The rate of ADRs induced by anti-infective agents in this study was 8.2%. This is higher than a standard (5%) which has been reported in other studies. This study also shows that some of the classes of anti-infective agents like anti-fungals need more attention.

Despite the advances made in the development of ethical frameworks for health technology assessment (HTA), there is no clear agreement on the scope and details of a practical approach to address ethical aspects in HTA. This systematic review aimed to identify existing guidance documents for incorporation of ethics in HTA to provide an overview of their methodological features. The review identified 43 conceptual frameworks or practical guidelines, varying in their philosophical approach, structure, and comprehensiveness. They were designed for different purposes throughout the HTA process, ranging from helping HTA-producers in identification, appraisal and analysis of ethical data to supporting decision-makers in making value-sensitive decisions. They frequently promoted using analytical methods that combined normative reflection with participatory approaches. The choice of a method for collection and analysis of ethical data seems to depend on the context in which technology is being assessed, the purpose of analysis, and availability of required resources.

ObjectiveTo evaluate cost-utility of infliximab and adalimumab for the treatment of moderate-to-severe ulcerative colitis (UC) refractory to conventional therapies in Canada.MethodsA Markov model was constructed to evaluate incremental cost-utility ratios (ICUR) of 5 mg/kg and 10 mg/kg infliximab and adalimumab therapies compared to 'usual care' in treating a hypothetical cohort of patients (aged 40 years and weighing 80 kg) over a five-year time horizon from the perspective of a publicly-funded health care system. Clinical parameters were derived from the Active Ulcerative Colitis Trials 1 and 2. Costs were obtained through provincial drug benefit plans. ICUR was the main outcome measure and both deterministic and probabilistic sensitivity analyses were conducted.ResultsCompared to the strategy A ('usual care') in the base case analysis, the ICURs were CA$358,088/QALY for the strategy B ('5 mg/kg infliximab + adalimumab') and CA$575,540/QALY for the strategy C ('5 mg/kg and 10 mg/kg infliximab + adalimumab'). The results were sensitive to: the remission rates maintained in responders to 'usual care' and to 5 mg/kg infliximab, the rate of remission induced by adalimumab in non-responders to 5 mg/kg infliximab, early surgery rate, and utility values. When the willingness to pay (WTP) was less than CA$150,000/QALY, the probability of 'usual care' being the optimal strategy was 1.0. The probability of strategy B being optimal was 0.5 when the WTP approximated CA$400,000/QALY.ConclusionsThe ICURs of anti-TNF-α drugs were not satisfactory in treating patients with moderate-to-severe refractory UC. Future research could be aimed at the long-term clinical benefits of these drugs, especially adalimumab for patients intolerant or unresponsive to infliximab treatment.