Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications

© 2019 Salek, Lussier Hoskyn, Johns, Allen and Sehgal. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).This analysis follows our recent study showing that Canadian public reimbursement delays have lengthened from regulatory approval to listing decisions by public drug plans and delayed public access to innovative medicines, mainly due to processes following the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR). Public drug plans participate in a pan-Canadian Pharmaceutical Alliance (pCPA) joint negotiation process before making decisions about whether or not to reimburse a product reviewed through CDR and pCODR. This research aims to report the findings from a comprehensive analysis of pCPA process times, times to reimbursement by public payers in Canada, and to explore the opportunities to reduce total delays in public reimbursement with a specific focus on the pCPA process. An analysis was conducted of pCPA timelines with respect to making decisions about products and indications reviewed through CDR/pCODR, and focusses on three separate time components: time to begin negotiating, time spent negotiating, and time to implement the negotiation (i.e., time to list) in each of nine jurisdictions (i.e., 10 provinces of Canada, excluding Quebec). This study demonstrates the role of post-CDR/pCODR processes in large and lengthening delays to listing new medicines. Notably, oncology products have experienced the longest increases in time to begin negotiating and to complete negotiations. Trends in listing times post-pCPA across provinces are less clear, however, it appears that consistency in terms of timelines across provinces is not happening quite so smoothly for oncology products compared to non-oncology products. Listing rates also appear to be declining for non-oncology products, although this trend is less conclusive for oncology products. Challenges need to be addressed to improve efficiency, transparency, and ultimately reduce pCPA timelines and total timelines to public reimbursement. Suggested ways to improve and streamline the listing process are: (1) transparent target timelines and associated performance incentives for the pCPA and public plan decisions, (2) parallel HTA-pCPA processes to enable pCPA negotiations to start part-way through the HTA review and allow pCPA negotiation information to be fed back into the HTA review, and (3) innovative agreements that consider patient input and earlier coverage with real-world evidence development.Peer reviewedFinal Published versio

Hospice Palliative Home Care in Canada: A Progress Report

This report is a snapshot of hospice palliative home care services available to Canadians in 2008. The information refers only to hospice palliative care services provided in the home. Other settings where Canadians die -- in hospital, long-term care homes and hospices, and on the street -- are equally important but were not covered in this survey

A Driving Force No More: Have Canadian Consumers Reached Their Limits?

In 2007, 2009, 2010 and then again in 2011, CGA-Canada set out to analyse the level of debt of Canadians, and to understand the extent to which the financial crisis and economic downturn worsened the financial situation of households, and whether the economic recovery have eased the financial stress. That was done by integrating the results of a public opinion survey commissioned by CGA-Canada with an analysis of available statistical information. The results of the analysis show that the financial condition of the aggregate household sector does not appear to be exceedingly distressful; however, focusing on the aggregate household sector conceals the fact that financial situation of certain groups of households may be much worse than average. Our ability to fully assess the state and level of household indebtedness is limited due to limited availability of data, whereas pan-Canadian perspective does not reflect significant regional differences. As such, the state and the dynamic of the household sector’s balance sheet should remain high on the radar of policy-makers.household debt, household finances, savings, wealth, household spending, income shock, ability to pay

Proceedings of the biosimilars workshop at the International Symposium on Oncology Pharmacy Practice 2019.

The International Society of Oncology Pharmacy Practitioners organized a workshop to create learning opportunities on biosimilars in pharmacy practice on 10 October 2019. The topics that were covered included (i) the development and testing of biosimilars, (ii) the challenges of bringing biosimilars to market, and (iii) real-world data on patient safety and perceptions during biosimilar implementation. The development of biosimilars can take up to eight years and the extensiveness of the process depends on several factors, such as the complexity of the production process and regulatory requirements. Compared to generic products of small-molecule drugs, there is a higher barrier to market entry for biosimilars, explaining the small number of biosimilars in the market. Appraisal of biosimilars for inclusion in hospital formularies is also different from the review process of originator biologics, where the former is usually institution-led and has fewer restrictions on use. When several biosimilar products are available, factors that should be considered besides cost are licensed indications, supply chain confidence, clinical data, and product attributes. Real-world data have shown that biosimilars are well-tolerated and have safety data that are comparable to that of the originator product. Oncology pharmacists from the United Kingdom, Kenya, and Canada also presented their respective experiences with biosimilar use. Different countries at varying stages of biosimilar implementation faced distinct challenges. Nevertheless, resources to assist biosimilar implementation can potentially be shared between different regions. International Society of Oncology Pharmacy Practitioners is well-positioned to foster professional cooperation at an international level to drive biosimilar implementation

Nurses\u27 Job Satisfaction in Northwest Arkansas

During the month of October 2013, approximately 450 registered nurses working at a hospital in Northwest Arkansas were surveyed. All registered nurses were included in the study and were given the survey with instructions to complete it and return it within 30 days. A modified version of the McCloskey/Mueller Satisfaction Scale by Tourangeau was utilized, evaluating factors as they related to job satisfaction such as control and responsibility, scheduling, professional opportunities, praise and recognition, balance of family and work, relationship with coworkers, salary/vacation/benefits, maternity leave/child care, care delivery, social contact, research opportunities, and decision making. These variables were all rated individually using the scale of seven factors. Ninety-three were returned, giving a response rate just over twenty percent, 20.67%. Of the 93 returned, 14 were incomplete, approximately 15.1%. After receiving the surveys, the data was entered into an excel spreadsheet. Demographics such as gender, employment status, were given numeric values. Analyses were completed using the IBM SPSS Statistics version 20. Demographics were analyzed along with factors affecting job satisfaction and factors affecting likelihood to remain at the hospital or in their current position. The only two statistically significant subscales included satisfaction with work conditions and supervisor support and satisfaction with collegial relationships and support. When grouped as likely or unlikely to remain working at the current hospital until retirement, 39 of the 80 RNs (49%) who responded to this item did not intend to stay until retirement. From these findings, the hospital will be able to improve retention strategies. The limitations of this study were that a better response rate would have been achieved had we been able to mail out the surveys and a reminder to return them after a certain amount of time, as well as the fact that the median age of those surveyed was 28 years, so it was unrealistic to ask if they planned on staying until retirement. Overall, a great deal can be taken away from this study and used to improve nursing turnover in this particular hospitals and in hospitals elsewhere

The Athabasca University edusource Project: Building An Accessible Learning Object Repository

Athabasca University - Canada's Open University (AU) made the commitment to put all of its courses online as part of its Strategic University Plan. In pursuit of this goal, AU participated in the eduSource project, a pan-Canadian effort to build the infrastructure for an interoperable network of learning object repositories. AU acted as a leader in the eduSource work package, responsible for the metadata and standards for learning objects. In addition, the team of professionals, academics, librarians and other researchers worked to create an accessible repository of learning objects across university departments and subjects. Most critically, the team worked beyond the development of a learning object repository and considered the adaptation of content and related applications, pedagogical approaches and the use of learning objects by instructional designers, faculty and the learners themselves. This paper describes one institution's approach to learning object repository development, from a technical and pedagogical perspective, along with some of the lessons learned during the process

Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT)

Background: The Canadian Study of Prediction of Death, Dialysis and Interim Cardiovascular Events (CanPREDDICT) is a large, prospective, pan-Canadian, cohort study designed to improve our understanding of determinants of renal and cardiovascular (CV) disease progression in patients with chronic kidney disease (CKD). The primary objective is to clarify the associations between traditional and newer biomarkers in the prediction of specific renal and CV events, and of death in patients with CKD managed by nephrologists. This information could then be used to better understand biological variation in outcomes, to develop clinical prediction models and to inform enrolment into interventional studies which may lead to novel treatments. Methods/Designs: Commenced in 2008, 2546 patients have been enrolled with eGFR between 15 and 45 ml/min 1.73m2 from a representative sample in 25 rural, urban, academic and non academic centres across Canada. Patients are to be followed for an initial 3 years at 6 monthly intervals, and subsequently annually. Traditional biomarkers include eGFR, urine albumin creatinine ratio (uACR), hemoglobin (Hgb), phosphate and albumin. Newer biomarkers of interest were selected on the basis of biological relevance to important processes, commercial availability and assay reproducibility. They include asymmetric dimethylarginine (ADMA), N-terminal pro-brain natriuretic peptide (NT-pro-BNP), troponin I, cystatin C, high sensitivity C-reactive protein (hsCRP), interleukin-6 (IL6) and transforming growth factor beta 1 (TGFβ1). Blood and urine samples are collected at baseline, and every 6 monthly, and stored at −80°C. Outcomes of interest include renal replacement therapy, CV events and death, the latter two of which are adjudicated by an independent panel. Discussion: The baseline distribution of newer biomarkers does not appear to track to markers of kidney function and therefore may offer some discriminatory value in predicting future outcomes. The granularity of the data presented at baseline may foster additional questions. The value of the cohort as a unique resource to understand outcomes of patients under the care of nephrologists in a single payer healthcare system cannot be overstated. Systematic collection of demographic, laboratory and event data should lead to new insights. The mean age of the cohort was 68 years, 90% were Caucasian, 62% were male, and 48% had diabetes. Forty percent of the cohort had eGFR between 30–45 mL/min/1.73m2, 22% had eGFR values below 20 mL/min/1.73m2; 61% had uACR < 30. Serum albumin, hemoglobin, calcium and 25-hydroxyvitamin D (25(OH)D) levels were progressively lower in the lower eGFR strata, while parathyroid hormone (PTH) levels increased. Cystatin C, ADMA, NT-proBNP, hsCRP, troponin I and IL-6 were significantly higher in the lower GFR strata, whereas 25(OH)D and TGFβ1 values were lower at lower GFR. These distributions of each of the newer biomarkers by eGFR and uACR categories were variable

Advantages of the net benefit regression framework for trial-based economic evaluations of cancer treatments: an example from the Canadian Cancer Trials Group CO.17 trial.

BackgroundEconomic evaluations commonly accompany trials of new treatments or interventions; however, regression methods and their corresponding advantages for the analysis of cost-effectiveness data are not widely appreciated.MethodsTo illustrate regression-based economic evaluation, we review a cost-effectiveness analysis conducted by the Canadian Cancer Trials Group's Committee on Economic Analysis and implement net benefit regression.ResultsNet benefit regression offers a simple option for cost-effectiveness analyses of person-level data. By placing economic evaluation in a regression framework, regression-based techniques can facilitate the analysis and provide simple solutions to commonly encountered challenges (e.g., the need to adjust for potential confounders, identify key patient subgroups, and/or summarize "challenging" findings, like when a more effective regimen has the potential to be cost-saving).ConclusionsEconomic evaluations of patient-level data (e.g., from a clinical trial) can use net benefit regression to facilitate analysis and enhance results