Research Protocol for an Observational Health Data Analysis on the Adverse Events of Systemic Treatment in Patients with Metastatic Hormone-sensitive Prostate Cancer: Big Data Analytics Using the PIONEER Platform.

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in "real-life" patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Cost-effectiveness of enzalutamide versus apalutamide versus androgen deprivation therapy alone for the treatment of metastatic castration-sensitive prostate cancer in Canada.

AIMS: There are no direct comparisons of the relative cost-effectiveness of second-generation anti-androgens (enzalutamide and apalutamide) used in managing metastatic castration-sensitive prostate cancer (mCSPC) in Canada. This study compared the cost-effectiveness of enzalutamide versus apalutamide versus androgen deprivation therapy (ADT) alone (standard of care) in patients with mCSPC from the Canadian public payer perspective using a Markov model with a 15-year time horizon. MATERIALS AND METHODS: Efficacy data for enzalutamide and ADT alone were informed by the ARCHES and ENZAMET clinical trials, while a Bayesian network meta-analysis enabled comparison with apalutamide and ADT alone. RESULTS: Over the 15-year period, enzalutamide achieved the highest number of life-years (LY, 7.6) and quality-adjusted life-years (QALY, 5.62) compared with apalutamide (LY, 6.1; QALY, 4.59) and ADTs (LY, 4.9; QALY, 3.61). Enzalutamide incurred the most costs ($349,345) compared with apalutamide ($294,349) and ADT ($162,550). Sequential analysis showed that enzalutamide lies on the cost-effectiveness frontier with ADT alone (incremental cost-effectiveness ratio: $92,868/QALY), with apalutamide extendedly dominated through enzalutamide and ADT alone. LIMITATIONS: Limitations include the heterogeneity of the studies included in the network meta-analysis and the validations for the treatment sequencing assumptions in the modeling. CONCLUSIONS: Enzalutamide was the most effective treatment option for mCSPC in the Canadian market, with the greatest LYs and QALYs, and incurred the most costs.

Evaluating Metrics Applied to the Medical Science Liaison (MSL) Role: A Survey-Based Study of Canadian MSL Leaders.

INTRODUCTION: Metrics utilized within the Medical Science Liaison (MSL) role are plentiful and traditionally quantitative. We sought to understand the current use and value of metrics applied to the MSL role, including the use of qualitative metrics. METHODS: We developed a list of 70 MSL leaders working in Canada, spanning 29 companies. Invitations were emailed Jun 16, 2020 and the 25-question online survey was open for 3 weeks. Questions were designed to assess demographics as well as how and why metrics are applied to the MSL role. Data analyses were descriptive. RESULTS: Responses were received from 44 leaders (63%). Of the 42 eligible, 45% had ≤ 2 years of experience as MSL leaders and 86% supported specialty care products over many phases of the product lifecycle. A majority (69%) agreed or strongly agreed that metrics are critical to understanding whether an MSL is delivering value, and 98% had used metrics in the past year. The most common reason to use metrics was 'to show value/impact of MSLs to leadership' (66%). The most frequently used metric was 'number of health-care professional (HCP) interactions', despite this being seen as having moderate value. Quantitative metrics were used more often than qualitative, although qualitative were more often highly valued. CONCLUSION: The data collected show a lack of agreement between the frequency of use for some metrics and their value in demonstrating the contribution of an MSL. Overall, MSL leaders in our study felt qualitative metrics were a better means of showing the true impact of MSLs.