Norwegian authorities reject new motor neurone disease medicine

Approval has been rejected for the use of the compound edaravone to treat motor neurone disease in Norway.

Norwegian authorities reject new motor neurone disease medicine
File photo: Thomas Winje Øijord / NTB scanpix

The medicine was assessed by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway (Nye Metoder, NM) on Monday, news agency NTB reports via media Vårt Land.

“We will not be introducing edaravone as a treatment option because it has an uncertain and likely small effect,” the authority’s CEO Stig A. Slørdahl told Dagens Medicin.

Motor neurone disease, also known as amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, is a serious disease that causes the death of neurons controlling voluntary muscles.

Many patients develop cognitive as well as physical symptoms. The cause of the disease is not fully understood.

Edaravone protects nerve cells from damage by a form of particle known as free radicals. Studies show that this can slow the progression of the disease, NTB writes.

It is yet to gain approval in Europe but has been used in the United States, Japan and South Korea.

According to the Norwegian Medicines Agency, 28 patients in Norway are currently receiving the treatment. The course of treatment is six months at a cost of one million kroner (134,000 euros) per patient.

The agency writes that only one out of three recognised medical journals, based on four various studies, concluded a positive overall effect of the drug compared to a placebo. In that conclusion, the medicine had a small effect on a subgroup of patients at an early stage of the progressive disease, NTB writes.

READ ALSO: Norwegian hepatitis C patients wait for treatment due to medicine monopoly: report


Norwegian hepatitis C patients wait for treatment due to medicine monopoly: report

Norwegian hepatitis C patients are waiting longer than they should for medical treatment due in part to a monopoly on its supply, according to a report.

Norwegian hepatitis C patients wait for treatment due to medicine monopoly: report
Photo: SimpleFoto/Depositphotos

Between 15,000 and 20,000 Norwegians live with the chronic condition, which is treated with a 12-week course of medicine.

The cost of a 12-week course of the Epclusa medicine in Norway is 540,000 kroner (57,000 euros), according to the Klassekampen newspaper.

American pharmaceutical company Gilead Sciences owns a monopoly on supply of the medicine in the Scandinavian country, according to the report.

The medicine, which can cure the disease, is not prescribed to patients with the type 2 and 3 forms of hepatitis C – around 60 percent of sufferers in Norway – until their livers show clear signs of damage.

Although it can take many years from contracting the disease until the liver starts to fail, patients not given the treatment sooner are left with uncertain physical consequences as well as the psychological distress of living with the infectious condition, writes Klassekampen.

People with hepatitis C are not automatically entitled to the treatment, but are given it once symptoms are present.

Ronny Bjørnestad, head of NGO Prolar, which works to improve understanding of the illness, told Klassekampen that he had decided to obtain the treatment by going abroad.

“I felt I couldn’t wait any longer. I have a ticking bomb in my liver and am still infectious. I have a teenager in my house and it wouldn’t take any more than him accidentally using my razor blade for an accident to happen,” he told Klassekampen.

Bjørnestad said that he had purchased the same medicine for the equivalent of 7,500 kroner (800 euros) in Bangladesh, and then had it sent on to a friend in Scotland.

It is legal for Bjørnestad to bring the medicine back to Norway provided he begins the course of treatment while in Scotland, writes Klassekampen.

“If it was an illness that [mainly] affected a group with stronger resources then this would never have been accepted,” he told the newspaper.

The disease has relatively high prevalence amongst former and active drug addicts.

Olav Dalgard, consultant at the department of infectious diseases at Akershus University Hospital, told Klassekampen that the price of Hepatitis C medicine in Norway is “amorally” high.

“If we had cheaper medicine, we would recommend treatment of far more people at a much earlier stage. It would reduce the risk of disease spread. But prices must be reduced for that to be possible” Dalgard told Klassekampen.

The newspaper has contacted Gilead Sciences for comment. 

READ ALSO: 'More Norwegians than ever' take medication