Interventions across all sectors in fragile states are called to contribute to tackling conflict and fragility despite the lack of evidence on how/if this is possible. This article reviews the existing literature to identify five entry points through which water supply and sanitation service delivery might interact, both positively and negatively, with state‐building and/or peace‐building processes. Evidence for the relevance of these entry points was assessed in the Republic of South Sudan and the Democratic Republic of Congo. Our research suggests that the way in which water and sanitation services are delivered is more important than the delivery of these services per se. Moreover, we find that the effects are largely modest and likely to be localised, and that greater attention is still needed to avoid potential negative consequences.
tions on epidemiological data; 12 specified that the uncertainty surrounding epidemiological data should be addressed, especially in terms of the transferability of international data. The party responsible for the conduct of the analysis (therefore responsible for providing the epidemiological data) was named by 20 guidelines, of which 14 explicitly referred to the marketing authorization holder. Furthermore, an acceptable level of evidence was mentioned only by 4 guidelines (Australia, Austria, Poland, and Scotland) and included surveys, registers, databases and experts' opinions. The relevance of epidemiological data for final reimbursement decisions was explicitly mentioned by 5 guidelines (Australia, Israel, Russia, Scotland, and South Africa). However, consequences for unacceptable epidemiological evidence (i.e., cases not following recommendations or requirements) were only indicated by Russia and Scotland in the form of refraining from giving positive reimbursement advice. CONCLUSIONS: Population-level epidemiological data is mentioned in 77% of the guidelines, but those focus mostly on issues of data transferability. Only few countries (19%) address the role of population-level epidemiological data for reimbursement decisions. To reduce decision uncertainty, approaches to address the often occurring paucity of epidemiological evidence should preferably be part of all pharmacoeconomic guidelines. OBJECTIVES:We investigated commonalities and significant differences in HTA evidence requirements in the EU5 (Germany, France, UK, Italy and France) and the implications on phase III programmes, focusing on three key, rapidly evolving elements of HTA: choice of the comparator, Health-Related Quality of Life (HRQL) and effectiveness. METHODS: In-depth, semi-structured 60-min telephone interviews were undertaken with 34 HTA experts across the EU5 (17 from HTA bodies and Academia, 17 from pharma). RESULTS: An active comparator in phase III is mandated or clearly preferred in all EU5 countries for HTA/payer purposes. It tends to be the therapy most commonly used in clinical practice, although best practice or cheapest therapy may be selected. Countries vary in the degree of flexibility in the approach to comparative evidence. UK appears to be the most flexible in the choice of comparator and acceptance of indirect evidence. Germany is the most demanding (e.g. head-to-head data vs. multiple, specific comparators for multiple sub-populations). HRQL is increasingly important in HTA, yet all respondents agreed that, in practice, HRQL is still only supportive to 'hard' end-points such as morbidity and mortality. Challenges in capturing HRQL as a measure of clinical benefit and/or a way to derive utilities, were discussed. Demonstrating effectiveness is becoming increasingly relevant to HTA, although efficacy data from phase III trials still have the major role -the greatest challenge is the generalisation of results to the wider, real-world patient population. Countries differ in their flexibility to addressing the demons...
more, regulatory requirements stipulate that a new orphan status application must be submitted for each indication. Under EMA regulations, orphan and nonorphan indications cannot be granted under the same marketing authorization. Although expansions between orphan and non-orphan indications are more common in the US, no examples of expansion from a non-orphan to orphan indication were identified by the authors. CONCLUSIONS: While indication expansion between orphan indications is relatively common, examples of expansion into or out of orphan indications are less frequent due to the regulatory restrictions. Pricing and reimbursement dynamics in all cases are reflective of the trade-offs between price potential and population size across indications. OBJECTIVES:Korea introduced a new positive list system in 2007 together with a price negotiation procedure. Importantly, these two systems are run by two different, independent organizations, namely the Health Insurance Review & Assessment Service (HIRA) and the National Health Insurance Corporation (NHIC). HIRA reviews the cost-effectiveness data in submissions and makes listing decisions, then NHIC takes over and sets the reimbursement price via negotiations with manufacturers. The aim of this study is to compare the difference in price after cost-effectiveness appraisal by HIRA and price negotiation by NHIC, and to analyze the factors that NHIC has considered to determine the reimbursement price. METHODS: All 35 submissions made to the NHIC between August 2007 and June 2008 were reviewed. 19 submissions concluded with agreement, 15 failed and one case was suspended. In this review only 15 cases of successful negotiations were included. The level of the reimbursement price compared to the submitted price for both essential drugs and non-essential ones and factors affecting the final price were analyzed. RESULTS: The discrepancy between reimbursement price and costeffective price was about 12.33Ϯ11.44% on average. For 3 essential drugs, the price level was almost equal to the submitted price whereas the average level was 84.94 Ϯ11.21% of the cost-effective price for non-essential drugs. The major factors affecting negotiations to determine the final price were narrowed down to total cost of substitutes, the foreign price, and the pharmaceutical budget impact. CONCLUSIONS: Our findings have demonstrated that drug pricing within the new environment has been done independently of cost-effectiveness appraisal. The payer has exhibited limited bargaining power for essential drugs. Overall, 87.67% of the cost-effective price was accepted during price negotiations, and the total cost of substitutes, foreign prices and pharmaceutical budget impact were considered equally when fixing the reimbursement price. A limitation of this study is that the result may not be generalized because of insufficient cases.
OBJECTIVES:To determine the factors associated with paediatric inappropriate use (IU) of the accident and emergency department (A&E) METHODS: An observational prospective survey was performed. All the patients attending A&E in 12 Belgian hospitals during 2 weeks in 2010 were included. The use of A&E was considered appropriate if, at least, one of the following criteria was met: child referred by a doctor or the police, brought by ambulance, need for a short stay[i], need for technical examination or orthopaedic treatment, in patient admission, death. RESULTS:The median age of the 3220 children included was 3.3 years old (0-15.9); 39.3% of the visits were not appropriate according to the definition above. Five determinants were included in a multivariate analyze: age, having a family doctor, night or week-end use of A&E, parents' perception of severity for child's illness and insurance status. Two factors were associated with a decrease of IU: parents' perception of high severity for child's illness (Adjusted OR 0.6; 95% IC 0.4-0.8) and having a family doctor (Adjusted OR 0.6; 95% IC 0.4-0.9). Two other factors were associated with an increase of IU: children age less than 2 years (Adjusted OR 1.8; 95% IC 1.5-2.2) and night or week-end use of A&E (Adjusted OR 1.4; 95% IC 1.1-1.7). After adjustment, the insurance status has no more impact on the appropriateness of A&E use. CONCLUSIONS: In a country like Belgium, where it is not compulsory to be registered with a family doctor, the risk of an IU is mainly due to the failure of outpatient care for children Ͻ2 years and the use of A&E during night or weekend. Parents' perception of high severity for child's health status and having a family doctor were associated with the appropriateness of A&E use.
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