Real-world treatment patterns for patients with metastatic head and neck squamous cell carcinoma treated with immuno-oncology therapy.

BACKGROUND: Real-world use of immuno-oncology (IO) therapies (nivolumab and pembrolizumab) in metastatic head and neck squamous cell carcinoma (mHNSCC) has not been well studied. METHODS: mHNSCC patients treated with an IO therapy were identified from a large US claims database from 2016 to 2017. Treatment patterns before and after initiation of IO therapy (index date) were described. RESULTS: Among 416 mHNSCC patients, 85% had ≥1 regimen prior to IO therapy. Ninety-seven percent of patients initiated IO as monotherapy and 3% initiated IO combined with another systemic treatment. One hundred seventeen (28%) patients had a subsequent regimen, usually chemotherapy (n = 58, 50%) or IO monotherapy (n = 27, 23%), of which 22 patients restarted the same IO therapy and 5 switched to another IO monotherapy. CONCLUSION: The majority of mHNSCC patients initiated IO as a monotherapy. Approximately half of patients with a subsequent regimen received chemotherapy and one-fourth received IO monotherapy.

Patient cost sharing and receipt of erythropoiesis-stimulating agents through medicare part D.

PURPOSE: Medicare Part D prescription benefits cover injected medications, normally covered under Part B, when administered outside of physician offices. Erythropoiesis-stimulating agents (ESAs) used for chronic anemia management in patients with myelodysplastic syndromes (MDS) are commonly injected in a physician office but can be administered safely at home. In this study, we explored out-of-pocket (OOP) costs and receipt of Part D-covered ESAs in Medicare beneficiaries with MDS. MATERIALS AND METHODS: Patients with MDS enrolled in Medicare Parts A, B, and D were identified using diagnosis codes from 100% claims from 2006 to 2008. OOP costs for the mean erythropoietin alfa claim were compared for Parts B and D. Multivariable models examined the effect of low-income subsidy (LIS) and other Part D cost sharing on receipt of any ESA and any Part D-covered ESA. RESULTS: A total of 13,117 (62.9%) of 20,848 patients received ESAs, but only 1,436 (6.9%) had any Part D claim. OOP payment was $348 under Part D versus $161 under Part B. Among patients with ESA use, those with LIS were 4× more likely to receive Part D ESAs (P < .01). CONCLUSION: Few patients with MDS received ESAs through Part D. OOP payments required under Part D were substantially higher than under Part B. Cost sharing, as reflected by LIS receipt, likely affected decisions to prescribe ESAs outside of the physician office. Improved coordination between Part B and D benefits regarding issues of home injection of medications may create incentives that improve patient access and convenience and reduce costs associated with administration.

Employee health and frequency of workers' compensation and disability claims.

OBJECTIVE: To assess the relationship between self-assessed employee health risk status and future workers' compensation (WC) and short-term disability (STD) claims. METHODS: A historical cohort study linking Health Risk Assessment (HRA) survey data with subsequent WC and STD claims. HRA participants who developed a WC or STD claim in the subsequent 12 months were identified as cases and compared with HRA participants who did not develop a claim in the subsequent 12 months. RESULTS: High-risk participants had higher odds of filing a WC claim, when compared with low-risk participants (OR: 2.99, 95% CI: 1.22 to 7.32) despite adjustment for demographic factors including job type. Medium-risk participants had 1.5 times higher odds, when compared with low-risk participants to file for STD (OR: 1.45, 95% CI: 1.15 to 1.82). Other relationships trended similarly but did not reach statistical significance. CONCLUSION: Self-assessed personal health risk does impact future lost productivity in WC and STD claims even after adjustment for demographic, health factors, and job type (WC only). Employers wishing to reduce the impact of lost productivity should consider a worker's personal health risks as predictors of future lost productivity and may want to address this in broad risk reduction programs.

Comparisons of rosiglitazone versus pioglitazone monotherapy introduction and associated health care utilization in medicaid-enrolled patients with type 2 diabetes mellitus.

BACKGROUND: Outcomes in patients with type 2 diabetes mellitus (DM) can differ based on the antidiabetic medication that is used. Thiazolidinediones (TZDs) are a newer class of agents used for the treatment of type 2 DM. No previous study has compared health care utilization associated with the 2 TZDs on the market. OBJECTIVE: The objective of this study was to compare health care utilization and costs associated with initiation of treatment with either rosiglitazone or pioglitazone by Medicaid-enrolled patients with type 2 DM. METHODS: This was a retrospective data analysis comparing cohorts of patients with type 2 DM starting a new antidiabetic medication in terms of hospitalizations, emergency department visits, outpatient physician visits, and health care costs reimbursed by the North Carolina Medicaid program. The perspective adopted in this analysis was that of the third-party payer (ie, the North Carolina Medicaid program). Patients starting rosiglitazone between July 1, 2001, and June 30, 2002, were compared with patients starting pioglitazone during the same period. The patients were followed up for 30 months to examine the difference in health care utilization over time. Multivariate regression techniques were employed for comparisons between the 2 different antidiabetic therapies. RESULTS: A total of 1705 patients with type 2 DM were identified and included in the final cohort. There were 660 patients (mean [SD] age, 49.0 [10.2] years) in the rosiglitazone arm and 1045 patients (mean [SD] age, 49.1 [10.5] years) in the pioglitazone arm. Multivariate analysis showed that the rosiglitazone monotherapy group was associated with a 12.2% decrease in the mean number of hospitalizations, a 10.4% decrease in the mean number of emergency department visits, and a 7.3% decrease in total health care costs compared with the pioglitazone monotherapy group (all, P < 0.05). This study only looked at patients who used the same drug for the entire follow-up period. It did not account for drug switching or addition of a new drug to an existing therapy. CONCLUSIONS: Introduction of rosiglitazone was associated with a decreased number of hospitalizations, emergency department visits, and total health care costs compared with pioglitazone. The utilization of oral antidiabetic agents, with documented clinical and economic benefits, should continue to be advocated to reduce avoidable medical care utilization and to improve patient outcomes in this population.

Comparisons of rosiglitazone versus pioglitazone monotherapy introduction and associated health care utilization in Medicaid-enrolled patients with type 2 diabetes mellitus.

BACKGROUND: Outcomes in patients with type 2 diabetes mellitus (DM) can differ based on the antidiabetic medication that is used. Thiazolidinediones (TZDs) are a newer class of agents used for the treatment of type 2 DM. No previous study has compared health care utilization associated with the 2 TZDs on the market. OBJECTIVE: The objective of this study was to compare health care utilization and costs associated with initiation of treatment with either rosiglitazone or pioglitazone by Medicaid-enrolled patients with type 2 DM. METHODS: This was a retrospective data analysis comparing cohorts of patients with type 2 DM starting a new antidiabetic medication in terms of hospitalizations, emergency department visits, outpatient physician visits, and health care costs reimbursed by the North Carolina Medicaid program. The perspective adopted in this analysis was that of the third-party payer (ie, the North Carolina Medicaid program). Patients starting rosiglitazone between July 1, 2001, and June 30, 2002, were compared with patients starting pioglitazone during the same period. The patients were followed up for 30 months to examine the difference in health care utilization over time. Multivariate regression techniques were employed for comparisons between the 2 different antidiabetic therapies. RESULTS: A total of 1705 patients with type 2 DM were identified and included in the final cohort. There were 660 patients (mean [SD] age, 49.0 [10.2] years) in the rosiglitazone arm and 1045 patients (mean [SD] age, 49.1 [10.5] years) in the pioglitazone arm. Multivariate analysis showed that the rosiglitazone monotherapy group was associated with a 12.2% decrease in the mean number of hospitalizations, a 10.4% decrease in the mean number of emergency department visits, and a 7.3% decrease in total health care costs compared with the pioglitazone monotherapy group (all, P < 0.05). This study only looked at patients who used the same drug for the entire follow-up period. It did not account for drug switching or addition of a new drug to an existing therapy. CONCLUSIONS: Introduction of rosiglitazone was associated with a decreased number of hospitalizations, emergency department visits, and total health care costs compared with pioglitazone. The utilization of oral antidiabetic agents, with documented clinical and economic benefits, should continue to be advocated to reduce avoidable medical care utilization and to improve patient outcomes in this population.

Comparison of medication adherence and associated health care costs after introduction of pioglitazone treatment in African Americans versus all other races in patients with type 2 diabetes mellitus: a retrospective data analysis.

OBJECTIVE: The aim of this study was to compare treatment adherence and health care costs in African Americans versus all other races (All Others) in patients with type 2 diabetes mellitus starting treatment with pioglitazone. METHODS: In this retrospective cohort study, the North Carolina Medicaid database was used (query dates: July 1, 2000, to June 30, 2003). Using at least 1 code from the International Classification of Diseases, Ninth Revision, Clinical Modification for type 2 diabetes (250.xx) and 1 National Drug Code for antidiabetic medication, we identified a cohort of male and female patients aged > or =18 years with type 2 diabetes who maintained continuous Medicaid eligibility for the entire 36-month follow-up period. Race was categorized as African American and All Others (white, Asian, Native American, Pacific Islander, other) based on self-reported data collected at the time of Medicaid enrollment. Medication adherence was expressed as medication possession ratio (calculated as the number of days of antidiabetic prescription supply dispensed [eg, a 30-day supply] divided by the number of days between the first and last dispensation). Reimbursements made by Medicaid were used to calculate diabetes-related and total health care costs, which included medical and dental care, including costs for regular checkups, office visits, home health care, inpatient and outpatient care, long-term care facility care, and prescription drugs. To compare the differences in medication adherence and annual total and diabetes-related health care costs between African Americans and All Others, multivariate regression analysis was performed using only data from the year after (year 2) the year in which pioglitazone treatment was started (year 1). RESULTS: Among the 1073 patients treated with pioglitazone (26.1% men; mean [SD] age, 49.5 [10.6] years; 50.2% African American; mean [SD] total health care costs in year 1, US $7906 [$12,256]; year 2, $9546 [$14,861]), African Americans had significantly higher adherence (62%) to pioglitazone treatment compared with All Others (57%) (P < 0.05) on unadjusted analysis. However, no significant differences in rates of adherence to the medication were found between African Americans and All Others on multivariate regression analysis. African American race was not found to be an independent predictor of increased or decreased annual total health care costs in this population. Significant reductions in total health care costs (2% for every 10% increase in adherence; P < 0.001) and diabetes-related costs (4% for every 10% increase in adherence; P < 0.01) with increased adherence were found. CONCLUSIONS: On multivariate analysis, this study found no significant differences in treatment adherence between African Americans versus all other races in this population of diabetic patients enrolled in a Medicaid program (query dates: July 1, 2000, to June 30, 2003). A higher adherence rate was associated with significantly lower diabetes-related and total health care costs in this population.

Race and medication adherence in Medicaid enrollees with type-2 diabetes.

OBJECTIVE: The association of medication adherence with race has been inadequately studied previously in type-2 diabetes patients. The study objective was to determine the association between race and medication adherence among type-2 diabetes patients. METHODS: This was a retrospective cohort study, which compared medication adherence among different races of Medicaid insured patients with type-2 diabetes newly starting oral antidiabetic medication. A total of 1,527 African-American patients newly starting antidiabetic medication between July 2001 and June 2002 were compared with 1,128 white patients and 514 patients of other race. Medication adherence was measured as medication possession ratio using prescription refill patterns. Multivariate regression analyses were used to determine the difference in adherence rates adjusting for other covariates. RESULTS: Medication adherence rate was significantly higher for whites [0.59 (0.31)] as compared to African Americans [0.54 (0.31), (p<0.05)]. In multivariate analyses, the adherence rate of African-American patients was found to be significantly lower by 12% as compared to whites after adjusting for other covariates. Metformin users were associated with a 62% decrease in adherence rate as compared with the sulfonylureas group (p<0.05). CONCLUSION: The antidiabetic medication adherence was associated with race. Future research should investigate patient-related factors affecting medication adherence in type-2 diabetes patients.

Outcomes associated with introduction of thiazolidinedione therapy in Medicaid enrolled patients with type 2 diabetes: an updated and expanded retrospective analysis.

OBJECTIVES: In an earlier analysis, differences in health-care costs, medication adherence, and persistence were examined between patients with type 2 diabetes, enrolled in the North Carolina Medicaid, who had newly started thiazolidinedione (TZD) therapy and those starting other oral antidiabetic agents. In this analysis, the size of the cohort was increased by including 18 months of additional Medicaid data (until December 2004) and sought to: (1) replicate the results of the original study in a larger cohort; and (2) extend the original analysis by providing an additional 18 months of observational follow-up. METHODS: A total of 2660 patients newly starting TZD therapy between July 2001 and December 2003 were compared to 2050 patients starting other oral antidiabetic medication for health-care costs and outcomes in the post-medication start year. In addition, the initial cohort was followed for an additional 18 months to examine if there were any differences in outcomes, such as hospitalization and total health-care costs, that could be associated with the type of therapy. Multivariate regression techniques, incorporating health-care utilization in the year prior to start of new therapy, were used to determine the net cost impact of one therapy versus the other. RESULTS: Multiple regression analyses found that patients starting TZD have better treatment persistence in the post-medication start year compared to patients starting other oral antidiabetic agents (4% increase in therapy persistence index, p < 0.001). In addition, patients starting TZDs had 18.9% lower total annual health-care costs (p < 0.01) compared to patients starting other oral antidiabetic agents. Examination of the original cohort of 3191 patients, for up to an additional 18 months, showed TZD's association with improved adherence rates but not with persistence. Importantly, treatment adherence remained the strongest independent predictor of decreased hospitalization risk and health-care cost reduction in this population. CONCLUSIONS: Introduction of thiazolidinedione therapy in a Medicaid-enrolled type 2 diabetic population was associated with significantly greater treatment adherence, in the post-start year, compared to patients starting other oral antidiabetic agents.

Prescribing patterns for topical retinoids within NAMCS data.

OBJECTIVE: Fears of potentially costly use of topical retinoids for cosmetic treatment of photodamaged skin have resulted in many managed care organizations placing prior authorization requirements on this class of medications. The purpose of this investigation was to examine whether prescribing patterns of a nationally representative sample of US physicians shed light on the incidence of use of topical retinoids for indications other than acne. METHODS: A retrospective, cross-sectional study of data from the National Ambulatory Medical Care Survey (1996--2000) was used to examine the impact of physician specialty as well as patient diagnosis of acne on the probability of retinoid prescription in weighted multivariate logistic regression models. RESULTS: Topical retinoids were prescribed in 0.4% (14.7 million out of 3.67 billion) physician visits for any diagnosis in the 5-year period from 1996 to 2000, and in nearly 31% (12.0 million out of 38.7 million) of physician visits for a diagnosis of acne. Topical retinoids were prescribed for acne in 77.1% of the cases. This finding held when individual retinoids (tretinoin and adapalene) were examined separately. Clear age-related prescription trends are observed, with a significant decrease in prescriptions beyond the teen years. In older patients, tretinoin prescribing did not decrease as much as adapalene prescribing. CONCLUSIONS: These data suggest that managed care organizations may want to examine their own data to determine the optimum criteria for operation of prior authorization (PA) programs for retinoids. PA requirements for these medications appear unnecessary in young patients, given the very small probability of non-acne related use. PA in older patients might be targeted to those patients on topical retinoids (such as tretinoin) for which there is evidence of efficacy in treatment of cosmetic photoaging.

Treatment of insomnia: a review and update.

The purpose of this review is to provide an update on the treatment options available and their usage and outcomes in the treatment of insomnia in the USA. Both pharmacotherapy and behavioral therapy are recommended in the physician guidelines for insomnia management. Although pharmacotherapy can produce a rapid pharmacologic effect, for long-term effectiveness, behavioral therapy can be considered for chronic primary insomniac patients. The cost of behavioral therapy is a notable barrier to its prescription for patients with sleep difficulties. Increased utilization of both behavioral- and pharmacotherapy may reduce insomnia-related healthcare costs and increase health-related quality of life. Further research should focus on the role of these therapies in outcomes of insomnia management.

Physician and patient factors associated with the prescribing of medications for sleep difficulties that are associated with high abuse potential or are expensive: an analysis of data from the National Ambulatory Medical Care Survey for 1996-2001.

OBJECTIVE: This study evaluated the association between various socioeconomic and clinical factors relating to patients and physicians and the prescribing of medications that have a high abuse potential or are expensive for the treatment of sleep difficulties in a nationally representative sample of outpatient physician visits in the United States. METHODS: This cross-sectional study used data from the National Ambulatory Medical Care Survey from 1996-2001. Patients aged > or =18 years who received treatment for sleep difficulties in US outpatient settings over this period were included in the study sample. Office visits were considered related to insomnia/sleep difficulties if relevant International Classification of Diseases, Ninth Revision, diagnosis codes were recorded and if insomnia was reported as the reason for the visit or any medication with a primary indication for insomnia was prescribed. Medications associated with dependence and withdrawal symptoms were categorized as having a high abuse potential. Medications were considered expensive if the average wholesale price of 100 tablets was > or =$150 (ie, the 75th percentile of the total cost of all medications prescribed for sleep disorders only). The data were subjected to multivariate logistic regression analysis. RESULTS: From 1996 through 2001, 2966 unweighted patient visits for insomnia/sleep difficulty were identified, representing approximately 94.6 million weighted observations in the overall US population; pharmacotherapy only was prescribed at 48% (45 million) of these visits. Medications with abuse potential were prescribed at 53% (24 million) of visits. Among visits at which pharmacotherapy was prescribed, visits by male patients were 39% less likely than visits by female patients to result in a prescription for a medication with abuse potential (odds ratio [OR] = 0.61; 95% CI, 0.45-0.81). Visits by patients with psychiatric comorbidities were 80% more likely to be associated with receipt of a prescription for a medication with abuse potential than were visits by patients with no such comorbidities (OR = 1.80; 95% CI, 1.31-2.47). Expensive medications were prescribed at 25% (15 million) of visits involving some pharmacotherapy. Patients aged > or =65 years were 44% less likely to receive a prescription for an expensive medication than was the reference group, patients aged 18 to 34 years (OR = 0.56; 95% CI, 0.35-0.90). Hispanic patients were 56% less likely to receive a prescription for an expensive medication than were non-Hispanic patients (OR = 0.44; 95% CI, 0.22-0.88). CONCLUSIONS: This study found an increased probability of female patients with sleep difficulties receiving a medication with high abuse potential in outpatient settings in the United States from 1996 through 2001. In addition, there was a possible association between the age and ethnicity of patients with insomnia/sleep difficulties and the prescribing of expensive medications for sleep difficulties.

Healthcare costs and prescription adherence with introduction of thiazolidinedione therapy in Medicaid type 2 diabetic patients: a retrospective data analysis.

OBJECTIVES: Outcomes in patients with type 2 diabetes may vary depending on the antidiabetic medication used. Observational studies of outcomes of diabetes pharmacotherapy are needed to understand the implications of choice of controller in different populations. This study compared differences in total health care costs, medication adherence, and persistence in patients with type 2 diabetes enrolled in the North Carolina Medicaid Program that were newly started on thiazolidinedione (TZD) therapy with patients starting other oral antidiabetics during the same period. In addition differences among the TZDs with respect to these outcomes were examined. METHODS: A total of 1774 patients newly starting TZD therapy between July 2001 and June 2002 were compared to 1709 patients starting other oral antidiabetic medication (metformin or sulfonylureas) for health care costs and outcomes in the post-medication start year. In addition, a sub-group analysis of health care costs in patients starting either TZD (pioglitazone [n = 1086] versus rosiglitazone [N = 688]) was compared. All included patients had complete enrollment for the 24 months of follow-up. Multivariate techniques incorporating health care utilization in the year prior to start of new therapy were utilized to determine the cost impact of one therapy versus another. RESULTS: Results of multiple regression analyses suggest that patients starting TZD have better treatment adherence and persistence in the post-medication start year compared to patients starting other oral antidiabetics (13% increase in Medication Possession Ratios, and 10% increase in therapy persistence index, both p < 0.001). In addition, patients starting TZDs had 16.1% lower total annual health care costs (p < 0.01) compared to patients starting other oral antidiabetics. There were no differences in adherence and cost outcomes between the 2 TZDs. CONCLUSIONS: Introduction of thiazolidinedione therapy in a Medicaid-enrolled type 2 diabetic population was associated with significantly improved treatment adherence, persistence, and lower annual health care costs in the post-start year compared to patients starting other oral antidiabetics.

How patient-physician encounters in critical medical situations affect trust: results of a national survey.

BACKGROUND: Patients' trust in physicians and in the medical profession is vital for a successful patient-physician relationship. Trust is especially salient in critical medical situations, such as serious side-effects, hospitalizations, and diagnoses of serious medical conditions, but most trust studies have been done with the general population or in routine primary care settings. This study examines the association between patient-physician encounters in such critical medical situations and patients' trust in their physician and in the medical profession in general. METHODS: A random national telephone survey was conducted using validated multi-item questionnaire measuring trust and satisfaction with physicians and with the medical profession. A seven item questionnaire measured the patient-physician encounters in critical medical situations. A total of 1117 subjects aged 20 years and older with health insurance were included for analyses. Spearman rank order correlations were used to determine the association of encounter variables with trust in physicians and the medical profession. RESULTS: Prescription of medications by primary care physicians that patients believed might have side effects was negatively correlated with trust in physician (rho = -0.12, p < 0.001, n = 1045) in multivariate analysis. A primary care physician evaluating the patient for a condition the patient believed was serious was positively correlated with trust in physician (rho= 0.08, p < 0.01). Being hospitalized was positively correlated with trust in the medical profession (rho = 0.12, p < 0.01, n = 475). CONCLUSION: Hospitalization, perceived seriousness of condition, and concerns about the risks of medications were found to be associated with patient trust in physicians or the medical profession. These findings highlight the salience of trust in serious physician-patient encounters and the role that patient vulnerability plays in determining patient trust.

Diabetes care management participation in a primary care setting and subsequent hospitalization risk.

Scant evidence exists that examines the impact of participation in primary care diabetes management programs and their educational components on the risk of subsequent significant patient morbidity. This study examined the association between participation in a diabetes management program in a primary care setting and the risk of subsequent hospitalization. Ten thousand nine hundred eighty patients with diabetes mellitus receiving some type of treatment in a large primary care clinic network in Houston, TX were examined for incidence of hospitalization in the year 2002. Information from the year preceding the hospitalization was obtained on several demographic, clinical, and diabetes care management participation related variables. Multivariate logistic regressions were used to examine the relationship between primary care diabetes management participation as well as individual educational components and the likelihood of subsequent-year hospitalization. Patients participating in some type of primary care diabetes management were 16% less likely to have an incidence of hospitalization (p = 0.05). When individual educational components of the diabetes care management program were examined, diabetes education sessions were more beneficial than certified diabetes educator visits in reducing the incidence of hospitalization. Patients with controlled blood glucose levels and a diabetes education session seemed to have the most significant reduction in hospitalization risk (odds ratio [OR] = 0.62; 95% CI: 0.40, 0.95). There seem to be beneficial effects associated with participation in primary care diabetes management programs in terms of reduced hospitalization risk. Attendance at diabetes educational sessions in primary care settings coupled with maintenance of blood glucose control seem to be associated with greatest risk reduction.

Outcomes associated with inhaled corticosteroid use in asthma and COPD: an update.

The aim of this review is to report the updates in the medical literature on the outcomes associated with inhaled corticosteroid use. This update finds that inhaled corticosteroids remain a frontline choice as controller therapy in the treatment of asthma. Adherence to medications, especially inhaled corticosteroids used as controller medications, is responsible for a decrease in hospital, emergency room and physician visits. All of these translate to reduced asthma-related healthcare costs and an increase in health-related quality of life. There is a need for further research on the role of inhaled corticosteroids in chronic obstructive pulmonary disease outcomes.