A Cost Analysis of Phosphodiesterase Type 5 Inhibitors in the United States.

OBJECTIVE: To perform a cost analysis of generic and brand-name Phosphodiesterase Type 5 (PDE5) inhibitors at different dosages and pharmacies across the US. METHODS: Using an all-payer retail pharmacy-claims database, we analyzed prescription drug data for three generic and six brand-name oral PDE5 inhibitors at different dosages across US chain and independent pharmacies in 2019. RESULTS: We obtained cash price data from 60,186 pharmacies (35,976 chain and 24,210 independent). The nationwide mean cash price per unit (PPU) ranged from $8.6 ± 5.2 (sildenafil 20 mg at chain pharmacies) to $107.1 ± 71 (Adcirca 20 mg at independent pharmacies) equal to 1145.3% difference. Chain pharmacies provided significantly lower average prices for one brand-name and six generic PDE5 inhibitors. Tadalafil PPU was cheaper at higher quantities, however, PPU increased with quantity prescribed for sildenafil. Looking at the top 10 metropolitan statistical areas, the highest PPUs were observed for tadalafil (Cialis) 10 mg and sildenafil (Viagra) 50 mg in Atlanta ($67.4 ± 8.7) and Los Angeles ($50.3 ± 24.0), while New York ($9.7 ± 2.6) and Miami ($27.9 ± 16.4) had the lowest PPUs for tadalafil (Cialis) 5 mg and sildenafil (Viagra) 100 mg, respectively. CONCLUSION: A substantial variability in PDE5 inhibitor cash prices exists across manufacturer, dosage, quantity, pharmacy type, and location. In addition, the pricing does not necessarily correlate with the regional socioeconomic factors. This highlights the importance of provider awareness and patient counseling on drug price including potentially assisting patients in identifying opportunities for cost savings.

Pharmacy and neighborhood-level variation in cash price of diabetes medications in the United States.

BACKGROUND: Diabetes medications place significant financial burden on patients but less is known about factors affecting cost variation. OBJECTIVE: To examine pharmacy and neighborhood factors associated with cost variation for diabetes drugs in the US. RESEARCH DESIGN, SUBJECTS AND MEASURES: We used all-payer US pharmacy data from 45,874 chain and independent pharmacies reflecting 7,073,909 deidentified claims. We divided diabetes drugs into insulins, non-insulin generic medications, and brand name medications. Generalized linear models, stratified by pharmacy type, identified pharmacy and neighborhood factors associated with higher or lower cash price-per-unit (PPU) for each set of drugs. RESULTS: Cash PPU was highest for brand name therapies ($149.4±203.2), followed by insulins ($42.4±25.0), and generic therapies ($1.3±4.4). Pharmacy-level price variation was greater for non-insulin generic therapies than insulins or brand name therapies. Chain pharmacies had both lower prices and lesser variation compared with independent pharmacies. CONCLUSIONS: Cash prices for diabetes medications in the US can vary considerably and that the greatest degree of price variation occurs in non-insulin generic therapies.

Capillary Transfer of Self-Assembled Colloidal Crystals.

Colloidal self-assembly has attracted significant interest in numerous applications including optics, electrochemistry, thermofluidics, and biomolecule templating. To meet the requirements of these applications, numerous fabrication methods have been developed. However, these are limited to narrow ranges of feature sizes, are incompatible with many substrates, and/or have low scalability, significantly limiting the use of colloidal self-assembly. In this work, we study the capillary transfer of colloidal crystals and demonstrate that this approach overcomes these limitations. Enabled by capillary transfer, we fabricate 2D colloidal crystals with nano-to-micro feature sizes spanning 2 orders of magnitude and on typically challenging substrates including those that are hydrophobic, rough, curved, or structured with microchannels. We developed and systemically validated a capillary peeling model, elucidating the underlying transfer physics. Due to its high versatility, good quality, and simplicity, this approach can expand the possibilities of colloidal self-assembly and enhance the performance of applications using colloidal crystals.

Characteristics of Cancer Hospitals with Written Language Access Policies.

Patients with limited English proficiency receive worse care due to communication barriers. Little is known about which cancer hospitals have written language access policies addressing bilingual clinicians. We conducted a cross-sectional survey of healthcare organizations, matching survey data to American Hospital Association Survey and American Community Survey data. We analyzed characteristics associated with hospitals having bilingual clinician policies. The response rate was 71% (127/178). Many hospitals (53 [42%]) did not have written policies on bilingual clinicians. Having bilingual clinicians available at the hospital was associated with having a written policy on bilingual clinicians, while being an NCORP site was associated with not having a written policy on bilingual clinicians. Patient demographic characteristics were not associated with hospitals having written policies on bilingual clinicians. A substantial proportion of cancer hospitals do not have policies that cover language use by bilingual clinicians, particularly at NCORP sites. Having written policies on bilingual clinicians has the potential to mitigate cancer disparities by facilitating accountability, improving communication, and reducing errors.

Rapid detection of multiple SARS-CoV-2 variants of concern by PAM-targeting mutations.

SARS-CoV-2 variants of concern (VOCs) that increase transmission or disease severity or reduce diagnostic or vaccine efficacy continue to emerge across the world. Current methods available to rapidly detect these can be resource intensive and thus sub-optimal for large-scale deployment needed during a pandemic response. Here, we describe a CRISPR-based assay that detects mutations in spike gene CRISPR PAM motif or seed regions to identify a pan-specific VOC single-nucleotide polymorphism (SNP)) ((D614G) and Alpha- and Delta-specific (S982A and D950N) SNPs. This assay exhibits good diagnostic sensitivity and strain specificity with nasal swabs and is designed for use in laboratory and point-of-care settings. This should enable rapid, high-throughput VOC identification required for surveillance and characterization efforts to inform clinical and public health decisions. Furthermore, the assay can be adapted to target similar SNPs associated with emerging SARS-CoV-2 VOCs, or other rapidly evolving viruses.

The Impact of Job and Insurance Loss on Prescription Drug use: A Panel Data Approach to Quantifying the Health Consequences of Unemployment During the Covid-19 Pandemic.

Due to the nature of health insurance in the United States, health care utilization is often tied to economic conditions, at both the individual and aggregate levels. This article examines how loss of employment may reduce medication adherence through the subsequent loss of insurance and income. At the individual level, the loss of employer-sponsored insurance is shown to be associated with lower prescription drug use and higher out-of-pocket expenditures. The rapid increase in unemployment during the COVID-19 pandemic provides a natural experiment to estimate the causal relationship between unemployment and prescription drug use at the aggregate level. In total, the growth in unemployment during the pandemic resulted in a 2.6% reduction in medication adherence and 57.5 million fewer prescriptions filled in 2020, with prescriptions declining for many chronic conditions. Unemployment-related reductions in prescription fills and medication adherence were highest in states without expanded Medicaid eligibility, further underscoring the importance of social safety nets such as Medicaid during times of economic hardship.

Prescription Filling Patterns of Evidence-Based Medical Therapies for Heart Failure During the COVID-19 Pandemic in the United States.

BACKGROUND: Maintaining a steady medication supply during a public health crisis is a major health priority. We leveraged a large U.S. pharmacy-claims database to understand the use of evidence-based therapies in heart failure (HF) care during the coronavirus disease-2019 (COVID-19) pandemic. METHODS: We analyzed 27,027,650 individual claims from an all-payer pharmacy-claims database across 56,155 chain, independent and mail-order pharmacies in 14,164 zip codes in 50 states. Prescriptions dispensed (in 2-week intervals) of evidence-based HF therapies in 2020 were indexed to comparable timeframes in 2019. We normalized these year-to-year changes in HF medical therapies relative to those observed with a stable basket of drugs. RESULTS: Fills of losartan, lisinopril, carvedilol, and metoprolol all peaked in the weeks of March 2020 and demonstrated trajectories thereafter that were relatively consistent with the reference set of drugs. Fills of spironolactone (+4%) and eplerenone (+18%) showed modest trends toward increased relative use during 2020. Fills of empagliflozin (+75%), dapagliflozin (+65%) and sacubitril/valsartan (+61%) showed striking longitudinal increases throughout 2020 that deviated substantially from year-to-year trends of the overall basket of drugs. For all 3 therapies, fills of all quantity sizes increased relatively throughout 2020. For both generic and brand-name therapies, prescription fill patterns from mail-order pharmacies increased substantially over expected trends beginning in March 2020 CONCLUSION: Prescription fills of most established generic therapies used in HF care were maintained, whereas those of sacubitril/valsartan and the sodium-glucose cotransporter-2 inhibitors steeply increased during the COVID-19 pandemic. These nationwide pharmacy claims data provide reassurance about therapeutic access, during a public health crisis, to evidence-based medications used in HF care.

Assessment of variation in 30-day mortality following cancer surgeries among older adults across US hospitals.

BACKGROUND: While public reporting of surgical outcomes for noncancer conditions is common, cancer surgeries have generally been excluded. This is true despite numerous studies showing outcomes to differ between hospitals based on their characteristics. Our objective was to assess whether three prerequisites for quality assessment and reporting are present for 30-day mortality after cancer surgery: low burden for timely reporting, hospital variation, and potential for public health gains. STUDY DESIGN: We used Fee-for-Service (FFS) Medicare claims to examine the extent of variation in 30-day cancer surgical mortality between 3860 US hospitals. We included 340 489 surgeries for 12 cancer types for FFS Medicare beneficiaries aged ≥66 years, 2011-2013. Hierarchical mixed-effects logistic regression models adjusted for patient and hospital characteristics and with a random hospital effect were fit to obtain hospital-specific risk-standardized mortality rates (RSMRs) and 99% confidence intervals (CI). We calculated a hospital odds ratio to describe the difference in mortality risk for a hospital above vs below average quality and estimated the potential mortality reduction. RESULTS: The median number of cancer surgeries per hospital was 34. The median RSMR overall was 2.41% (99% CI 2.28%, 2.66%). In aggregate and for most cancers, variation between hospitals exceeded that due to differences in patient and hospital characteristics. For individual cancers, relative differences exceeded 20% in mortality risk between patients undergoing surgery at a hospital below vs above average quality, with the potential for an estimated 500 deaths prevented annually given hypothetical improvements. CONCLUSION: Quality measurement and reporting of 30-day mortality for cancer surgery is worthy of consideration.

Inpatient folate testing at an academic cancer center: single-year experience.

PURPOSE: The value of testing for folate deficiency has been scrutinized recently given low prevalence of deficiency with widespread dietary fortification. Numerous studies have shown folate testing to be low yield overall. However, the value of such testing in the inpatient cancer population has not been defined. METHODS: We queried all folate tests performed during 2017 at our center on admitted cancer patients. We used diagnosis codes and manual chart review to assess risk factors for folate deficiency. Descriptive statistics were used to summarize characteristics of patients undergoing folate testing, the frequency of vitamin B12 co-testing, and repeat folate testing. Fisher's exact test was used to compare the proportion of deficient vs. not deficient tests based on the presence of risk factors. A Cox proportional hazards model was fit to examine the association between folate deficiency and survival. RESULTS: In total, 937 patients had 1065 tests performed during 2017. Among all tests, 7.0% indicated folate deficiency. In patients who underwent two folate tests in a single hospitalization, 89% were deficient neither instance. Risk factors for folate deficiency were equally common in instances with deficient compared with replete testing (25.3 vs. 20.4%, P = 0.334). Folate deficiency was associated with higher risk for death (HR 1.49, 95% CI 1.10-2.03, P = 0.01). CONCLUSION: Folate deficiency was present in 7% of hospitalized cancer patients and associated with shorter overall survival. Repeat testing in the same patient over time was low yield. Traditional risk factors for folate deficiency do not appear to apply in this patient population.

Assessing whether cancer stage is needed to evaluate measures of hospital surgical performance.

RATIONAL, AIMS, AND OBJECTIVES: While public reports of hospital-level surgical quality measures are becoming increasingly common in health care, a comprehensive national assessment of surgical quality across multiple cancer sites has yet to be developed. Fee-for-service (FFS) Medicare claims present a potential resource from which to measure outcomes following cancer surgery given the national scope of patients and providers. However, due to the administrative nature of the data, clinical cancer information such as stage is not recorded. Leveraging the Surveillance, Epidemiology, and End Results (SEER) registry linked to FFS Medicare claims to analyse outcomes for patients whom we ultimately know stage information, we determined whether Medicare claims are suitable for measuring provider quality following cancer surgery by assessing the extent to which the lack of stage information modifies assessments of provider performance. METHODS: We identified patients aged 66 and older undergoing cancer surgery between 2011 and 2013 from SEER-Medicare. We compared the changes in the risk-standardized rates (RSRs), decile rankings, and c-statistics with and without risk adjustment for cancer stage for three measures of hospital performance: 30-day mortality, surgical complications, and unplanned readmissions. RESULTS: The RSR changed by at most 11.4% for mortality and by less than 4% for complications and readmissions, indicating that measures of hospital performance were stable with and without adjustment for stage. The relative performance of hospitals was also stable, as demonstrated by fewer than 20% of hospitals changing decile rank. The c-statistic declined by less than 2% across all measures, indicating that model fit was not substantially worsened without this information. CONCLUSION: These findings support the use of FFS Medicare claims for hospital-level analyses of short-term outcomes following cancer surgery. Quality reporting based on these analyses can be used to help patients choose among hospitals and for evaluating policies to improve surgical cancer care.

Facts and Fears in Public Reporting: Patients' Information Needs and Priorities When Selecting a Hospital for Cancer Care.

Objective. Public reporting on the quality of provider care has the potential to empower patients to make evidence-based decisions. Yet patients seldom consult resources such as provider report cards in part because they perceive the information as irrelevant. To inform more effective public reporting, we investigated patients' information priorities when selecting a hospital for cancer treatment. We hypothesized that patients would be most interested in data on clinical outcomes. Methods. An experienced moderator led a series of focus groups using a semistructured discussion guide. Separate sessions were held with patients aged 18 to 54 years and those older than 54 years in Philadelphia, Pennsylvania; Phoenix, Arizona; and Indianapolis, Indiana, in 2017. All 38 participants had received treatment for cancer within the past 2 years and had a choice of hospitals. Results. In selecting hospitals for cancer treatment, many participants reported that they considered factors such as reputation, quality of the facilities, and experiences of other patients. For most, however, decisions were guided by trusted advisors, with the majority agreeing that a physician's opinion would sway them to disregard objective data about hospital quality. Nonetheless, nearly all expressed interest in having comparative data. Participants varied in selecting from a hypothetical list, "the top 3 things you would want to know when choosing a hospital for cancer care." The most commonly preferred items were overall care quality, timeliness, and patient satisfaction. Contrary to our hypothesis, many preferred to avoid viewing comparative clinical outcomes, particularly survival. Conclusions. Patients' information preferences are diverse. Fear or other emotional responses might deter patients from viewing outcomes data such as survival. Additional research should explore optimal ways to help patients incorporate comparative data on the components of quality they value into decision making.

Identifying Cancer-Directed Surgeries in Medicare Claims: A Validation Study Using SEER-Medicare Data.

PURPOSE: Medicare claims provide a rich data source for large-scale quality assessment because data are available for all beneficiaries nationally. For cancer surgery, the absence of information regarding site of cancer and date of diagnosis on an administrative claim necessitates testing to ensure accurate quality assessment and public reporting. METHODS: Using the SEER Medicare-linked database as the gold standard, we developed and tested an approach to identify cancer-directed surgeries from Medicare fee-for-service claims alone. Our analysis evaluated two questions: (1) Can we identify a large percentage of patients who underwent a cancer-directed surgery using only Medicare claims? (2) Of all patients identified as having undergone a cancer-directed surgery, what percentage had cancer? We evaluated this approach for 17 primary cancer sites. RESULTS: The number of Medicare beneficiaries diagnosed with their first cancer during the years 2011 to 2013 and who underwent cancer-directed surgery ranged from 45 patients (bones and joints) to 20,163 patients (breast). The percentage of cancer-directed surgeries identified using Medicare claims alone ranged from 62% (skin melanoma) to 94% (prostate). For all but three cancer sites (skin melanoma, thyroid, and urinary bladder), more than 80% of cancer-directed surgeries were identified using our approach. Of all surgeries identified, more than 90% were for patients with cancer. CONCLUSION: Identifying patients who underwent a cancer-directed surgery from Medicare claims is feasible for many cancer sites, although careful consideration needs to be given to the validity of each site. Our findings support the use of Medicare claims for large-scale quality assessment of cancer surgery by disease site.

Nonanastomotic strictures after colonic interposition.

OBJECTIVE: The purpose of this study was to describe the clinical and radiographic findings in a series of patients with nonanastomotic strictures after colonic interposition. CONCLUSION: Nonanastomotic strictures usually appear on upper gastrointestinal tract radiography as relatively long segments of smooth, tapered narrowing involving the interposed colon, most likely resulting from chronic ischemia. Unlike strictures at the esophagocolic or cologastric anastomosis, these long nonanastomotic strictures generally have a poor response to endoscopic dilatation procedures and are more likely to necessitate surgical revision of the colonic interposition.

Real-time quantitative PCR measurement of thyroglobulin mRNA in peripheral blood of thyroid cancer patients and healthy subjects.

Follow-up of recurrent differentiated thyroid carcinoma involves the measurement of serum thyroglobulin (Tg). However, Tg autoantibodies are present in a high proportion of thyroid carcinoma patients (up to 25%) and these can interfere with the Tg immunoassays. To overcome this obstacle, investigators have used real-time quantitative reverse transcriptase polymerase chain reaction (RT-PCR) to measure Tg mRNA in the blood of patients with differentiated thyroid cancer, with varying degrees of success. In the present study, we demonstrate the first reported use of the PAXgene Blood RNA collection tube and extraction kit method for the preparation of RT-PCR-quality RNA with subsequent deployment of the latter in the development of a specific, sensitive, and reproducible Taqman assay for the detection and quantification of thyroglobulin mRNA. Beta-actin mRNA was also assayed and results are expressed as a ratio of Tg to beta-actin mRNA. The intra-assay coefficient of variations (CVs) for Tg and beta-actin mRNA assay were 27.7% and 25.4%, respectively. Inter-assay CVs were 20.8% and 28.8%, respectively, for the two assays. Tg mRNA was detected in all cancer subjects (n = 42) and healthy individuals (n = 20). Tg mRNA was significantly higher in cancer patients than in the healthy subjects (0.00169 +/- 0.00013 vs. 0.00051 +/- 0.00015; P<0.0001). Fourteen cancer patients had detectable levels of serum Tg, and Tg mRNA levels tended to be higher in these than in cancer subjects with undetectable serum Tg (0.00188 +/- 0.00021 vs. 0.00157 +/- 0.000178; P = 0.08). Circulatory Tg mRNA measurement may serve a useful role in the assessment of thyroid cancer.