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Objectives: This study aimed to identify the barriers and facilitators of the utilization of health technology assessment (HTA), a process which is infrequently applied to the selection of medicines listed in the medicine pricing and reimbursement policies in Indonesia. Methods: Semi-structured interviews were conducted to collect qualitative data. Purposive sampling was used to recruit the stakeholders, which consisted of policymakers, a pharmaceutical industry representative, healthcare providers, and patients. The data were analyzed using directed content analysis to systematically organize the data into a structured format. A COnsolidated criteria for REporting Qualitative studies (COREQ) checklist was followed to ensure a high quality and comprehensive report of the findings. Results: The twenty-five participants interviewed provided a range of barriers and promoting factors for the implementation of HTA in Indonesia. A lack of capability of local human resources, a lack of incentives, unintegrated data, as well as a lack of a clear framework were mentioned as barriers. An important promoting factor was seen in the Indonesian law which stipulated that HTA was mandatory for selecting medicines listed in the medicine pricing and reimbursement policies. Strategies suggested to overcome the barriers include setting up an HTA department in several Indonesian universities, introducing a clear framework for the implementation of HTA in the guidelines, and establishing relationships with other countries with a well-developed HTA or with HTA associations. Conclusions: Several barriers are currently preventing the implementation of HTA in medicine pricing and reimbursement policy in Indonesia, however, solutions to these issues exist.

BACKGROUND: There is a debate on the added clinical value of new, expensive, anticancer treatments. Among European decision makers, the relevance of commonly used endpoints in trials, especially overall survival (OS), progression-free survival (PFS) and quality of life (QoL) varies, leading to the available evidence being valued differently. This research studies the extent to which the value of endpoints for cancer medicines differs among European decision makers. METHODS: We compared guidelines and relative effectiveness assessments (REAs) of medicines for pricing or reimbursement decisions in England, France, Germany, Netherlands, Poland and Scotland. Anticancer medicines that received marketing authorisation in Europe between 2011-2013 with at least four available national REAs were evaluated. A total of 79 REAs were included. RESULTS: Health technology assessment (HTA) guidelines indicate a preference for clinically and patient relevant endpoints such as OS and QoL above surrogate endpoints. Most guidelines do not specify whether PFS is considered a surrogate or patient-relevant endpoint. The number of REAs included per jurisdiction varied between 7 (The Netherlands) and 18 (Germany). OS data were included in all REAs and were the preferred endpoint by HTA agencies, but these data were not always mature or robust. QoL data are included in only 54% of the REAs, with a limited impact on the recommendations. PFS data are included in 70% of the REAs, but the extent to which HTA agencies find PFS relevant varies. CONCLUSIONS: European decision making on relative effectiveness of anticancer medicines is affected by a gap in requested versus available clinical evidence, mainly because the regulator is willing to accept some degree of clinical uncertainty. A multi-stakeholder debate would be essential to align concrete robust evidence requirements in oncology and a collectively shared definition for relevant clinical benefit, which will benefit patients and society in general.

As a results of a depletion of atmospheric ozone all living organisms on the earth"s surface may be exposed to increased amounts of ultraviolet radiation. In man, ultraviolet radiation (UVR, especially UV-B) can cause, in addition to some beneficial effects like vitaming D formation, deleterious effects on the human health. Examples are diseasesof the skin, like erythema, photoageing and skin cancer and diseases of the eye, like keratitis and cataract. There are reasons to believe that UV-B radiation depresses the immunity against tumours and infectious diseases. It was demonstrated that UV-B suppresses the resistance against UV-induced tumours in mice and that this suppression is transferable to other mice if lymphocytes of UV-irradiated animals are used. Clinical research showed the induction of suppressor cells and inhibition of the NK activity by exposure to sunlight. UV-B can interact in diffrent ways with the immune system; antigen-presenting cells in the skin can be affected, the homing of lymphocytes may be distrurbed and the amount of suppressor cells often increased. More research is needed to establish relations between depressed immunity and decreased resistance against infections and tumours, so that these can serve as the basis for risk assessment of UV-B

As a result of a depletion of atmospheric ozone all living organisms on the earth's surface may be exposed to increased amounts of ultraviolet radiation. An elevated exposure to UV-B radiation may lead to an increased incidence of deleterious effects on human health. Our experiments showed that UV-B affects the resistance to infectious diseases in rats. In this study non-invasive methods were used to analyse the differences in susceptibility between man, rat and mouse for UV-B induced immunosuppression in order to extrapolate data from studies on the effect of UV-B on the resistance against infectious diseases in rats, to men. In this study particularly the effect of UV-B radiation on the Mixed Lymphocyte Reaction (MLR), which analyses specific activity of T cells, was determined. Lymphocyte Transformation Tests (LTT) were performed in order to analyse aspecific proliferation T lymphocytes. In vitro UV-B radiation suppressed the MLR responses of splenic lymphocytes of rats and mice, suppressed the MLR responses of blood lymphocytes of rats and humans and suppressed the LTT responses of splenic lymphocytes of rats (P

Aim. This study was undertaken to increase understanding of the utilization of a newly introduced statin through evaluation of characteristics of 'real-life' patients in a pharmacoepidemiology program in the USA, the Netherlands, the UK and Canada. Methods. This was an observational analysis of prospectively collected data from primary care patients classified as new users of rosuvastatin or any other statin. New users (naïve or switched initiators) of rosuvastatin were compared with initiators of other statins, as identified from automated healthcare databases in the first 1 to 2 years of rosuvastatin availability. Demographics, statin doses, previous statin use and other lipid-lowering therapies, and relevant comorbidities were recorded. The main outcome measure was proportion of naïve and non-naïve statin users in patients prescribed rosuvastatin or 'other statins'. Results. Among 346 547 new statin users identified in the cohorts, 46 838 (13.5%) were new users of rosuvastatin and most (84.1%) were statin-naive. Patients receiving rosuvastatin were more likely to have been previously treated with another statin or non-statin lipid-lowering therapy and tended to be younger, compared with first users of other statins. Conclusion. These findings suggest that rosuvastatin is preferentially prescribed to patients who have not responded satisfactorily to established treatment.

A key step in endothelin-1 (ET-1) synthesis is the proteolytic cleavage of big ET-I by the endothelin-converting enzyme-1 (ECE-1). Four alternatively spliced isoforms, ECE-1a to ECE-1d, have been discovered; however, regulation of the expression of specific ECE-1 isofomis is not well understood. Therefore, we stimulated primary human umbilical vein endothelial cells (HUVECs) with angiotensin II (Ang II). Furthermore, expression of ECE-1 isoforms was determined in internal mammary arteries of patients undergoing coronary artery bypass grafting surgery. Patients had received one of 4 therapies: angiotensin-converting enzyme inhibitors (ACE-I), Ang II type I receptor blockers (ARB), HMG-CoA reductase inhibitors (statins), and a control group that had received neither ACE-I, ARB (that is, treatment not interfering in the renin-angiotensin system), nor statins. Under control conditions, ECE-1a is the dominant isoform in HUVECs (4.5 +/- 2.8 amol/mu g RNA), followed by ECE-1a (2.7 1.0 amol/mu g), ECE-1a (0.49 +/- 0.17 amol/pg), and ECE-1b (0.17 +/- 0.04 amol/mu g). Stimulation with Ang II did not change the ECE-1 expression pattern or the ET-1 release. We found that ECE-1 mRNA expression was higher in patients treated with statins than in patients treated with ARB therapy (5.8 +/- 0.76 RU versus 3.0 +/- 0.4 RU), mainly attributed to ECE-la. In addition, ECE-la mRNA expression was higher in patients receiving ACE-1 therapy than in patients receiving ARB therapy (1.68 +/- 0.27 RU versus 0.83 +/- 0.07 RU). We conclude that ECE-1a is the major ECE-1 isoform in primary human endothelial cells. Its expression in internal mammary arteries can be regulated by statin therapy and differs between patients with ACE-I and ARB therapy.

Results from clinical trials and clinical practice have shown statins to be generally well tolerated with a low frequency of clinically relevant side effects. Nevertheless, there are rare occasions when adverse events (AEs), sometimes serious, may occur. Rosuvastatin is the newest statin to be approved in the USA and many other countries. As part of the continued assessment of the benefit-risk profile of rosuvastatin, AstraZeneca has developed a progressive, comprehensive pharmacoepidemiology programme to complement safety data obtained from randomised clinical trials and spontaneous reporting systems, which have demonstrated that rosuvastatin has a safety profile in line with comparator statins. This programme comprises nine studies conducted in recognised centres of excellence assessing over 50,000 patients treated with rosuvastatin. It consists of three components: patient characteristics studies (four studies), safety evaluation studies (four studies); and review of data generated from the Prescription-Event Monitoring (PEM) study, designed and run by an independent third party. Patient characteristics studies are designed to describe the characteristics and drug utilisation patterns of new users of rosuvastatin compared with new users of other statins in automated databases. Safety evaluation studies will examine the rates of specific AEs in different cohorts of statin users and determine risk factors for these events using data recorded prospectively in automated databases with case adjudication via medical record review. The independent PEM study will monitor any significant events recorded by general practitioners since starting rosuvastatin treatment. This article is an overview of the rationale and methodology of the rosuvastatin pharmacoepidemiology programme.

In Europe, antimicrobial resistance has been monitored since 1998 by the European Antimicrobial Resistance Surveillance System (EARSS). We examined the relationship between penicillin nonsusceptibility of invasive isolates of Streptococcus pneumoniae and antibiotic sales. Information was collected on 1998-99 resistance data for invasive isolates of S. pneumoniae to penicillin, based on surveillance data from EARSS and on outpatient sales during 1997 for beta-lactam antibiotics and macrolides. Our results show that in Europe antimicrobial resistance of S. pneumoniae to penicillin is correlated with use of beta-lactam antibiotics and macrolides.