The aim of this study is to evaluate the range, quality and availability of diagnostic services for non-viral sexually transmitted infections (STIs), i.e. C. trachomatis, N. gonorrhoeae, T. vaginalis and T. pallidum, in Lithuania from September 2002 to December 2003. Surveillance data describing the organisation and performance characteristics of non-viral STI diagnostic services in Lithuania were collected using a questionnaire and subsequent site-visits. International evidence-based recommendations for non-viral STI diagnosis were used to evaluate the quality of the STI diagnostics. There were 171 facilities providing non-viral STI diagnostic services for the 3.5 million inhabitants of Lithuania. However, only 6% (n=9) of the respondents (n=153) could provide a confirmatory diagnosis, in accordance with international recommendations, for the full minimum range of relevant non-viral STIs in Lithuania, i.e. C. trachomatis, N. gonorrhoeae, T. pallidum, and T. vaginalis. In addition, accessibility to STI diagnostic services differed significantly among the different counties in Lithuania. Several of the respondents analysed low numbers of samples each year, and overall the sampling size was extremely low, especially for C. trachomatis diagnostics. In Lithuania, optimisation of non-viral STI diagnostics as well as of epidemiological surveillance and management of STIs is crucial. It may be worth considering a decrease in the number of laboratories, with those remaining having the possibility of performing STI diagnostic services that are optimised, in concordance with international recommendations, standardised, and quality assured using systematic internal and external quality controls and systems. In addition, establishment of national inter-laboratory networks and reference centres for non-viral STIs is recommended.
Background and Objective Enthusiasm for the use of outcomes-based managed entry agreements (OBMEAs) to manage uncertainties apparent at the time of appraisal/pricing and reimbursement of new medicines has waned over the past decade, as challenges in establishment, implementation and re-appraisal have been identified. With the recent advent of innovative treatments for rare diseases that have uncertainties in the clinical evidence base, but which could meet a high unmet need, there has been renewed interest in the potential of OBMEAs. The objective of this research was to review the implementation of OBMEAs for two case studies across countries in the European Union, Australia and Canada, to identify good practices that could inform development of tools to support implementation of OBMEAs. Methods To investigate how OBMEAs are being implemented with rare disease treatments, we collected information from health technology assessment/payer experts in countries that had implemented OBMEAs for either nusinersen in spinal muscular atrophy or tisagenlecleucel in two cancer indications. Operational characteristics of the OBMEAs that were publicly available were documented. Then, the experts discussed issues in implementing these OBMEAs and specific approaches taken to overcome challenges. Results The OBMEAs identified were based on individual outcomes to ensure appropriate use, manage continuation of treatment and in two cases linked to payment schedules, or they were population based, coverage with evidence development. For nusinersen, population-based OBMEAs are documented in Belgium, England and the Netherlands and individual-based schemes in Bulgaria, Ireland, Italy and Lithuania. For tisagenlecleucel, there were population-based schemes in Australia, Belgium, England and France and individual-based schemes in Italy and Spain. Comparison of the OBMEA constructs showed some clear published frameworks and clarity of the uncertainties to be addressed that were similar across countries. Agreements were generally made between the marketing authorisation holder and the payer with involvement of expert physicians. Only England and the Netherlands involved patients. Italy used its long-established, national, web-based, treatment-specific data collection system linked to reimbursement and Spain has just developed such a national treatment registry system. Other countries relied on a variety of data collection systems (including clinical registries) and administrative data. Durations of agreements varied for these treatments as did processes for interim reporting. The processes to ensure data quality, completeness and sufficiency for re-analysis after coverage with evidence development were not always clear, neither were analysis plans. Conclusions These case studies have shown that important information about the constructs of OBMEAs for rare disease treatments are publicly available, and for some jurisdictions, interim re...
The aims of this study were to compare performance characteristics and cost-effectiveness of pooling urine samples for screening and diagnosis of Chlamydia trachomatis using Digene Hybrid Capture II CT/NG Test (HCII), and to examine the prevalence of C. trachomatis in male military recruits in Lithuania. A total of 410 urine samples were individually tested and pooled by 5 and 10 samples, respectively. The sensitivity and specificity of diagnosis were not affected by either pooling strategy. The estimated population prevalence of C. trachomatis infection was nearly identical, i.e. 4.4%, 4.4% and 4.1% based on individually tested samples, and samples pooled by 5 and 10, respectively. For this estimation of the population prevalence, pooling 5 samples reduced the costs by 80% and pooling 10 samples reduced the costs by 90%. For diagnosis of each individual sample, the pooling strategies resulted in cost savings of 60% (5 samples per pool) and 56% (10 samples per pool). The present pooling strategies were sensitive, specific and cost-efficient for screening and diagnosis of C. trachomatis infection in male military recruits in Lithuania. The strategies would be most useful for reasonably inexpensive large-scale screening, prevalence studies and even diagnostics in Lithuania and many other low-resource countries.
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