Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network.

OBJECTIVES: The MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times within a large community-based oncology network. MATERIALS AND METHODS: This retrospective observational chart review study investigated patients with mNSCLC initiating first-line (1L) systemic therapy between 01-April-2018 and 31-March-2020. Biomarker testing rates and timing relative to 1L therapy for EGFR, ALK, ROS1, BRAF, and PD-L1 were assessed, including use of next-generation sequencing (NGS). RESULTS: Among 3474 adults: 74% had adenocarcinoma and 76% had a documented ECOG performance status of 0 or 1. Ninety percent had testing for at least one biomarker, and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 51% to 59% for BRAF, 82% to 84% for PD-L1, and 42% to 49% for all 5 biomarkers. NGS testing increased from 33% to 45% (p < 0.0001). Median time from mNSCLC diagnosis to 1L therapy was 35 days. Median turnaround times from biomarker testing orders to results ranged from 10 to 15 days for the individual biomarkers and 18 days for NGS. CONCLUSION: In this real-world study, while most patients received at least one biomarker test prior to 1L, <50% received all 5 tests. NGS testing also occurred in < 50% of patients but appeared to increase over time. The next phase of MYLUNG will evaluate contemporary ordering practices and turnaround times prospectively.

Treatment patterns and outcomes in older patients with advanced malignant pleural mesothelioma: Analyses of Surveillance, Epidemiology, and End Results-Medicare data.

BACKGROUND: Malignant mesothelioma is a rare neoplasm associated with asbestos exposure. Characterizing treatment patterns and outcomes of older patients with advanced malignant pleural mesothelioma (MPM) is important to understand the unmet needs of this population. AIM: To evaluate the demographic and clinical characteristics, treatment patterns, and outcomes among older patients diagnosed with advanced MPM in the United States between 2007 and 2013. METHODS: This was a retrospective cohort study using Surveillance, Epidemiology, and End Results (SEER) data linked with Medicare claims. We included patients who were age 66 or older at the time of their primary MPM diagnosis between 2007 and 2013 and followed them through 2014. Treated patients who received first-line chemotherapy with pemetrexed and platinum within 90 days of diagnosis, second-line, or third-line therapy were identified for evaluation of outcomes. RESULTS: There were 666 older patients with advanced MPM, of whom 82% were male, 87% White, 78% stage IV, and 70% had no mobility limitation indicators at diagnosis. There were 262 patients who received first-line chemotherapy for advanced MPM, most of whom (80%; n = 209) received pemetrexed-platinum. Of these 209 patients, 41% (n = 86) initiated second-line therapy, and 26% (n = 22) initiated third-line therapy. Median overall survival for the cohort of 209 patients was 7.2 months. Patients with epithelioid histology had better median overall survival (12.2 months) compared with other histologies (4.4-5.6 months). Within 90 days of diagnosis of advanced MPM, 78% of patients were hospitalized, 52% visited an emergency department, and 21% had hospice care. The 2-year cost of care was over $100 000 for all patients with advanced MPM treated with first-line pemetrexed-platinum. CONCLUSIONS: Although first-line systemic anticancer treatment was generally consistent with guidelines (e.g., pemetrexed-platinum), poor patient outcomes highlight the need for effective treatment options for older patients with advanced MPM.

Treatment patterns and outcomes of patients with advanced malignant pleural mesothelioma in a community practice setting.

Aim: To assess real-world treatment patterns and outcomes among patients with advanced malignant pleural mesothelioma. Patients & methods: Retrospective database analysis. Results: In all, 469 patients received first-line systemic anticancer therapy (SACT) at community centers. Median follow-up from diagnosis was 11.6 months. Pemetrexed + platinum was the most common first-line SACT; similar proportions of patients received cisplatin or carboplatin with pemetrexed. Only a small proportion of patients received second- and third-line therapies. Median overall survival for first-line SACT was 12.0 months (95% CI: 10.7-14.2). Results were similar with pemetrexed + cisplatin and pemetrexed + carboplatin. Median overall survival with second-line SACT was 6.4 months (95% CI: 5.1-7.6). Conclusion: There is a need for more effective SACTs for advanced malignant pleural mesothelioma.

Lay abstract Real-world data on treatment patterns and outcomes among patients with advanced malignant pleural mesothelioma (MPM), largely a cancer of the lining surrounding the lungs, are limited. In this analysis based on patients treated in the USA, pemetrexed + cisplatin or pemetrexed + carboplatin was shown to be the most common treatment received by patients when first diagnosed with advanced MPM. Only a few patients received any subsequent treatments. Survival among patients receiving treatment was poor, with a median of approximately 12 months. Immunotherapy regimens are currently being investigated, with nivolumab + ipilimumab being the first immunotherapy regimen approved in October 2020 for the treatment of advanced MPM.

Examining the heterogeneity of treatment patterns in attention deficit hyperactivity disorder among children and adolescents in the Texas Medicaid population: modeling suboptimal treatment response.

Objectives: To examine suboptimal responses (SR) in attention deficit hyperactivity disorder (ADHD) among pediatric patients in the Texas Medicaid program receiving osmotic-release oral system methylphenidate (OROS-MPH) or lisdexamfetamine (LDX) and apply an SR prediction model to identify patients most likely to experience an SR to either OROS-MPH or LDX therapies. Methods: A retrospective cohort study was conducted using Texas Medicaid claims data of ADHD children and adolescents (6-17 years of age) initiating OROS-MPH or LDX. Primary SR endpoints were drug discontinuation, switching, and augmentation 12-months post-ADHD drug initiation. Logistic regression models were developed to predict SR to OROS-MPH and LDX in 1:1 matched groups of children and adolescent cohorts. Results: A total of 3,633 children and 1,611 adolescents were matched for each cohort. SR was observed among more children (76.4% vs 72.3%; p < 0.001) and adolescents (82.7% vs 78.2%; p = 0.002) initiating OROS-MPH compared to LDX. Patient sub-groups with the highest predicted risk of OROS-MPH SR experienced significantly lower observed SR rates (p < 0.05) when initiating LDX (children: 80.6% for OROS-MPH vs 75.8% for LDX; OR = 0.75, 95% CI = 0.60-0.94; adolescents: 87.2% for OROS-MPH vs 80.6% for LDX; OR = 0.61, 95% CI = 0.41-0.89). For patients with highest predicted SR rates to LDX, observed SR rates were not significantly different between patients initiating LDX or OROS-MPH. Conclusions: This study demonstrated how a personalized medicine approach using administrative claims data can be used to identify sub-groups of child and adolescent ADHD patients with different risks for suboptimal response with OROS-MPH or LDX in a Medicaid population.

Understanding total cost of care in advanced non-small cell lung cancer pre- and postapproval of immuno-oncology therapies.

This study assesses resource utilization and total direct medical cost among patients in the United States starting systemic antineoplastic therapy (ST) pre- and postapproval of immuno-oncology (IO) agents for advanced non-small cell lung cancer. Adults diagnosed with lung cancer initiating first-line ST within 6 months of diagnosis during either the pre- (March 2013-March 2014) or post-IO (March 2015-December 2016) approval period were identified in a US-based multipayer administrative claims database. Excluded were patients with small cell lung cancer, secondary malignancies, less than 1 month follow-up, and those in clinical trials. Total cost (TC) was calculated from the date of initiation of treatment until the last follow-up. Propensity score matching was adjusted for differences in patient cohorts, including follow-up time. Binary multiple logistic regression assessed predictors of high TC (above mean) pre- and post IO. Mean TC per patient was higher pre-IO versus post IO in both unmatched ($165,548 vs $95,715) and matched analyses($129,977 vs $113,177). Hospitalization and emergency department (ED) visit rates were higher pre-IO versus postapproval. Predictors of high TC pre-IO included use of first-line combination therapy, radiation, targeted therapy, maintenance therapy, biomarker testing, more comorbidities, longer follow-up, first-line hospitalization, first-line cost above mean, and age 65 years and older. In the post-IO period, additional predictors of higher TC included use of IO, having mild liver disease or hemiplegia, and longer time to ST initiation. Early data show lower ED visit and hospitalization rates and associated lower TC in the post-IO era.

Automated profile review for transdermal fentanyl to verify opioid tolerance in the military health system.

OBJECTIVE: Describe a patient safety program designed to decrease use of transdermal fentanyl (TF) among opioid-naïve patients in the U.S. Military Health System (MHS). METHODS: The program automatically reviewed patient profiles for prior strong opioid use when starting treatment with TF. New prescriptions for TF among users without a prior strong opioid generated a rejection message indicating that the patient may not be opioid tolerant and stopped the fill. However, pharmacists could override the rejection. We collected pharmacy claims data to measure the use of TF among seemingly opioid-naïve patients following implementation of the program in August 2007. RESULTS: During the first 10 months, 26,366 patients attempted to fill TF prescriptions in the MHS; 10,025 patients (38%) encountered a claim rejection, with a warning message advising the pharmacist to verify opioid tolerance. The majority of rejection messages were overridden by the pharmacist; however, 1,402 patients did not receive a TF prescription following the rejection, representing a 14% decrease in TF claims dispensed to patients who appeared opioid naïve in the MHS. CONCLUSION: A patient safety program with targeted pharmacy messaging reduced TF use among seemingly opioid-naïve patients in the MHS without disrupting treatment for patients whose rejections were overridden.

Evaluating patient adherence to antidepressant therapy among uninsured working adults diagnosed with major depression: results of the Texas Demonstration to Maintain Independence and Employment study.

This study examined antidepressant adherence and persistence among uninsured working adults diagnosed with major depression enrolled in the Texas Demonstration to Maintain Independence and Employment (DMIE) program. Antidepressant adherence was measured between intervention and control cohorts using proportion of days covered (PDC) during a 365-day observation period. Persistence examined duration of time from drug initiation to discontinuation based on a ≥35-day refill supply gap. Older, non-minority patients with higher education were more adherent or persistent to antidepressant therapy. Adjusting for covariates, results showed no significant difference in PDC at the end of 12-months between intervention and control participants (b = .07, P = .054, semi-partial η (2) = .02). Exploratory analysis found subgroup differences in PDC among the study recruitment cohorts. No significant difference between intervention and control groups was found in persistence between the groups. Follow-up investigation is planned to assess the longer term impact of the DMIE program on antidepressant adherence and persistence.

Development of the burden of prior authorization of psychotherapeutics (BoPAP) scale to assess the effects of prior authorization among Texas Medicaid providers.

This study describes an instrument to measure the perceived effects of prior authorization on quality of care among Texas Medicaid patients with severe mental illness. A questionnaire was mailed to 1,650 prescribers of psychiatric medications and 226 responses were used for analyses (17.5% response rate). Factor analysis revealed a 3-factor, 25-item instrument (BoPAP scale). Overall, prescribers reported a moderate burden of PA (BoPAP Mean = 3.90 +/- 0.52, possible range = 1-5). They perceived a high burden (4.49 +/- 0.57) on "administrative issues," a moderate burden (3.93 +/- 0.66) on "patient care processes/outcomes" and the lowest burden (3.30 +/- 0.74) on "system/societal costs." BoPAP scores differed based on provider characteristics, indicating evidence of discriminant validity.

Pharmacoepidemiology education in US colleges and schools of pharmacy.

OBJECTIVE: To examine the type and extent of pharmacoepidemiology education offered by US colleges and schools of pharmacy. METHODS: An electronic Web-survey was sent to all 89 US colleges and schools of pharmacy between October 2005 and January 2006 to examine the type and extent of pharmacoepidemiology education offered to professional (PharmD) and graduate (MS/PhD) students. RESULTS: The response rate was 100%. Of the 89 schools surveyed, 69 (78%) provided pharmacoepidemiology education to their professional students. A mean of 119 (+/-60) PharmD students per college/school per year received some pharmacoepidemiology education (range 1-60 classroom hours; median 10 hours). Thirty-five schools (39%) provided education to a mean of 6 (+/-5) graduate students (range 2-135 classroom hours; median 15 hours). CONCLUSIONS: A majority of US colleges and schools of pharmacy offer some pharmacoepidemiology education in their curriculum. However, the topics offered by each school and number of classroom hours varied at both the professional and graduate level.

Influences of attitudes on family physicians' willingness to prescribe long-acting opioid analgesics for patients with chronic nonmalignant pain.

BACKGROUND: The treatment of moderate to severe chronic nonmalignant pain (CNMP) is a challenge for both the patient and health care provider. Conflicting information exists regarding the appropriate use of long-acting (ie, controlled-release [CR]) opioid analgesics for CNMP, and physicians may be reluctant to prescribe them even when medically appropriate. OBJECTIVE: This study examined physicians' willingness and attitudes toward prescribing long-acting opioids to patients with moderate to severe CNMP METHODS: As part of a larger survey sent to 2750 family physicians, one question was used to assess physicians' willingness to prescribe, and 20 Likert-type questions were used to measure physicians' attitudes toward prescribing CR opioids. RESULTS: Of the 267 usable responses (10% response rate), two thirds of physicians indicated that they were "somewhat willing" to "extremely willing" to prescribe long-acting opioids to their patients with CNMP Physicians indicated an overall slightly favorable attitude (mean [SD], +2.96 [17.75] [possible range, -90 to +90]) toward prescribing long-acting opioids for CNMP Physicians who were unwilling to prescribe had an overall unfavorable attitude (mean [SD], -7.87 [17.43]) compared with willing physicians (mean [SD], +9.56 [14.81]). Approximately 80% of physicians believed that long-acting opioids would be effective in controlling pain and would improve overall quality of life in patients with CNMP. However, 78% indicated that they were "somewhat likely" to "extremely likely" to encounter regulatory scrutiny if they prescribed long-acting opioids for CNMP, and about half (51%) of the respondents believed prescribing them would lead to patient addiction. Unwilling physicians held stronger beliefs that prescribing opioids would lead to patient abuse, addiction, and regulatory scrutiny compared with willing physicians. CONCLUSIONS: About two thirds of physician respondents were willing to prescribe long-acting opioids for patients with CNMP, and physician attitudes were marginally favorable. Further study should investigate how physicians' attitudes and willingness translate into actual prescribing behavior.