The different clinical guideline standards in Brazil: High cost treatment diseases versus poverty-related diseases.

Each year, evidence-based clinical guidelines gain more space in the health professionals' practice and in services organization. Due to the scarcity of scientific publications focused on diseases of poverty, the development of well-founded clinical guidelines becomes more and more important. In view of that, this paper aims to evaluate the quality of Brazilian guidelines for those diseases. The AGREE II method was used to evaluate 16 guidelines for poverty-related diseases (PRD) and 16 guidelines for global diseases whose treatment require high-cost technologies (HCD), with the ultimate aim of comparing the results. It was found that, in general, the guideline development quality standard is higher for the HCD guidelines than for the PRD guidelines, with emphasis on the "rigour of development" (48% and 7%) and "editorial independence" (43% and 1%) domains, respectively, which had the greatest discrepancies. The HCD guidelines showed results close to or above international averages, whereas the PRD guidelines showed lower results in the 6 domains evaluated. It can be concluded that clinical protocol development priorities need some redirecting in order to qualify the guidelines that define the healthcare organization and the care of vulnerable populations.

Surviving niche busters: Main strategies employed by Canadian private insurers facing the arrival of high cost specialty drugs.

The Canadian patchwork system of prescription drug coverage and the employer sponsored private health benefits group plans appear vulnerable to cost growth due to insufficient balance of power between fragmented public and private buyers, and pharmaceutical manufacturers. The emergence of "bad" insurance risks caused by new and very expensive treatments featuring high cost specialty medicines - also known as niche buster drugs - exposes this vulnerability. This study fills a gap in knowledge by seeking to better understanding how Canadian private insurers face the arrival of specialty pharmaceuticals. It completes an overview of a body of grey literature composed of publicly available online articles from the employment benefits and group insurance consulting and administration industry; online documents from group benefits sector conferences; and online or on demand materials from Canadian life and health insurers. Claims for high cost specialty drugs generate new bad insurance risks that Canadian health insurers attempt to mitigate through isolated corporate initiatives, industry-wide strategies and calls for universal, public catastrophic coverage. The outcomes of these strategies are limited cost-control measures as well as risk and cost transfers onto plan sponsors, patients and provincial public programs.

Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access.

Cellular therapies and other regenerative medicines are emerging as potentially transformative additions to modern medicine, but likely at a staggering financial cost. Public health care systems' budgets are already strained by growing and aging populations, and many private insurer's budgets are equally stretched. The current systems that most payers employ to manage their cash flow are not structured to absorb a sudden onslaught of very expensive prescriptions for a large portion of their covered population. Despite this, developers of new regenerative medicines tend to focus on the demands of regulators, not payers, in order to be compliant throughout the clinical trials phases, and to develop a product that ultimately will be approvable. It is not advisable to assume that an approved product will automatically become a reimbursed product, as examples from current practice in hematopoietic stem cell transplantation in the U.S. demonstrate; similarly, in Europe numerous Advanced-therapy Medicinal Products achieved market authorization but failed to secure reimbursement (e.g., Glybera, Provenge, ChondroCelect, MACI). There are however strategies and approaches that developers can employ throughout clinical development, in order to generate clinical and health economic data which will be necessary to demonstrate the value proposition of the new product and help ensure market access for patients; furthermore, performance based managed entry agreements coupled with post-launch evidence generation can help overcome challenges around product uncertainty at launch and reduce market access delays. Stem Cells Translational Medicine 2017;6:1723-1729.

Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management.

We examined evidence on whether mobile health (mHealth) tools, including interactive voice response calls, short message service, or text messaging, and smartphones, can improve lifestyle behaviors and management related to cardiovascular diseases throughout the world. We conducted a state-of-the-art review and literature synthesis of peer-reviewed and gray literature published since 2004. The review prioritized randomized trials and studies focused on cardiovascular diseases and risk factors, but included other reports when they represented the best available evidence. The search emphasized reports on the potential benefits of mHealth interventions implemented in low- and middle-income countries. Interactive voice response and short message service interventions can improve cardiovascular preventive care in developed countries by addressing risk factors including weight, smoking, and physical activity. Interactive voice response and short message service-based interventions for cardiovascular disease management also have shown benefits with respect to hypertension management, hospital readmissions, and diabetic glycemic control. Multimodal interventions including Web-based communication with clinicians and mHealth-enabled clinical monitoring with feedback also have shown benefits. The evidence regarding the potential benefits of interventions using smartphones and social media is still developing. Studies of mHealth interventions have been conducted in >30 low- and middle-income countries, and evidence to date suggests that programs are feasible and may improve medication adherence and disease outcomes. Emerging evidence suggests that mHealth interventions may improve cardiovascular-related lifestyle behaviors and disease management. Next-generation mHealth programs developed worldwide should be based on evidence-based behavioral theories and incorporate advances in artificial intelligence for adapting systems automatically to patients' unique and changing needs.

[Brachytherapy in France: current situation and economic outlook due to the unavailability of iridium wires]. / Curiethérapie en France : état des lieux et perspectives économiques après l'arrêt de la commercialisation des fils d'iridium.

In 2013, about 6000 patients were treated with brachytherapy, the number diminishing by 2.6% per year since 2008. Prostate, breast and gynecological cancers are the most common types of cancers. Since 2008, the number of brachytherapy facilities has decreased by 18%. In medicoeconomic terms, brachytherapy faces many problems: the coding system is outdated; brachytherapy treatments cost as much as internal radiation; fees do not cover costs; since iridium wire has disappeared from the market, the technique will be transferred to more expensive high-speed or pulse dose rates. The French financing grid based on the national study of costs lags behind changes in such treatments and in the best of cases, hospitals resorting to alternatives such as in-hospital brachytherapy are funded at 46% of their additional costs. Brachytherapy is a reference technique. With intense pressure on hospital pricing, financing brachytherapy facilities will become even more problematic as a consequence of the disappearance of iridium 192 wires. The case of brachytherapy illustrates the limits of the French financing system and raises serious doubts as to its responsiveness.

[Clinical and economical comparison between in-house (Make) and outsourcing (Buy) management of the cardiac catheterization laboratory from two high-volume diagnostic and interventional centers: immediate and 6-month results]. / Confronto clinico ed economico tra gestione aziendale (Make) ed esternalizzata (Buy) del laboratorio di emodinamica di due centri ad elevato volume di procedure diagnostiche ed interventistiche coronariche: risultati immediati e a 6 mesi.

BACKGROUND: Percutaneous coronary interventions (PCI) are widespread procedures in the Italian Healthcare System, but concerns are raised about their economic sustainability. In the last decade, public hospitals have outsourced the PCI services (building and maintaining the technological instruments and the personnel) "buying" them from private companies (Buy) rather than building and maintaining them through public expenditure (Make). The aim of this study was to compare the economic and clinical impact of these two management solutions (Buy and Make) in two community hospitals located in the Turin metropolitan area (Italy). METHODS: We conducted: 1) a quantitative assessment in order to compare differences in the economic impact between Buy and Make for providing PCI; 2) a qualitative assessment comparing the clinical characteristics of two inpatient populations undergoing PCI and then analyzing the efficacy of the procedure in-hospital and at 6-month follow-up. RESULTS: Between January and June 2010, a total of 332 patients underwent PCI at the "degli Infermi" Hospital in Rivoli and 340 at the "Maria Vittoria" Hospital in Turin (Italy). There were no significant differences between the two populations neither about the clinical characteristics nor in procedural efficacy (either immediate or at follow-up). For 600 units of diagnostic-therapeutic pathway, the net present value at a discount rate of 3.5% of the Make project is higher than that of the Buy by €278.402,25, and is therefore the less convenient of the two solutions. The Buy solution is still the more convenient of the two at volumes <700 units. CONCLUSIONS: Our findings show that the Buy solution, if tailored to the specific local needs, provides access to sophisticated technology without making worse quality of services and may save capital expenditure below 700 PCI/years.

Navigating time and uncertainty in health technology appraisal: would a map help?

Healthcare systems are increasingly under pressure to provide funding for innovative technologies. These technologies tend to be characterized by their potential to make valued contributions to patient health in areas of relative unmet need, and have high acquisition costs and uncertainty within the evidence base on their actual impact on health. Decision makers are increasingly interested in linking reimbursement strategies to the degree of uncertainty in the evidence base and, as a result, reimbursement for innovative technologies is frequently linked to some form of patient access or risk-sharing scheme. As the dominant methods of economic evaluation report final outcomes only at the time horizon of the analysis, they present only aggregated information. This omits much of the information available on how net benefit is distributed within the time horizon. In this article, we introduce the Net Benefit Probability Map (NBPM), which maps net health benefit versus time to identify how certain decision makers can be about the benefit of technologies at multiple time points. Using an illustrative example, we show how the NBPM can inform decision makers about how long it will take for innovative technologies to 'pay off', how methodological choices on discount rates affect results and how alternative payment mechanisms can reduce the risk for decision makers facing innovative technologies.

[Robotic medicine in Germany: quo vadis?]. / Robotische Medizin in Deutschland: quo vadis?

Today, one can hardly imagine the medical daily routine without computer-assisted systems, although their benefit usually is not investigated by prospective randomised trials. While in the industrial working environment computer-assisted systems are thoroughly accepted because of their precision and endurance, in medicine there are fierce debates about their use at considerably high costs. At least the perioperative advantages (e.g. less blood loss, shorter period of hospitalization), to a large extent, are beyond dispute. The high costs may be compensated by a higher volume of treated patients. Only the treatment of a higher volume of patients will lead to a reduction of infrastructure costs per case. On the other hand, only a large number of cases ensure the achievement of skills to handle such a complex system. This, in return, reduces the chance of the occurrence of complications and shorter operation times will lead to economic advantages.

The potential impact of comparative effectiveness research on U.S. health care expenditures.

Comparative effectiveness research (CER) has the potential to slow health care spending growth by focusing resources on health interventions that provide the most value. In this article, we discuss issues surrounding CER and its implementation and apply these methods to a salient clinical example: treatment of prostate cancer. Physicians have several options for treating patients recently diagnosed with localized disease, including removal of the prostate (radical prostatectomy), treatment with radioactive seeds (brachytherapy), radiation therapy (IMRT), or--if none of these are pursued--active surveillance. Using a commercial health insurance claims database and after adjustment for comorbid conditions, we estimate that the additional cost of treatment with radical prostatectomy is $7,300, while other alternatives are more expensive--$19,000 for brachytherapy and $46,900 for IMRT. However a review of the clinical literature uncovers no evidence that justifies the use of these more expensive approaches. These results imply that if patient management strategies were shifted to those supported by CER-based criteria, an estimated $1.7 to $3.0 billion (2009 present value) could be saved each year.

Medicine as ecoculture.

The use of diagnostic tests, especially imaging studies, varies markedly across the United States-with higher costs but no better patient outcomes associated with the highest-use regions. A proposed new model of the health care system draws on an analogy with the ecosystem to explain the geographic variations in physician test ordering. This framework emphasizes the adaptability and interdependence of the components of the system. Patients and physicians are influenced by the health care organizations in their community, including the practice site in which the physician works, local hospitals, malpractice lawyers, and imaging centers. These are in turn influenced by institutions in society at large, including the media, health care plans, and the government. Further adaptations to the explanatory model account for the psychologic and sociologic aspects of physician behavior. Understanding the medical ecoculture is essential for effective health care reform because widely touted changes, such as the introduction of an electronic medical record or comparative effectiveness studies, do not address the adaptability and interdependence that characterize the medical ecoculture.

Does advanced medical technology encourage hospitalist use and their direct employment by hospitals?

In the United States, inpatient medical care increasingly encompasses the use of expensive medical technology and, at the same time, is coordinated and supervised more and more by a rapidly growing number of inpatient-dedicated physicians (hospitalists). In the production of inpatient care services, Hospitalist services can be viewed as complementary to sophisticated and expensive medical equipment in the provision of inpatient medical care. We investigate the causal relationship between a hospital's access to three types of sophisticated diagnostic and therapeutic medical equipment - intensity-modulated radiation therapy, gamma knife, and multi-slice computed tomography - and its likelihood of using hospitalists. To rule out omitted variables bias and reverse causality, we use technology-specific Certificate of Need regulation to predict technology use. We find a strong positive association, yet no causal link between access to medical technology and hospitalist use. We also study the choice of employment modality among hospitals that use hospitalists, and find that access to expensive medical technology reduces the hospital's propensity to employ hospitalists directly.

[Calculating the price of a new diagnostic or therapeutic option. Example of transurethral resection of bladder tumors using photodynamic diagnostics with hexaminolevulinic acid]. / Kalkulation einer neuen Untersuchungs- und Behandlungsmethode (NUB). Analyse am Beispiel der PDD-gestützten TUR-B mit Hexaminolävulinsäure.

New diagnostic or therapeutic options (NDTOs) are remunerated separately in the German DRG system. The Institute for Remuneration in Hospitals decides which proposed NDTOs are accepted for separate remuneration for 1 year. With this acceptance, hospitals can enter negotiations with insurance companies for an individual price of the NDTO. Because there are no general recommendations for these negotiations, we present a scheme for how to calculate an NDTO, based on the example of the NDTO for transurethral resection of bladder tumors using photodynamic diagnostic with hexaminolevulinic acid.

[A method for reassessment of cost-intensive cases in visceral surgery. Results of project by the German Society for Visceral Surgery]. / Methode zur Abbildung kostenintensiver Fälle in der Viszeralchirurgie. Ergebnisse des DRG-Projekts der Deutschen Gesellschaft für Viszeralchirurgie.

Since the introduction of diagnosis-related groups (DRGs) many surgical departments report inappropriate reimbursement for complex cases and a shift in costly cases. To evaluate this situation, the German Society for Visceral Surgery inaugurated the present cost calculation project. In three university hospitals for 50 cases each, we depicted possible cost separators and utilized the complete cost calculation data (so-called Paragraph 21 data set) to test these separators. We identified "admission from another hospital", "severe surgically relevant concomitant disease", and "reoperation during the same hospital admission". The last was considered the economically most significant and medically most valid factor and was submitted as a possible modification to the german DRG system. The proposed cost separator "reoperation during the same hospital admission" was introduced into the DRG system after validation and leads to better allocation of reimbursements to complex and costly cases.