RESUMO
BACKGROUND: Pembrolizumab is a new drug approved in several countries for second-line therapy in non-small cell lung cancer (NSCLC) being programmed cell death ligand (PD-L1) positive. This drug has a high cost, and the cost-effectiveness ratio has been debated. PATIENTS AND METHODS: The budget impact to the Northern Norwegian Regional Health Authority trust of implementing pembrolizumab in second-line therapy in patients with PD-L1-positive NSCLC was calculated. A model was developed employing data from the Cancer Registry of Norway, the KEYNOTE-010 study, the price list from The Hospital Pharmacy of North Norway, the cost of analysing PD-L1 expression and the cost of travelling. Today's cost of second-line therapy was compared with the new standard employing pembrolizumab. The sale price of pembrolizumab in Norway was not published due to price confidentiality. Norwegian krone (NKr) was converted into Euros () at a rate of 1=Nkr 8.8138. (Bank of Norway, 21 February 2017). RESULTS: 105 new patients were identified available for pembrolizumab per year. The annual cost of pembrolizumab was 5.2 million, hospital pharmacy administration costs 0.1 million, PD-L1 testing 0.3 million, oncologist/pulmonologist/nurses 0.2 million, radiology 0.06 million and transportation 0.4 million. Savings due to avoided present second-line therapy was calculated 0.4 million. Consequently, the cost of implementing pembrolizumab was 5.5 million and the annual budget impact was 5.0 million. A mean gain of at least 9 months per patient treated was necessary to make pembrolizumab cost-effective. CONCLUSIONS: The net budget impact of pembrolizumab was 5.0 million. The expenditure could not be indicated cost-effective. Price confidentiality is a growing problem in health economics and it has become a 'menu without prices' setting.
