Complete Primary Pathological Response Following Neoadjuvant Treatment and Radical Resection for Pancreatic Ductal Adenocarcinoma.

INTRODUCTION: Neoadjuvant treatment (NAT) for borderline (BD) or locally advanced (LA) primary pancreatic cancer (PDAC) is now a widely adopted approach. We present a case series of patients who have achieved a complete pathological response of the primary tumour on final histology following neoadjuvant chemotherapy +/- chemoradiation and radical surgery. METHODS: Patients who underwent radical pancreatic resection following neoadjuvant treatment between March 2006 and March 2023 at a single institution were identified by retrospective case note review of a prospectively maintained database. RESULTS: Ten patients were identified to have a complete primary pathological response (ypT0) on postoperative histology. Before treatment, five patients were considered BD and five were LA according to National Comprehensive Cancer Network guidelines. All patients underwent staging Computed Tomography (CT) and nine underwent 18Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET/CT) imaging, with a mean maximum standardized uptake value (SUVmax) of the primary lesion at 6.14 ± 1.98 units. All patients received neoadjuvant chemotherapy, and eight received further chemoradiotherapy prior to resection. Mean pre- and post-neoadjuvant treatment serum Ca19-9 was 148.0 ± 146.3 IU/L and 18.0 ± 18.7 IU/L, respectively (p = 0.01). The mean duration of NAT was 5.6 ± 1.7 months. The mean time from completion of NAT to surgery was 13.1 ± 8.3 weeks. The mean lymph node yield was 21.1 ± 10.4 nodes, with one patient found to have 1 lymph node involved. All resections were reported to be R0. The mean length of stay was 11.8 ± 6.2 days. At the time of analysis, one death was reported at 35 months postoperatively. Two cases of recurrence were reported at 16 months (surgical bed) and 33 months (pulmonary). All other patients remain alive and under active surveillance. The current overall survival is 26.6 ± 20.7 months and counting. CONCLUSIONS: Complete primary pathological response is uncommon but possible following neoadjuvant treatment in patients with PDAC. Further work to identify the common denominator within this unique cohort may lead to advances in the therapeutic approach and offer hope for patients diagnosed with borderline or locally advanced pancreatic ductal adenocarcinoma.

Characterizing patient assistance program use and patient responsiveness to specialty drug price for multiple sclerosis in a mid-size integrated health system.

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.

Costs of using evidence-based implementation strategies for behavioral health integration in a large primary care system.

OBJECTIVE: To describe the cost of using evidence-based implementation strategies for sustained behavioral health integration (BHI) involving population-based screening, assessment, and identification at 25 primary care sites of Kaiser Permanente Washington (2015-2018). DATA SOURCES/STUDY SETTING: Project records, surveys, Bureau of Labor Statistics compensation data. STUDY DESIGN: Labor and nonlabor costs incurred by three implementation strategies: practice coaching, electronic health records clinical decision support, and performance feedback. DATA COLLECTION/EXTRACTION METHODS: Personnel time spent on these strategies was estimated for five broad roles: (a) project leaders and administrative support, (b) practice coaches, (c) clinical decision support programmers, (d) performance metric programmers, and (e) primary care local implementation team members. PRINCIPAL FINDING: Implementation involved 286 persons, 18 131 person-hours, costing $1 587 139 or $5 per primary care visit with screening or $38 per primary care visit identifying depression, suicidal thoughts and/or alcohol or substance use disorders, in a single year. The majority of person-hours was devoted to project leadership (35%) and practice coaches (34%), and 36% of costs were for the first three sites. CONCLUSIONS: When spread across patients screened in a single year, BHI implementation costs were well within the range for commonly used diagnostic assessments in primary care (eg, laboratory tests). This suggests that implementation costs alone should not be a substantial barrier to population-based BHI.

Long-Term Patterns of Oral Anticancer Agent Adoption, Duration, and Switching in Patients With CML.

BACKGROUND: Oral tyrosine kinase inhibitors (TKIs) have been the standard of care for chronic myeloid leukemia (CML) since 2001. However, few studies have evaluated changes in the treatment landscape of CML over time. This study assessed the long-term treatment patterns of oral anticancer therapies among patients with CML. METHODS: This retrospective cohort study included patients newly diagnosed with CML between January 1, 2000, and December 31, 2016, from 10 integrated healthcare systems. The proportion of patients treated with 5 FDA-approved oral TKI agents-bosutinib, dasatinib, imatinib, nilotinib, and ponatinib-in the 12 months after diagnosis were measured, overall and by year, between 2000 and 2017. We assessed the use of each oral agent through the fourth-line setting. Multivariable logistic regression estimated the odds of receiving any oral agent, adjusting for sociodemographic and clinical characteristics. RESULTS: Among 853 patients with CML, 81% received an oral agent between 2000 and 2017. Use of non-oral therapies decreased from 100% in 2000 to 5% in 2005, coinciding with imatinib uptake from 65% in 2001 to 98% in 2005. Approximately 28% of patients switched to a second-line agent, 9% switched to a third-line agent, and 2% switched to a fourth-line agent. Adjusted analysis showed that age at diagnosis, year of diagnosis, and comorbidity burden were statistically significantly associated with odds of receiving an oral agent. CONCLUSIONS: A dramatic shift was seen in CML treatments away from traditional, nonoral chemotherapy toward use of novel oral TKIs between 2000 and 2017. As the costs of oral anticancer agents reach new highs, studies assessing the long-term health and financial outcomes among patients with CML are warranted.