The European journal of health economics : HEPAC : health economics in prevention and care
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The Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss, G-BA) defines the health-care elements that are to be reimbursed by sickness funds. To define a directive, the FJC can commission benefit assessments, which provide an overview of the scientific evidence regarding the efficacy and benefits of an intervention. This paper describes the operational implementation of the legal requirements with regard to the benefit assessments of medicines. ⋯ During the writing of the final report, a separation between the evidence assessment and the evidence-appraisal phase should be implemented. Ideally, this separation should be legally enforced to prevent any confusion about conflict of interests. Such a process guarantees a feasible combination of the legal requirements for transparency and involvement of relevant parties with international standards of EBM to ensure that the benefit assessments of medicines in Germany are performed according to the highest standards.
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Decision-analytical modelling is widely used in health-care economic evaluations, especially in situations where evaluators lack clinical trial data, and in circumstances where such evaluations factor into reimbursement pricing decisions. This paper aims to improve the understanding and use of modelling techniques in this context, with particular emphasis on Markov modelling. ⋯ Good practice of modelling requires careful planning, conduct and analysis of the model, and needs input from modellers and users.
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In Italy the price setting of medicines reimbursed by the National Health Service is regulated at the central level by AIFA, the national regulatory authority. Prices of non reimbursed medicines are indeed freely established, with some limitations, by pharmaceutical companies. To contain pharmaceutical expenditure and rationalise the whole sector the following measures have been introduced in the past years: a threshold to public pharmaceutical expenditure (PPE); a reference price system (RPS) for off-patent medicines; a pay-back mechanism as an alternative to price cut. In 2008 Italy launched a reform of the pharmaceutical expenditure governance system with the aim to introduce stability and promote development and competitiveness in the pharmaceutical sector.
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Comparative Study
Cost utility analysis of early adjuvant letrozole or anastrozole versus tamoxifen in postmenopausal women with early invasive breast cancer: the UK perspective.
Five years with the aromatase inhibitors letrozole or anastrozole is clinically superior to 5 years tamoxifen in postmenopausal women with early breast cancer. This paper analyses the cost-effectiveness of the aromatase inhibitors compared to tamoxifen using the same health economic model. A Markov model describes lifetime incidence of breast cancer events and treatment-related adverse events. ⋯ If a 5-year carry over effect for the reduction in breast cancer events is assumed, the incremental costs per QALY gained compared to tamoxifen are 6,253pounds (95% CI 3,675-14,766pounds) for letrozole and 7,015pounds (95% CI 3,316-31,997pounds) for anastrozole. Five years of letrozole or anastrozole therapy is cost-effective in postmenopausal women with early breast cancer. Though the respective confidence intervals show significant overlap, letrozole has a 95% probability of being more cost-effective than tamoxifen at a 20,000pounds QALY value, whilst anastrozole has an 85% probability.