Suchergebnisse

Genetic testing has far-reaching consequences, not only in terms of immediate patient management and the wider implications for the patient and their families, but also with respect to disclosure to insurance companies. The focus of this review is the controversial but important topic of the use of genetic data in private medical insurance. We discuss the current legal regulation of genetic data in the context of Swiss insurance, what type(s) of information is relevant to insurance companies, and why 'genetic exceptionalism' (the notion that genetic data has special status) persists. Furthermore, we discuss the sensitive area of handling genetic data from children. The consequences of legal regulation of disclosure of genetic information are considered, particularly from the economic perspective. Finally, we examine how legal conditions correspond to current insurance practice and contrast the Swiss system with the handling of genetic data in other countries in the context of private insurance. Switzerland has adopted fairly 'laissez-faire' regulations compared to other countries, and the public need education on the potential effects of genetic testing on their insurance, especially with respect to direct-to-consumer genetic testing, where there is no consultation from a qualified doctor, or when minors are involved.

The poor perception of the benefits of vaccines, and their subsequent underuse, can result in substantial economic, societal, and political burden. Adequate support and communication from health authorities and governments is essential to promote the benefits of vaccination and reduce the risk of infectious diseases outbreaks. Cost-containment policies in the vaccine procurement processes could also be a threat to the long-term sustainability of the vaccine industry and manufacturing sites in Europe. Biologicals, such as vaccines, are highly technical and complex products to manufacture and only a few industries are engaged in this activity. Developing incentives to encourage vaccine manufacturers and identifying means of taking into consideration the specificities of vaccines in economic evaluations could allow the full value of vaccination to be appreciated. In conclusion, governments, international agencies, and other stakeholders have an important role to play to help society regain confidence in vaccination and ensure that the benefits of vaccination programmes are fully recognised and valued.

Abstract Background Only limited data exist on the costs of genital herpes (GH) in the USA. We estimated the economic burden of GH in the USA using two different costing approaches. Methods The first approach was a cross-sectional survey of a sample of primary and secondary care physicians, analyzing health care resource utilization. The second approach was based on the analysis of a large administrative claims data set. Both approaches were used to generate the number of patients with symptomatic GH seeking medical treatment, the average medical expenditures and estimated national costs. Costs were valued from a societal and a third party payer's perspective in 1996 US dollars. Results In the cross-sectional study, based on an estimated 3.1 million symptomatic episodes per year in the USA, the annual direct medical costs were estimated at a maximum of $984 million. Of these costs, 49.7% were caused by drug expenditures, 47.7% by outpatient medical care and 2.6% by hospital costs. Indirect costs accounted for further $214 million. The analysis of 1,565 GH cases from the claims database yielded a minimum national estimate of $283 million direct medical costs. Conclusions GH appears to be an important public health problem from the health economic point of view. The observed difference in direct medical costs may be explained with the influence of compliance to treatment and possible undersampling of subpopulations in the claims data set. The present study demonstrates the validity of using different approaches in estimating the economic burden of a specific disease to the health care system.

Vaccine policy, decision processes and outcomes vary widely across Europe. The objective was to map these factors across 16 European countries by assessing (A) national vaccination strategy and implementation, (B) attributes of healthcare vaccination systems, and (C) outcomes of universal mass vaccination (UMV) as a measure of how successful the vaccination policy is.These findings reflect an individual approach to vaccination by country. High VCRs can be achieved, particularly for paediatric vaccinations, despite different approaches, targets and reporting systems; these are not replicated in vaccines for other age groups in the same country. Additional measures to improve VCRs across all age groups are needed and could benefit from greater harmonisation in target setting, vaccination data collection and sharing across EU countries.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20-30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20-30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20–30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/ private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.

Recent advances in biomedicine are opening the door to new approaches, and treatment and prevention are being transformed by novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products, and combinations of a medical device with embedded cell or tissue components. These advanced therapy medicinal products (ATMPs) hold one of the keys to making a reality of genuinely personalised medicine. There are an estimated 450 companies across the globe working on the development of gene therapies and more than 1,000 clinical trials underway worldwide, and some 20–30 new ATMPs filings are expected in Europe annually over the next 5 years. But challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment. Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncertainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regulatory and market access framework for these products, focused development of data, public/private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies. This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data and patient registries or standardisation of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs.