Table 2 Context to the ipilimumab debate

Ipilimumab as second-line treatment against inoperable metastatic malignant melanoma was first evaluated in 2012, prior to the implementation of New Methods. The Norwegian Medicines Agency initially estimated the cost-effectiveness to be approximately US$145 K/QALY, substantially higher than the perceived existing willingness to pay for health [39]. Before New Methods, the National Council for Quality Improvement and Priority Setting in Health Care made transparent and evidence-informed recommendations on the implementation of specialist healthcare treatments of principal interest. Recommendations were given to the Directorate of Health, which then decided on implementation together with the bodies responsible for budgeting, that is, the Regional Health Authorities [40]. For ipilimumab, the Norwegian Medicines Agency produced a single technology assessment [39], while the Directorate appointed an advisory expert panel to evaluate new cancer drugs. The panel advised against implementation in April 2012 [41], before medically recommending implementation in January 2013. In March 2013, the Directorate decided against implementation due to cost-effectiveness considerations [42]. Three days later, the Minister of Health intervened on the decision and allocated the equivalent of about US$18 M in research funds for a nationwide phase IV-study, which, in practice, implemented the drug for the entire patient group [43]. Simultaneously, the minister announced the creation of the third committee on priority setting in healthcare. New Methods was introduced later in 2013, and ipilimumab was implemented as standard therapy for the metastatic malignant melanoma patient group in October 2014 [44, 45].