Feb 10, 2019
Ipilimumab in advanced or metastatic renal cell carcinoma is approved in Norway
Norway established in 2013 a framework for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. This framework is called the "New Method."

In this framework, all innovations should undergo HTA before being funded. If the method concerns only one or two hospitals, the assessment shall be initiated by clinicians and ran at the hospital level. The final report is disseminated via a mini-HTA database. If the method is of national concern, it undergoes Single Technology Appraisal at the national level, followed by the funding decision by the group of payers (Decision Forum, Beslutningsforum).

At the end of January 2020, the Decision Forum released several drugs' assessments with the only positive decision for Ipilimumab (Yervoy) in combination with Nivolumab (Opdivo) for previously untreated patients in advanced or metastatic renal cell carcinoma. It was explicitly outlined that the drug cost is equal or lower than comparators; it could already be used from the 15th of February, 2020.

The rest of the drugs were rejected due to the insufficient evidence and its higher price compared to standard treatment:
  • Emicizumab (Hemlibra) as routine prophylaxis for hemophilia A without antibody to factor VII;
  • Elotuzumab (Empliciti) in combination with lenalidomide and dexamethasone in refractory and recurrent myeloma;
  • Lorlatinib (Lorviqua) for the treatment of ALK-positive advanced non-small cell lung cancer in the second-line or later treatment lines;
  • Lanadelumab (Takhzyro) for the treatment of hereditary angioedema;
  • Daunorubicin/cytarabine (Vyxeos liposomal) for the treatment of adults with newly diagnosed, therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes.
See the full details in Norwegian here.

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