Search Results (13)

Background: The cost and uptake of cancer medications dispensed as take-home treatments are not well understood. Therefore, in this study, we describe trends and the impact of SARS-CoV-2 on the utilization and cost of take-home cancer medications dispensed through the public payer system in Ontario, Canada. Methods: We conducted a repeated cross-sectional time-series analysis examining monthly and fiscal-year trends in the utilization and cost of take-home cancer medications reimbursed by the public payer between 1 April 2017 and 31 March 2021, in Ontario, Canada. Our primary outcome was per-beneficiary spending. Total public payer spending and the number of unique beneficiaries who were dispensed take-home cancer medications were reported as secondary outcomes. All outcomes were reported overall and stratified by drug class. We used autoregressive integrated moving average (ARIMA) models to assess the impact of the SARS-CoV-2 pandemic on the aforementioned trends. Results: Annual per-beneficiary spending on take-home cancer medications increased by 32.8% (from CAD 4422 in 2017/18 to CAD 6579 in 2020/21) over the study period. The rise in per-beneficiary spending was driven by the cost of medications within the small-molecule targeted therapy and immunotherapy drug classes, which accounted for three-quarters of total public payer spending on take-home cancer medications in 2020/21 despite being dispensed to less than 8% of beneficiaries. Upon the declaration of emergency for SARS-CoV-2, a short-term decline in per-beneficiary spending (CAD −179 per month; p-value < 0.01) was observed between March and June 2020. This temporary decline was driven by an increase in the number of beneficiaries (5582 per month; p-value < 0.01) receiving low-cost take-home cancer medications within the cytotoxic chemotherapy and hormonal therapy drug class without a corresponding rise in public payer spending. Conclusion: Future research should investigate barriers to the widespread uptake of take-home cancer medications during periods of public emergencies, particularly for high-cost drugs. Full article

The treatment landscape for patients with advanced ALK-positive NSCLC has rapidly evolved following the approval of several ALK TKIs in Canada. However, public funding of ALK TKIs is mostly limited to the first line treatment setting. Using linked provincial health administrative databases, we examined real-world outcomes of patients with advanced ALK-positive NSCLC receiving ALK TKIs in Ontario between 1 January 2012 and 31 December 2021. Demographic, clinical characteristics and treatment patterns were summarized using descriptive statistics. Kaplan–Meier analysis was performed to evaluate progression-free survival (PFS) and overall survival (OS) among the treatment groups. A total of 413 patients were identified. Patients were administered alectinib (n = 154), crizotinib (n = 80), or palliative-intent chemotherapy (n = 55) in the first-line treatment. There was a significant difference in first-line PFS between the treatment groups. The median PFS (mPFS) was not reached for alectinib (95% CI, 568 days—not reached), compared to 8.2 months (95% CI, 171–294 days) for crizotinib (HR = 0.34, p < 0.0001) and 2.4 months (95% CI, 65–100 days) for chemotherapy (HR = 0.14, p < 0.0001). There was no significant difference in first-line OS between the treatment groups. In patients who received more than one line of treatment, there was a significant difference in mOS between patients who received two or more lines of ALK TKIs compared to those who received one line of ALK TKI (mOS = 55 months (95% CI, 400–987 days) and 26 months (95% CI, 1448–2644 days), respectively, HR = 4.64, p < 0.0001). This study confirms the effectiveness of ALK TKIs in real-world practice and supports the potential benefit of multiple lines of ALK TKI on overall survival in patients with ALK-positive NSCLC. Full article

Background/Objective: The purpose of this study was to investigate the impact of the COVID-19 pandemic on mortality rates in a community-dwelling spinal cord injury (SCI) population in Ontario. Methods: Using health administrative databases, monthly mortality rates were evaluated pre-pandemic, during the pandemic, and post-pandemic from March 2014 to May 2024. Data were stratified by sex, injury etiology, and mental health status. Group differences were evaluated using t-tests. Autoregressive integrated moving average (ARIMA) models evaluated the pandemic’s impact on mortality rates. Results: A significant increase of 21.4% in mortality rates during the pandemic was found for the SCI cohort. With the exception of the traumatic group, all subgroups also experienced a significant increase in mortality rates (males: 13.9%, females: 31.9%, non-traumatic: 32.3%, mental health diagnoses: 19.6%, and mental health diagnoses: 29.4%). During the pandemic, females had a significantly higher mortality rate than males. The non-traumatic group had higher mortality rates than the traumatic group at all time periods. Individuals with mental health diagnoses had higher mortality rates than those without at the pre-pandemic and pandemic periods. Conclusions: The variation in mortality rates across groups highlights inequitable access to medical care in the SCI population, with further research and interventions needed. Full article

Persons with disabilities experience numerous barriers to healthcare access including vaccine accessibility. The purpose of this study was to determine COVID-19 vaccine uptake in the spinal cord injury and disease (SCI/D) population of Ontario and identify potential factors influencing C OVID-19 vaccine uptake. This was a retrospective closed-cohort study using administrative health data on individuals with SCI/D of traumatic and non-traumatic causes to examine the monthly number of COVID-19 vaccine doses received between December 2020 and December 2023. Logistic regression analysis was used to examine the potential association between socio-demographic, clinical, and neighbourhood characteristics with initial COVID-19 vaccine receipt and booster dose uptake. By the end of the observation period in December 2023, 82.9% received the full two-dose coverage and 65.6% received at least one additional booster dose in a cohort of 3574 individuals with SCI/D. SCI/D individuals showed a comparable COVID-19 vaccine uptake percentage to the general population. Sociodemographic, clinical, and neighbourhood characteristics were associated with COVID-19 vaccine uptake in the SCI/D population, including age, type of injury, number of comorbidities, mental health history, and neighbourhood characteristics such as income. Further investigation is necessary to determine the causation effects of these relationships with vaccine uptake to address health equity concerns. Full article

Niraparib was recently funded in Canada for the maintenance treatment of ovarian cancer following platinum-based chemotherapy. However, the drug’s safety profile in the real world remains uncertain. We conducted a cohort study to describe the patient population using niraparib and the proportion that experienced adverse events between June 2019 and December 2022 in four Canadian provinces (Ontario, Alberta, British Columbia [BC], and Quebec). We used administrative data and electronic medical records from Ontario Health, Alberta Health Services, and BC Cancer, and registry data from Exactis Innovation. We summarized baseline characteristics using descriptive statistics and reported safety outcomes using cumulative incidence. We identified 514 patients receiving niraparib. Mean age was 67 years and most were initiated on a daily dose of 100 or 200 mg/day. Grade 3/4 anemia, neutropenia, and thrombocytopenia occurred in 11–16% of the cohort. In Ontario, the three-month cumulative incidence of grade 3/4 thrombocytopenia was 11.6% (95% CI, 8.3–15.4%), neutropenia was 7.1% (95% CI, 4.6–10.4%), and anemia was 11.3% (95% CI, 8.0–15.2%). Cumulative incidences in the remaining provinces were similar. Initial daily dose and proportions of hematological adverse events were low in the real world and may be related to cautious prescribing and close monitoring by clinicians. Full article

Multi-criteria decision analysis (MCDA) is a value assessment tool designed to help support complex decision-making by incorporating multiple factors and perspectives in a transparent, structured approach. We developed an MCDA rating tool, consisting of seven criteria evaluating the importance and feasibility of conducting potential real-world evidence (RWE) studies aimed at addressing uncertainties stemming from initial cancer drug funding recommendations. In collaboration with the Canadian Agency for Drugs and Technologies in Health’s Provincial Advisory Group, a validation exercise was conducted to further evaluate the application of the rating tool using RWE proposals varying in complexity. Through this exercise, we aimed to gain insight into consensus building and deliberation processes and to identify efficiencies in the application of the rating tool. An experienced facilitator led a multidisciplinary committee, consisting of 11 Canadian experts, through consensus building, deliberation, and prioritization. A total of nine RWE proposals were evaluated and prioritized as low (n = 4), medium (n = 3), or high (n = 2) priority. Through an iterative process, efficiencies and recommendations to improve the rating tool and associated procedures were identified. The refined MCDA rating tool can help decision-makers prioritize important and feasible RWE studies for research and can enable the use of RWE for the life-cycle evaluation of cancer drugs. Full article

The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug’s perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health’s Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations. Full article

Healthcare workers have been under a great deal of stress and have been experiencing burnout throughout the COVID-19 pandemic. Among these, healthcare workers are pharmacists who have been instrumental in the fight against the pandemic. This scoping review examined the impact of the pandemic on pharmacists’ mental health and their antecedents using three databases (CINAHL, MEDLINE, and PsycINFO). Eligible studies included primary research articles that examined the mental health antecedents and outcomes among pharmacists during the first two years of the pandemic. We used the Social Ecological Model to categorize antecedents per outcome. The initial search yielded 4165 articles, and 23 met the criteria. The scoping review identified pharmacists experiencing poor mental health during the pandemic, including anxiety, burnout, depression, and job stress. In addition, several individual, interpersonal, organizational, community, and policy-level antecedents were identified. As this review revealed a general decline in pharmacists’ mental health during the pandemic, further research is required to understand the long-term impacts of the pandemic on pharmacists. Furthermore, we recommend practical mitigation strategies to improve pharmacists’ mental health, such as implementing crisis/pandemic preparedness protocols and leadership training to foster a better workplace culture. Full article

The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration established the Engagement Working Group (WG) to ensure that all key stakeholders had an opportunity to provide input into the development and implementation of the CanREValue Real-World Evidence (RWE) Framework. Two consultations were held in 2021 to solicit patient perspectives on key policy and data access issues identified in the interim policy and data WG reports. Over 30 individuals, representing patients, caregivers, advocacy leaders, and individuals engaged in patient research were invited to participate. The consultations provided important feedback and valuable lessons in patient engagement. Patient leaders actively shaped the process and content of the consultation. Breakout groups facilitated by patient advocacy leaders gave the opportunity for open and thoughtful contributions from all participants. Important recommendations were made: the RWE framework should not impede access to new drugs; it should be used to support conditional approvals; patient relevant endpoints should be captured in provincial datasets; access to data to conduct RWE should be improved; and privacy issues must be considered. The manuscript documents the CanREValue experience of engaging patients in a consultative process and the useful contributions that can be achieved when the processes to engage are guided by patients themselves. Full article

Canadian provinces routinely collect patient-level data for administrative purposes. These real-world data (RWD) can be used to generate real-world evidence (RWE) to inform clinical care and healthcare policy. The CanREValue Collaboration is developing a framework for the use of RWE in cancer drug funding decisions. A Data Working Group (WG) was established to identify data assets across Canada for generating RWE of oncology drugs. The mapping exercise was conducted using an iterative scan with informant surveys and teleconference. Data experts from ten provinces convened for a total of three teleconferences and two in-person meetings from March 2018 to September 2019. Following each meeting, surveys were developed and shared with the data experts which focused on identifying databases and data elements, as well as a feasibility assessment of conducting RWE studies using existing data elements and resources. Survey responses were compiled into an interim data report, which was used for public stakeholder consultation. The feedback from the public consultation was used to update the interim data report. We found that databases required to conduct real-world studies are often held by multiple different data custodians. Ninety-seven databases were identified across Canada. Provinces held on average 9 distinct databases (range: 8–11). An Essential RWD Table was compiled that contains data elements that are necessary, at a minimal, to conduct an RWE study. An Expanded RWD Table that contains a more comprehensive list of potentially relevant data elements was also compiled and the availabilities of these data elements were mapped. While most provinces have data on patient demographics (e.g., age, sex) and cancer-related variables (e.g., morphology, topography), the availability and linkability of data on cancer treatment, clinical characteristics (e.g., morphology and topography), and drug costs vary among provinces. Based on current resources, data availability, and access processes, data experts in most provinces noted that more than 12 months would be required to complete an RWE study. The CanREValue Collaboration’s Data WG identified key data holdings, access considerations, as well as gaps in oncology treatment-specific data. This data catalogue can be used to facilitate future oncology-specific RWE analyses across Canada. Full article

The CanREValue Collaboration established the Reassessment & Uptake Working Group to develop a preliminary process to reassess funded cancer drugs in Canada. A simulated exercise was conducted to evaluate the proposed reassessment process using a real-world case. We invited 32 attendees including representatives from Health Canada and Health Technology Assessment (HTA) agencies, along with payers, clinicians, academics, and patient representatives. A case was developed using a real-world study on a publicly funded cancer drug. In facilitated group sessions, participants were asked to deliberate upon the evidence presented in the case to issue reassessment recommendations. Several themes were identified through the deliberation discussions. While the generalizability of real-world evidence (RWE) is perceived as a strength, trust in the RWE depends largely on the source of the real-world data. The attendees suggested several improvements to the proposed reassessment process including evidence requirement for reassessment, recommendation categories, and a priori study protocols. This exercise generated important insights on the evidence required for conducting reassessment and considerations for improvements of the proposed reassessment process. Building upon lessons from this exercise, future work would continue to refine the reassessment process as part of the overall CanREValue framework. Full article

The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration was established to develop a framework for generating and using real-world evidence (RWE) to inform the reassessment of cancer drugs following initial health technology assessment (HTA). The Reassessment and Uptake Working Group (RWG) is one of the five established CanREValue Working Groups. The RWG aims to develop considerations for incorporating RWE for HTA reassessment and strategies for using RWE to reassess drug funding decisions. Between February 2018 and December 2019, the RWG attended four teleconferences (with follow-up surveys) and two in-person meetings to discuss recommendations for the development of a reassessment process and potential barriers and facilitators. Modified Delphi methods were used to gather input. A draft report of recommendations (to December 2018) was shared for public consultation (December 2019 to January 2020). Initial considerations for developing a reassessment process were proposed. Specifically, reassessment can be initiated by diverse stakeholders, including decision makers from public drug plans or industry stakeholders. The reassessment process should be modelled after existing deliberation and recommendation frameworks used by HTA agencies. Proposed reassessment outcome categories include maintaining status quo, revisiting funding criteria, renegotiating price, or disinvesting. Overall, these initial considerations will serve as the basis for future advancements by the Collaboration. Full article

The 2019 novel coronavirus (COVID-19) pandemic has placed a significant strain on hepatitis programs and interventions (screening, diagnosis, and treatment) at a critical moment in the context of hepatitis C virus (HCV) elimination. We sought to quantify changes in Direct Acting Antiviral (DAA) utilization among different countries during the pandemic. We conducted a cross-sectional time series analysis between 1 September 2018 and 31 August 2020, using the IQVIA MIDAS database, which contains DAA purchase data for 54 countries. We examined the percent change in DAA units dispensed (e.g., pills and capsules) from March to August 2019 to the same period of time in 2020 across the 54 countries. Interrupted time-series analysis was used to examine the impact of COVID-19 on monthly rates of DAA utilization across each of the major developed economies (G7 nations). Overall, 46 of 54 (85%) jurisdictions experienced a decline in DAA utilization during the pandemic, with an average of −43% (range: −1% in Finland to −93% in Brazil). All high HCV prevalence (HCV prevalence > 2%) countries in the database experienced a decline in utilization, average −49% (range: −17% in Kazakhstan to −90% in Egypt). Across the G7 nations, we also observed a decreased trend in DAA utilization during the early months of the pandemic, with significant declines (p < 0.01) for Canada, Germany, the United Kingdom, and the United States of America. The global response to COVID-19 led to a large decrease in DAA utilization globally. Deliberate efforts to counteract the impact of COVID-19 on treatment delivery are needed to support the goal of HCV elimination. Full article