Predictors of nonresponse to dupilumab in patients with atopic dermatitis: A machine learning analysis.

BACKGROUND: Many patients with atopic dermatitis (AD) have a suboptimal response to systemic therapy. OBJECTIVE: This study assessed predictors of nonresponse to dupilumab in patients with AD. METHODS: Data (April 2017 through June 2019) for patients aged 12 years and above with AD (International Classification of Diseases-9/10-Clinical Modification: 691.8/L20.x) who initiated dupilumab on or after April 1, 2017 (index date) were collected from an electronic health record and insurance claims database. Nonresponse indicators (dupilumab discontinuation, addition of another systemic therapy or phototherapy, addition of a high-potency topical corticosteroid, AD-related hospital visit, AD-related emergency department visit, incident skin infection) were predicted from available demographic and clinical variables using machine learning. RESULTS: Among 419 patients (mean age: 45 years), 145 (35%) experienced at least 1 indicator of nonresponse in the 6-month postindex period. In patients with at least 1 indicator, the most common was dupilumab discontinuation (47% [68/145]). Of note, this analysis could not capture nonmedical reasons for dupilumab discontinuation (eg, cost, access). The most common predictors of nonresponse were a claim for ibuprofen (in 69% of patients with a nonresponse indicator) and a Quan-Charlson Comorbidity Index value of 3 to 4 (59%). CONCLUSION: Systemic dupilumab therapy for AD can be associated with a relatively high prevalence of nonresponse indicators. Factors associated with these indicators-that is, predictors of nonresponse-may be used to optimize disease management.

Costs and Treatment Patterns Among Patients with Atopic Dermatitis Using Advanced Therapies in the United States: Analysis of a Retrospective Claims Database.

INTRODUCTION: For many, atopic dermatitis (AD) is not adequately controlled with topical regimens. This analysis examined treatment using advanced therapies and associated costs. METHODS: The IQVIA Health Plan Claims data set was analyzed. Patients aged ≥ 12 years with AD who newly initiated advanced therapy after the availability of dupilumab (March 28, 2017) and had ≥ 6 months continuous enrollment before and after their first advanced therapy claim (index date) were included. Advanced therapies included dupilumab, systemic corticosteroids (SCSs), systemic immunosuppressants (SISs), and phototherapy. A multivariate regression model was used to predict annualized follow-up healthcare costs. RESULTS: In total, 1980 patients were included (61.1% female; mean age, 41.2 years [SD, 17.4]; 11.3% < 18 years). Pre-index date, 65.2% of patients used topical corticosteroids (TCSs; 40.7% and 32.1% used medium and high potency, respectively). The most common advanced therapy was SCSs (N = 1453 [73.4%]; 69.2% prednisone) followed by dupilumab (N = 265 [13.4%]), SISs (N = 99 [5.0%]; 47.5% methotrexate), and phototherapy (N = 163 [8.2%]). Of patients treated with dupilumab, SISs, and phototherapy, 17.4%, 26.3%, and 14.1%, respectively, were prescribed SCSs post-index date. Overall, 62.6% of patients initiating SCSs, 49.1% initiating dupilumab, 64.6% initiating SISs, and 36.2% initiating phototherapy were prescribed TCSs post-index date. Mean annualized total costs (SD) post-index date were $20,722 ($47,014): $11,196 ($41,549) in medical costs ($7973 [$35,133] in outpatient visit costs) and $9526 ($21,612) in pharmacy costs. Mean annualized total cost (SD) varied significantly (P < 0.05) by index treatment: dupilumab, $36,505 ($14,028); SCSs, $17,924 ($49,019); SISs, $24,762 ($47,583); phototherapy, and $17,549 ($57,238). CONCLUSIONS: Switching to combination therapy with SCSs and TCSs was common within 6 months of initiating advanced therapy in patients with AD. Patients also incurred significant pharmacy and outpatient costs. These results highlight the difficulty of managing AD with these existing treatment options.

Oncologists' Perceptions of Drug Affordability Using NCCN Evidence Blocks: Results from a National Survey.

BACKGROUND: The increasing prevalence of cancer coupled with approvals of new drugs and technologies used in therapy have brought increased scrutiny to the cost and value of treatments in oncology. To address the rising concern about oncology drug costs, several organizations have developed value frameworks to help assess the value of oncology regimens. The objective of this study was to assess oncologists' perceptions, awareness, and knowledge of all oncology value frameworks in the United States and to understand oncologists' perceptions of affordability in the context of National Comprehensive Cancer Network (NCCN) Evidence Blocks. OBJECTIVES: To (a) assess oncologists' awareness, knowledge, perceptions, and ratings of the American Society of Clinical Oncology Value Framework (AVF), the Institute for Clinical and Economic Review (ICER) value framework, NCCN Evidence Blocks, and Memorial Sloan Kettering Cancer Center's DrugAbacus; (b) assess oncologists' knowledge and perceptions of drug affordability as defined by the NCCN Evidence Blocks methodology; and (c) determine the factors that influence drug affordability ratings. METHODS: Data were collected from an electronic cross-sectional survey of 200 U.S.-based oncologists from a variety of practice settings. Oncologists were asked about their knowledge and perceptions of 4 value frameworks-NCCN Evidence Blocks, AVF, the ICER value framework, and DrugAbacus. Using NCCN Evidence Blocks, oncologists were asked to rate a variety of hypothetical cancer therapies and assign costs (in U.S. dollars) to the 5 levels of affordability. Additional questions that assessed perceived patient out-of-pocket (OOP) costs and comfort level in assessing affordability were also included in the survey. RESULTS: Oncologists were most familiar with NCCN Evidence Blocks (90%), followed by the AVF (84%), ICER value framework (57%), and DrugAbacus (56%). Oncologists rated affordability higher (mean rating 3: moderately expensive) versus the actual NCCN panel affordability rating (mean rating 1: very expensive). The affordability rating was similar across a variety of hypothetical cancer therapies and tumor types (rating: 3). Oncologists estimated the costs for this rating of 3 to range from $4,600 to $6,000 per month, which was inconsistent with actual drug costs. Oncologists estimated the mean monthly OOP costs for patients with insurance to range from $1,260 for a new oral medication to $1,700 for a new infused medication. Only 26% of oncologists were comfortable or very comfortable with rating costs associated with affordability levels. CONCLUSIONS: Surveyed oncologists rated cancer therapies as more affordable (per NCCN Evidence Blocks criteria) than NCCN panel ratings. Costs associated with affordability were not consistent with actual treatment costs; however, most oncologists were not comfortable with rating affordability. Patient OOP costs had the biggest influence on affordability ratings; however, physicians overestimated patient OOP costs significantly. There is an opportunity to improve the value frameworks, especially with regard to affordability assessment. DISCLOSURES: This study was funded by Genentech. Shah-Manek is employed by Ipsos Healthcare, a health care consulting company that received funding from Genentech to conduct this study. DiBonaventura was employed by Ipsos Healthcare at the time of this study. Wong and Ravelo are employed by Genentech. Shah-Manek has consulted with Genentech, Merck, Alkermes, Avanis, Alnylam, Novo Nordisk, Teva, Lilly, and BMS. This work was presented as an oral presentation at the ASCO 2017 Annual Meeting in Chicago, Illinois, on June 2-6, 2017.

Comparison of health-related quality of life among patients using atypical antipsychotics for treatment of depression: results from the National Health and Wellness Survey.

BACKGROUND: Use of atypical antipsychotics (AA) in combination with an antidepressant is recommended as an augmentation strategy for patients with depression. However, there is a paucity of data comparing aripiprazole and other AAs in terms of patient reported outcomes. Therefore, the objective of this study was to examine the levels of HRQoL and health utility scores in patients with depression using aripiprazole compared with patients using olanzapine, quetiapine, risperidone and ziprasidone. METHODS: Data were obtained from the 2009, 2010, and 2011 National Health and Wellness Survey (NHWS), a cross-sectional, internet-based survey that is representative of the adult US population. Only those patients who reported being diagnosed with depression and taking an antidepressant and an atypical antipsychotic for depression were included. Patients taking an atypical antipsychotic for less than 2 months or who reported being diagnosed with bipolar disorder or schizophrenia were excluded. Patients taking aripiprazole were compared with patients taking other atypical antipsychotics. Health-related quality of life (HRQoL) and health utilities were assessed using the Short Form 12-item (SF-12) health survey. Differences between groups were analyzed using General Linear Models (GLM) controlling for demographic and health characteristics. RESULTS: Overall sample size was 426 with 59.9% taking aripiprazole (n=255) and 40.1% (n=171) taking another atypical antipsychotic (olanzapine (n=19), quetiapine (n=127), risperidone (n=14) or ziprasidone (n=11)). Of the SF-12 domains, mean mental component summary (MCS) score (p=.018), bodily pain (p=.047), general health (p=.009) and emotional role limitations (p=.009) were found to be significantly higher in aripiprazole users indicating better HRQoL compared to other atypical antipsychotics. After controlling for demographic and health characteristics, patients taking aripiprazole reported significantly higher mean mental SF-12 component summary (34.10 vs. 31.43, p=.018), bodily pain (55.19 vs. 49.05, p=.047), general health (50.05 vs. 43.07, p=.009), emotional role limitations (49.44 vs. 41.83, p=.009), and SF-6D utility scores (0.59 vs. 0.56, p=.042). CONCLUSIONS: Comparison of patients taking aripiprazole with a cohort of patients using another AA for depression demonstrated that aripiprazole was independently associated with better (both statistically and clinically) HRQoL and health utilities.