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- Estudo de custo-efectividade do aliscireno no tratamento da hipertensão em doentes com diabetes tipo 2 e nefropatia em PortugalPublication . Gouveia, Miguel; Borges, Margarida; Costa, João; Pinheiro, Luís; Vaz Carneiro, AntónioObjectives: aliskiren is a direct human renin inhibitor that is efficacious in the treatment of high blood pressure in patients with diabetes mellitus type 2 and nephropathy. The purpose of this study is to provide an economic evaluation of aliskiren in a social perspective. We estimated the incremental cost-effectiveness of a therapeutical strategy based on aliskiren and losartan versus a strategy based on a losartan and placebo. The measures of effectiveness used were life expectancy, quality adjusted life years, and the incidence of end stage renal disease. Methods: the estimates of efficacy in clinical trials and other studies were extrapolated for a 20 years time horizon by using Markov chains with six month length cycles. We estimated the direct costs of the alternative strategies in the context of Portuguese clinical practice, including costs with aliskiren, losartan, other drugs, tests, doctor visits, and the costs of renal transplants. We also estimated indirect costs due to absenteeism and premature retirement from the labor market. Results: In the baseline case the strategy with aliskiren always dominates the placebo strategy, with mean costs inferior by €552,32 and superior effectiveness. The dominance result was robust to plausible variations in the time horizon, the management costs for patients with hypertension and type 2 diabetes and the transplant costs. The result was also robust to using different discount rates and to the non inclusion of indirect costs in the analysis. In a pessimistic alternative scenario with lower aliskiren efficacy in the initial cycle the incremental cost utility was €7246 per QALY ganied. Probabilistic sensitivity analysis shows that aliskiren is dominant witha 56,8% probability and that for willingnesses to pay between €20 000 and 30 000€ the probability aliskirenis cost-effective goes from 72,3% up to 76,6%. Conclusions: In the context of the Portuguese health system, the use of aliskiren is cost-effective. Thus aliskiren is a valuable addition to the therapeutic arsenal for the treatment of patients with diabetes mellitus type 2, high blood pressure and nephropathy.
- Cost-effectiveness of sacubitril/valsartan for the treatment of patients with heart failure with reduced ejection fraction in PortugalPublication . Borges, Margarida; Afonso Silva, Marta; Laires, Pedro A.; Gouveia, Miguel; Alarcão, Joana; Ascenção, Raquel; Costa, JoãoObjectives: This study assesses the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with symptomatic heart failure with reduced ejection fraction (HFrEF). Methods: We used a previously developed Markov model calibrated with patient-level data from the PARADIGM-HF trial, adapted to the Portuguese setting. The model considers two health states (alive or dead) and uses regression analyzes to estimate hospitalizations and deaths over time. A panel of experts estimated resource consumption in the outpatient setting. To estimate resource consumption with hospitalizations, the National Health Service Diagnosis Related Groups database was used. Unit costs were based on national legislation, and on the Infomed database. The model considers a societal perspective, a time horizon of 30-years, and a 5% annual discount rate. Sensitivity analyses assessed the robustness of results. Results: Sacubitril/valsartan increases life expectancy by 0.5 life-years, corresponding to 0.4 incremental quality adjusted life-years (QALY) versus enalapril. The estimated incremental cost-effectiveness ratio (ICER) is 22,702€/QALY. Sensitivity analysis shows that results are robust, but sensitive to the parameter estimates of the cardiovascular survival curve. Conclusion: Sacubitril/valsartan is a cost-effective therapeutic option in the treatment of Portuguese patients with HFrEF and translate into significant health gains and increased life expectancy versus the current standard of care.
- Custo‐efetividade dos novos anticoagulantes orais na fibrilhação auricular em PortugalPublication . Costa, João; Fiorentino, Francesca; Caldeira, Daniel; Inês, Mónica; Pereira, Catarina Lopes; Pinheiro, Luís; Carneiro, António Vaz; Borges, Margarida; Gouveia, MiguelIntroduction and Objectives: Recently, three novel non-vitamin K antagonist oral anticoagulants received approval for reimbursement in Portugal for patients with non-valvular atrial fibrillation (AF). It is therefore important to evaluate the relative cost-effectiveness of these new oral anticoagulants in Portuguese AF patients. Methods: A Markov model was used to analyze disease progression over a lifetime horizon. Relative efficacy data for stroke (ischemic and hemorrhagic), bleeding (intracranial, other major bleeding and clinically relevant non-major bleeding), myocardial infarction and treatment discontinuation were obtained by pairwise indirect comparisons between apixaban, dabigatran and rivaroxaban using warfarin as a common comparator. Data on resource use were obtained from the database of diagnosis-related groups and an expert panel. Model outputs included life years gained, quality-adjusted life years (QALYs), direct healthcare costs and incremental cost-effectiveness ratios (ICERs). Results: Apixaban provided the most life years gained and QALYs. The ICERs of apixaban compared to warfarin and dabigatran were D 5529/QALY and D 9163/QALY, respectively. Apixaban was dominant over rivaroxaban (greater health gains and lower costs). The results were robust over a wide range of inputs in sensitivity analyses. Apixaban had a 70% probability of being cost-effective (at a threshold of D 20 000/QALY) compared to all the other therapeutic options. Conclusions: Apixaban is a cost-effective alternative to warfarin and dabigatran and is dominant over rivaroxaban in AF patients from the perspective of the Portuguese national healthcare system. These conclusions are based on indirect comparisons, but despite this limitation, the information is useful for healthcare decision-makers.
- Avaliação económica de Fidaxomicina no tratamento de infeções por Clostridium difficile graves ou recorrentesPublication . Gouveia, Miguel; Costa, João; Alarcão, Joana; Borges, MargaridaObjectives: Fidaxomicin is a macrocyclic antibiotic drug indicated for the treatment of Clostridium difficile infections (CDI). The purpose of this study was to evaluate from a societal perspective the cost-effectiveness and cost-utility of fidaxomicin in the treatment of severe or recurrent CDI compared to the recommended alternative therapy, vancomycin. Methods: The effectiveness estimates of fidaxomicin and vancomycin, provided by two clinical trials in addition to other studies, were extrapolated to 10 days cycles and a time horizon of 1 year using a Markov model. The costs considered in the study included medication, hospitalization, complications and outpatient visits. Estimates of the indirect costs generated by productivity losses due to absenteeism were not included, for lack of relevant evidence for the Portuguese reality and because the population affected by CDI tends to be no longer active in the labor market. Results: Over a one year horizon and compared to vancomycin treatment, in the base case, fidaxomicin treatment in patients with severe ICD is associated with a gain of 0.010 QALY and a cost increase of 138 €. The treatment of patients with recurrent CDI with fidaxomicin is associated with a gain of 0.019 QALYs and a cost reduction of 626 €. Fidaxomicin treatment has an acceptable incremental cost-utility ratio in patients with severe CDI (ICUR: 13,245 €/ QALY) and dominates in patients with recurrent CDI (ICUR: -33,701 €/ QALY). Fidaxomicin treatment in patients with severe and recurrent CDI is also associated with a reduction in the number of recurrences (ICER: 321 €/ recurrence avoided in patients with severe CDI and ICER: -828 €/ recurrence avoided in patients with recurrent CDI). These results are sensitive to the cost of hospitalization, decreasing with a rising cost of hospitalization. In the probabilistic sensitivity analysis the model predicts that the probability of cost-effectiveness of fidaxomicin is 44,9% in the case of severe CDI and 58% for recurrent CDI for a willingness to pay threshold of 30.000 €. Conclusions: In the Portuguese health system context, fidaxomicin presents good cost-effectiveness and cost-utility results, representing a valuable addition to the therapeutic arsenal for the treatment of CDI.