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.
RESUMO
OBJECTIVE: We studied prescription patterns for non-vitamin K oral anticoagulants (NOACs) in Norway between 2012 and 2015, and compared NOAC and warfarin patient characteristics such as age, gender and cardiovascular (CV) co-medications across reimbursed indications. Factors associated with NOAC prescribing in atrial fibrillation (AF) were also analysed. METHODS: All Norwegian patients (N = 156,124) who received at least one dispensed NOAC or warfarin prescription within the indications of AF, deep vein thrombosis and pulmonary embolism (DVT_PE) or prevention of venous thromboembolic events after a hip or knee surgery (VTE_surg) between 2012 and 2015 were included in the study. Descriptive statistics was applied to compare patient characteristics between NOACs and warfarin across indications and a logistic regression model was used to identify factors associated with NOAC prescribing in AF. RESULTS: NOACs and warfarin were most commonly prescribed in AF (83,729 patients in 2015), followed by DVT_PE (16,077 patients) and lastly in VTE_surg (4060 patients). In 2015, NOACs achieved a dominant (>50%) patient share over warfarin in AF and DVT_PE, and were prescribed in >80% of new oral anticoagulation (OAC) patients. Apixaban, despite its delayed market entry, emerged as the preferred NOAC in VTE_surg (46% share), whereas rivaroxaban captured a 43% patient share in DVT_PE. Warfarin patients were on average older and received more CV co-medication than NOAC patients in AF and DVT_PE. Age, gender and certain CV co-medications emerged as significant predictors of NOAC prescribing in AF. AF patients <70 years old had higher odds of NOAC prescribing (OR 1.19-1.29, depending on age category), in contrast to patients >74 years old (OR 0.51-0.77). Women had 32% higher odds of receiving a NOAC in AF. CONCLUSION: NOACs achieved a dominant market share over warfarin within 3 years from receiving reimbursement in Norway. There were significant differences in patient characteristics between drugs and indications.
