Cost-effectiveness analysis of nivolumab-chemotherapy as first-line therapy for locally advanced/metastatic gastric cancer: a United States payer perspective.

OBJECTIVES: Nivolumab, an immune checkpoint inhibitor, was approved by the United States (US) Food and Drug administration as a first-line systemic therapy for locally advanced/metastatic gastric cancer patients. The current study aimed to investigate the cost-effectiveness of nivolumab-chemotherapy combination versus chemotherapy alone as a first-line therapy from a US payer perspective. METHODS: An economic evaluation was conducted using a partitioned survival model in Microsoft Excel® using data from the CheckMate 649 trial. Three discrete mutually exclusive health states (progression-free, post-progression, and death) were included in the model. The health state occupancy was calculated using the overall survival and progression-free survival curves derived from the CheckMate 649 trial. Cost, resource use, and health utility estimates were estimated from a US payer perspective. Deterministic and probabilistic sensitivity analyses assessed the uncertainty of the model parameters. RESULTS: Nivolumab-chemotherapy provided additional 0.25 life years compared to chemotherapy alone and the quality-adjusted life years (QALYs) were 0.701 and 0.561, respectively, producing a gain of 0.140 QALYs and an incremental cost-effectiveness ratio of $574,072/QALY. CONCLUSION: From the US payer perspective, at a willingness to pay threshold of $US150,000/QALY, nivolumab-chemotherapy was not found to be cost-effective as a first-line therapy for locally advanced/metastatic gastric cancer.

Changing paradigms in detecting rare adverse drug reactions: from disproportionality analysis, old and new, to machine learning.

PLAIN LANGUAGE SUMMARYYour physician, pharmacist, nurse, or even you can voluntarily report suspected adverse events associated with drugs. The FDA Adverse Reporting System (FAERS) and the WHO Vigibase are large databases that store individual reports of adverse drug reactions (ADRs). While some ADRs are very common, others are seen rarely. Detecting rare and very rare ADRs is extremely difficult but very important for the safe use of drugs. Databases such as FAERS and WHO Vigibase contain a large amount of data and are commonly used for analysis applying a statistical method called disproportionately analysis. This type of analysis determines whether there is a higher-than-expected number of adverse reactions for a particular drug. In the future, machine learning will complement this process by applying algorithms to the data, constructing and refining rules of inference, and building predictive models of ADRs. This paradigm change in testing for ADRs is expected to provide a better understanding of the factors impacting drug safety.

Evaluating the reliability and validity of a questionnaire used to measure experiences of teamwork among student pharmacists in a quality improvement course.

INTRODUCTION: The psychometric properties of instruments used to capture student pharmacists' perspectives of teamwork have not been well assessed. This study measured the reliability and validity of an instrument designed to assess teamwork experiences among student pharmacists in a quality improvement (QI) class at one United States pharmacy school. METHODS: The psychometric properties of a previously conducted 17-item questionnaire (response options: "strongly agree," "agree," "disagree," or "strongly disagree") about second-year student pharmacists' teamworking experiences were assessed. A Rasch rating scale model was used to construct measures of teamwork experience. Principal component analysis (PCA) assessed unidimensionality. Item- and person-fit statistics were assessed. Construct and content validity and reliability were estimated utilizing student and item separation indices (SI) and reliability coefficients (RC). RESULTS: Sixty student pharmacists were included. PCA conveyed a unidimensional construct. Four items with infit and outfit mean-squared values outside the suggested range were removed. Item responses "disagree" and "strongly disagree" were merged to improve scale functionality. The average person measure was 1.74 ± 2.03 logits. Student and item RC were 0.81 (SI = 2.04) and 0.97 (SI = 2.17), respectively. The easiest item endorsed was team's ability to reach consensus, while the most difficult item was interest to do collaborative work again. Mismatch of student experience and item difficulty level on the continuum scale suggested additional items are needed to match student teamwork experience. CONCLUSION: The instrument demonstrated evidence of reliability and validity to measure student pharmacists' teamwork experience in a QI class, but additional instrument modifications are recommended.

Program of All-Inclusive Care for the Elderly (PACE) versus Other Programs: A Scoping Review of Health Outcomes.

The Program of All-Inclusive Care for the Elderly (PACE) provides comprehensive health and social services to community-dwelling older United States (US) adults. However, little is known about how PACE outcomes compare to similar caregiving programs. This scoping review searched nine databases to identify studies that compared economic, clinical, or humanistic outcomes of PACE to other caregiving programs in the US. Two reviewers independently screened and extracted data from relevant articles and resolved discrepancies through consensus. From the 724 articles identified, six studies were included. Example study outcomes included: limitations and needs, survival and mortality, healthcare utilization, and economic outcomes. In conclusion, there are few published comparisons of PACE outcomes versus other caregiving programs for older US adults, and identified studies indicate mixed results. Further studies are needed to compare PACE outcomes to other programs so that policymakers are well informed to manage and optimize health outcomes for the growing US older adult population.

Use of Melatonin and/on Ramelteon for the Treatment of Insomnia in Older Adults: A Systematic Review and Meta-Analysis.

To investigate the efficacy of melatonin and/or ramelteon reporting sleep outcomes for older adults with chronic insomnia, a systematic review and a meta-analysis of PubMed, EMBASE, Cochrane library, International Pharmaceutical Abstracts, PsycINFO, science citation index, center for reviews and dissemination, CINAHL, grey literature and relevant sleep journal searches were conducted from 1 January 1990 to 20 June 2021. Randomized controlled trials and other comparative studies with melatonin and/or ramelteon use among older patients with chronic insomnia were included. Funnel plot and Egger's test was used to determine publication bias. A forest plot was constructed to obtain a pooled standardized mean difference using either a fixed or random effects model for each of the two broad categories of sleep outcomes: objective and subjective. Of 5247 studies identified, 17 studies met the inclusion criteria for MA. Study sample size ranged from 10 to 829 with the mean age ≥55 years. There were significant improvements in total sleep time (objective), sleep latency and sleep quality (objective and subjective) for melatonin and/or ramelteon users compared with placebo. Sleep efficiency was not significantly different. The effects of these agents are modest but with limited safe treatment options for insomnia in older adults, these could be the drugs of choice.

Assessing the Impact of an Advanced Clinical Decision Support System on Medication Safety and Hospital Readmissions in an Innovative Transitional Care Model: A Pilot Study.

(1) Background: Adverse drug events and inappropriate use of medications lead to hospitalizations, medication-related morbidity, and mortality. This study examined whether a novel medication risk prediction tool, the MedWise Risk Score™, was associated with medication safety-related problem (MRP) identification and whether integration into an existing innovative transitions of care (TOC) service could decrease readmissions. (2) Methods: This retrospective comparator group study assessed patients discharged from a hospital in southern Arizona between January and December 2020. Participants were included in the study if they were 18 years of age or older, referred to the pharmacist for TOC services, and received a pharmacist consultation within one-week post discharge. Patients were categorized into two groups: (1) medication safety review (MSR)-TOC service (intervention) or (2) existing innovative TOC service (control). (3) Results: Of 164 participants, most were male (57%) and were between 70−79 years of age. Overall, there were significantly more drug-drug interactions (DDI) MRPs identified per patient in the intervention vs. control group for those who were readmitted (3.7 ± 1.5 vs. 0.9 ± 0.6, p < 0.001) and those who were not readmitted (2 ± 1.3 vs. 1.3 ± 1.2, p = 0.0120). Furthermore, of those who were readmitted, the average number of identified MRPs per patient was greater in the intervention group compared to the control (6.3 vs. 2.5, respectively, p > 0.05). Relative to the control, the readmission frequency was 30% lower in the treatment group; however, there was insufficient power to detect significant differences between groups. (4) Conclusions: The integration of a medication risk prediction tool into this existing TOC service identified more DDI MRPs compared to the previous innovative TOC service, which lends evidence that supports its ability to prevent readmissions. Future work is warranted to demonstrate the longitudinal impact of this intervention in a larger sample size.

Associations of multiple (≥5) chronic conditions among a nationally representative sample of older United States adults with self-reported pain.

OBJECTIVES: The association between an individuals' demographic and health characteristics and the presence of multiple chronic conditions is not well known among older United States (US) adults. This study aimed to identify the prevalence and associations of having multiple chronic conditions among older US adults with self-reported pain. METHODS: This retrospective, cross-sectional study used data from the 2017 Medical Expenditure Panel Survey. Study subjects were aged ≥50 years and had self-reported pain in the past four weeks. The outcome variable was multiple (≥5) chronic conditions (vs. <5 chronic conditions). Hierarchical logistic regression models were used to identify significant associations between demographic and health characteristics and multiple chronic conditions with significance indicated at an a priori alpha level of 0.05. The complex survey design was accounted for when obtaining nationally-representative estimates. RESULTS: The weighted population was 57,074,842 US older adults with pain, of which, 66.1% had ≥5 chronic conditions. In fully-adjusted analyses, significant associations of ≥5 comorbid chronic conditions included: age 50-64 vs. ≥65 years (adjusted odds ratio [AOR]=0.478, 95% confidence interval [CI]=0.391, 0.584); male vs. female gender (AOR=1.271, 95% CI=1.063, 1.519); white vs. other race (AOR=1.220, 95% CI=1.016, 1.465); Hispanic vs. non-Hispanic ethnicity (AOR=0.614, 95% CI=0.475, 0.793); employed vs. unemployed (AOR=0.591, 95% CI=0.476, 0.733); functional limitations vs. no functional limitations (AOR=1.862, 95% CI=1.510, 2.298); work limitations vs. no work limitations (AOR=1.588, 95% CI=1.275, 1.976); little/moderate vs. quite a bit/extreme pain (AOR=0.732, 95% CI=0.599, 0.893); and excellent/very good (AOR=0.375, 95% CI=0.294, 0.480) or good (AOR=0.661, 95% CI=0.540, 0.810) vs. fair/poor physical health. CONCLUSIONS: Approximately 38 million of the 57 million US older adults with pain in this study had ≥5 chronic conditions in 2017. Several characteristics were associated with multiple chronic conditions, which may be important for health care professionals to consider when working with patients to manage their pain. This study was approved by The University of Arizona Institutional Review Board (2006721124, June 12, 2020).

Comparing jurisdiction-specific pharmaco-economic evaluations using medical purchasing power parities.

OBJECTIVES: To demonstrate how medical purchasing power parities (mPPP) may harmonize economic evaluations from different jurisdictions and enable comparisons across jurisdictions. METHODS: We describe the use of mPPPs and illustrate this with an example of economic evaluations of nab-paclitaxel with gemcitabine (Nab-P + Gem) versus gemcitabine monotherapy in the setting of metastatic pancreatic cancer. Following a literature search, we extracted data from cost-effectiveness studies on these treatments performed in various countries. mPPPs from the Organization for Economic Co-operation and Development were used to convert reported costs in the jurisdiction of origins to US dollars for the most current year using two possible pathways: (1) reported costs first adjusted by mPPP then adjusted by exchange index; and (2) reported costs first adjusted by exchange index then adjusted by mPPP. RESULTS: Despite many of the pharmaco-economic evaluations sharing similar assumptions and inputs, even after mPPP conversion, residual heterogeneity was attributable to perspectives, discount rate, outcomes, and costs, among others; including in studies conducted in the same jurisdiction. CONCLUSION: Despite the methodological challenges and heterogeneity within and across jurisdictions, we demonstrated that mPPP offers a way to compare economic evaluations across jurisdictions.