Biologics represent a large segment of drug spending in Canada: although they constituted just 1.5% of prescription volumes, biologics accounted for 27.3% of expenditures in 2018. As of 2018, the ...price of biologics in Canada, including spending per capita, was second only to that in the US among the Organisation for Economic Cooperation and Development countries. Here, McClean et al evaluate the current state of biosimilar policies and use across Canada. They also discuss interchangeability and indication extrapolation before making suggestions for enhancing the market through harmonization of biosimilar policies, patient and prescriber education, and manufacturer collaboration.
Objective
Uptake of biosimilars has been suboptimal in North America. This study was undertaken to quantify the impact of various policy interventions (namely, new start and switching policies) on ...uptake and spending on biosimilar infliximab and etanercept in British Columbia (BC), Canada.
Methods
We used administrative claims data to identify BC residents ≥18 years of age with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and/or plaque psoriasis who qualified for public drug coverage from January 2013 to November 2020. Using interrupted time series analysis, we studied the change in proportion spent on and prescriptions dispensed of biosimilar infliximab and etanercept out of the total amount per agent after new start and biosimilar switching policies were implemented.
Results
Our study included 208,984 individuals living with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, and/or psoriatic arthritis, corresponding to 5,884 patients taking infliximab and etanercept. After the new start policy, we detected a small gradual increase in the proportion of dispensed biosimilar etanercept prescriptions of 0.65% per month (95% confidence interval 95% CI 0.44, 0.85). The trend related to the proportion of total spending on biosimilar etanercept also increased (0.51% 95% CI 0.28, 0.73). After the switching policy, there was a sustained increase in the proportion of dispensed biosimilar etanercept and infliximab prescriptions of 76.98% (95% CI 75.56, 78.41) and 58.43% (95% CI 52.11, 64.75), respectively. Similarly, there was a persistent increase in monthly spending on biosimilar etanercept and infliximab of 78.22% (95% CI 76.65, 79.79) and 71.23% (95% CI 66.82, 75.65), respectively.
Conclusion
We found that mandatory switching policies were much more effective than new starting policies for increasing the use of biosimilar medications.
We assessed the relationship between tobacco smoking and immunologic and virologic response among people living with HIV (PLWH) initiating combination antiretroviral therapy (cART) in the Canadian ...HIV Observational Cohort (CANOC). Positive immunologic and virologic response, respectively, were defined as ≥50 cells/mm
3
CD4 count increase (CD4+) and viral suppression ≤50 copies/mL (VL+) within 6 months of cART initiation. Using multinomial regression, we examined the relationship between smoking, immunologic, and virologic response category. Model A adjusted for birth sex, baseline age, enrolling province, and era of cohort entry; models B and C further adjusted for neighbourhood level material deprivation and history of injection drug use (IDU), respectively. Among 4267 individuals (32.7%) with smoking status data, concordant positive (CD4+/VL+) response was achieved by 64.2% never, 66.9% former, and 59.4% current smokers. In the unadjusted analysis, current smoking was significantly associated with concordant negative response (odds ratio OR 1.85, 95% confidence interval CI 1.40-2.45). Similarly, models A and B showed an increased odds of concordant negative response in current smokers (adjusted OR aOR 1.78, 95% CI 1.32-2.39 and 1.74, 95% CI 1.29-2.34, respectively). The association between current smoking and concordant negative response was no longer significant in model C (aOR 1.18, 95%CI 0.85-1.65).
The use of data intensive health research has allowed for greater understandings of population health. When conducting data intensive health research, engaging and involving the community is ...essential for conducting meaningful research that is responsive to the public's needs. Particularly, when engaging Indigenous communities in research, there is a need to understand historical and ongoing impacts of colonialism and recognize the strengths in Indigenous Peoples' knowledges and experiences while supporting Indigenous leadership and self-determination in research. This article describes the approach our research team/organization used to engage and involve Indigenous people living with HIV in three research projects using large, linked datasets and looking at HIV outcomes of Indigenous populations in Canada. The foundation of these projects was simultaneously: 1) supporting Indigenous people living with HIV to be involved as research team members, 2) developing research questions to answer with available datasets, and 3) integrating Indigenous and Western ways of knowing. We have identified important considerations and suggestions for engaging and involving Indigenous communities and individuals in the generation of research ideas and analysis of linked data using community-based participatory research approaches through our work. These include engaging stakeholders at the start of the project and involving them throughout the research process, honouring Indigenous ways of knowing, the land, and local protocols and traditions, prioritizing Indigenous voices, promoting co-learning and building capacity, and focusing on developing longitudinal relationships. We describe keys to success and learnings that emerged. Importantly, the methodology practiced and presented in this manuscript is not a qualitative study design whereby research
are surveyed about their experiences or beliefs. Rather, the study approach described herein is about engaging people with living experience to co-lead as
Our approach supported Indigenous people to share research that addresses their research priorities and responds to issues relevant to Indigenous Peoples and communities.
Advances in treatment have turned HIV from a terminal illness to a more manageable condition. Over the past 20 years, there have been considerable changes to HIV treatment guidelines, including ...changes in preferred antiretrovirals and timing of initiation of combination antiretroviral therapy (cART).
To examine real-world trends in cART utilization, viral control, and immune reconstitution among people living with HIV in Canada.
Data were obtained from the Canadian Observational Cohort (CANOC). CANOC participants were eligible if they were antiretroviral therapy-naive at entry and initiated 3 or more antiretrovirals on or after January 1, 2000; if they were at least 18 years of age at treatment initiation; if they were residing in Canada; and if they had at least 1 viral load determination and CD4 count within 1 year of CANOC entry. Baseline and annual mean CD4 counts were categorized as less than 200, 200-350, 351-500, and more than 500 cells/mm
. Annual mean viral loads were reported as suppressed (< 50 copies/mL), low (50-199 copies/mL), or high detectable (≥ 200 copies/mL). The cART regimens were reported yearly.
All CANOC participants were included (
= 13 040). Over the study period, the proportion of individuals with an annual mean CD4 count above 500 cells/mm
increased from 16.3% to 65.8%, while the proportion of individuals with an undetectable mean viral load increased from 10.6% to 83.2%. As of 2007, the most commonly prescribed 2-agent nucleoside reverse transcriptase inhibitor backbone was tenofovir disoproxil fumarate and emtricitabine. In terms of third agents, non-nucleoside reverse transcriptase inhibitors were the most common class in the periods 2000-2003 and 2014-2015, protease inhibitors were most common in the period 2004-2013, and integrase inhibitors were most common in 2016.
Concordance with treatment guidelines was demonstrated over time with respect to cART prescribing and immunologic and virologic response.
Socioeconomic status has been associated with higher viral loads and lower CD4 cell counts among people living with HIV. The objective of this study was to evaluate the relation between ...neighbourhood-level material deprivation and immunologic and virologic response to combination antiretroviral therapy (ART) among people living with HIV in Canada.
The Canadian Observational Cohort (CANOC) is a longitudinal cohort of people living with HIV, containing data from 2000-2016 from 5 Canadian provinces. We defined response to combination ART as positive if the CD4 cell count increased by 50 cells/mm
(0.05 cells × 10
/L) or more (CD4+) and viral load decreased to 50 copies/mL or less (VL+) within 6 months of treatment initiation. We further categorized response to therapy as concordant positive (CD4+/VL+), concordant negative (CD4-/VL-) or discordant (CD4+/VL- or CD4-/VL+). We used adjusted multinomial logistic regression to quantify the relation between neighbourhood-level material deprivation and immunologic and virologic response.
This study included 8274 people living with HIV, of which 1754 (21.2%) lived in the most materially deprived neighbourhoods. Most individuals (62.2%) showed a concordant positive response to combination ART. After adjustment, living in the most materially deprived neighbourhoods was associated with a CD4-/VL+ discordant response (adjusted odds ratio OR 1.31, 95% confidence interval CI 1.06-1.62) and a concordant negative response (adjusted OR 1.45, 95% CI 1.13-1.86), using a concordant positive response as the reference. No other deprivation quartile was independently associated with a particular response.
People living with HIV from the most materially deprived neighbourhoods had increased odds of poor immunologic or virologic response to combination ART. These results motivate further study of the specific socioeconomic factors that potentially affect response to combination ART among people living with HIV in Canada.
Hepcidin-25 is a peptide hormone involved in iron absorption and homeostasis and found at increased serum levels in conditions involving systemic inflammation, renal dysfunction, and increased ...adiposity. Hepcidin may play a role in the pathogenesis of anemia, but its role in kidney transplantation is undefined.
This study enrolled 100 stable patients beyond 12 months after transplantation, from a large single United Kingdom center. Serum hepcidin-25 level, and relevant demographic and laboratory data pertinent to posttransplantation anemia, were measured and collected. Independent predictors of serum hepcidin were evaluated, and the relationship between hepcidin and hemoglobin, assessed.
Independent associations were seen between higher hepcidin levels and allograft dysfunction (estimated glomerular filtration rate), increased inflammation (high-sensitivity C-reactive peptide), higher transferrin saturation (a marker of iron stores), and the use of marrow-suppressive medication (P<0.05 for all). Higher fat tissue index (whole-body multifrequency bioimpedance measurement) was also associated with higher hepcidin levels, but this relationship did not persist after adjustment for inflammation (high-sensitivity C-reactive peptide). In turn, inflammation was associated with increased fat tissue index (P=0.01) and male gender (P=0.04). A nonlinear association between serum hepcidin level and hemoglobin was seen, with a progressive fall in hemoglobin as hepcidin levels rose to 100 ng/mL, but little effect thereafter (P=0.009). This association was independent of renal dysfunction and female gender, both of which were also independently associated with a lower hemoglobin level.
These results highlight possible mechanisms of hemoglobin reduction in kidney transplantation patients, and the therapeutic opportunities from understanding the role of hepcidin in this context.
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