Clinical and economic benefits of image-guided system in functional endoscopicsinus surgery: a retrospective chart review study in China.

BACKGROUND: Image-guided system (IGS) has been gradually applied in the field of rhinology, making functional endoscopic sinus surgery (FESS) a truly minimally invasive and precise surgery. This study was based on real-world data from China hospitals and aimed to evaluate the clinical and economic benefits of the IGS navigation system in FESS. METHODS: This was a two-center retrospective chart review of patients with chronic rhinosinusitis who underwent FESS, including open frontal sinus between July 1, 2018 and December 31, 2019 in China. The intervention group consisted of 100 patients who underwent FESS with the IGS navigation system (IGS group), and the control group consisted of 100 patients who underwent conventional FESS (Non-IGS group). Data were collected from surgical notes and hospital medical records. The primary endpoints for clinical effectiveness and safety were avoid rehospitalization due to bleeding, avoid reoperation due to bleeding, and avoid reoperation due to recurrence. RESULTS: There were no cases of rehospitalization due to bleeding, reoperation due to bleeding, and reoperation due to recurrence in the IGS group, with an avoidance rate of 100%. In the non-IGS group, there were four cases of rehospitalization and reoperation due to bleeding, with an avoidance rate 96.00% (P = 0.121). No cases of reoperation due to recurrence were in the non-IGS group. The total hospitalization cost was 17,391.51 CNY in the IGS group and 17,742.41 CNY in the non-IGS group per patient, with no statistical difference between the two groups (P = 0.715). Compared with the non-IGS group, the IGS group had an overall cost saving of 350.90 CNY per patient. Although the procedure-related medical costs of IGS group were increased by 1,286.12 CNY compared with the non-IGS group, this was more than offset by other costs. CONCLUSION: The results of the study indicated that the IGS may avoid occurrence of rehospitalization and reoperation due to postoperative bleeding. Although the use of navigation technology increased the cost of surgery, its clinical effectiveness brought other medical cost savings, resulting in no significant difference in the overall cost of navigation surgery compared to conventional surgery. The IGS should be considered cost-effectiveness in the treatment of FESS.

Ambient heat stress and urolithiasis attacks in China: Implication for climate change.

BACKGROUND: Although the existing studies have suggested a significant association between high temperatures and urolithiasis, no nationwide studies have quantified the burden attributable to environmental heat stress and explored how the urolithiasis burden would vary in a warming climate. METHODS: We collected data on urolithiasis attacks from 137 hospitals in 59 main cities from 20 provincial regions of China from 2000 to 2020. An individual-level case-crossover analysis was conducted to estimate the effect of daily wet-bulb globe temperature (WBGT), a heat stress index combining temperature and humidity, on urolithiasis attacks. Stratified analyses were performed by region, age, and sex. We further quantified the future WBGT-related burden of urolithiasis from the Coupled Model Intercomparison Project Phase 6 under three Shared Socioeconomic Pathway (SSP) scenarios. RESULTS: In total, 118,180 urolithiasis patients were evaluated. The exposure-response curve for the association between WBGT and urolithiasis attacks was J-shaped, with a significantly increased risk for WBGT higher than 14.8 °C. The middle-aged and elderly group (≥45 years old) had a higher risk of WBGT-related urolithiasis attacks than in the younger group, while no significant sex difference was observed. The attributable fraction (AF) due to high WBGT would increase from 10.1% in the 2010s to 16.1% in the 2090s under the SSP585 scenario. Warm regions were projected to experience disproportionately higher AFs and larger increments in the future. CONCLUSIONS: This nationwide investigation provides novel evidence on the acute effect of high WBGT on urolithiasis attacks and demonstrates the increasing disease burden in a warming climate.

Ambient air pollution and hospitalization for type 2 diabetes in China: A nationwide, individual-level case-crossover study.

Scarce evidence is available on the short-term association between air pollution and type 2 diabetes (T2D). We aimed to evaluate the associations between short-term exposure to six criteria air pollutants and hospitalization for T2D based on a national registry. We conducted an individual-level, time-stratified case-crossover study among inpatients with a primary diagnosis of T2D from 153 hospitals across 20 provincial regions in China (2013-2021). Daily concentrations of fine particulate matter (PM2.5), inhalable particle (PM10), nitrogen dioxide (NO2), sulfur dioxide (SO2) and carbon monoxide (CO), and ozone were collected from the nearest monitoring stations. T2D patients were separated into those admission for T2D with and without complications. Distributed lag non-linear models combined with conditional logistic regressions were used to estimate the associations. A total of 88,904 patients were hospitalized for T2D. Short-term exposures to all six air pollutants above except for ozone were significantly associated with the risk of hospitalization for T2D and both subclasses. An interquartile range increase in the concentrations of PM2.5, PM10, NO2, SO2, and CO at lag 0-2 d was associated with higher hospitalization risk of T2D by 1.71% (95%CI: 0.56%, 2.87%), 2.08% (0.88%, 3.29%), 4.85% (3.29%, 6.44%), 2.44% (1.22%, 3.67%) and 2.55% (1.24%, 3.88%), respectively. The associations of T2D hospitalizations were stronger in cold season than in warm season. Air pollutants had more acute and stronger associations with T2D with complications. The exposure-response relationship curves showed no thresholds, and the slopes were larger for T2D with complications. This nationwide individual-level, case-crossover study provides the first comprehensive evidence that short-term exposure to multiple criteria air pollutants may increase the risk of hospitalizations for T2D, especially for T2D with complications.

The impact of preloaded intraocular lens implantation system (TECNIS iTec®) in routine cataract surgery in China: a time-motion analysis.

OBJECTIVE: To evaluate the impact on surgical efficiency and labor time cost of preloaded intraocular lens (IOL) implantation system compared with manual IOL implantation system in age-related cataract surgery in China. METHODS: This study was an observational, multicenter, prospective time-motion analysis. IOL preparation time, operation time, cleaning time, number and cost of cataract surgeries in eight participating hospitals were collected. The linear mixed model was used to explore factors associated with the difference in operation time between the preloaded IOL implantation system and the manual IOL implantation system. A time-motion model was constructed to convert the operation time cost saved by using preloaded IOL into economic benefits from hospital and social perspective, respectively. RESULTS: There were 2,591 cases included in the study (preloaded IOL: 1,591 cases; manual IOL: 1,000 cases). The preloaded IOL implantation system was significant time-saving in both preparation time and operation time compared to the manual IOL implantation system (25.48s vs. 47.04s, P < 0.001 and 353.84s vs. 367.46s, P = 0.004, respectively). An average total of 35.18s can be saved by using preloaded IOL per procedure. The results of linear mixed model showed that the type of IOL was the main factor leading to the difference in preparation time between preloaded IOL and manual IOL implantation system. By switching from manual IOL to preloaded IOL, the model projected additional 392 surgeries can be performed each year and an increase in revenue of $565,282 per hospital, a 9% increase from hospital perspective. And the annual productivity loss saved by using preloaded IOL was $3,006 in eight hospitals from perspective of society. CONCLUSION: Compared with manual IOL implantation system, the preloaded IOL implantation system reduces lens preparation time and operation time, which increases potential surgical volume and revenue, and reduces the loss of work productivity. This study provides real-world evidence to support the advantages of the preloaded IOL implantation system in improving efficiency of ophthalmic surgery in China.

Ultrasonic surgical and electrosurgical system (USES) with conventional ultrasonic scalpel (CUS) in gastrectomy: a retrospective cohort study.

BACKGROUND: Harmonic ACE +7 Shears with Advanced Hemostasis is an upgraded ultrasonic device, an ultrasonic surgical and electrosurgical system (USES). The study aimed to evaluate the economic and clinical effectiveness of the USES compared with the conventional ultrasonic scalpel (CUS) in gastrectomy. METHODS: We conducted a single-center, retrospective cohort study using the electronic medical records in China. We collected intraoperative and postoperative data from gastric cancer patients who underwent the endoscope-assisted distal gastrectomy from 2018 to June 30, 2019. Procedure-related costs were estimated. We used linear regression by controlling a set of covariates to assess the effect of USES on outcomes. RESULT: Out of 87 eligible patients, the USES group (40 patients) and CUS group (47 patients) were comparable in terms of age, medical history and stages of cancer. Compared with the CUS, the USES saved 4.27 hemoclips per person (95% CI 0.57-7.97, p < 0.05) and 34.18 ml intraoperative blood per person (95% CI 8.74-59.62 ml, p < 0.05), respectively. Postoperative length of stay (LOS) was shorter in the USES group (7.90 ± 1.95 vs. 9.26 ± 2.81 days) but the difference was not statistically significant (p = 0.05). CONCLUSIONS: The USES group was associated with fewer hemoclips use and intraoperative blood loss in patients undergoing laparoscopic gastrectomy at comparable costs.

A head-to-head comparison of the EQ-5D-3L index scores derived from the two EQ-5D-3L value sets for China.

OBJECTIVE: Two EQ-5D-3L (3L) value sets (developed in 2014 and 2018) co-exist in China. The study examined the level of agreement between index scores for all the 243 health states derived from them at both absolute and relative levels and compared the responsiveness of the two indices. METHODS: Intraclass correlations coefficient (ICC) and Bland-Altman plot were adopted to assess the degree of agreement between the two indices at the absolute level. Health gains for 29,403 possible transitions between pairs of 3L health states were calculated to assess the agreement at the relative level. Their responsiveness for the transitions was assessed using Cohen effect size. RESULTS: The mean (SD) value was 0.427 (0.206) and 0.649 (0.189) for the 3L2014 and 3L2018 index scores, respectively. Although the ICC value showed good agreement (i.e., 0.896), 88.9% (216/243) of the points were beyond the minimum important difference limit according to the Bland-Altman plot. The mean health gains for the 29,403 health transitions was 0.234 (3L2014 index score) and 0.216 (3L2018 index score). The two indices predicted consistent transitions in 23,720 (80.7%) of 29,403 pairs. For the consistent pairs, Cohen effective size value was 1.05 (3L2014 index score) or 1.06 (3L2018 index score); and the 3L2014 index score only yielded 0.007 more utility gains. However, the results based on the two measures varied substantially according to the direction and magnitude of health change. CONCLUSION: The 3L2014 and 3L2018 index scores are not interchangeable. The choice between them is likely to influence QALYs estimations.

Treatment and economic burden of mucormycosis in China: Case report review and burden estimation.

WHAT IS KNOWN AND OBJECTIVE: Mucormycosis is an opportunistic fungal infection associated with low incidence but high mortality. Few studies have shown the treatment and disease burden of mucormycosis in China. This study aims at collecting all the reported cases to describe the characteristics and treatment patterns and to assess the economic burden of mucormycosis in China. METHODS: We conducted a literature review of mucormycosis case reports in Chinese patients to summarize the characteristics and treatment patterns of the disease in China. An economic model was built to evaluate the total cost of mucormycosis per person, including direct medical cost, direct non-medical cost and indirect cost. RESULTS AND DISCUSSION: A total of 676 case reports showed that the most common type of mucormycosis was pulmonary mucormycosis (299/676, 44.2%), and rhinocerebral mucormycosis had the highest case fatality rate (122/185, 68.5%). Among those who used empiric therapies, 48.8% (231/473) did not include anti-mucor drugs; 79.8% (336/421) of the therapies include amphotericin B (AMB) or AMB-lipo after detection of mucormycetes; 98.6% (69/70) of the reported adverse events were associated with AMB and AMB-lipo. The duration of treatment ranged from 90 to 180 days; the length of stay ranged from 22 to 95 days. The average total cost per patient was 166 thousand Chinese Yuan (CNY), of which 93.1% was the direct medical cost (155 thousand CNY). WHAT IS NEW AND CONCLUSION: There are a limited number of antifungal treatment options for mucormycosis in China. This study highlights the critical need to introduce innovative and broader spectrum antifungal drugs with improved safety, better clinical efficacy, easier administration and reduced economic burden to Chinese mucormycosis patients.

A comparison of the real world effectiveness of catheter ablation and drug therapy in atrial fibrillation patients in a Chinese setting.

BACKGROUND: Studies have demonstrated that catheter ablation of atrial fibrillation is associated with better rhythm control than drug therapy. The present study aimed to assess the clinical outcomes and health-related quality of life of ablation therapy in a real world setting. METHODS: A prospective, non-randomized, single center study in a real-world clinical setting in China was conducted. Patients were followed up at 3, 6, and 9 months after baseline encounter. Propensity score matched patients receiving ablation or anti-arrhythmic drug therapy were compared. Incidence rate of atrial fibrillation recurrence and quality of life outcomes were measured and analyzed using log-rank test, multivariate logistic regression and mixed-effects linear regression respectively. RESULTS: In this study, 151 atrial fibrillation patients treated by ablation therapy and 318 patients treated by anti-arrhythmic drugs were enrolled. During follow up, 82.0% in the ablation arm and 22.4% in the drug arm had no documented atrial fibrillation recurrence [HR for atrial fibrillation recurrence 0.07 (95%CI: 0.02-0.21, p < 0.0001)] among paroxysmal atrial fibrillation patients. The corresponding no recurrent rate were 66.7% and 18.5% [0.21 (0.05-0.95, p = 0.04)] respectively among persistent atrial fibrillation patients. Improvement in Short Form-36 physical component scores, Short Form-36 mental component scores and total Atrial Fibrillation Effect on Quality-of-life scores were 16.33 (14.05-18.61, p < 0.001), 8.10 (6.11-10.09, p < 0.001) and 18.28 (16.11-20.45, p < 0.001) respectively among paroxysmal AF patients and 6.32 (3.15-9.49, p < 0.001), 3.99 (1.82-6.16, p < 0.001) and 13.97 (10.89-17.05, p < 0.001) respectively among persistent AF patients. Improvements in total Atrial Fibrillation Effect on Quality-of-life score were also significant in ablation arm while no significant improvement of total Atrial Fibrillation Effect on Quality-of-life score in the drug arm. CONCLUSION: Compared with drug therapy, catheter ablation is associated with significant lower AF recurrence and improved overall quality of life. TRIAL REGISTRATION: The present study has been registered on clinicaltrials.gov. The ClinicalTrials.gov ID is NCT01878981 . The registration date is May 29, 2013.

Trends in hospital admissions due to antidepressant-related adverse drug events from 2001 to 2011 in the U.S.

BACKGROUND: Depression is a prevalent mental health disorder and the fourth leading cause of disability in the world as per the World Health Organization. Use of antidepressants can lead to adverse drug events (ADEs), defined as any injury resulting from medication use. This study aimed to examine changes in hospital admissions due to antidepressant-related ADEs (ArADEs) among different socio-demographic groups and changes in lengths of stay (LOS) and hospital charges in ArADE admissions from 2001 to 2011. METHODS: The Healthcare Cost and Utilization Project database was used. ArADE admissions in different socio-demographic groups were examined including characteristics such as age, gender, rural/urban, and income. LOS and hospital charges for ArADE cases were compared between 2001 and 2011. Chi-square test and t test were used for statistical analyses. RESULTS: There were 17,375 and 20,588 ArADE related admissions in 2001 and 2011, respectively. There was a 17.6% increase among the group of 18 to 64 years old and a 64.8% increase among the group of 65 years or older while the other age groups experienced decreased admission rates. Males and females had similar increases. Patients from the lower income areas experienced a two-fold increase while those from the higher income areas experienced a decrease. The mean LOS for all ArADE related admissions increased from 2.18 to 2.81 days and mean hospital charges increased from $8,456.2 to $21,572.5. CONCLUSIONS: There was an increase in ArADE hospital admissions. The greater increase in ArADE admissions among elderly, urban or low-income patients should be noted and addressed by practitioners and policy makers. The large increase in hospital charges needs further research.

Clinical outcomes of radiofrequency catheter ablation guided by intracardiac echocardiography for Chinese atrial fibrillation patients: a single-center, retrospective study.

Background: Intracardiac echocardiography (ICE) is a novel technology with certain advantages in treatment of atrial fibrillation (AF), yet there is limited research on the use of ICE in radiofrequency ablation for AF treatment in China. The aim of this study was to investigate the total fluoroscopy time and dose, safety, and effectiveness of ICE guided vs. traditional fluoroscopy (non-ICE) guided radiofrequency ablation for AF in China. Methods: We conducted a single-center retrospective analysis of patients who underwent ICE or traditional fluoroscopy-guided radiofrequency ablation for AF. The primary endpoint of this study was total fluoroscopy time, and the secondary endpoints included total fluoroscopy dose, acute surgery failure, transseptal puncture time, ablation time, total procedure time, and 6-month surgery success (no AF recurrence or atrial flutter). As an exploratory analysis, outcomes of interest by different types of AF were examined. Results: A total of 97 patients were included in the analysis. Forty-eight were in the ICE group and 49 were in the non-ICE group with comparable demographic and clinical characteristics at the baseline. None of patients experienced acute surgery failure with no major procedure-related complications occurred. The fluoroscopic time and dose were significantly lower in the ICE group compared to the non-ICE group (0.00 vs. 9.67±4.88 min, P<0.001; 0.00 vs. 77.10±44.28 mGy/cm2, P<0.001, respectively). There were no statistically significant differences in transseptal puncture time, ablation time and total procedure time between the two groups. There were two AF recurrences observed during the 6-month follow-up in each group (P>0.99). Conclusions: ICE significantly reduced the fluoroscopic time and dose for radiofrequency catheter ablation in AF patients. There were no significant differences in safety or effectiveness outcomes between the ICE and non-ICE groups.

Quantification of the Heat-Related Risk and Burden of Hospitalizations for Cause-Specific Injuries and Contribution of Human-Induced Climate Change: A Time-Stratified Case-Crossover Study in China.

BACKGROUND: Although ambient temperature has been linked with injury incidence, there have been few nationwide studies to quantify the temperature-related risk and burden of cause-specific injury hospitalizations. Additionally, the impact of human-induced climate change to injury burden remains unknown. OBJECTIVES: Our objectives are to examine the associations between ambient temperature and injury hospitalizations from various causes and to quantify the contribution of human-induced warming to the heat-related burden. METHODS: We collected injury hospitalization data from a nationwide hospital-based registry in China during 2000-2019. Using a time-stratified case-crossover design, we investigated the associations between daily mean temperature (°C) and cause-specific injury hospitalizations. We also quantified the burden of heat-related injuries under the scenarios with and without anthropogenic forcing, using the Detection and Attribution Model Intercomparison Project to assess the contribution of human-induced warming. RESULTS: Our study included a total of 988,087 patients with hospitalization records for injuries. Overall, compared to the temperature at minimum risk of hospitalization (-12.1°C), the relative risk of hospitalization at extreme hot temperature (30.8°C, 97.5th percentile) was 1.18 [95% confidence interval (CI): 1.14, 1.22], with an approximately linear association between temperature and hospitalization. Vulnerability to heat-related injuries was more pronounced among males, young (<18 years of age) or middle-aged (45-64 years of age) individuals, and those living in the North. The heat-related attributable fraction increased from 23.2% in the 2000s to 23.6% in the 2010s, with a corresponding increase in the contribution of human-induced change over time. In the 2010s, the heat-related attributable fractions for specific causes of injury ranged from 12.4% to 54.4%, with human-induced change accounting for 6.7% to 10.6% of the burden. DISCUSSION: This nationwide study presents new evidence of significant associations between temperature and cause-specific injury hospitalizations in China and highlights the increasing contribution of human-induced warming to the injury burden. https://doi.org/10.1289/EHP14057.

Radiofrequency ablation using the ThermoCool SmartTouch Catheter guided by ablation index versus antiarrhythmic drugs in atrial fibrillation treatment in China: a cost-consequence analysis.

Aim: To evaluate the costs and consequences of two front-line atrial fibrillation (AF) treatments from Chinese healthcare system perspective: radiofrequency catheter ablation (RFCA) using ThermoCool SmartTouch Catheter guided by Ablation Index (STAI), in comparison to antiarrhythmic drugs (AADs). Patients & methods: We simulated clinical and economic consequences for AF patients initially receiving STAI or AADs using a short-term decision tree model leading to a 10-year long-term Markov model. The model projected both clinical consequences and costs associated with, among others, AF, heart failure (HF), strokes, and deaths due to AF or AF related complications. Data informing the models included combination of a local real-world study and published clinical studies. Results: STAI was advantageous versus AADs on all 4 main clinical outcomes evaluated; AF: 25.83% lower (12.84% vs 38.67%), HF: 2.22% lower (1.33% vs 3.55%), stroke or post stroke: 1.82% lower (10.00% vs 11.82%) and deaths due to AF or AF related complications: 0.64% lower (4.11% vs 4.75%). The average total cost per patient in STAI group was ¥16,682 lower (¥123,124 vs ¥139,806). The one-way sensitivity analysis indicated that the difference in total cost was most sensitive to annual AF recurrence probability in AADs-treated patients. Probabilistic sensitivity analysis indicated a 98.5% probability that RFCA treatment would result in cost savings by the end of the 10th year. Conclusion: Radiofrequency catheter ablation using SmartTouch catheter guided by Ablation Index was superior to AADs as the first-line AF treatment in Chinese setting with better clinical outcomes and at lower costs over a 10-year time horizon.

A Cost-effectiveness Analysis of iGlarLixi Versus IDegAsp and Appropriate Price Exploration of iGlarLixi for Type 2 Diabetes Mellitus Patients in China.

BACKGROUND AND OBJECTIVE: The efficacy and safety of iGlarLixi, a fixed-ratio combination (FRC) of basal insulin glargine plus lixisenatide, have been demonstrated in type 2 diabetes mellitus (T2DM) patients. However, no relevant economic analysis of iGlarLixi has been done in China. Thus, the primary objective of this study is to evaluate the cost effectiveness of iGlarLixi versus IDegAsp in Chinese T2DM patients, and then back-calculate the appropriate drug price of iGlarLixi to support its pricing after listing in China. METHODS: The United Kingdom Prospective Diabetes Study Outcome Model 2 (UKPDS OM2) was applied to estimate lifetime health and economic outcomes from the Chinese health-care system perspective. As no head-to-head comparison data are currently available, the baseline cohort characteristics and the initial clinical data for iGlarLixi were derived from the randomized LixiLan-L-China trial. The relative treatment effects for IDegAsp were based on an indirect treatment comparison. Due to the unavailability of iGlarLixi pricing data, the annual medication cost of iGlarLixi was assumed to be equal to that of IDegAsp at the beginning of the study. Afterwards, a break-even analysis using comparator drug price and the willingness-to-pay (WTP) threshold was performed to back-calculate the appropriate drug price of iGlarLixi. One-way sensitivity analysis, scenario analysis and probabilistic sensitivity analysis (PSA) were conducted to assess the robustness of the model. RESULTS: Based on the initial assumption of equal annual medication cost of iGlarLixi and IDegAsp, iGlarLixi was cost effective compared to IDegAsp with an incremental cost-effectiveness ratio (ICER) far below the WTP threshold in Chinese T2DM patients. From the back calculation for the price of iGlarLixi, the annual medication cost of iGlarLixi was $656.96 and $1075.96 to obtain an ICER of iGlarLixi versus IDegAsp close to 1 × GDP and 3 × GDP, respectively. When the discount rate was changed from the base value to 8% (the most sensitive parameter to the model results in one-way sensitivity analysis), the ICER was nearly equal to 1 × GDP and 3 × GDP with the annual medication cost of iGlarLixi decreasing to $590.41 and $865.03, respectively. Thus, iGlarLixi was dominant over IDegAsp with an annual medication cost of $590.41 to $865.03. The findings were robust to one-way sensitivity analysis, PSA and scenario analysis. CONCLUSION: This long-term cost-effectiveness analysis in Chinese T2DM patients indicates that iGlarLixi, assuming equal price to IDegAsp, is cost-effective versus IDegAsp with an ICER far below the WTP threshold. With 1 × GDP and 3 × GDP threshold set we back-calculate the appropriate annual medication cost of iGlarLixi to be $590.41 to $865.03, respectively.

Cost-Effectiveness Analysis of Relmacabtagene Autoleucel for Relapsed or Refractory Large B-Cell Lymphoma in China.

OBJECTIVES: Relmacabtagene autoleucel (relma-cel) was recently approved in China for treating relapsed or refractory large B-cell lymphoma (r/r LBCL). We conducted a cost-effectiveness analysis from the perspective of Chinese healthcare system. METHODS: A mixture-cure model was developed to project life-years (LYs), quality-adjusted LYs (QALYs), and overall direct cost with a lifetime horizon for patients with r/r LBCL treated with relma-cel versus salvage chemotherapy. Patient-level data from RELIANCE trial and published data from Collaborative Trial in Relapsed Aggressive Lymphoma extension study were used to inform the model. The incremental cost-effectiveness ratio (ICER) was estimated and cost-effectiveness was evaluated at the willingness-to-pay threshold of 3 times the national gross domestic product per capita. RESULTS: The model projected that treatment with relma-cel was associated with incremental gains of 5.11 LYs and 5.26 QALYs compared with salvage chemotherapy at an increased cost of ¥1 067 430 (∼$154 152), resulting in an ICER of ¥203 137 (∼$29 435) per QALY. The model was most sensitive to the uncertainty around the estimated cure rate. The ICER of relma-cel was within the willingness-to-pay threshold in the base case and the probability of relma-cel treatment being considered cost-effective was approximately 74%. CONCLUSIONS: Compared with salvage chemotherapy, treatment with relma-cel for r/r LBCL in patients who have failed at least 2 lines of systemic therapy is within the cost-effective range from the perspective of Chinese healthcare system and represents a good use of healthcare resources.

Access to innovative drugs and the National Reimbursement Drug List in China: Changing dynamics and future trends in pricing and reimbursement.

BACKGROUND AND OBJECTIVES: Multiple reforms aimed at improving the Chinese population's health have been introduced in recent years, including several designed to improve access to innovative drugs. We sought to review current factors affecting access to innovative drugs in China and to anticipate future trends. METHODS: Targeted reviews of published literature and statistics on the Chinese healthcare system, medical insurance and reimbursement processes were conducted, as well as interviews with five Chinese experts involved in the reimbursement of innovative drugs. RESULTS: Drug reimbursement in China is becoming increasingly centralized due to the removal of provincial pathways, the establishment of the National Healthcare Security Administration and the implementation of the National Reimbursement Drug List (NRDL), which is now the main route for drug reimbursement in China. There is also an increasing number of other channels via which patients may access innovative treatments, including various types of commercial insurance and special access. Health technology assessment (HTA) and health economic evidence are becoming pivotal elements of the NRDL decision-making process. Alongside the optimization of HTA decision making, innovative risk-sharing agreements are anticipated to be increasingly leveraged in the future to optimize access to highly specialized technologies and encourage innovation while safeguarding limited healthcare funds. CONCLUSIONS: Drug public reimbursement in China continues to align more closely with approaches widely used in Europe in terms of HTA, health economics and pricing. Centralization of decision-making processes for public reimbursement of innovative drugs allows consistency in assessment and access, which optimizes the improvement of the Chinese population's health.

Fine and coarse particulate air pollution and hospital admissions for a wide range of respiratory diseases: a nationwide case-crossover study.

BACKGROUND: The associations between fine and coarse particulate matter (PM2.5 and PM2.5-10) air pollution and hospital admissions for full-spectrum respiratory diseases were rarely investigated, especially for age-specific associations. We aim to estimate the age-specific associations of short-term exposures to PM2.5 and PM2.5-10 with hospital admissions for full-spectrum respiratory diseases in China. METHODS: We conducted an individual-level case-crossover study based on a nationwide hospital-based registry including 153 hospitals across 20 provincial regions in China in 2013-20. We applied conditional logistic regression models and distributed lag models to estimate the exposure- and lag-response associations. RESULTS: A total of 1 399 955 hospital admission records for various respiratory diseases were identified. The associations of PM2.5 and PM2.5-10 with total respiratory hospitalizations lasted for 4 days, and an interquartile range increase in PM2.5 (34.5 µg/m3) and PM2.5-10 (26.0 µg/m3) was associated with 1.73% [95% confidence interval (95% CI): 1.34%, 2.12%)] and 1.70% (95% CI: 1.31%, 2.10%) increases, respectively, in total respiratory hospitalizations over lag 0-4 days. Acute respiratory infections (i.e. pneumonia, bronchitis and bronchiolitis) were consistently associated with PM2.5 or PM2.5-10 exposure across different age groups. We found the disease spectrum varied by age, including rarely reported findings (i.e. acute laryngitis and tracheitis, and influenza) among children and well-established associations (i.e. chronic obstructive pulmonary disease, asthma, acute bronchitis and emphysema) among older populations. Besides, the associations were stronger in females, children and older populations. CONCLUSIONS: This nationwide case-crossover study provides robust evidence that short-term exposure to both PM2.5 and PM2.5-10 was associated with increased hospital admissions for a wide range of respiratory diseases, and the spectra of respiratory diseases varied by age. Females, children and older populations were more susceptible.

Evaluation of COVID-19 vaccines in primary prevention against infections and reduction in severity of illness following the outbreak of SARS-CoV-2 omicron variant in Shanghai.

Objectives: To evaluate COVID-19 vaccines in primary prevention against infections and lessen the severity of illness following the most recent outbreak of the SARS-CoV-2 Omicron variant in Shanghai. Data sources: Data from 153,544 COVID-19 patients admitted to the Shanghai "Four-Leaf Clover" Fangcang makeshift shelter hospital were collected using a structured electronic questionnaire, which was then merged with electronic medical records of the hospital. For healthy controls, data on vaccination status and other information were obtained from 228 community-based residents, using the same structured electronic questionnaire. Methods: To investigate whether inactivated vaccines were effective in protecting against SARS-CoV-2 virus, we estimated the odds ratio (OR) of the vaccination by comparing cases and matched community-based healthy controls. To evaluate the potential benefits of vaccination in lowering the risk of symptomatic infection (vs. asymptomatic), we estimated the relative risk (RR) of symptomatic infections among diagnosed patients. We also applied multivariate stepwise logistic regression analyses to measure the risk of disease severity (symptomatic vs. asymptomatic and moderate/severe vs. mild) in the COVID-19 patient cohort with vaccination status as an independent variable while controlling for potential confounding factors. Results: Of the 153,544 COVID-19 patients included in the analysis, the mean age was 41.59 years and 90,830 were males (59.2%). Of the study cohort, 118,124 patients had been vaccinated (76.9%) and 143,225 were asymptomatic patients (93.3%). Of the 10,319 symptomatic patients, 10,031 (97.2%), 281 (2.7%), and 7 (0.1%) experienced mild, moderate, and severe infections, respectively. Hypertension (8.7%) and diabetes (3.0%) accounted for the majority of comorbidities. There is no evidence that the vaccination helped protect from infections (OR = 0.82, p = 0.613). Vaccination, however, offered a small but significant protection against symptomatic infections (RR = 0.92, p < 0.001) and halved the risk of moderate/severe infections (OR = 0.48, 95% CI: 0.37-0.61). Older age (≥60 years) and malignant tumors were significantly associated with moderate/severe infections. Conclusion: Inactivated COVID-19 vaccines helped provide small but significant protection against symptomatic infections and halved the risk of moderate/severe illness among symptomatic patients. The vaccination was not effective in blocking the SARS-CoV-2 Omicron Variant community spread.

Association of statin use and increase in lipoprotein(a): a real-world database research.

BACKGROUND: There is an increased concern that statins may have an unintended effect of elevated lipoprotein(a) [Lp(a)]. We conducted a large sample real-world study to test the association. METHODS: This retrospective cohort study was conducted using data from an integrated SuValue database, which includes 221 hospitals across China covering more than 200,000 of population with longitudinal follow-up to 10 years. Propensity score matching was applied to identify two comparable cohorts with statin users and non-statin users. Detailed follow-up information such as Lp(a) levels were extracted. The hazard ratio was calculated on Lp(a) changes based on the statin usage cohorts. Detailed subgroup and different characteristic cohorts' analyses were also conducted. RESULTS: After baseline propensity score matching, a total of 42,166 patients were included in a 1:1 matched ratio between statin users and non-statin users. In the case of no difference in low density lipoprotein (LDL-C), Lp(a) was increased significantly with the use of statins (adjusted HR 1.47; 95% confidence interval [CI] 1.43-1.50). Lp(a) increase was observed in various subgroup analyses and different cohorts. The dose intensity of statin was positively associated with the evaluated Lp(a) level. CONCLUSION: The use of statins was associated with an increased risk of Lp(a) elevation compared with non-statin use counterparts. The clinical relevance of these increases needs to be addressed in surrogate marker trials and/or large, cardiovascular outcomes trials.

Cost-Effectiveness of Linaclotide Compared to Osmotic Laxatives in the Treatment of Irritable Bowel Syndrome with Constipation in China.

INTRODUCTION: Linaclotide, a selective agonist of guanylate cyclase C, was highly recommended for the treatment of irritable bowel syndrome with constipation (IBS-C). However, the cost-effectiveness of linaclotide in Chinese is not known, and this study aimed to assess the cost-effectiveness of linaclotide for patients with IBS-C. METHODS: An economic evaluation was conducted with a Markov model from a societal perspective. The Markov model was structured to simulate the discontinuation and continuation of medication in IBS-C patients in clinical practice, as well as the revisit and non-visit of non-responding patients. The cycle of the model was 4 weeks, and the time horizon was 1 year. The efficacy data in the model was from the risk ratios obtained by the meta-analysis and the calculation of the response rate of the three medications. The utility, discontinuation rate of the medication, and revisit rate data were from published literature, while the cost data were obtained from experts' opinions and published literature. A series of sensitivity analyses was performed on parameters potentially having impact on the model outputs. RESULTS: The QALYs (quality-adjusted life years) gained for 1-year treatment with linaclotide, polyethylene glycol, and lactulose were 0.821, 0.795, and 0.781, respectively. The corresponding total costs were CNY 7,721 (USD 1,120), CNY 8,797 (USD 1,276) and CNY 9,481 (USD 1,375). In both comparisons, linaclotide was dominant. Compared with polyethylene glycol and lactulose, the likelihood of linaclotide being cost-effective was 100% for both, using 1 times per capita GDP per QALY as willingness-to-pay threshold. CONCLUSIONS: IBS-C seriously affects the quality of life of patients with IBS-C, and linaclotide can improve symptoms and quality of life at less cost.

Cost-effectiveness analysis of continuous subcutaneous insulin infusion versus multiple daily insulin for treatment of children with type 1 diabetes.

OBJECTIVE: To evaluate the health economics of using continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in children and adolescent patients with type 1 diabetes (T1D) in Qingdao, China. METHODS: A long-term cost-effectiveness analysis was conducted using the IQVIA Core Diabetes Model (CDM). The baseline characteristics of the simulated cohorts were obtained from 213 pediatric T1D patients who received care with CSII(104 cases) or MDI(109 cases) in Qingdao from 1 January 2015 to 31 March 2019. In the essential case, the expenditure of the complications and treatment of the disease with both therapies were evaluated in Chinese currency from the perspective of healthcare system. In a secondary analysis, the model used a 70-year time horizon, and a discount rate of 5% was applied to all future health outcomes and costs. A one-way sensitivity analysis was conducted on delta HbA1c, different prices of insulin pump, price of each upgrade cycle rates and different discount rates. Uncertainty was also evaluated by the probability sensitivity analysis and scenario analysis. RESULTS: In the base-case analysis, the lifetime total costs were lower for CSII group at ¥630,871 per patient compared with ¥672,672 for MDI group. The quality-adjusted life years (QALYs) gained were 11.612 and 11.197 for patients treated with CSII group and MDI group, respectively. The CSII group was cost-saving compared to MDI group. The feasibility of CSII group being cost-effective was 100% under the threshold of 3 times per capita GDP of China in 2019 (¥212,676) which was indicated from the probabilistic sensitivity analysis. Regarding scenario analysis, the ICER of the CSII group compared to MDI was between -151,583 and 153,366 RMB/QALYs, which is cost-effective. CONCLUSIONS: This economic evaluation compared CSII therapy versus MDI therapy for T1D children and adolescent patients in China and findings indicate that CSII should be considered a preferred treatment modality to MDI.