Cost calculation for a flash glucose monitoring system for UK adults with type 1 diabetes mellitus receiving intensive insulin treatment.

AIMS: To estimate the costs associated with a flash glucose monitoring system as a replacement for routine self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) using intensive insulin, from a UK National Health Service (NHS) perspective. METHODS: The base-case cost calculation was created using the maximum frequency of glucose monitoring recommended by the 2015 National Institute for Health and Care Excellence guidelines (4-10 tests per day). Scenario analyses considered SMBG at the frequency observed in the IMPACT clinical trial (5.6 tests per day) and at the frequency of flash monitoring observed in a real-world analysis (16 tests per day). A further scenario included potential costs associated with severe hypoglycaemia. RESULTS: In the base case, the annual cost per patient using flash monitoring was £234 (19%) lower compared with routine SMBG (10 tests per day). In scenario analyses, the annual cost per patient of flash monitoring compared with 5.6 and 16 SMBG tests per day was £296 higher and £957 lower, respectively. The annual cost of severe hypoglycaemia for flash monitoring users was estimated to be £221 per patient, compared with £428 for routine SMBG users (based on 5.6 tests/day), corresponding to a reduction in costs of £207. CONCLUSIONS: The flash monitoring system has a modest impact on glucose monitoring costs for the UK NHS for patients with T1DM using intensive insulin. For people requiring frequent tests, flash monitoring may be cost saving, especially when taking into account potential reductions in the rate of severe hypoglycaemia.

InnovaSEC in Action: Cost-effectiveness of Barostim in the Treatment of Refractory Hypertension in Spain.

INTRODUCTION AND OBJECTIVES: In Spain, 0.3% of patients with hypertension are refractory to conventional treatment. The complications resulting from deficient control of this condition can lead to poor quality of life for the patient and considerable health care costs. Barostim is an implantable device designed to lower blood pressure in these patients. The aim of this study was to analyze the cost-effectiveness of Barostim compared with drug therapy in hypertensive patients refractory to conventional treatment (at least 3 antihypertensive drugs, including 1 diuretic agent). METHODS: We used a Markov model adapted to the epidemiology of the Spanish population to simulate the natural history of a cohort of patients with refractory hypertension over their lifetime. Data on the effectiveness of the treatments studied were obtained from the literature, and data on costs were taken from hospital administrative databases and official sources. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Barostim increased the number of quality-adjusted life years by 0.78 and reduced the number of hypertension-associated clinical events. The incremental cost-effectiveness ratio in a cohort of men reached 68 726 euros per year of quality-adjusted life. One of the main elements that makes this technology costly is the need for battery replacement. The results were robust. CONCLUSIONS: Barostim is not a cost-effective strategy for the treatment of refractory hypertension in Spain. The cost-effectiveness ratio could be improved by future reductions in the cost of the battery.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Medical device procurement in low- and middle-income settings: protocol for a systematic review.

BACKGROUND: Medical device procurement processes for low- and middle-income countries (LMICs) are a poorly understood and researched topic. To support LMIC policy formulation in this area, international public health organizations and research institutions issue a large body of predominantly grey literature including guidelines, manuals and recommendations. We propose to undertake a systematic review to identify and explore the medical device procurement methodologies suggested within this and further literature. Procurement facilitators and barriers will be identified, and methodologies for medical device prioritization under resource constraints will be discussed. METHODS/DESIGN: Searches of both bibliographic and grey literature will be conducted to identify documents relating to the procurement of medical devices in LMICs. Data will be extracted according to protocol on a number of pre-specified issues and variables. First, data relating to the specific settings described within the literature will be noted. Second, information relating to medical device procurement methodologies will be extracted, including prioritization of procurement under resource constraints, the use of evidence (e.g. cost-effectiveness evaluations, burden of disease data) as well as stakeholders participating in procurement processes. Information relating to prioritization methodologies will be extracted in the form of quotes or keywords, and analysis will include qualitative meta-summary. Narrative synthesis will be employed to analyse data otherwise extracted. The PRISMA guidelines for reporting will be followed. DISCUSSION: The current review will identify recommended medical device procurement methodologies for LMICs. Prioritization methods for medical device acquisition will be explored. Relevant stakeholders, facilitators and barriers will be discussed. The review is aimed at both LMIC decision makers and the international research community and hopes to offer a first holistic conceptualization of this topic.

Cost analysis of integrating the PrePex medical device into a voluntary medical male circumcision program in Zimbabwe.

BACKGROUND: Fourteen African countries are scaling up voluntary medical male circumcision (VMMC) for HIV prevention. Several devices that might offer alternatives to the three WHO-approved surgical VMMC procedures have been evaluated for use in adults. One such device is PrePex, which was prequalified by the WHO in May 2013. We utilized data from one of the PrePex field studies undertaken in Zimbabwe to identify cost considerations for introducing PrePex into the existing surgical circumcision program. METHODS AND FINDINGS: We evaluated the cost drivers and overall unit cost of VMMC at a site providing surgical VMMC as a routine service ("routine surgery site") and at a site that had added PrePex VMMC procedures to routine surgical VMMC as part of a research study ("mixed study site"). We examined the main cost drivers and modeled hypothetical scenarios with varying ratios of surgical to PrePex circumcisions, different levels of site utilization, and a range of device prices. The unit costs per VMMC for the routine surgery and mixed study sites were $56 and $61, respectively. The two greatest contributors to unit price at both sites were consumables and staff. In the hypothetical scenarios, the unit cost increased as site utilization decreased, as the ratio of PrePex to surgical VMMC increased, and as device price increased. CONCLUSIONS: VMMC unit costs for routine surgery and mixed study sites were similar. Low service utilization was projected to result in the greatest increases in unit price. Countries that wish to incorporate PrePex into their circumcision programs should plan to maximize staff utilization and ensure that sites function at maximum capacity to achieve the lowest unit cost. Further costing studies will be necessary once routine implementation of PrePex-based circumcision is established.

[Real per capita health spending by age and sex in Spain (1998-2008): changes and effects on public healthcare expenditure projections]. / Evolución de la prestación real media en España por edad y sexo (1998-2008) y su repercusión en las proyecciones de gasto sanitario público.

OBJECTIVES: To analyze changes in real per capita spending by age and sex from 1998 to 2008 in Spain, and to assess their effects on public healthcare expenditure projections. METHODS: Age- and sex-related expenditure profiles in constant terms were estimated for the Spanish population for 3 distinct years (1998, 2003 and 2008) by using data from hospital records and several National Health Surveys. These profiles were used to compare actual healthcare expenditure for 2003 and 2008 with the projections obtained by considering 1998 as the base year and by applying the methodology used by the Working Group on Aging of the European Union. RESULTS: The average annual growth rate of real per capita spending per person from 1998 to 2008 was 2.79%, which was higher than the GDP per capita growth rate (1.90%), basically due to its high rate of increase in the second half of the decade. From 1998 to 2008, per capita healthcare expenditure increased in most age groups, particularly in the groups aged 45-49 years, 60-64 years and 75 years and older. Projections of per capita expenditure in constant terms covered the real value observed for 2003, but were below the real value for 2008. CONCLUSIONS: Changes in the quantity and quality of healthcare services consumed by each person are an important factor in changes in healthcare expenditure and must be included in spending projections.

Trends in home phototherapy adoption in the US: monetary disincentives are only the tip of the iceberg.

There are often multiple hurdles that must be crossed to obtain home phototherapy devices. To identify these obstacles, we examined survey data from the National Biological Corporation on patients who never acquired a home unit after being given a prescription from their doctors. Additionally, physicians' prescribing patterns were assessed from data gathered by IMS Health. Physician education of and willingness to prescribe home phototherapy was assessed via a survey distributed at the 9th Annual Dermatology Chief Residents' Meeting. When psoriasis patients were written a prescription for home phototherapy, less than half acquired a unit. Most patients (72%) stated that they did not get a unit secondarily to the high out-of-pocket expenses. In 2006, dermatologists wrote 94,385 new scripts for etanercept, compared with only 1073 scripts for home phototherapy. Very few (35%) dermatology residents receive formal training on home phototherapy. When it comes to the reasons behind patients receiving significantly more expensive biologics instead of home phototherapy for their psoriasis, high copays and deductibles are just the tip of the iceberg. It is likely that even more patients are never prescribed a home unit due to lack of physician training or frustration with meager and often inadequate reimbursements from insurance.

[Assessment of benefit and efficiency of innovative medical devices]. / Nutzen- und Wirtschaftlichkeitsbewertung der biomedizinischen Technik.

Medical devices cover a wide spectrum of products with very different diagnostic and therapeutic applications. However, for market licensing, uniform rules apply. Uniform rules are also valid for coverage decisions in German health care. In this article, the criteria for the assessment of benefit and efficiency of innovative biomedical technologies are described from the perspective of the statutory health insurance system. The key concepts relevant in the mandatory health insurance' "innovation"' "benefit", and "economic efficiency" are characterized. Only measurable effects of an intervention which lead to a more than marginal improvement in prognosis, symptoms, or quality of life as compared to a standard treatment are considered as beneficial. An innovative device is, therefore, subject to a benefit assessment if it is not yet reimbursed (or not yet part of the benefit package), when it is relevant to the health care system and a high public interest exists. In addition, it is important to consider a positive benefit assessment as a part of the value added chain to avoid conflicts of interest. Within the scope of early technology assessment, some conclusions can already be drawn in the early developmental stage of a device.

Sustainable universal salt iodization in low-income countries - time to re-think strategies?

OBJECTIVE: Sustained iodine deficiency control requires sustainable mechanisms for iodine supplementation. We aim to describe the status of salt iodation machines, salt producers' experiences and quality of salt produced in Tanzania. METHODS: Qualitative and quantitative data was collected from the factory sites, observations were made on the status of UNICEF-supplied assisted-iodation machines and convenience samples of salt from 85 salt production facilities were analysed for iodine content. RESULTS: A total of 140 salt works visited had received 72 salt iodation machines in 1990s, but had largely abandoned them due to high running and maintenance costs. Locally devised simple technology was instead being used to iodate salt. High variability of salt iodine content was found and only 7% of samples fell within the required iodation range. CONCLUSION: Although iodine content at factory level is highly variable, overall iodine supply to the population has been deemed largely sufficient. The need for perpetual iodine fortification requires reassessment of salt iodation techniques and production-monitoring systems to ensure sustainability. The emerging local technologies need evaluation as alternative approaches for sustaining universal salt iodation in low-income countries with many small-scale salt producers.

Biobanking for better healthcare.

Translational cancer research is highly dependent of large series of cases including high quality samples and their associated data. Comprehensive Cancer Centers should be involved in networks to enable large-scale multi-center research projects between the centers [Ringborg, U., de Valeriola, D., van Harten, W., Llombart-Bosch, A., Lombardo, C., Nilsson, K., Philip, T., Pierotti, M.A., Riegman, P., Saghatchian, M., Storme, G., Tursz, T., Verellen, D, 2008. Improvement of European translational cancer research. Collaboration between comprehensive cancer centers. Tumori 94, 143-146.]. Combating cancer knows many frontiers. Research is needed for prevention as well as better care for those who have acquired the disease. This implies that human samples for cancer research need to be sourced from distinct forms of biobanking. An easier access to these samples for the scientific community is considered as the main bottleneck for research for health, and biobanks are the most adequate site to try to resolve this issue [Ozols, R.F., Herbst, R.S., Colson, Y.L., Gralow, J., Bonner, J., Curran Jr., W.J., Eisenberg, B.L., Ganz, P.A., Kramer, B.S., Kris, M.G., Markman, M., Mayer, R.J., Raghavan, D., Reaman, G.H., Sawaya, R., Schilsky, R.L., Schuchter, L.M., Sweetenham, J.W., Vahdat, L.T., Winn, R.J., and the American Society of Clinical Oncology, 2007. Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening: a report from the American Society of Clinical Oncology. J. Clin. Oncol. 25, 146-162.]. However, biobanks should not be considered a static activity. On the contrary, biobanking is a young discipline [Morente, M.M., Fernandez, P.L., de Alava, E. Biobanking: old activity or young discipline? Semin. Diagn. Pathol., in press.], which need continuously evolve according to the permanent development of new techniques and new scientific goals. To accomplish current requirements of the scientific community biobanks need to face some essential challenges including an appropriate design, harmonized and more suitable procedures, and sustainability, all of them in the framework of their ethic, legal and social dimensions. This review therefore presents an overview on these issues, based on the works and discussions of the Marble Arch International Working Group on Biobanking for Biomedical Research, integrated by experts in biobanking from five continents.

Creating a multisensory environment for dementia: the goals of a Snoezelen room.

The MR provides a means for a variety of sensory experiences that can increase the quality of life for an individual with dementia. It is an example of an innovative approach to meeting the social and recreational needs of individuals with dementia. In addition, the MR enables staff and family members to communicate and build relationships with residents on a new and different level.

Industry economics in the United States.

Demand for medical equipment in the United States (US) is projected to grow by 8% between 2001 and 2006, to reach 105 billion dollars. In 2001,the market was valued at 71.4 billion dollars, based on an annual growth of 7.5% between 1996 and 2001, according to The Freedonia Group. Product innovation and the growing ageing population is driving the industry, despite health-care cost containment measures. Medical and surgical instruments continue to be the largest sector, which is expected to grow to 30.5 billion dollars in 2006. However, electromedical/electrotherapeutic apparatus will remain the fastest growing sector, with annual gains of 10.8% predicted for this period.