Monday, September 9, 2013

Denmark Regulator KRIS follows NICE recommendation and Rejects Afinitor for use in patients with HR+ve breast cancer

Coordination Council for the deployment of hospital medicine, KRIS , rejected experts call for taking the cancer drug Afinitor in use nationally. It amazes Danish Breast Cancer Cooperation Group ( DBCG ) , which is behind the application to make Afinitor in combination with exemestane aromatasehæmmeren to standard treatment for women with advanced estrogen -sensitive breast cancer.

" Afinitor has been approved by the FDA and EMA (European Medicines Agency , ed.) On the basis of the experiments carried out , showing effect. We are astonished that KRIS has not approved the treatment , because we believe - like a lot of our colleagues in the rest of the world - the documentation is sufficient. The scientific assessment , KRIS comes with , they are quite alone , "says medical director of DBCG Professor Bent Ejlertsen .

Afinitor is introduced to selected post-menopausal women with advanced breast cancer in Norway and Sweden and is incorporated in the Canadian guidelines . Also in Germany has taken the treatment in use.

In England and Scotland the authorities , however, skeptical about Afinitor. The British prioritization institute NICE ( The National Institute of Health and Care Excellence ) rejected a few weeks ago that Afinitor will be used generally for the treatment of hormone- sensitive breast cancer in the National Health Service . The assessment came NICE forward to , although Novartis , which markets Afinitor , had entered into a special pricing agreement with the Department of Health .

Bent Ejlertsen do not believe that NICE 's assessment is based on lack of efficacy , but the economy.

" NICE has said that Afinitor has power , but not an effect that is sufficiently large that it is economically justifiable. So it is the economy and not the professional grounds NICE focuses on , "says Bent Ejlertsen .

It is KRIS ' Chairman Steen Werner Hansen disagrees in. He does not believe that NICE emphasizes economy in its rejection of Afinitor as national treatment. On the contrary , he believes that NICE 's assessment is in line with KRIS ' .

"Our rejection is completely in line with NICE 's and the Scottish assessments of the control group , as Afinitor is compared with is too bad. We believe that there is an alternative called chemotherapy , and we have been supported by NICE . Although Novartis went in and offered discount , says NICE , just as we know that the control group is too bad that you can get a real impression on this matter with all its side effects has a place in treatment , "says Steen Werner Hansen.

There must come a new data showing greater effect , that Afinitor may be approved as national treatment , emphasizes Steen Werner Hansen.

A treatment option less DBCG searched first time KRIS for approval of Afinitor in combination with exemestane as standard treatment for women with advanced breast cancer at the beginning of this year. 

KRIS rejected at a meeting of 30 January to take the product in use due to lack of evidence that Afinitor has a significant effect compared with standard chemotherapy.

The message is that it is too early to introduce Afinitor as standard treatment echoed in June after KRIS had reassessed DBCG 's application.

KRIS ' refusal to take Afinitor in use nationally will have the consequence that the Danish breast cancer patients do not get the same treatment as patients in the countries we normally compare ourselves with , says Bent Ejlertsen .

"Because it is a new drug , it will not impact in relation to the practices we already have. But Danish patients receive a treatment option less compared to their fellow patients in other Scandinavian countries and a large part of Europe, "he said.

There will be some patients where it will be particularly relevant to be treated with Afinitor , and here you will be able to apply for one grant , says Bent Ejlertsen . When applying for one grant treatment should be funded under the department's own budget.

DBCG estimates that about 300 new patients per year will benefit from treatment with Afinitor .

DBCG will monitor the situation , and when new evidence , the group will apply again , says Bent Ejlertsen .

Afinitor is currently being tested in a global clinical trial of the drug , among other things compared with chemotherapy. 76 centers in the world participating in the trial , including six centers in Denmark : At the University Hospital in Odense , Aarhus , Roskilde , Næstved and Vejle.

Approximately 4,000 Danish women a year are diagnosed with breast cancer and about . 56,000 living with the diagnosis.



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