Greater Adherence and Persistence with Injectable Dulaglutide Compared with Injectable Semaglutide at 1-Year Follow-up: Data from US Clinical Practice.

PURPOSE: Greater medication adherence and persistence have been associated with improved glycemic control in patients with type 2 diabetes mellitus. This study compared adherence, persistence, and treatment patterns among patients naïve to glucagon-like peptide 1 receptor agonists initiating once-weekly injectable treatment with dulaglutide versus semaglutide over 6-month (6M) and 12-month (12M) follow-up periods. METHODS: This retrospective, observational cohort study used administrative claims data from three IBM MarketScan research databases. Data from adult patients with type 2 diabetes newly initiating treatment with dulaglutide or semaglutide between January 2018 and January 2020 (index date was defined as the earliest fill date), without evidence of glucagon-like peptide 1 receptor agonist use in the 6M baseline period, and with continuous enrollment in the 6M baseline and 6M or 12M follow-up period were included. Dulaglutide initiators were propensity score-matched, in a 1:1 ratio, to semaglutide initiators in each 6M and 12M follow-up cohort (26,284 and 13,837 pairs, respectively). FINDINGS: In the matched cohorts, baseline characteristics were balanced; the mean age was 53 years, and 50% of patients were women. Compared to semaglutide initiators, dulaglutide initiators were more adherent (6M, 63.4% vs 47.8%; 12M, 54.4% vs 43.3%; both, P < 0.0001), more persistent on therapy (6M, 72% vs 62%, 12M, 55.5% vs 45.3%, both, P < 0.001), and had more mean days of persistence (6M, 145 vs 132, 12M, 254.3 vs 220.7; both, P < 0.001). IMPLICATIONS: At both 6M and 12M follow-up, dulaglutide initiators had significantly greater adherence and greater persistence compared with matched semaglutide initiators.

Validation of an International Classification of Disease, 10th revision coding adaptation for the Charlson Comorbidity Index in United States healthcare claims data.

PURPOSE: An International Classification of Disease (ICD-10) Charlson Comorbidity Index (CCI) adaptation had not been previously developed and validated for United States (US) healthcare claims data. Many researchers use the Canadian adaption by Quan et al (2005), not validated in US data. We sought to evaluate the predictive validity of a US ICD-10 CCI adaptation in US claims and compare it with the Canadian standard. METHODS: Diverse patient cohorts (rheumatoid arthritis, hip/knee replacement, lumbar spine surgery, acute myocardial infarction [AMI], stroke, pneumonia) in the IBM® MarketScan® Research Databases were linked with the IBM MarketScan Mortality file. Predictive performance was measured using c-statistics for binary outcomes (1-year and postoperative mortality, in-hospital complications) and root mean square prediction error (RMSE) for continuous outcomes (1-year all-cause medical costs, index hospitalization costs, length of stay [LOS]), after adjusting for age and sex. C-statistics were compared by the method of DeLong and colleagues (1988); RMSEs, by resampling. RESULTS: C-statistics were generally high (≥ ~ 0.8) for mortality but lower for in-hospital complications (~0.6-0.7). RMSEs for costs and hospitalization LOS were relatively large and comparable to standard deviations. Results were similar overall between the US and Canadian adaptations, with relative differences typically <1%. CONCLUSIONS: This US-based coding adaptation and a previously published Canadian adaptation resulted in similar predictive ability for all outcomes evaluated but may have different construct validity (not evaluated in our study). We recommend using adaptations specific to the country of data origin based on good research practice.

Assessing the Association of Formulary Copayment Changes with Real-World Treatment Patterns in Patients with Rheumatoid Arthritis on Etanercept.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic disease that requires long-term treatment to improve or maintain stable disease activity. Tumor necrosis factor inhibitors (TNFi), a class of biologic disease-modifying antirheumatic drugs (bDMARD), are effective at treating symptoms and inhibiting joint progression. Although treatment changes are not recommended in patients with stable disease, health plans have recently enacted formulary changes with higher copayments that could disrupt patient access to TNFis. OBJECTIVE: To assess the association of formulary copayment changes with real-world treatment patterns, treatment effectiveness, and health care costs among bDMARD-naive patients with RA receiving the TNFi etanercept. METHODS: This retrospective observational cohort analysis used the IBM Watson Health MarketScan Commercial Claims and Encounters Database. Adult patients with RA with 6 months of stable etanercept use (no refill gap ≥ 45 days) from January 1, 2013, through December 31, 2015, were selected and the index date was set to the first fill date after the stable-use period. Average etanercept copayment was calculated at the drug-plan level. Copayment change was defined as a monthly increase of at least $40 to account for copayment changes attributable to etanercept wholesale acquisition costs between 2014 and 2015. This amount also corresponded to the 90th percentile of average plan-level changes in etanercept copayments in the database, representing an average change in copayment by a payer. Patients were followed ≥ 12 months before and after the index date to track etanercept treatment changes and ≥ 12 months after a treatment change to track costs after etanercept copayment changes. Etanercept persistence, bDMARD switching, refill gaps, and treatment effectiveness (using a validated effectiveness algorithm) were described for patients with or without copayment change during the 12 months post-index or postchange. We also assessed the mean total of all-cause and RA-related expenditure during the 12-month post-index (or postchange) period. RESULTS: 1,970 stable patients met study inclusion criteria (mean [standard deviation] age: 50.3 [9.5] years; 77.8% female) and were evaluated. Of these, 133 (6.8%) patients had a copayment change ≥$40 during follow-up. Overall, most patients (60.3%) persisted on etanercept for the 12-month follow-up period, while 13.0% switched from etanercept, and 8.1% discontinued (refill gap of ≥ 45 days). Nearly half (48.0%) of all patients were considered effectively treated according to a validated algorithm. Compared with patients without a copayment change, those with a copayment change were more likely to switch biologics (19.5% vs. 12.6%; P = 0.021). Although statistical significance was not reached, patients with a copayment change were less likely to be persistent (54.1% vs. 60.7%; P = 0.135), and less likely to be effectively treated (42.1% vs. 48.4%; P = 0.161) than patients without a copayment change. All-cause and RA-related expenditures at baseline and post-copayment change were similar between patients with and without a copayment change. CONCLUSIONS: Changing formulary copayment of etanercept was associated with higher switching without difference in costs or health care utilization between copayment and no copayment change groups. DISCLOSURES: This study was sponsored by Amgen. Bonafede, Manjelievskaia, and Lopez-Gonzalez are employees of IBM Watson Health, which received funding from Amgen to conduct this study. Oko-osi, Collier, and Stolshek are employees and shareholders of Amgen. Gharaibeh was an employee of Amgen at the time of study execution and manuscript drafting. The authors have no other relationships that present a potential conflict of interest. Data pertaining to this study were presented in a poster at the 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL.

Impact of cytomegalovirus complications on resource utilization and costs following hematopoietic stem cell transplant.

Objective: The impact of cytomegalovirus (CMV) infection on healthcare resource utilization (HCRU) and costs post-allogeneic hematopoietic stem cell transplant (allo-HSCT) has not been well studied in the US. This retrospective, observational cohort study examined such outcomes in the first year following allo-HSCT.Methods: The IBM MarketScan administrative claims database was used to identify adults who underwent a first allo-HSCT between 1 January 2010 and 30 April 2015. Patients were required to have continuous medical and pharmacy enrollment for ≥12 months before and after the allo-HSCT. HCRU and medical costs (2016 US$) were compared by the presence or absence of CMV infection over 1-year follow-up.Results: A total of 1825 adults met the inclusion criteria (57.5% male; mean age 50.8 years). During the follow-up period, 410 (22.5%) patients had a CMV-related claim. Patients with CMV infection were significantly more likely to have a 60-day-(31.2 vs. 19.4%), 100-day-(50.0 vs. 30.5%) or 365-day readmission (78.0 vs. 57.8%) compared to those without a CMV-related event (all p < .001). During follow-up, patients with CMV infection had significantly greater mean total costs, reflecting higher inpatient costs ($677,240 vs. $462,562), outpatient costs ($141,366 vs. $94,312) and prescription drug costs ($27,391 vs. $22,082) (all p < .001). Valganciclovir (59.8%) and ganciclovir (33.7%) were the most commonly utilized anti-viral agents in patients with CMV.Conclusions: CMV infection was associated with significantly higher healthcare resource utilization and costs during the first year post-allo-HSCT. Additional research is warranted to further evaluate the consequences of post-HSCT CMV infection, as well as cost-effective measures to minimize its occurrence.

Costs for Breast Cancer Care in the Military Health System: An Analysis by Benefit Type and Care Source.

Introduction: Breast cancer care imposes a significant financial burden to U.S. healthcare systems. Health services factors, such as insurance benefit type and care source, may impact costs to the health system. Beneficiaries in the U.S. Military Health System (MHS) have universal healthcare coverage and access to a network of military facilities (direct care) and private practices (purchased care). This study aims to quantify and compare breast cancer care costs to the MHS by insurance benefit type and care source. Materials and Methods: We conducted a retrospective analysis of data linked between the MHS data repository administrative claims and central cancer registry databases. The institutional review boards of the Walter Reed National Military Medical Center, the Defense Health Agency, and the National Institutes of Health Office of Human Subjects Research reviewed and approved the data linkage. We used the linked data to identify records for women aged 40-64 yr who were diagnosed with breast cancer between 2003 and 2007 and to extract information on insurance benefit type, care source, and cost to the MHS for breast cancer treatment. We estimated per capita costs for breast cancer care by benefit type and care source in 2008 USD using generalized linear models, adjusted for demographic, pathologic, and treatment characteristics. Results: The average per capita (n = 2,666) total cost for breast cancer care was $66,300 [standard error (SE) $9,200] over 3.31 (1.48) years of follow-up. Total costs were similar between benefit types, but varied by care source. The average per capita cost was $34,500 ($3,000) for direct care (n = 924), $96,800 ($4,800) for purchased care (n = 622), and $60,700 ($3,900) for both care sources (n = 1,120), respectively. Care source differences remained by tumor stage and for chemotherapy, radiation, and hormone therapy treatment types. Conclusions: Per capita costs to the MHS for breast cancer care were similar by benefit type and lower for direct care compared with purchased care. Further research is needed in breast and other tumor sites to determine patterns and determinants of cancer care costs between benefit types and care sources within the MHS.

The continuum of breast cancer care and outcomes in the U.S. Military Health System: an analysis by benefit type and care source.

PURPOSE: This study investigates transition rates between breast cancer diagnosis, recurrence, and death by insurance benefit type and care source in U.S. Military Health System (MHS). METHODS: The MHS data repository and central cancer registry linked data were used to identify women aged 40-64 with histologically confirmed breast cancer between 2003 and 2007. Three-state continuous time Markov models were used to estimate transition rates and transition rate ratios (TRRs) by TRICARE benefit type (Prime or non-Prime) and care source (direct, purchased, or both), adjusted for demographic, tumor, and treatment variables. RESULTS: Analyses included 2668 women with transitions from diagnosis to recurrence (n = 832), recurrence to death (n = 79), and diagnosis to death without recurrence (n = 91). Compared to women with Prime within each care source, women with non-Prime using both care sources had higher transition rates (TRR 1.47, 95% CI 1.03, 2.10). Compared to those using direct care within each benefit type, women utilizing both care sources with non-Prime had higher transition rates (TRR 1.86, 95% CI 1.11, 3.13), while women with Prime utilizing purchased care had lower transition rates (TRR 0.82, 95% CI 0.68, 0.98). CONCLUSIONS: In the MHS, women with non-Prime benefit plans compared to Prime had higher transition rates along the breast cancer continuum among both care source users. Purchased care users had lower transition rates than direct care users among Prime beneficiaries. IMPLICATIONS FOR CANCER SURVIVORS: Benefit plan and care source may be associated with breast cancer progression. Further research is needed to demonstrate differences in survivorship.

Breast Cancer Treatment and Survival Among Department of Defense Beneficiaries: An Analysis by Benefit Type and Care Source.

Background: Use of treatment for breast cancer is dependent on the patient's cancer characteristics and willingness to undergo treatment and provider treatment recommendations. Receipt of breast cancer treatment varies by insurance status and type. It is not clear whether different benefit types and care sources differ in breast cancer treatment and outcomes among Department of Defense beneficiaries. Methods: The objectives of this study are to assess whether receipt of breast cancer treatment varied by benefit type (TRICARE Prime vs non-Prime) or care source (direct care, purchased care, and both) and to examine whether survival and recurrence differed by benefit type and/or care source among female Department of Defense beneficiaries with the disease. Study subjects were women aged 40-64 yr, diagnosed with malignant breast cancer between 2003 and 2007. Multivariable logistic regression analyses were conducted to assess the likelihood of receiving treatment by benefit type or care source. Multivariable Cox proportional hazard models were used to investigate differences in survival and recurrence by benefit type or care source. Findings: A total of 2,668 women were included in this study. Those with Prime were more likely to have chemotherapy, radiation, hormone therapy, breast-conserving surgery, surveillance mammography, and recurrence than women with non-Prime. Survival was high, with 94.86% of those with Prime and 92.58% with non-Prime alive at the end of the study period. Women aged 50-59 yr with non-Prime benefit type had better survival than women with Prime of the same age. No survival differences were seen by care source. In regard to recurrence, women aged 60-64 yr with TRICARE Prime were more likely to have recurrent breast cancer than women with non-Prime. Additionally, women aged 50-59 yr who used purchased care were less likely to have a recurrence than women who used direct care only. Discussion/Impact/Recommendations: To our knowledge, this is the first study to examine breast cancer treatment and survival by care source and benefit type in the Military Health System. In this equal access health care system, no differences in treatment, except mastectomy, by benefit type, were observed. There were no overall differences in survival, although patients with non-Prime tended to have better survival in the age group of 50-59 yr. In regard to care source, women who utilized mostly purchased care or utilized both direct and purchased care were more likely to receive certain types of treatment, such as chemotherapy and radiation, as compared with women who used direct care only. However, survival did not differ between different care sources. Future research is warranted to further investigate variations in breast cancer treatment and its survival gains by benefit type and care source among Department of Defense beneficiaries.

Recommendations for Treating Males: An Ethical Rationale for the Inclusion of Testicular Self-Examination (TSE) in a Standard of Care.

The phrase "standard of care" is primarily a legal term representing what procedure a reasonable person (i.e., health practitioner) would administer to patients across similar circumstances. One major concern for health practitioners is delivering and advocating for treatments not defined as a standard of care. While providing such treatments may meet certain ethical imperatives, doing so may unwittingly trigger medical malpractice litigation fears from practitioners. Apprehension to deviate, even slightly, from the standard of care may (seem to) put the practitioner at significant risk for litigation, which, in turn, may limit options for treatment and preventive measures recommended by the practitioner. Specific to testicular treatment, certain guidelines exist for cancer, torsion, vasectomy, and scrotal masses, among others. As it relates to screening, practitioner examination is expected for patients presenting with testicular abnormalities. Testicular self-examination (TSE) advocacy, however, is discouraged by the U.S. Preventive Services Task Force, which may prompt a general unwillingness among health practitioners to promote the behavior. Considering the benefits TSE has beyond cancer detection, and the historical support it has received among health practitioners, it is paramount to consider the ethical implications of its official "exclusion" from preventive health and clinical care recommendations (i.e., standard of care). Since good ethics should lead practitioner patient care guidelines, not fear of increased malpractice risks, we recommend the development of a standard of care for counseling males to perform TSE.

CDC Screening Recommendation for Baby Boomers and Hepatitis C Virus Testing in the US Military Health System.

OBJECTIVES: Chronic hepatitis C virus (HCV) is the most common blood-borne infection in the United States, with an estimated 2.7 to 3.9 million cases as of 2014. In August 2012, the Centers for Disease Control and Prevention (CDC) recommended 1-time HCV testing of all baby boomers. The objectives of this study were to (1) determine the proportion of people screened for HCV in the US Department of Defense Military Health System before and after the CDC screening recommendation for baby boomers and (2) assess whether certain patient or system factors were associated with screening for HCV before and after August 2012. METHODS: We used a dataset containing 5% of beneficiaries randomly selected from the Military Health System Data Repository medical claims database for the period July 2011 through September 2013. RESULTS: Of 108 223 people eligible for HCV screening during the first period (July 2011 through July 2012), 1812 (1.7%) were screened. Of 109 768 people eligible during the second period (September 2012 through September 2013), 2599 (2.4%) were screened. HCV screening receipt was related to benefit type (Prime before August 2012: adjusted odds ratio [aOR] = 2.16; 95% confidence interval [CI], 1.89-2.46; Prime after August 2012: aOR = 1.93; 95% CI, 1.73-2.16) and care source (direct care before August 2012: aOR = 1.80; 95% CI, 1.57-2.07; direct care after August 2012: aOR = 2.45; 95% CI, 2.18-2.75); male sex (aOR = 1.17; 95% CI, 1.06-1.29) and black race (aOR = 1.20; 95% CI, 1.05-1.37) were associated with HCV testing only before August 2012. CONCLUSIONS: Interventions should be implemented to increase awareness and knowledge of the current national HCV testing recommendation among baby boomers to seek out testing and health care providers to perform screening.

Benefit Type and Care Source in Relation to Mammography Screening and Breast Cancer Stage at Diagnosis Among DoD Beneficiaries.

BACKGROUND: Type of insurance and out-of-pocket costs influence the use of medical care. Specifically, type of insurance can impact an individual's likelihood of receiving a screening mammogram. Additionally, variation in tumor stage at diagnosis exists for patients with different types of insurance. It is not clear whether different benefit types and care sources differ in breast cancer care and outcomes among Department of Defense (DoD) beneficiaries. METHODS: The objective of this study was to examine differences in screening mammography and tumor stage at diagnosis between different benefit types (TRICARE Prime vs. non-Prime) and among different care sources (direct care, purchased care, and both) in the DoD Military Health System. Study subjects were women 40 to 64 years of age, diagnosed with malignant breast cancer between 2003 and 2007. Multivariable logistic regression analyses were conducted to assess differences by benefit type and care source in receipt of screening mammography before diagnosis and tumor stage at diagnosis. FINDINGS: A total of 2,668 women were included in this study. Patients with Prime were more likely to receive a screening mammography and have an earlier tumor stage than those with non-Prime. Women with direct care were more likely to have an earlier tumor stage but less likely to receive a screening mammogram than those with purchased care. DISCUSSION: In an equal access health care system, the use of mammography screening and tumor stage at diagnosis may differ by benefit type and care source among DoD beneficiaries. To our knowledge, this was the first study to assess mammography screening and tumor stage differences by benefit type and care source in the Military Health System. Although underlying reasons for the differences are not clear, they may be related to out-of-pocket costs, distance from medical treatment facilities, and frequency of doctor visits for other medical problems. Further research is needed to assess these differences and related factors among DoD beneficiaries.

Chemotherapy Use and Survival Among Young and Middle-Aged Patients With Colon Cancer.

Importance: Treatment options for patients with young-onset colon cancer remain to be defined and their effects on prognosis are unclear. Objective: To investigate receipt of adjuvant chemotherapy by age category (18-49, 50-64, and 65-75 years) and assess whether age differences in chemotherapy matched survival gains among patients diagnosed as having colon cancer in an equal-access health care system. Design, Setting, and Participants: This cohort study was based on linked and consolidated data from the US Department of Defense's Central Cancer Registry and Military Heath System medical claims databases. There were 3143 patients aged 18 to 75 years with histologically confirmed primary colon adenocarcinoma diagnosed between 1998 and 2007. This study was conducted from December 2015 to August 2016. Exposures: Patients who underwent surgery and postoperative systemic chemotherapy. Main Outcomes and Measures: The primary outcome measure of the study was overall survival of patients who only received surgery and those who received both surgery and postoperative systemic chemotherapy. Results: Of the 3143 patients, 1841 were men (58.6%). Young (18-49 years) and middle-aged (50-64 years) patients were 2 to 8 times more likely to receive postoperative systemic chemotherapy compared with older patients (65-75 years) across all tumor stages. Middle-aged patients with stage I (odds ratio, 5.04; 95% CI, 2.30-11.05) and stage II (odds ratio, 2.42; 95% CI, 1.58-3.72) disease were more likely to receive postoperative chemotherapy compared with older patients. Both groups were more likely to receive multiagent chemotherapy than were older patients (patients aged 18-49 years: odds ratio, 2.48; 95% CI, 1.42-4.32 and patients aged 50-64 years: odds ratio, 2.66; 95% CI, 1.70-4.18). Among patients who received surgery and postoperative systemic chemotherapy, no significant differences were observed in survival among age groups (the 95% CIs of hazard ratios included 1 for young and middle-aged patients compared with older patients for all tumor stages). Conclusions and Relevance: In an equal-access health care system, we found potential overuse of chemotherapy among young and middle-aged adults with colon cancer. The addition of postoperative systemic chemotherapy did not result in matched survival improvement.

From 'D' to 'I': A critique of the current United States preventive services task force recommendation for testicular cancer screening.

In 2004, the United States Preventive Services Task Force (USPSTF) gave testicular cancer (TCa) screening a 'D' recommendation, discouraging the use of this preventive service. The USPSTF suggested that screening, inclusive of testicular self-examination (TSE) and clinician examination, does not reduce TCa mortality rates and that the high risk of false positives could serve as a detriment to patient quality of life. Others suggests that TCa screening is ineffective at detecting early-stage cases of TCa and readily highlights a lack of empirical evidence demonstrating said efficacy. These assertions, however, stand in stark contrast to the widely held support of TCa screening among practicing public health professionals, advocacy groups, and clinicians. In this present study, a review was conducted of the methods and processes used by the USPSTF in their 2011 reaffirmation of the 'D' grade recommendation. The evidence base and commentary offered as to why TSE, as part of the overall recommendation for TCa screening, was given a 'D' grade were analyzed for logical reasoning and methodological rigor. Considering the methodological flaws and the veritable lack of evidence needed to grant a conclusive recommendation, the question is raised if the current 'D' grade for TCa screening (i.e. discourage the use of said service) should be changed to an 'I' statement (i.e. the balance of benefits and harms is indeterminate). Therefore the purpose of this paper is to present the evidence of TCa screening in the context of efficacy and prevention in order for the field to reassess its relative value.

Cardiovascular health among Philadelphia adolescents: analysis of youth risk behaviour data, 2011.

Improving population-level cardiovascular health is a public health priority. Guided by the American Heart Association's metrics for ideal heart health, we examined the prevalence of behavioural heart health indicators using a representative sample of urban adolescents. Less than 1% (0.6%) of the sample had ideal heart health. The alarmingly low percentage of ideal behavioural heart health suggests that primary prevention approaches to address cardiovascular health in youth are warranted.