Insights into insurance coverage for digital therapeutics: A qualitative study of US payer perspectives.

BACKGROUND: In the last decade there has been an increase in the development and marketing of digital therapeutic (DTx) products aiming to prevent, manage, or treat a medical disorder or disease. Health insurance coverage for these products is not well established, and payers are facing increasing pressure to include these products as a covered benefit. OBJECTIVE: To examine factors and characteristics that could drive health insurance coverage of DTx products from US payers' and coverage decision-makers' perspectives. METHODS: This was a qualitative noninterventional, cross-sectional study conducted from August 2022 to October 2022. Virtual focus group meetings with pharmacy benefit managers/directors or medical directors representing a range of health insurance organizations were held following a semistructured interview guide. Convenience and snowball sampling techniques were used to identify participants. Transcripts were coded and analyzed with Atlas.ti software to identify common themes and subthemes. RESULTS: Five focus group meetings and 1 individual interview were held from August to October 2022. Participants (n = 22) were mostly pharmacists (n = 18, 85%) with more than 15 years of experience (n = 18, 85%). Some participants indicated that DTx products for diabetes (n = 6, 29%), mental/behavioral health (n = 3, 14%), and substance abuse disorders (n = 3, 14%) were already covered by their organizations. The topics generating the most comments grouped by code were issues around the evidence for DTx (67 unique comments) and barriers for coverage (60 unique comments). Participants indicated they want to have evidence of effectiveness that is similar to traditional pharmaceutical products. Barriers for coverage included a need to revise benefit policies, exclusion of nonprescription products, and mechanisms for billing. DTx products with an indication for mental/behavioral health were viewed as most likely to be reimbursed. Coverage of DTx products may occur under either the pharmacy or medical benefit. CONCLUSIONS: Health care payers stated that evidence of effectiveness was a necessary condition for health insurance coverage of DTx products. Given these are relatively new in health care, payers had more questions than answers regarding how these products will be integrated into health benefits.

Network meta-analysis and cost-effectiveness analysis of infliximab, cyclosporine and tacrolimus for ulcerative colitis.

BACKGROUND: Assess the efficiency and cost-effectiveness of infliximab, cyclosporine and tacrolimus for the treatment of ulcerative colitis (UC). METHODS: A literature search identified studies that investigated infliximab, cyclosporine or tacrolimus compared with placebo in UC patients. Short-term, long-term remission rates and response rates were employed to assess efficacy. Odds ratios with 95% confidence intervals were analyzed. A Markov model was constructed to simulate the progression in a cohort of patients with UC, with an over 10 years of time horizon, with a discount rate of 3%, and established threshold of €30,000/quality-adjusted life-year (QALY) or ¥82442/QALY. RESULTS: Results of network meta-analysis showed that the order was cyclosporine, tacrolimus, infliximab and placebo from high rate to low with regard to short-term clinical response. The comparison between infliximab versus cyclosporine achieved an incremental cost effectiveness ratio (ICER) of €184435/QALY and ¥531607/QALY, with a 0.34893 QALYs difference of efficacy, and an incremental cost of €64355 and ¥185494. Tacrolimus versus cyclosporine reached an ICER of €44236/QALY and ¥57494/QALY, with a difference of 0.40963 QALYs in efficacy, and a raising cost to €18120 and ¥23551. The probabilistic sensitivity analysis shows that cyclosporine would be cost-effective in the 75.8% of the simulations, tacrolimus in the 24.2%, and infliximab for the 0%. CONCLUSION: Infliximab, cyclosporine and tacrolimus as salvage therapies are efficacious. For long-term of clinical remission, the order of pharmacological agents was tacrolimus, infliximab and cyclosporine from high efficacy to low while no significant difference is seen. In cost-effectiveness analysis, the cyclosporine versus infliximab or tacrolimus is expected to be at best.

Exploring human health risk assessment based on the screening of primary targeted metal and chemical balance simulation of ionic speciation in an industrial area, China.

A comprehensive human health risk assessment methodology based on major hazard element screening and morphological evolution simulation is proposed. The primary targeted metal (PTM) screened by classical health risk assessment was introduced into chemical balance simulation to obtain speciation distribution and corresponding risk. According to the results of risk assessment of morphological evolution of primary targeted metal (PTM), a potential methodology for the remediation is proposed, which could reduce the risk level efficiently and quickly by changing the pH of soil environment with additional acid and alkali substances. A case study was performed in a dye factory in Suzhou city, Jiangsu Province, China. The results of classical health risk assessment showed that the regional health risk index for children exceeded tolerance value of 1, in which Cr accounted for high risk level of 61%. Chemical balance simulation results showed that CrO42- and CaCrO4 had the highest risk index, and the change of pH value would affect the proportion of CrO42- and CaCrO4 in Cr6+ ionic speciation, which may indirectly change the risk level. It is recommended to adjust the pH of the soil environment to quickly reduce regional human health risk. This study will provide a theoretical basis for public health protection and site restoration management.

Global supply-chain effects of COVID-19 control measures.

Countries have sought to stop the spread of coronavirus disease 2019 (COVID-19) by severely restricting travel and in-person commercial activities. Here, we analyse the supply-chain effects of a set of idealized lockdown scenarios, using the latest global trade modelling framework. We find that supply-chain losses that are related to initial COVID-19 lockdowns are largely dependent on the number of countries imposing restrictions and that losses are more sensitive to the duration of a lockdown than its strictness. However, a longer containment that can eradicate the disease imposes a smaller loss than shorter ones. Earlier, stricter and shorter lockdowns can minimize overall losses. A 'go-slow' approach to lifting restrictions may reduce overall damages if it avoids the need for further lockdowns. Regardless of the strategy, the complexity of global supply chains will magnify losses beyond the direct effects of COVID-19. Thus, pandemic control is a public good that requires collective efforts and support to lower-capacity countries.

Effects of perioperative supplementation with pro-/synbiotics on clinical outcomes in surgical patients: A meta-analysis with trial sequential analysis of randomized controlled trials.

BACKGROUND & AIMS: The Potential benefits and possible risks of perioperative supplementation with probiotics/synbiotics in surgical patients are not fully understood. Recent evidence has rapidly evolved and conveys conflicting results. Thus, we undertook a meta-analysis of randomized controlled trials (RCTs) to valuate the effectiveness, safety, cost-effectiveness and quality of life of perioperative supplementation with pro-/synbiotics. METHODS: We systematically searched PubMed, Embase and the Cochrane Library through October 2015 to identify RCTs that assessed the effects of perioperative supplementation with pro-/synbiotics in surgical patients. The predefined primary efficacy outcome was surgical site infection (SSI). Random-effects model was applied to pool outcome data accounting for clinical heterogeneity. RESULTS: Our meta-analysis included data from 34 trials comprising 2634 participants, of whom 1300 received perioperative pro-/synbiotics intervention and 1334 received valid control treatment. Compared with the control group, patients in the pro-/synbiotics group had a lower risk of SSI (relative risk: 0.65; 95% confidence interval: 0.51, 0.84; P = 0.0007). Trial sequential analysis confirmed the evidence was sufficient and conclusive. Subgroup analyses indicated the findings were consistent in all subgroup analyses except for the probiotics, enteral feeding, pre-/postoperative and live transplantation subgroups. Pro-/synbiotics also reduced the incidence of other infectious complications (including any infection, pneumonia, urinary tract infection, wound infection and sepsis); shortened antibiotic therapy, intensive care unit stay and hospital stay; and promoted earlier first defecation and first bowel movement. Pro-/synbiotics further reduced the incidence of abdominal side effects, lowered hospital costs and improved the Gastro-Intestinal Quality of Life. CONCLUSIONS: For surgical patients, perioperative supplementation with pro-/synbiotics is effective in preventing or controlling SSI and other infectious complications. Perioperative pro-/synbiotics might also be associated with fewer side effects, lower hospital cost and better quality of life. Current evidence indicated that perioperative synbiotics supplementation is preferred and recommended as an adjunct in surgical patients.

Stakeholder views on financing carbon capture and storage demonstration projects in China.

Chinese stakeholders (131) from 68 key institutions in 27 provinces were consulted in spring 2009 in an online survey of their perceptions of the barriers and opportunities in financing large-scale carbon dioxide capture and storage (CCS) demonstration projects in China. The online survey was supplemented by 31 follow-up face-to-face interviews. The National Development and Reform Commission (NDRC) was widely perceived as the most important institution in authorizing the first commercial-scale CCS demonstration project and authorization was viewed as more similar to that for a power project than a chemicals project. There were disagreements, however, on the appropriate size for a demonstration plant, the type of capture, and the type of storage. Most stakeholders believed that the international image of the Chinese Government could benefit from demonstrating commercial CCS and that such a project could also create advantages for Chinese companies investing in CCS technologies. In more detailed interviews with 16 financial officials, we found striking disagreements over the perceived risks of demonstrating CCS. The rate of return seen as appropriate for financing demonstration projects was split between stakeholders from development banks (who supported a rate of 5-8%) and those from commercial banks (12-20%). The divergence on rate alone could result in as much as a 40% difference in the cost of CO(2) abatement and 56% higher levelized cost of electricity based on a hypothetical case study of a typical 600-MW new build ultrasupercritical pulverized coal-fired (USCPC) power plant. To finance the extra operational costs, there were sharp divisions over which institutions should bear the brunt of financing although, overall, more than half of the support was expected to come from foreign and Chinese governments.