Background: We analysed the impact of clinical study design for oncological pharmaceuticals on the subsequent price negotiations after early benefit assessment between pharmaceutical companies and the German National Association of Statutory Health Insurance Funds. The analysis was conducted for all oncology pharmaceuticals that underwent the early benefit assessment in Germany since its introduction in 2011 up to September 2016. Methods: It was differentiated between additive (new therapy in addition to baseline therapy) and substitutive study designs (baseline therapy to be replaced). The study design was derived from the dossiers of the pharmaceutical companies submitted to the Federal Joint Committee. Subgroup specific costs in case of granted added benefit were calculated as annual therapy costs and compared with the costs of the appropriate comparators to quantify price premiums. Further price influencing factors were analysed in univariate and multivariate regression analysis considering the budget impact for the statutory health insurance as well. Results: The mean and the median of the additive premiums for substitutive designs (€50,477.68 and €49,841.24) were higher than for additive designs, if the comparator was different to best supportive care (€48,750.00 and €42,820.44). The mean multiplicative premium for the substitutive designs was 15.07 versus 2.29 for the additive designs. EU-Prices and target population size had a significant effect on the reimbursement. The adjusted R-square in the log Premium OLS-regressions reached 0.708 when including all explanatory variables and considering interaction between target population and annual costs of the comparator.
A 3 4 7 -A 7 6 6 implement NICE recommendations. Similar results have been observed in France, where costs associated to NOAC prescriptions dispensed in the non-hospital setting have increased from € 56.3M in 2012 to € 309,8M in 2015. In response to increasing NOAC prescription, the ANSM and Assurance Maladie consider there is a need for increased vigilance in their use. These findings highlight the considerable increase in NOAC prescriptions and costs in both England and France, and should inform future policy efforts to encourage adequate use of NOACs in order to control increasing expenditure. ConClusions: Between 2012 and 2015, there was a considerable increase in NOAC drug expenditures from prescriptions dispensed in the non-hospital setting, in both England and France, which suggests that policies aimed at incentivizing NOAC prescriptions have been effective, but should further factor in the increasing economic impact of these treatments.objeCtives: Programme Budgeting Marginal Analysis (PBMA) is framework that accommodates economic analysis, multi-stakeholder inputs, values, needs and perspectives within the one framework -balancing health services, outcomes and budgets to optimise use of limited resources. In Wales PBMA aligns with 'Prudent Healthcare' and the need for informed resource reallocation. A Welsh Health Board (HB) had challenges providing and funding anticoagulation services for people with Atrial Fibrillation (AF) within a fixed budget, which provided the context for this research, which involved the implementation of PBMA process along with a process evaluation to assess its replicability and utility for future use. Methods: The PBMA was based on a synthesis of the literature and consideration of the criteria for successful PBMAs (Tsourapas, 2011). A HB project team and stakeholder community supported PBMA delivery. Results: The costs of the service were challenging to define and determine but eventually were ascertained to a reasonable extent. A NICE costing model enabled some estimates of the impact of an ageing population, AF prevalence and stroke rates, changes in use of anticoagulants, monitoring requirements, potential to generate hypothetical 'savings' and reduction in stroke rates related to improved anticoagulation. The NICE model was restrictive/password protected and frustrating to use. The PBMA outcomes suggested some modest service reorganisation and quality improvement could be made within budget, but no substantial improvement/expansion of services could be undertaken as it would exceed the available budget. The HB commissioning team found the information from the PBMA 'journey' as useful as much as the recommendations. The process of undertaking the pilot enabled a PBMA framework -RADAR -for the HB to be created and available for future exercises. ConClusions: A 'lean' PBMA framework for the time-poor environment of the HB is possible, indeed essential, to operationalise realworld resource reallocation in healthcare commissioning and delivery environment.
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