had to come to this because it’s not an easy decision to make. It leads to anxiety with the patients and we hope that the company will deliver significantly better economic evidence and perhaps a lower price”.

A price negotiation where patients’ lives and their peace of mind are just another card to play.


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