Impacts of national volume-based drug procurement policy on the utilization and costs of antihypertensive drugs in a Chinese medicine hospital: an interrupted time series analysis of 5138 patients.

Objectives: The study aimed to estimate the effects of National Volume-based Drug Procurement (NVBP) policy on drug utilization and medical expenditures of hypertension patients in public medical institutions in mainland China. Methods: This study used patient-level data based on electronic health records retrieved from the hospital information system of Nanjing Hospital of Chinese Medicine. Data on patients with hypertension who received care at this institution between 2016 and 2021 was used for analysis. Segmented linear regression models incorporating Interrupted Time Series (ITS) analysis were adopted to examine the effects of NVBP policy on drug utilization and health expenditures of eligible patients. Drug utilization volume and health expenditures were the primary outcomes used to assess the policy effects, and were measured using the prescription proportion of each drug class and the overall per-encounter treatment costs. Results: After the implementation of NVBP policy, the volume of non-winning drugs decreased from 54.42% to 36.25% for outpatient care and from 35.62% to 15.65% for inpatient care. The ITS analysis showed that the volume of bid-winning drugs in outpatient and inpatient settings increased by 9.55% (p < 0.001) and 6.31% (p < 0.001), respectively. The volume changes in non-volume based purchased (non-VBP) drugs differed between outpatients and inpatients. The proportion of non-VBP drugs immediately increased by 5.34% (p = 0.002) overall, and showed an upward trend in the outpatient setting specially (p < 0.001) during the post-intervention period. However, no significant differences were observed in the proportion of non-VBP drugs in inpatient setting (p > 0.05) in term of level change (p > 0.05) or trend change (p > 0.05). The average per-visit expenditures of outpatients across all drug groups exhibited an upward trend (p < 0.05) post policy intervention. In addition, a similar increase in the overall costs for chemical drugs were observed in inpatient settings (coefficient = 2,599.54, p = 0.036), with no statistically significant differences in the regression slope and level (p = 0.814). Conclusion: The usage proportion of bid-winning drugs increased significantly post policy intervention, indicating greater use of bid-winning drugs and the corresponding substitution of non-winning hypertensive drugs. Drug expenditures for outpatients and health expenditures per visit for inpatients also exhibited an upward trend, suggesting the importance of enhanced drug use management in Traditional Chinese Medicine hospital settings.

Population-based recurrence rates among older women with HR-positive, HER2-negative early breast cancer: Clinical risk factors, frailty status, and differences by race.

BACKGROUND: Multiple independent risk factors are associated with the prognosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC), the most common BC subtype. This study describes U.S. population-based recurrence rates among older, resected women with HR+/HER2- early BC. METHODS: We conducted a retrospective cohort study of older women diagnosed with incident, invasive stages I-III HR+/HER2- BC who underwent surgery to remove the primary tumor using the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked Database (2007-2015). SEER records and administrative health claims data were used to ascertain patient and tumor-specific characteristics, treatment, and frailty status. Cumulative incidences of BC recurrence were estimated using a validated algorithm for administrative claims data. Multivariable Fine-Gray competing risk models estimated adjusted subdistribution hazards ratios and 95 % confidence intervals for associations with BC recurrence risk. RESULTS: Overall, 46,027 women age ≥65 years were included in our analysis. Over a median follow up of 7 years, 6531 women experienced BC recurrence with an estimated 3 and 5-year cumulative incidence rates of 10 % and 16 %, respectively. Higher 3- and 5-year cumulative incidences were observed in women with larger tumor size (5+ cm, 21 % and 28 %), lymph node involvement (4+ nodes, 27 % and 37 %), and with frail health status at diagnosis (13 % and 20 %). Independent of these clinical risk factors, Black, Hispanic and American Indian/Alaskan Native women had significantly increased BC recurrence risks. CONCLUSIONS: Rates of recurrence in HR+/HER2- early BC differs by several patient and clinical factors, including high-risk tumor characteristics. Racial differences in BC outcomes deserve continued attention from clinicians and policymakers.

Effectiveness and Efficiency of Non-drug Therapy Among Community-Dwelling Adults With Hypertension in China: A Protocol for Network Meta-Analysis and Cost-Effectiveness Analysis.

Introduction: The Chinese government has established a nationwide community-based chronic disease management program since 2009 with hypertension a vital part of it. Though drugs have been proven effective with hypertensive patients, they bring economic burden as well, especially for those who with elevated blood pressure and are potentially eligible for national programs. When the effectiveness of pharmacotherapy-only interventions remains uncertain on these patients, non-pharmacological interventions have demonstrated non-inferior effectiveness and may have economic advantages. To date, there rarely are evidences on the effectiveness and cost-effectiveness of non-pharmacological treatment in comparison with pharmacological interventions for patients with varying severity of blood pressure. This study aims to propose a study for a network meta-analysis and cost-effectiveness analysis to explore what kind of intervention is potentially effective and cost-effective to four specific patient groups, stage I-III hypertensive patients and patients with elevated blood pressure, and to provide recommendations for hypertensive management to Chinese decision makers. Methods: We will systematically search databases (MEDLINE, PubMed, Cochrane Library, etc.,) for randomized controlled trials and observational studies with qualified study design in recent decade that assess the effectiveness of non-pharmacological, pharmacological, or combined intervention aimed at adult populations who are diagnosed with the above four types of hypertension in China. The effectiveness outcomes will include changes in SBP/DBP, rate of comorbidities, mortality, and health related quality of life. We will use network meta-analysis to compare and rank effectiveness of different interventions. Subgroup analyses and meta-regression analyses will be performed to analyze and explain heterogeneity. The economic outcome will include cost-effectiveness based on simulation results from Markov models. Under study perspective of Chinese health system, life-time direct cost will be included. Discussion: This study aims to compare and rank the effectiveness and cost-effectiveness of pharmacological, non-pharmacological and combined interventions for stage I-III hypertensive patients and those who with elevated blood pressure. Compared to existing studies, this comprehensive synthesis of relevant evidences will influence future practice with better efficiency and generalizability for community-based hypertensive management programs in China. The study might also be valuable for other low- and middle-income countries to find their own solutions. PROSPERO registration number: CRD42020151518.

Racial Disparities in Intravenous Bisphosphonate Use Among Older Patients With Multiple Myeloma Enrolled in Medicare.

PURPOSE: Intravenous (IV) bisphosphonates reduce the risk of skeletal-related events in patients with multiple myeloma (MM). However, data describing racial differences in IV bisphosphonate utilization outside of clinical trial settings are limited. We evaluated population-level IV bisphosphonate initiation and discontinuation among patients of age ≥ 65 years with MM. METHODS: We conducted a retrospective cohort study of patients of age ≥ 65 years diagnosed with first primary MM between 2001 and 2011. Patients were identified using the SEER-Medicare linked database and followed through December 2013. Cumulative incidences of IV bisphosphonate initiation and time to discontinuation among users were compared between racial and ethnic groups. In Fine and Gray competing risk models, we estimated subdistribution hazard ratios (SHRs) and 95% CIs for initiation and discontinuation. RESULTS: We included 14,231 eligible patients with MM (median age, 76 years; 52% male). Over a median follow-up of 23.1 months, 54% of patients received at least one IV bisphosphonate dose. Our final analytical sample included 10,456 non-Hispanic (NH) Whites, 2,267 NH Blacks, 548 Asian and Pacific islanders, and 815 Hispanic and Latino patients. A higher proportion of White patients (56.1%) newly received IV bisphosphonates after MM diagnosis compared with NH Blacks (45.4%). Compared with White patients, NH Black patients were less likely to initiate IV bisphosphonates (SHR, 0.74; 95% CI, 0.70 to 0.79) and slightly more likely to discontinue treatment (SHR, 1.10; 95% CI, 1.01 to 1.19). CONCLUSION: Approximately half of the patients with MM of age ≥ 65 years did not receive IV bisphosphonates, with significant delay among racial minority groups. These findings highlight the need for improvement of IV bisphosphonate uptake in patients with MM of age ≥ 65 years.

Potentially Inappropriate Medication Combination with Opioids among Older Dental Patients: A Retrospective Review of Insurance Claims Data.

BACKGROUND: Opioid prescribing by dentists for older patients receiving medications with potential contraindications and the subsequent impact on acute care outcomes is not well described. OBJECTIVES: Our objective of this paper was to evaluate the use of potentially inappropriate medication combinations (PIMCs) involving opioids prescribed by dentists according to the Beers Criteria and risks of 30-day emergency department (ED) visits and all-cause hospitalization among commercially insured dental patients ages 65 years and older. METHODS: We conducted a retrospective cohort study of 40,800 older dental patient visits in which opioids were prescribed between 2011 and 2015 using the IBM MarketScan databases. Data collection from dental, medical, and pharmacy claims included information on the concurrent use of PIMCs and outcomes of all-cause acute care utilization over the 30-day period after dental encounters. RESULTS: For the overall cohort, the median age was 69 years, and 45% were women. The prevalence of PIMCs per Beers Criteria was 10.4%. A total of 947 all-cause acute care events were observed in the 30 days post-dental visit. Patients with PIMCs involving opioids prescribed by dentists according to the Beers Criteria had higher rates of acute care use (3.3% vs 2.2%, p<0.001), which were associated with an increased risk of all-cause acute care utilization (adjusted risk ratio [RR] 1.23, 95% confidence interval [CI] 1.02-1.48). A dose-response relationship was seen with increasing oral morphine equivalents prescribed and increased acute care utilization (p<0.001). CONCLUSION: A significant proportion of older patients receiving opioids at dental visits use psychotropic medications that in combination should be avoided according to the American Geriatric Society Beers Criteria.

Self-reported health and survival in older patients diagnosed with multiple myeloma.

PURPOSE: Patient-reported outcomes such as self-reported health (SRH) are important in understanding quality cancer care, yet little is known about links between SRH and outcomes in older patients with multiple myeloma (MM). We evaluated associations between SRH and mortality among older patients with MM. METHODS: We analyzed a retrospective cohort of patients ages ≥ 65 years diagnosed with first primary MM using the Surveillance, Epidemiology, and End Results (SEER)-Medicare Health Outcomes Survey (MHOS) data resource. Pre-diagnosis SRH was grouped as high (excellent/very good/good) or low (fair/poor). We used Cox proportional hazards models to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI) for associations between SRH and all-cause and MM-specific mortality. RESULTS: Of 521 MM patients with mean (SD) age at diagnosis of 76.8 (6.1) years, 32% reported low SRH. In multivariable analyses, low SRH was suggestive of modest increased risks of all-cause mortality (HR 1.32, 95% CI 1.02-1.71) and MM-specific mortality (HR 1.22, 95% CI 0.87-1.70) compared to high SRH. CONCLUSION: Findings suggest that low pre-diagnosis SRH is highly prevalent among older patients with MM and is associated with modestly increased all-cause mortality. Additional research is needed to address quality of life and modifiable factors that may accompany poor SRH in older patients with MM.

Clinical trajectories, healthcare resource use, and costs of long-term hematopoietic stem cell transplantation survivors: a latent class analysis.

PURPOSE: To identify patterns of healthcare utilization in allogeneic and autologous hematopoietic stem cell transplantation (HSCT) recipients and evaluate factors associated with high-need and high-cost post-transplantation care. METHODS: Latent class analysis of a retrospective cohort of long-term allogeneic (n = 436) and autologous (n = 888) HSCT survivors within the Truven MarketScan database (2009-2014). We assessed factors associated with the latent classes by comparing post-transplantation healthcare utilization including inpatient admissions and length of stay, emergency room visits, specialist visits, and primary care provider visits. RESULTS: Four utilization classes were identified in allogeneic and autologous HSCT recipients: (i) outpatient specialist care dominant (51.8% and 57.3%), (ii) outpatient primary care dominant (10.3% and 25.7%), (iii) outpatient/inpatient balanced (20.6% and 13.5%), and (iv) inpatient dominant (17.2% and 3.5%). Mean monthly healthcare expenditures in the inpatient dominant utilization class were $41,097 and $25,556 for allogeneic and autologous survivors, respectively, which were two to five times higher compared with other classes during the 2-year post-transplantation period. Factors associated with the high utilization class were transfusion (OR = 1.87, 95% CI 1.06-3.30) and 100-day post-transplant graft-versus-host-disease (OR = 1.76, 95% CI 1.05-2.94) in allogeneic HSCT; higher baseline Charlson comorbidity index (OR = 1.45, 95% CI 1.19-1.76) in autologous HSCT. CONCLUSION: Based on distinct patterns of healthcare utilization following HSCT, we identified factors associated with higher resource utilization and greater healthcare related expenditures. IMPLICATIONS FOR CANCER SURVIVORS: Earlier identification of high-cost and high-need HSCT long-term survivors could pave the way for clinicians to offer more continuous engagement in survivorship care delivery.

Economic burden of fatigue or morning stiffness among patients with rheumatoid arthritis: a retrospective analysis from real-world data.

Objective: Determine healthcare resource utilization (HCRU) and costs associated with fatigue and stiffness among patients with rheumatoid arthritis (RA).Methods: A retrospective claims analysis compared RA patients with fatigue or stiffness to matched RA control patients with neither. Claims from a large US commercial insurance database identified new cases of stiffness/fatigue among newly diagnosed patients. Study patients had ≥2 medical claims for RA ≥45 days apart, continuous insurance coverage ≥12 months before RA index (baseline period) and ≥12 months after fatigue/stiffness index (follow-up period). Controls had no diagnosis of fatigue or stiffness ≥12 months before index. Cases had ≥1 claim of fatigue/stiffness after RA index; the first such claim was the index date. Multivariate logistic regressions, adjusting for baseline demographics, comorbidities, medication use and HCRU, were used to predict the propensity of having a fatigue/stiffness diagnosis. Controls were propensity-score matched to cases. Generalized linear models estimated all-cause and RA-specific costs associated with resource use as well as prescription drugs, adjusting for any unbalanced covariates after propensity-score matching.Results: Approximately 32% of newly diagnosed RA patients suffer from fatigue/stiffness. Matched cohorts were analyzed: fatigue vs. control; stiffness vs. control; fatigue and stiffness vs. control. After RA diagnosis, hospitalizations increased: 83% for fatigue, 117% for stiffness and 148% for both; total office visits increased 63%, 113% and 135%, respectively. Greater HCRU yielded significantly greater (all p < .001) per-patient-per-year hospitalization costs vs. matched controls: fatigue ($2554 vs. $1293); stiffness ($2792 vs. $892); fatigue and stiffness ($3322 vs. $1033). Per-patient-per-year costs of office visits increased significantly (all p < .001) vs. matched controls: fatigue ($1373 vs. $908); stiffness ($1580 vs. $761); fatigue and stiffness ($1989 vs. $921).Conclusions: RA patients with fatigue and/or stiffness report more HCRU and incur significantly higher medical costs than RA patients without them.

Bevacizumab Use and the Risk of Arterial and Venous Thromboembolism in Patients with High-Grade Gliomas: A Nested Case-Control Study.

STUDY OBJECTIVE: Bevacizumab is used in the treatment of recurrent glioblastoma, but evidence is limited on the incidence of thromboembolic complications regarding the use of this drug in real-world settings. We evaluated the risk of arterial thromboembolism (ATE) and venous thromboembolism (VTE) associated with the use of bevacizumab among adults diagnosed with high-grade gliomas in a commercially insured U.S. DESIGN: Nested case-control study. DATA SOURCE: Truven Health MarketScan Commercial and Medicare Supplemental health claims databases (2009-2015). PATIENTS: A total of 2157 patients with high-grade gliomas who underwent incident (first-time) craniotomy, radiation, and concurrent temozolomide treatment between 2009 and 2015 were identified. Overall, 25 cases of ATE and 99 cases of VTE were each identified in this cohort, and each case was matched to up to 10 controls (170 for ATE and 819 for VTE) based on sex, age, quarter year of index time, and follow-up duration by using incidence density sampling without replacement from the overall cohort. Controls were at risk for the outcome of interest (ATE or VTE) at the time of case occurrence and survived at least as long as their referent case. MEASUREMENTS AND MAIN RESULTS: Exposure to bevacizumab was determined during inpatient or outpatient encounters between the index date (date of the incident craniotomy) and the ATE or VTE event or corresponding matched control date. Multivariable conditional logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the risk of ATE and VTE separately. A higher proportion of patients with ATE received bevacizumab compared with controls (28% vs 17%; adjusted OR 1.51, 95% CI 0.54-4.24), but this excess in odds was not statistically significant. Similarly, bevacizumab was not significantly associated with VTE (13% vs 9%; adjusted OR 1.40, 95% CI 0.71-2.75). CONCLUSION: We found no significant association between the use of bevacizumab and the occurrence of thromboembolic events in patients with high-grade gliomas, although our study was limited by the small number of ATE events. Because the potential for complications from arterial thrombosis cannot be completely ruled out, further research is needed to confirm the thromboembolic safety of bevacizumab in a larger sample of patients with high-grade gliomas.

Assessment of the Appropriateness of Antibiotic Prescriptions for Infection Prophylaxis Before Dental Procedures, 2011 to 2015.

Importance: Antibiotics are recommended before certain dental procedures in patients with select comorbidities to prevent serious distant site infections. Objective: To assess the appropriateness of antibiotic prophylaxis before dental procedures using Truven, a national integrated health claims database. Design, Setting, and Participants: Retrospective cohort study. Dental visits from 2011 to 2015 were linked to medical and prescription claims from 2009 to 2015. The dates of analysis were August 2018 to January 2019. Participants were US patients with commercial dental insurance without a hospitalization or extraoral infection 14 days before antibiotic prophylaxis (defined as a prescription with ≤2 days' supply dispensed within 7 days before a dental visit). Exposures: Presence or absence of cardiac diagnoses and dental procedures that manipulated the gingiva or tooth periapex. Main Outcomes and Measures: Appropriate antibiotic prophylaxis was defined as a prescription dispensed before a dental visit with a procedure that manipulated the gingiva or tooth periapex in patients with an appropriate cardiac diagnosis. To assess associations between patient or dental visit characteristics and appropriate antibiotic prophylaxis, multivariable logistic regression was used. A priori hypothesis tests were performed with an α level of .05. Results: From 2011 to 2015, antibiotic prophylaxis was prescribed for 168 420 dental visits for 91 438 patients (median age, 63 years; interquartile range, 55-72 years; 57.2% female). Overall, these 168 420 dental visits were associated with 287 029 dental procedure codes (range, 1-14 per visit). Most dental visits were classified as diagnostic (70.2%) and/or preventive (58.8%). In 90.7% of dental visits, a procedure was performed that would necessitate antibiotic prophylaxis in high-risk cardiac patients. Prevalent comorbidities include prosthetic joint devices (42.5%) and cardiac conditions at the highest risk of adverse outcome from infective endocarditis (20.9%). Per guidelines, 80.9% of antibiotic prophylaxis prescriptions before dental visits were unnecessary. Clindamycin was more likely to be unnecessary relative to amoxicillin (odds ratio [OR], 1.10; 95% CI, 1.05-1.15). Prosthetic joint devices (OR, 2.31; 95% CI, 2.22-2.41), tooth implant procedures (OR, 1.66; 95% CI, 1.45-1.89), female sex (OR, 1.21; 95% CI, 1.17-1.25), and visits occurring in the western United States (OR, 1.15; 95% CI, 1.06-1.25) were associated with unnecessary antibiotic prophylaxis. Conclusion and Relevance: More than 80% of antibiotics prescribed for infection prophylaxis before dental visits were unnecessary. Implementation of antimicrobial stewardship in dental practices is an opportunity to improve antibiotic prescribing for infection prophylaxis.