Impact of adherence to hydroxyurea on health outcomes among patients with sickle cell disease.

Although new pharmaceutical therapy options have recently become available, hydroxyurea is still the most commonly used and affordable treatment option for sickle cell disease (SCD). This study aimed to update the evidence on hydroxyurea adherence and its association with clinical and economic outcomes among individuals with SCD. This retrospective study used Texas Medicaid claims data from 09/2011-08/2016. Individuals were included if they had ≥1 inpatient or ≥2 outpatient SCD diagnoses, had ≥1 hydroxyurea prescription, were 2-63 years of age, and were continuously enrolled in Texas Medicaid between 6 months before and 1 year after the first hydroxyurea prescription fill date (index date). Hydroxyurea adherence (Medication Possession Ratio; MPR), vaso-occlusive crisis (VOC)-related outcomes, healthcare utilization and expenditures (SCD-related and all-cause) during the 1 year following the index date were measured. Bivariate and multivariable analyses were used to address the study objectives. Among 1035 included individuals (age: 18.8 ± 12.5 years, female: 52.1%), 20.9% were adherent to hydroxyurea (defined as MPR≥0.8). After adjustment for demographic and clinical characteristics, compared to being non-adherent, adhering to hydroxyurea was significantly associated with: a lower risk (Odds Ratio [OR] = 0.480, p = .0007) and hazard rate (Hazard Ratio [HR] = 0.748, p = .0005) of a VOC event, fewer VOC events (Incidence Rate Ratio [IRR] = 0.767, p = .0009), fewer VOC-related hospital days (IRR = 0.593, p = .0003), fewer all-cause and SCD-related hospitalizations (IRR = 0.712, p = .0008; IRR = 0.707, p = .0008, respectively) and emergency department visits (IRR = 0.768, p = .0037; IRR = 0.746, p = .0041, respectively), and lower SCD-related total healthcare expenditures (IRR = 0.796, p = .0266). Efforts to increase adherence to hydroxyurea could improve clinical and economic outcomes among individuals with SCD.

Neoadjuvant chemotherapy use trends among older women with breast cancer: 2010-2017.

PURPOSE: This study assessed chemotherapy use trends before (neoadjuvant chemotherapy [NAC]) or after surgery (adjuvant chemotherapy [AdC]) among older women with breast cancer and examined factors related to NAC receipt. METHODS: Women (> 65 years) diagnosed with stage I-III breast cancer during 2010-2017 who received NAC or AdC were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. All patients were stratified into six strata based on subtype (hormone receptor-positive/human epidermal growth factor receptor 2-negative [HR + /HER2-], HER2 + , and triple-negative breast cancer [TNBC]) and stage (I-II and III). Cochran-Armitage tests were performed to test temporal trends of NAC use in each stratum. Multivariable logistic regression analyses were performed to identify factors (sociodemographic and clinical) related to NAC use. RESULTS: Among included older (mean ± standard deviation: 72.3 ± 5.2 years) women (N = 8,495) with stage I-III breast cancer, NAC use increased from 11.7% (2010) to 32.6% (2017). Significant increases in NAC were found in all strata (p < .0001) with more substantial increases in HER2 + disease and TNBC compared to HR + /HER2- disease. Multivariable logistic regressions identified the youngest age category (66-69 years) and later stage as significant (p < 0.05) predictors of NAC receipt in most strata, in addition to diagnosis year. CONCLUSION: Similar to the overall breast cancer population, NAC use increased among a population of older women. NAC was received by most patients with stage III HER2 + disease or TNBC in more recent years and was more common among younger elderly women and those in stage III.

Economic Burden of Chronic Comorbidities Among Community-Dwelling Older Adults With Dementia: A Propensity Score Matched National-Level Study.

OBJECTIVE: This study examined the extent to which chronic comorbidities contribute to excess health care expenditures between older adults with dementia and propensity score (PS)-matched nondementia controls. METHODS: This was a retrospective, cross-sectional, PS-matched case (dementia): control (nondementia) study of older adults (65 y or above) using alternative years data from pooled 2005 to 2015 Medical Expenditure Panel Surveys (MEPS). Chronic comorbidities were identified based on Clinical Classifications System or ICD-9-CM codes. Ordinary least squares regression was utilized to quantify the impact of chronic comorbidities on the excess expenditures with logarithmic transformation. Expenditures were expressed as 2019 US dollars. All analyses accounted for the complex survey design of MEPS. RESULTS: The mean yearly home health care expenditures were particularly higher among older adults with dementia and co-occurring anemia, eye disorders, hyperlipidemia, and hypertension compared with PS-matched controls. Ordinary least squares regression models revealed that home health care expenditures were 131% higher (ß=0.837, P <0.001) among older adults with dementia compared with matched nondementia controls before adjusting for chronic comorbidities. When additionally adjusting for chronic comorbidities, the percentage increase, while still significant ( P <0.001) decreased from 131% to 102%. CONCLUSIONS: The excess home health care expenditures were partially explained by chronic comorbidities among community-dwelling older adults with dementia.

Healthcare utilization and costs among patients with chronic migraine, episodic migraine, and tension-type headache enrolled in commercial insurance plans.

OBJECTIVE: To quantify and compare healthcare utilization and costs for patients with chronic migraine (CM), episodic migraine (EM), and tension-type headache (TTH) enrolled in US commercial health plans. METHODS: This retrospective cohort study used the Optum Clinformatics® Data Mart database from January 2015 to December 2018. Adult patients with a diagnosis of EM, CM or TTH and at least 12 months of continuous enrollment before and after diagnosis were included. Inverse probability of treatment weighting was used to adjust for baseline differences among the three groups. Patient demographic and clinical characteristics at baseline, and healthcare utilization and costs during follow-up, were described and compared between the three groups. RESULTS: A total of 45,849 patients were included: 8955 with CM, 31,961 with EM, and 4933 with TTH. The total all-cause annual direct medical costs of patients with CM ($17,878) were 1.38 times higher (95% CI: 1.31-1.44) than those with EM ($12,986), and 2.26 times higher (95% CI: 2.08-2.47) than those with TTH ($7902). The annual migraine/TTH-related costs of patients with CM ($1869) were 4.19 times higher (95% CI: 3.92-4.48) than those with EM ($446), and 11.90 times (95% CI: 10.59-13.52) higher than those with TTH ($157). In the adjusted analyses, for all service categories (emergency department, inpatient, outpatient, and prescriptions), the expected costs in the migraine groups were higher than in the TTH group (all p < 0.001), while controlling for covariates. Main findings were consistent in both weighted and unweighted samples, and with both unadjusted and adjusted analyses. CONCLUSION: This study provides an updated assessment of healthcare utilization and expenditures for adult patients with primary headache disorders. Compared to TTH, migraine is associated with higher resource use and direct medical costs, especially for those with a chronic condition. Future studies are needed to understand the indirect medical costs (productivity loss) and humanistic burden (quality of life) between migraine and TTH.

General versus disease-specific health literacy in patients with breast cancer: a cross-sectional study.

Health literacy is recognized as a critical factor affecting communication across the continuum of cancer care and plays a key role in patients' ability to meaningfully discuss their condition with healthcare providers. However, there is no consensus on the best approach to measure health literacy in clinical practice. The aims of this study were to compare general and disease-specific measurements of health literacy in patients with breast cancer as well as examine their relationships with patient-provider communication. During office visits, patients with HER-2 + breast cancer who received care at oncology clinics with value-based models of care completed a survey including the 6-item cancer health literacy tool (CHLT-6), 6-item newest vital sign (NVS), 2 items measuring difficulty of patient-provider communication, and 11 demographic/clinical items. The mean age of 146 participants was 57.1 ± 10.8 years. Most participants had adequate general health literacy as measured by the NVS (79%) and a high probability of adequate cancer health literacy (≥ 0.7) as measured by the CHLT-6 (92%). Most patients easily communicated with healthcare providers (90.2%) and understood information they provided (83.5%). However, there was no significant relationship between patient-provider communication and health literacy. Both the CHLT-6 and NVS may be useful tools to assess the health literacy of patients with cancer in clinical practice. Study findings of adequate health literacy and ease of communication might have been influenced by the value-based care models adopted by participating clinics. Further research in more diverse samples of patients with cancer and different types of oncology practice settings is warranted.

Impact of emergency department opioid use on future health resource utilization among patients with migraine.

OBJECTIVE: The purpose of this study was to evaluate the subsequent health resource utilization (HRU) between patients with migraine who received opioid medications at their emergency department (ED) visits ("opioid recipients") versus patients with migraine who did not receive opioid medications at their ED visits ("non-recipients"). BACKGROUND: Previous studies have found that opioid use is common among patients with migraine at emergency settings. Medication overuse, especially the use of opioids, is associated with migraine progression, which can ultimately lead to substantial health resource use and costs. There is limited evidence on opioid use specifically in emergency settings and its impact on future HRU among people with migraine. METHOD: This retrospective cohort study used electronic health record data from the Baylor Scott & White Health between December 2013 and April 2017. Adult patients who had at least 6 months of continuous enrollment before (baseline or pre-index) and after (follow-up) the first date they had an ED visit with a diagnosis of migraine (defined as index date) were enrolled in the study. Opioid use and HRU during follow-up period between opioid recipients and non-recipients were summarized and compared. RESULTS: A total of 788 patients met the eligibility criteria and were included in this study. During the 6-month follow-up period, compared to patients with migraine who were non-recipients at their index ED visits, opioid recipients had significantly more all-cause (3.6 [SD = 6.3] vs. 1.9 [SD = 4.8], p < 0.0001) and migraine-related (1.6 [SD = 4.2] vs. 0.6 [SD = 2.1], p < 0.0001) opioid prescriptions (RXs), and more all-cause (2.6 [SD = 4.3] vs. 1.6 [SD = 2.6], p = 0.002) and migraine-related (0.6 [SD = 1.4] vs. 0.3 [SD = 0.8], p = 0.001) ED visits. In addition, opioid recipients had higher risk of future migraine-related ED visits controlling for covariates (HR = 1.49, 95% CI = 1.09-2.03, p = 0.013). Factors that were significantly (p < 0.05) related to future migraine-related ED visits include previous opioid use (HR = 2.12, 95% CI = 1.24-3.65, p = 0.007), previous ED visits (HR = 2.38, 95% CI = 1.23-4.58, p = 0.010), hypertension (HR = 1.46, 95% CI = 1.07-2.00, p = 0.017), age between 45 and 64 years (HR = 0.68, 95% CI = 0.48-0.97, p = 0.033), female sex (HR = 1.82, 95% CI = 1.12-2.86, p = 0.015), and tobacco use disorder (HR = 1.45, 95% CI = 1.07-1.97, p = 0.017). Sub-analyses were restricted to the group of patients who were opioid naïve at baseline (n = 274, defined as having ≤1 opioid RXs during the 6-month pre-index period). Patients who were baseline opioid naïve but received opioids during their index ED visits were more likely to have future migraine-related ED visits compared to patients who were baseline opioid naïve and did not receive any opioids during their index ED visits, controlling for covariates (HR = 2.90, 95% CI = 1.54-5.46, p = 0.001). CONCLUSION: Opioid use among patients with migraine presenting to the ED is associated with increased future HRU, which highlights the need for optimizing migraine management in emergency settings.

A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma.

WHAT IS KNOWN AND OBJECTIVE: Metastatic renal cell carcinoma (mRCC) is the most common type of kidney cancers. Disease-specific survival for mRCC has been significantly improved with the introduction of new targeted agents since 2005. However, there is a lack of head-to-head clinical trials comparing the efficacy between therapies. This study compared indirectly progression-free survival (PFS) and overall survival (OS) among first-line and second-line therapies in patients with mRCC using network meta-analysis (NMA). METHODS: The PubMed, MEDLINE, Cochrane Library and Web of Science were searched to identify phase II or phase III randomized controlled trials (RCTs) of targeted and biological therapies in patients with mRCC published between January 2000 and June 2020. The Bayesian fixed-effect NMA was performed to evaluate relative PFS and OS of first-line and second-line therapies of axitinib, bevacizumab, cabozantinib, everolimus, lenvatinib, nivolumab, ipilimumab, pazopanib, sorafenib, sunitinib, temsirolimus, tivozanib, avelumab and pembrolizumab, which were approved by the Food and Drug Administration or European Medicines Agency. End points were compared using hazard ratio (HR) and 95% credible interval (CrI). The surface under the cumulative ranking curve (SUCRA) was estimated to assess the probability of being the best treatment. RESULTS AND DISCUSSION: A total of 26 RCTs (first line: 19, second line: 9) with 13 893 patients were included in the NMA. For the first-line therapy, cabozantinib was associated with the highest improved PFS (HR = 0.26, 95% CrI = 0.14-0.44) followed by avelumab + axitinib and pembrolizumab + axitinib (HR = 0.27, SUCRA = 90%). Pembrolizumab + axitinib had a high likelihood of being the preferred treatment when using OS as the outcome measure (HR = 0.41, 95% CrI = 0.16-0.85). Avelumab + axitinib had the lowest HR compared with placebo + interferon on discontinuations due to AE (HR = 1.04, 95% CrI = 0.54-1.86). For second-line therapy, cabozantinib was identified as the most effective treatment option when assessing PFS (HR = 0.17, 95% CrI = 0.12-0.24). Axitinib had the lowest HR of OS and discontinuation due to AE (HR = 0.54, 95% CrI = 0.40-0.71; HR = 0.98, 95% CrI = 0.42-1.97, respectively). Pazopanib was the second choice in terms of OS (HR = 0.56, 95% CrI = 0.28-1.00; SUCRA = 76%) compared with placebo. WHAT IS NEW AND CONCLUSION: With respect to PFS and OS improvement, cabozantinib, avelumab + axitinib and pembrolizumab + axitinib are likely to be the preferred options for the first-line therapy and cabozantinib and axitinib for the second-line therapy in the management of mRCC. Regarding safety, avelumab + axitinib and temsirolimus were considered preferred treatment options in first-line and second-line therapies. More future research is needed to establish subgroup analyses, allowing evaluation of the impact of some of the differences in patient characteristics, including treatment effect modifiers.

Patterns and predictors of opioid use among migraine patients at emergency departments: A retrospective database analysis.

OBJECTIVES: To compare medication use and health resource utilization between migraineurs with evidence of opioid use at emergency department visit versus no opioid use at emergency department visit, and to examine predictors of opioid use among migraineurs at emergency department visits. METHODS: This was a retrospective study using REACHnet electronic health records (December 2013 to April 2017) from Baylor Scott & White Health Plan. The index date was defined as the first migraine-related emergency department visit after ≥6 months of enrollment. Adult patients with a migraine diagnosis and ≥6 months of continuous enrollment before and after their index dates were included. Descriptive statistics and bivariate analyses were used to compare medication use and health resource utilization between opioid users and non-opioid users. Multivariable logistic regression was used to examine predictors of opioid use at emergency department visits. RESULTS: A total of 788 migraineurs met eligibility criteria. Over one-third (n = 283, 35.9%) received ≥1 opioid medication during their index date emergency department visit. Morphine (n = 103, 13.1%) and hydromorphone (n = 85, 10.8%) were the most frequently used opioids. Opioid users had more hospitalizations and emergency department visits during their pre-index period (both p < 0.05). Significant (p < 0.05) predictors of opioid use at emergency department visits included past migraine-related opioid use (2-4 prescriptions, Odds Ratio = 1.66; 5-9 prescriptions, Odds Ratio = 2.12; ≥10 prescriptions, Odds Ratio = 4.43), past non-migraine-related opioid use (≥10 prescriptions, Odds Ratio = 1.93), past emergency department visits (1-3 visits, Odds Ratio = 1.84), age (45-64 years, Odds Ratio = 1.45), and sleep disorder (Odds Ratio = 1.43), controlling for covariates. CONCLUSION: Opioids were commonly given to migraineurs at emergency departments. Previous opioid use, health resource utilization, age, and specific comorbidities might be used to identify migraineurs with a high risk of opioid use.

The Role of Physical Activity in the Association Between Smoking Status and Quality of Life.

OBJECTIVES: Nonsmoking status and physical activity have, individually, been shown to be associated with health-related quality of life (HRQoL). The objective of this study was to assess whether the relationship between smoking status and HRQoL is modified or influenced by physical activity. METHODS: Data were extracted from the 2014 Behavioral Risk Factor Surveillance Survey dataset (N = 332680) in 2015. Logistic regression models were used to address study objectives. Health-related quality of life (HRQoL), measured using eight domains (general health, physical health, mental health, activity limitations, pain, depressive symptoms, anxiety, and vitality), was regressed on smoking status without and with adjustment for age, race, gender, education, marital status, income, employment, healthcare coverage, comorbidity, body mass index, flu vaccination, alcohol use, and physical activity. Smoking status by physical activity interaction term was added to the adjusted model and evaluated for significance. RESULTS: There were significant smoking status by physical activity interaction effects on general health, physical health, activity limitations, and depressive symptoms domains. Among those who exercised, relative differences in the odds of a high HRQoL was smaller between former smokers and nonsmokers and larger between current smokers and nonsmokers when compared to those who did not exercise. Similarly, there were sharper relative differences between those who exercised and those who did not exercise among former smokers than among current smokers. CONCLUSIONS: Smokers who successfully quit smoking (former smokers) may benefit from enhanced HRQoL that tends towards that of nonsmokers if they adopt physical activity in their daily routine. IMPLICATIONS: Behavioral interventions that combine smoking cessation and physical activity may be more effective than either smoking cessation or physical activity alone in improving the quality of life measures such as overall, physical and mental health, and degree of limitation to activities due to poor health. Health care providers can support patients who successfully quit smoking to add exercise to their daily routine with the expectation of enhanced HRQoL.

Increased Fracture Risk with Furosemide Use in Children with Congenital Heart Disease.

OBJECTIVES: To determine the association of furosemide therapy with the incidence of bone fractures in children with congenital heart disease. STUDY DESIGN: We conducted a retrospective cohort study with data extracted from the 2008-2014 Texas Medicaid databases. Pediatric patients aged <12 years diagnosed with congenital heart disease, cardiomyopathy, or heart failure were included. Patients taking furosemide were categorized into a furosemide-adherent group (medication possession ratio of ≥70%), and a furosemide-nonadherent group (medication possession ratio of <70%). A third group of patients was matched to the furosemide user groups by using propensity score matching. A multivariate logistic regression and Cox proportional hazard model with a Kaplan-Meier plot (time-to-fracture) were used to compare the 3 groups, controlling for baseline demographics and clinical characteristics. RESULTS: After matching, 3912 patients (furosemide adherent, n = 254; furosemide nonadherent, n = 724; no furosemide, n = 2934) were identified. The incidence of fractures was highest for the furosemide-adherent group (9.1%; 23 of 254), followed by the furosemide-nonadherent group (7.2%; 52 of 724), which were both higher than for patients who did not receive furosemide (5.0%; 148 of 2934) (P < .001). Using logistic regression, both furosemide groups were more likely to have fractures than the no furosemide group: furosemide-adherent OR of 1.9 (95% CI, 1.17-2.98; P = .009); furosemide nonadherent OR of 1.5 (95% CI, 1.10-2.14; P = .01). In the Cox proportional hazard model, the risk of fractures for the furosemide-adherent group was significantly higher compared with the no furosemide group (HR, 1.6; 95% CI, 1.00-2.42; P = .04). CONCLUSIONS: Furosemide therapy, even with nonconsistent dosing, was associated with an increased risk of bone fractures in children with congenital heart disease.

Patterns of antiepileptic drug use in patients with potential refractory epilepsy in Texas Medicaid.

OBJECTIVES: Antiepileptic drug (AED) monotherapy is usually effective in 60% of the patients with epilepsy while the remaining patients have refractory epilepsy. This study compared treatment patterns (adherence, persistence, addition, and switching) associated with refractory and nonrefractory epilepsy. METHODS: Texas Medicaid claims from 09/01/07-12/31/13 were analyzed, and patients eligible for the study 1) were between 18 and 62 years of age, 2) had a prescription claim for an AED during the identification period (03/01/08-12/31/11) with no prior baseline AED use (6-month), and 3) had evidence of epilepsy diagnosis within 6 months of AED use. Based on AED use in the identification period, patients were categorized into "refractory" (≥3AEDs) and "nonrefractory" (<3AEDs) cohorts. The index date was the date of the first AED claim. Patients in both cohorts were matched 1:1 using propensity scoring and compared for adherence (proportion of days covered (PDC) ≥80% vs. <80%), persistence, addition (yes/no), and switching (yes/no) using multivariate conditional regression models. Conditional logistic regression and Cox proportional hazard models were used to address the study objectives. RESULTS: Of the 10,599 eligible patients, 2798 (26.5%) patients in the refractory cohort were matched to patients in the nonrefractory cohort. Patients in the refractory cohort had significantly higher (p < 0.005) mean (±Standard deviation (SD)) adherence (88.6% (±19.1%) vs. 77.0% ±â€¯(25.8%)) and persistence (328.0 (±87.3) days vs. 294.9 ±â€¯(113.4) days) as compared with patients in the nonrefractory cohort. Compared with patients with nonrefractory epilepsy, patients with refractory epilepsy were 3.6 times (odds ratio (OR) = 3.553; 95% confidence interval (CI) = 3.060-4.125; p < 0.0001) more likely to adhere to AEDs and had a 34.7% (hazard ratio (HR) = 0.653; 95% CI = 0.608-0.702; p < 0.0001) lower hazard rate of discontinuation of AEDs. Also, patients with refractory epilepsy were 3.7 times (OR = 3.723; 95% CI = 2.902-4.776; p < 0.0001) more likely to add an alternative AED and 3.6 times (OR = 3.591; 95% CI = 3.010-4.284; p < 0.0001) more likely to switch to an alternative AED. CONCLUSION: Patients with refractory epilepsy were significantly more likely to adhere and persist to AED regimen and were significantly more likely to add and switch to an alternative AED than patients with nonrefractory epilepsy.

Direct and indirect costs among patients with binge-eating disorder in the United States.

OBJECTIVE: To quantify the economic burden of binge-eating disorder (BED) in terms of work productivity loss, healthcare resource utilization, and healthcare costs. METHODS: Respondents of the US National Health and Wellness Survey 2013 were invited to participate in a follow-up internet survey to identify adults with BED using DSM-5 criteria. Work productivity loss, healthcare resource utilization, and direct and indirect costs were assessed for BED respondents and matched non-BED respondents using generalized linear models or two-part models as appropriate. RESULTS: A total of 1,720 people were included in our analysis (N = 344 with BED; N= 1,376 without BED). BED respondents had higher levels of activity impairment than non-BED respondents (41.29% vs. 23.18%, p < .001). Employed BED respondents (N = 178) had a greater level of work impairment than employed non-BED respondents (N = 686) (36.83% vs. 14.41%, p = .009). Higher healthcare resource utilization in the past 6 months among BED respondents was reported than matched non-BED respondents: numbers of surgeries (0.23 vs. 0.13, p = .021), ER visits (0.26 vs. 0.15, p = .016), and physician visits (6.09 vs. 4.56, p = .002). BED respondents reported higher total direct costs than matched non-BED respondents ($20,194 vs. $14,465, p = .005). The indirect costs among employed BED respondents were also higher than those without BED ($19,327 vs. $9,032, p < .001). DISCUSSION: Individuals with BED reported significantly greater economic burden with respect to work productivity loss, level of healthcare resource utilization, and costs compared to non-BED respondents. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:523-532).

PHARMACOECONOMIC STUDIES IN WORLD HEALTH ORGANIZATION EASTERN MEDITERRANEAN COUNTRIES: REPORTING COMPLETENESS.

OBJECTIVES: The aim of this study was to evaluate the extent of reporting necessary information in published health economic research in World Health Organization Eastern Mediterranean Countries (WHO EMC). METHODS: A systematic literature search was conducted using PubMed and Google Scholar to identify pharmacoeconomic studies conducted in WHO EMC. The inclusion criteria for the studies were: (i) original studies, (ii) compared pharmaceutical services or drugs, (iii) conducted in WHO EMC, (iv) manuscript published in English. The articles were reviewed by two independent reviewers using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: A total of seventeen studies were included, each of which were published in seventeen different journals. The mean CHEERS checklist score was 16 ± 4. Most studies were published in journals outside WHO EMC (n = 12; 71 percent). Cost-effectiveness (n = 5; 29 percent) and cost-utility analyses (n = 5; 29 percent) were the most frequently used methods of economic evaluation. CONCLUSIONS: Pharmacoeconomic studies in WHO EMC are limited and sometimes incomplete. Economic evaluation of pharmaceuticals should be encouraged in WHO EMC to ensure the appropriate allocation of healthcare resources.

Integration of pharmacists into patient-centered medical homes in federally qualified health centers in Texas.

OBJECTIVES: To describe the integration and implementation of pharmacy services in patient-centered medical homes (PCMHs) as adopted by federally qualified health centers (FQHCs) and compare them with usual care (UC). SETTING: Four FQHCs (3 PCMHs, 1 UC) in Austin, TX, that provide care to the underserved populations. PRACTICE DESCRIPTION: Pharmacists have worked under a collaborative practice agreement with internal medicine physicians since 2005. All 4 FQHCs have pharmacists as an integral part of the health care team. Pharmacists have prescriptive authority to initiate and adjust diabetes medications. PRACTICE INNOVATION: The PCMH FQHCs instituted co-visits, where patients see both the physician and the pharmacist on the same day. PCMH pharmacists are routinely proactive in collaborating with physicians regarding medication management, compared with UC in which pharmacists see patients only when referred by a physician. EVALUATION: Four face-to-face, one-on-one semistructured interviews were conducted with pharmacists working in 3 PCMH FQHCs and 1 UC FQHC to compare the implementation of PCMH with emphasis on 1) structure and workflow, 2) pharmacists' roles, and 3) benefits and challenges. RESULTS: On co-visit days, the pharmacist may see the patient before or after physician consultation. Pharmacists in 2 of the PCMH facilities proactively screen to identify diabetes patients who may benefit from pharmacist services, although the UC clinic pharmacists see only referred patients. Strengths of the co-visit model include more collaboration with physicians and more patient convenience. Payment that recognizes the value of PCMH is one PCMH principle that is not fully implemented. CONCLUSION: PCMH pharmacists in FQHCs were integrated into the workflow to address specific patient needs. Specifically, full-time in-house pharmacists, flexible referral criteria, proactive screening, well defined collaborative practice agreement, and open scheduling were successful strategies for the underserved populations in this study. However, reimbursement plans and provider status for pharmacists should be established to sustain this model of care.

Insomnia, hypnotic use, and health-related quality of life in a nationally representative sample.

PURPOSE: To assess health-related quality of life (HRQoL) associated with insomnia and prescription hypnotic use. METHODS: Primary outcomes were mental component summary (MCS) and physical component summary (PCS) scores from the 12-item Short-Form Health Survey. Using multiple regression, subjects in the 2005 through 2009 Medical Expenditure Panel Survey with diagnosed insomnia were compared against those without that diagnosis. Among subjects with diagnosed insomnia, users of prescription hypnotics were compared against nonusers. RESULTS: Of 104,274 adults, 1.3 % (n = 1,401) had an insomnia diagnosis. Of those, 45.6 % (n = 639) used prescription hypnotics. For subjects with insomnia, mean PCS and MCS scores were 9.2 and 7.0 points lower (p < 0.001), respectively. After controlling for demographic and clinical covariates, differences remained significant (PCS:5.1; MCS: 6.2; p < 0.001). Among subjects with insomnia, HRQoL scores were not different between prescription hypnotic users (n = 639) and nonusers (n = 762). Analysis by drug class revealed lower PCS scores (difference: 7.5, p < 0.001) with benzodiazepine use (n = 129) versus benzodiazepine receptor agonist use (n = 493), but the adjusted difference was not significant (difference: 3.8, p = .018). CONCLUSIONS: Diagnosed insomnia was associated with consistent decreases in both physical and mental HRQoL scores, regardless of whether prescription hypnotics were used. Benzodiazepine use may be associated with a further decrease in physical HRQoL scores. Although limited by its retrospective design, this study provides a first look at real-world hypnotic use outcomes at a national level. Important next steps include studies with patients serving as their own controls, and further evaluation of the sensitivity of HRQoL instruments to the effects of insomnia treatments.

Cost-Effectiveness Evaluation of Oral CGRP Antagonists, Atogepant and Rimegepant, for the Preventative Treatment of Episodic Migraine: Results from a US Societal Perspective Model.

BACKGROUND AND OBJECTIVES: Two oral calcitonin gene-related peptide (CGRP) antagonists, atogepant and rimegepant, were approved in 2021 for the preventive treatment of episodic migraine (EM), yet no formal cost-effectiveness analysis has been published. The objective of this study was to evaluate the cost-effectiveness of atogepant 60 mg and rimegepant 75 mg compared with placebo. METHODS: A decision tree model was constructed over a 1-year time horizon from a US societal perspective. Patient cohorts were simulated using baseline and change from baseline monthly migraine days (MMDs) reported in the trials to incorporate responder rates and within patient response into the model. Due to heterogeneity between the trial populations, each medication was compared with its respective trial's placebo group. Direct healthcare resource costs, productivity costs, acute medication costs, and quality-of-life values were obtained from the literature. RESULTS: The atogepant cohort experienced an incremental increase in healthcare plus productivity costs of $11,978 when compared with placebo, with a gain of 0.026 quality-adjusted life-years (QALYs). This yielded an incremental cost-effectiveness ratio (ICER) of more than $450,000/QALY. The rimegepant cohort experienced an incremental increase of $21,692 when compared with placebo, with a gain of 0.024 QALYs. This yields an ICER of more than $890,000/QALY when comparing rimegepant with placebo. Cost savings between atogepant and atogepant placebo were greatest with respect to acute medication costs at $735 of savings over 1 year, followed by savings of $135 for healthcare resource utilization and $34 for productivity costs. A similar relationship was seen between rimegepant and rimegepant placebo. One-way deterministic sensitivity analysis found that monthly acquisition costs of atogepant and rimegepant had the largest impact on the ICER, respectively. CONCLUSIONS: Atogepant and rimegepant were both unable to meet generally accepted cost-effectiveness thresholds < 150,0000/QALY. Additional studies are needed to better guide decision making regarding oral CGRPs' place in therapy.

Exploring factors related to clinically advanced fibrosis in patients with nonalcoholic fatty liver disease or nonalcoholic steatohepatitis.

OBJECTIVES: To describe the clinical profile of nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) patients in a Texas integrated delivery network (IDN) and elucidate the local relationship between patient factors and the risk of advanced fibrosis. METHODS: This observational, retrospective, cross-sectional study utilized existing data from the electronic health record at a large Texas IDN. Data was collected during the study period from 1 January 2019, to 1 March 2023. Patient characteristics, comorbidities, labs, and medication orders were collected from the most recent encounter in which a Fibrosis-4 (FIB-4) score could be calculated. Chi square tests and analysis of variance (ANOVA) tests were conducted to evaluate differences among the three fibrosis risk categories. Ordinal logistic regression was utilized to assess associations between select variables and a higher risk of advanced fibrosis. RESULTS: A total of 56,253 patients were included in the study. 34,839 (61.9%) were Low-Risk 15,578 (27.7%) were Intermediate-Risk, and 5,836 (10.4%) were High-Risk of advanced fibrosis. Results showed that up to 70.4% of patients within a risk group were obese. Only 49.5% of patients in the High-Risk group had at least one gastroenterologist or hepatologist visit. Males, Medicare patients, former smokers, and those with hypertension, type 2 diabetes, and chronic kidney disease were associated with a higher risk of advanced fibrosis. CONCLUSION: This study highlights the need for early screening and proactive management of metabolic risk factors for patients with NAFLD/NASH. The findings indicate a notable prevalence of obesity in the study population, a need for specialist referral for those at High-Risk of advanced fibrosis, and the importance of routine labs to evaluate metabolic factors. Primary care providers may be ideal providers to target these interventions and address this care need.

Treatment patterns and outcomes among adults with immune thrombocytopenia receiving pharmaceutical second-line therapies: a retrospective cohort study using administrative claims data.

OBJECTIVES: To describe and compare real-world treatment patterns and clinical outcomes among individuals with immune thrombocytopenia (ITP) receiving second-line therapies (rituximab, romiplostim, or eltrombopag). METHODS: A retrospective cohort study was conducted using a large administrative claims database (January 2013-May 2020) among continuously enrolled patients ≥18 years prescribed second-line ITP therapies. The index date was the date of the first claim of the study medications. Treatment patterns and outcomes were measured during the 12-month follow-up period. Inverse probability of treatment weighting (IPTW) was used to balance covariates across treatment groups. Multivariable logistic regression was used to compare treatment patterns and bleeding risk outcomes. RESULTS: A total of 695 patients were included (rituximab, N = 285; romiplostim, N = 212; eltrombopag, N = 198). After IPTW, all baseline covariates were balanced. Compared to eltrombopag, patients in the rituximab cohort were 57% more likely to receive other ITP therapies (systematic corticosteroids or third-line therapies) during the follow-up period (odds ratio [OR] = 1.571, p = .030). There was no significant difference in the odds of receiving a different second-line therapy or experiencing a bleeding-related episode among three groups (p > .050). Patients in the romiplostim cohort were 69% more likely to receive rescue therapy compared to those in the rituximab cohort (OR = 1.688, p = .025). CONCLUSION: Patients with ITP receiving rituximab were more likely to need other ITP therapies but did not experience higher risk of bleeding compared to those receiving eltrombopag or romiplostim. Benefits, risks, cost-effectiveness, and patient preference should all be considered in optimizing second-line therapy for ITP.

Comparing survival outcomes between neoadjuvant and adjuvant chemotherapy within breast cancer subtypes and stages among older women: a SEER-Medicare analysis.

BACKGROUND: This study aimed to compare survival outcomes of neoadjuvant (NAC) and adjuvant chemotherapy (AdC) within each breast cancer subtype and stage among older women. METHODS: Older (≥ 66 years) women newly diagnosed with stage I-III invasive ductal breast cancer during 2010-2017 and treated with both chemotherapy and surgery within one year were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Analyses were performed within each of six groups, jointly defined based on subtype (hormone receptor [HR]-positive/human epidermal growth factor receptor 2 [HER2]-negative, HER2 + , and triple-negative) and stage (I-II and III). Kaplan-Meier curves and multivariable Cox models were used to compare overall and recurrence-free survival between NAC and AdC, with optimal full matching performed for confounding adjustment. RESULTS: Among 8,495 included patients, 8,329 (20.6% received NAC) remained after matching. Before multiple testing adjustment, Cox models showed that NAC was associated with a lower hazard for death among stage III HER2 + patients (hazard ratio = 0.347, 95% confidence interval CI 0.161-0.745) but a higher hazard for death among triple-negative patients (stage I-II: hazard ratio = 1.558, 95% CI 1.024-2.370; stage III: hazard ratio = 2.453; 95% CI 1.254-4.797). A higher hazard for death/recurrence was associated with NAC among stage I-II HR + /HER2- patients (hazard ratio = 1.305, 95% CI 1.007-1.693). No significant difference remained after multiple testing adjustment. CONCLUSIONS: The opposite trends (before multiple testing adjustment) of survival comparisons for advanced HER2 + and triple-negative disease warrant further research. Caution is needed due to study limitations such as cancer stage validity.

Cost-effectiveness of expanded newborn screening in Texas.

OBJECTIVE: Texas House Bill 790 resulted in the expansion of the newborn screening panel from 7 disorders to 27 disorders. Implementation of this change began in 2007. The objective of this study was to estimate the incremental cost-effectiveness of the expanded newborn screening program compared with the previous standard screening in Texas. METHODS: A Markov model (for a hypothetical cohort of Texas births in 2007) was constructed to compare lifetime costs and quality-adjusted life-years (QALYs) between the expanded newborn screening and preexpansion newborn screening. Estimates of costs, probabilities of sequelae, and utilities for disorder categories were obtained from a combination of Texas statistics, the literature, and expert opinion. A baseline discount rate of 3% was used for both costs and QALYs, with a range of 0% to 5%. Analyses were conducted from a payer's perspective, and so only direct medical cost estimates were included. RESULTS: The lifetime incremental cost-effectiveness ratio for expanded versus preexpansion screening was about $11,560 per QALY. The results remained robust to both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Expanded newborn screening does result in additional expenses to the payer, but it also improves patient outcomes by preventing avoidable morbidity and mortality. The screened population benefits from greater QALYs as compared with the unscreened population. Overall, expanded newborn screening in Texas was estimated to be a cost-effective option as compared with unexpanded newborn screening.