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Papers by Adam Raymakers

Search strategies. This additional file contains a detailed description of the search strategies ... more Search strategies. This additional file contains a detailed description of the search strategies for the individual databases and other resources searched. (DOCX 49Â kb)

Background: Lung cancer incidence is elevated in patients with chronic obstructive pulmonary dise... more Background: Lung cancer incidence is elevated in patients with chronic obstructive pulmonary disease (COPD), often due to smoking, but potentially also resulting from inflammation. COPD patients are also often diagnosed with comorbidities, the most prominent being cardiovascular disease (CVD). Statins, due to the increased prevalence of CVD, and inhaled corticosteroids (ICS), are two commonly prescribed medications for COPD patients that may reduce lung cancer risk. Objective: To evaluate the association between lung cancer risk with ICS and statin use in COPD patients. A priori, the hypothesis of this study was that use of these medications would be associated with a reduction in lung cancer risk. Methods: This study used population-based data for the province of British Columbia to identify a cohort COPD patients. To be included, patients were to have filled three prescriptions for COPD-related medications within a twelve-month period. To evaluate the association between statin and ICS use with lung cancer risk, an array of methods of defining medication exposure were used, including a novel recency-weighed approach. Results: In the analysis evaluating the association between ICS use and lung cancer diagnosis, time-dependent ICS exposure was associated with a 30% reduction in lung cancer risk. The recency-weighted duration of use exposure metric also demonstrated a iii protective effect from ICS exposure (HR: 0.74 (95% CI: 0.66-0.82). This protective effect was consistent over all exposure metrics. Evaluation of the association between statin use and lung cancer risk produced less consistent results. However, the best-fitting model which incorporated the recency-weighted duration of use exposure metric indicated a protective effect from statin exposure (HR: 0.85 (95% CI: 0.77-0.93). Statin exposure in patients 65 or over was protective against lung cancer diagnosis consistently for all exposure metrics. An interaction term between ICS and statin use was also explored, but was not found to be statistically significant. Conclusions: These results suggest that the benefits of ICS and statin use might extend beyond their primary indication. The results also underscore the importance of using appropriate methods for measuring medication exposure in observational studies, particularly those using administrative data. Finally, this work highlights the importance of 'real-world' evidence. iv Lay Summary Chronic obstructive pulmonary disease (COPD) is a debilitating disease that is associated with increased patient morbidity and mortality. The disease is also associated with several comorbidities, with one of the most common being cardiovascular disease (CVD). Patients with COPD face a higher risk of lung cancer, partially due to a history of smoking. However, the evidence also suggests that the increased risk of lung cancer extends beyond what can be attributed to smoking. Patients with COPD are often prescribed inhaled corticosteroids (ICS). Many COPD patients also receive statins, due to the presence, or risk of, CVD. Evidence suggests that ICS and statins might be associated with reduced lung cancer risk, but this evidence is limited in its generalizability. Therefore, this study aims to evaluate whether ICS and statin use in COPD patients is associated with a reduced risk of lung cancer, using data for the province of British Columbia. v Preface This dissertation comprises my research in the evaluation of the association between inhaled corticosteroid and statin use with lung cancer risk in a population-based cohort of chronic obstructive pulmonary disease patients. I was chiefly responsible for all data cleaning and setup, data analysis, compiling, interpretation, and presentation of results.

Current Oncology, 2021

This retrospective cohort study of cancer decedents during 2004–2015 examined end-of-life cancer ... more This retrospective cohort study of cancer decedents during 2004–2015 examined end-of-life cancer care quality indicators (QIs) in the provinces of British Columbia (BC), Ontario, and Nova Scotia (NS). These included: emergency department use, in-patient hospitalization, intensive care unit admissions, physician house calls, home care visits, and death experienced in hospital. Ontario saw the greatest 12-year decrease in in-hospital deaths from 52.8% to 41.1%. Hospitalization rates within 30 days of death decreased in Ontario, increased in NS, and remained the same in BC. Ontario’s usage of aggressive end-of-life measures changed very little, while BC increased their utilization rates. Supportive care use increased in both NS and Ontario. Those who were male or living in a lower income/smaller community (in Ontario) were associated with a decreased likelihood of receiving supportive care. Despite the shift in focus to providing hospice and home care services, approximately 50% of onc...

Radiotherapy and Oncology, 2021

The Journal of Climate Change and Health, 2021

The health impacts of the climate crisis demand that health systems adapt their practices and mit... more The health impacts of the climate crisis demand that health systems adapt their practices and mitigate their carbon emissions. Health services and policy research (HSPR) is crucial for the transformation of these systems. We report on an initiative by HSPR trainees from across Canada to ideate on health systems transformation towards environmental sustainability. We outline how environmental sustainability must be embedded into HSPR. We suggest that this process must include a justice-based approach and that HSPR curricula, conduct, and content must consider the health of people and the planet. Furthermore, these endeavours must be supported by funding opportunities and granting organizations. We then offer ways forward for trainees, and those who support them, to ensure environmental sustainability is embedded within HSPR.

Journal of Cancer Policy, 2021

Current Oncology, 2021

Background: Recent clinical trial results reported that stereotactic radiotherapy (SABR) may impr... more Background: Recent clinical trial results reported that stereotactic radiotherapy (SABR) may improve survival for patients with oligometastatic (OM) cancer. Given that these results come from a phase II trial, there remains considerable uncertainty about this finding, and about the cost-effectiveness of SABR for patients with OM cancer. In this analysis, we estimate the cost-effectiveness of SABR for oligometastatic cancer patients. Methods: A probabilistic time-dependent Markov model was constructed to simulate treatment of oligometastatic cancer patients over five- and ten-year time horizons. The primary data source was the phase II, Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastases (SABR-COMET )trial and supplemented with data from the literature. We estimated the effect of SABR and the standard of care (SoC) using quality-adjusted life-years (QALYs). Costs were measured from a provincial payer perspective (2018 Canadian dollars). Results: In t...

Journal of Cancer Policy, 2021

Journal of Cancer Policy, 2021

Abstract Introduction Several chimeric antigen receptor (CAR-T) T-cell therapies have been approv... more Abstract Introduction Several chimeric antigen receptor (CAR-T) T-cell therapies have been approved for use for haematological malignancies. Despite known safety, access, and cost issues, little is known about how patients and caregivers understand novel treatments such as CAR-T and their associated uncertainties. Methods We gathered data from Reddit, an online public social media site. We performed a keyword search in three relevant subreddit threads: r/cancer, r/lymphoma, r/leukemia. We systematically extracted threads and associated comments and reviewed against our inclusion criteria. Results We identified a total of 186 posts and 87 were included in the qualitative analysis from March 1, 2013, to April 15, 2021. Qualitative content analysis was used to identify themes. Of those excluded, 88 contained discussions of other immunotherapies and 11 were scientific profiles. We identified four themes: 1) navigating uncertainty with community, 2) finding a cure, 3) managing treatment-related uncertainties, and 4) overcoming uncertainties related to access. We found patients experience numerous barriers when seeking access to novel therapeutics, such as CAR-T therapies. Conclusions The perceptions and struggles of patients and their families are relevant for developing technology assessments that are sensitive to patient experiences, as well as to inform policies for equitable resource allocation. Policy summary Our study underscores the importance of balanced decision making between patients and physicians to ensure patients understand the risk and benefits of cancer treatments. Study investigators might evaluate trial participants based on patient demographics to ensure equitable access to studies for individuals in settings where internet access is less common.

Journal of Nuclear Medicine, 2021

Rationale: The objective was to assess the cost-effectiveness of staging positron emission tomogr... more Rationale: The objective was to assess the cost-effectiveness of staging positron emission tomography/computed tomography (PET/CT) in early-stage follicular lymphoma from the Canadian health care system perspective. Methods: The study population was FL patients staged as early-stage using conventional CT imaging and planned for curative-intent radiation therapy (RT). A decision analytic model simulated the management after adding a staging PET/CT vs. using staging CT alone. In the no-PET/CT strategy, all patients proceeded to curative-intent RT as planned. In the PET/CT strategy, PET/CT information could result in an increased RT volume, switching to a non-curative approach, or no change in RT treatment as planned. Subsequent disease course was described using a state-transition cohort model over a 30-year time horizon. Diagnostic characteristics, probabilities, utilities and costs were derived from the literature. Baseline analysis was performed using quality-adjusted life years (QALYs), costs (2019 Canadian dollars, CAD$) and the incremental cost-effectiveness ratio. Deterministic sensitivity analyses were conducted, evaluating net monetary benefit at a willingness-to-pay threshold of 100,000/QALY.Probabilisticsensitivityanalysisusing10,000simulationswasperformed.CostsandQALYswerediscountedatarateof1.5100,000/QALY. Probabilistic sensitivity analysis using 10,000 simulations was performed. Costs and QALYs were discounted at a rate of 1.5%. Results: In the reference case scenario, staging PET/CT was the dominant strategy, resulting in an average lifetime cost saving of 100,000/QALY.Probabilisticsensitivityanalysisusing10,000simulationswasperformed.CostsandQALYswerediscountedatarateof1.53,165 and a gain of 0.32 QALYs. In deterministic sensitivity analyses, the PET/CT strategy remained the preferred strategy for all scenarios supported by available data. In probabilistic sensitivity analysis, the PET/CT strategy was strongly dominant in 77% of simulations (i.e., reduced cost and increased QALYs), and was cost-effective in 89% of simulations (i.e., either cost-saving or with an incremental cost-effectiveness ratio below $100,000/QALY). Conclusion: Our analysis shows that the use of PET/CT to stage early-stage FL patients reduces cost and improves QALYs. Patients with early-stage FL should undergo PET/CT prior to curative-intent RT.

PharmacoEconomics, 2021

Patients and physicians want rapid access to novel cancer therapies, particularly for advanced ca... more Patients and physicians want rapid access to novel cancer therapies, particularly for advanced cancers with poor prognoses. However, many purported novel therapies are associated with considerable uncertainty and are only available at a substantial cost to health systems [1, 2]. In oncology, clinical trials often form the evidence base that informs drug approvals and reimbursement decisions; however, methodological limitations mean these studies introduce a significant amount of uncertainty into decision-making and thus the healthcare system. Further, recent studies have indicated that anticancer drugs enter the clinical space on the basis of early-phase clinical trials, which introduces even more uncertainty because of methodological limitations such as non-randomization and non-comparative designs [3]. Uncertainty associated with clinical trials can be exacerbated by accelerated approval pathways. While these processes are intuitively attractive, the result is that decision makers are often forced to make reimbursement decisions that can have significant implications for a publicly funded health system on the basis of immature evidence. The US FDA, the European Medicines Agency (EMA), and Health Canada (HC) all have pathways to accelerate and facilitate patient access to novel therapies. Research into the Canadian process of providing accelerated approval (with conditions) for promising new therapies has reported that manufacturers often do not adhere to these non-binding conditions [4]. As early-phase clinical trials (i.e., phases I and II) receive more attention concurrently with the use of mechanisms for accelerated approval, there is also a growing scepticism of the benefit of these new cancer drugs [2]. Since the clinical benefit of new therapeutics is rarely reassessed post-approval, this means ineffective drugs might continue in clinical use, incurring opportunity costs because other treatments cannot be funded or researched. In Canada, after receiving HC approval, cancer drugs are evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH), specifically the pan-Canadian Oncology Drug Review (pCODR). The pCODR assesses the value of a new therapy through a deliberative framework that includes clinical evidence, economic evidence, patient input, and adoption feasibility (additional details of this process can be found online: www.cadth .ca/pcodr ). These assessments are typically based on a ‘pivotal’ clinical trial that has demonstrated some measure of clinical benefit, and is almost exclusively driven by manufacturers, who are required to submit supporting clinical and economic evidence. These submissions are evaluated by pCODR and then reviewed by the pCODR expert review committee (pERC). After the review, the pERC provides provincial and territorial decision makers with recommendations for whether the drug should be reimbursed. The objective of this study was to determine the frequency with which early-phase clinical trials are used as the primary source of evidence in the submission for reimbursement to pCODR in Canada. * Adam J. N. Raymakers araymakers@bccrc.ca

BMC Cancer, 2020

Background Treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) is a well-e... more Background Treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) is a well-established therapy for advanced Hodgkin’s lymphoma (HL). However, the recently completed ECHELON-1 trial showed potential net clinical benefit for brentuximab vedotin (BREN+AVD) compared to ABVD as frontline therapy in patients with advanced Hodgkin’s lymphoma. The objective of this analysis is to determine whether, on current evidence, BREN+AVD is cost-effective relative to ABVD as frontline therapy in patients with advanced HL. Methods We constructed a probabilistic Markov model with two arms and six mutually exclusive health states, using six-month cycle lengths, and a 15-year time horizon. Time-dependent transition probabilities were calculated from ‘real-world’ data collected by the BC Cancer’s Centre for Lymphoid Cancer database or from the literature for ABVD. Time-dependent transition probabilities for BREN+AVD were taken from the ECHELON-1 trial. We estimated the incremental cos...

European Respiratory Journal, 2020

The study used population-based administrative data from the province of Quebec, Canada, to evalu... more The study used population-based administrative data from the province of Quebec, Canada, to evaluate the association between inhaled corticosteroid (ICS) exposure and lung cancer risk in patients with COPD. The results of the study indicated that ICS use was not associated with lung cancer risk in this patient population.

Journal of Clinical Oncology, 2018

94 Background: For health technologies, and cancer treatments specifically, economic evaluation i... more 94 Background: For health technologies, and cancer treatments specifically, economic evaluation is often used to assess the value of new treatments. The preferred approach to economic evaluation is often cost-utility analysis (CUA). In CUA, incremental costs and benefits of a new treatment and a standard of care are calculated with benefits quantified using the quality-adjusted life-year (QALY); the QALY attempts to account for the quantity and quality of life (using a utility weight). The utility weight often comes from a generic, preference-based measure of health-related quality of life (HRQoL), such as the 5-dimension EuroQol measure (EQ-5D). Many submissions for reimbursement by manufacturers, and indeed many clinical trials, still do not include HRQoL data which may result in lower quality submissions and thus, sub-optimal decisions. Methods: We reviewed submissions to the pan-Canadian Oncology Drug Review (pCODR), the body charged with making reimbursement recommendations in ...

Healthcare Management Forum, 2019

Expenditure on cancer therapies is rising rapidly in many countries, particularly for cancer drug... more Expenditure on cancer therapies is rising rapidly in many countries, particularly for cancer drugs. In recent years, this has stimulated a global debate among the public, patients, clinicians, decision-makers, and the pharmaceutical industry on value, affordability, and sustainability propositions relating to cancer therapies. In this article, we discuss some recent developments in evidence-based approaches to priority setting and resource allocation in Canadian cancer systems. These developments include new methods for deliberative public engagement, generating and using real-world evidence, multi-criteria decision analysis, and handling uncertainty with evidence for gene therapies.

Health Policy and Technology, 2019

Search strategies. This additional file contains a detailed description of the search strategies ... more Search strategies. This additional file contains a detailed description of the search strategies for the individual databases and other resources searched. (DOCX 49Â kb)

Background: Lung cancer incidence is elevated in patients with chronic obstructive pulmonary dise... more Background: Lung cancer incidence is elevated in patients with chronic obstructive pulmonary disease (COPD), often due to smoking, but potentially also resulting from inflammation. COPD patients are also often diagnosed with comorbidities, the most prominent being cardiovascular disease (CVD). Statins, due to the increased prevalence of CVD, and inhaled corticosteroids (ICS), are two commonly prescribed medications for COPD patients that may reduce lung cancer risk. Objective: To evaluate the association between lung cancer risk with ICS and statin use in COPD patients. A priori, the hypothesis of this study was that use of these medications would be associated with a reduction in lung cancer risk. Methods: This study used population-based data for the province of British Columbia to identify a cohort COPD patients. To be included, patients were to have filled three prescriptions for COPD-related medications within a twelve-month period. To evaluate the association between statin and ICS use with lung cancer risk, an array of methods of defining medication exposure were used, including a novel recency-weighed approach. Results: In the analysis evaluating the association between ICS use and lung cancer diagnosis, time-dependent ICS exposure was associated with a 30% reduction in lung cancer risk. The recency-weighted duration of use exposure metric also demonstrated a iii protective effect from ICS exposure (HR: 0.74 (95% CI: 0.66-0.82). This protective effect was consistent over all exposure metrics. Evaluation of the association between statin use and lung cancer risk produced less consistent results. However, the best-fitting model which incorporated the recency-weighted duration of use exposure metric indicated a protective effect from statin exposure (HR: 0.85 (95% CI: 0.77-0.93). Statin exposure in patients 65 or over was protective against lung cancer diagnosis consistently for all exposure metrics. An interaction term between ICS and statin use was also explored, but was not found to be statistically significant. Conclusions: These results suggest that the benefits of ICS and statin use might extend beyond their primary indication. The results also underscore the importance of using appropriate methods for measuring medication exposure in observational studies, particularly those using administrative data. Finally, this work highlights the importance of 'real-world' evidence. iv Lay Summary Chronic obstructive pulmonary disease (COPD) is a debilitating disease that is associated with increased patient morbidity and mortality. The disease is also associated with several comorbidities, with one of the most common being cardiovascular disease (CVD). Patients with COPD face a higher risk of lung cancer, partially due to a history of smoking. However, the evidence also suggests that the increased risk of lung cancer extends beyond what can be attributed to smoking. Patients with COPD are often prescribed inhaled corticosteroids (ICS). Many COPD patients also receive statins, due to the presence, or risk of, CVD. Evidence suggests that ICS and statins might be associated with reduced lung cancer risk, but this evidence is limited in its generalizability. Therefore, this study aims to evaluate whether ICS and statin use in COPD patients is associated with a reduced risk of lung cancer, using data for the province of British Columbia. v Preface This dissertation comprises my research in the evaluation of the association between inhaled corticosteroid and statin use with lung cancer risk in a population-based cohort of chronic obstructive pulmonary disease patients. I was chiefly responsible for all data cleaning and setup, data analysis, compiling, interpretation, and presentation of results.

Current Oncology, 2021

This retrospective cohort study of cancer decedents during 2004–2015 examined end-of-life cancer ... more This retrospective cohort study of cancer decedents during 2004–2015 examined end-of-life cancer care quality indicators (QIs) in the provinces of British Columbia (BC), Ontario, and Nova Scotia (NS). These included: emergency department use, in-patient hospitalization, intensive care unit admissions, physician house calls, home care visits, and death experienced in hospital. Ontario saw the greatest 12-year decrease in in-hospital deaths from 52.8% to 41.1%. Hospitalization rates within 30 days of death decreased in Ontario, increased in NS, and remained the same in BC. Ontario’s usage of aggressive end-of-life measures changed very little, while BC increased their utilization rates. Supportive care use increased in both NS and Ontario. Those who were male or living in a lower income/smaller community (in Ontario) were associated with a decreased likelihood of receiving supportive care. Despite the shift in focus to providing hospice and home care services, approximately 50% of onc...

Radiotherapy and Oncology, 2021

The Journal of Climate Change and Health, 2021

The health impacts of the climate crisis demand that health systems adapt their practices and mit... more The health impacts of the climate crisis demand that health systems adapt their practices and mitigate their carbon emissions. Health services and policy research (HSPR) is crucial for the transformation of these systems. We report on an initiative by HSPR trainees from across Canada to ideate on health systems transformation towards environmental sustainability. We outline how environmental sustainability must be embedded into HSPR. We suggest that this process must include a justice-based approach and that HSPR curricula, conduct, and content must consider the health of people and the planet. Furthermore, these endeavours must be supported by funding opportunities and granting organizations. We then offer ways forward for trainees, and those who support them, to ensure environmental sustainability is embedded within HSPR.

Journal of Cancer Policy, 2021

Current Oncology, 2021

Background: Recent clinical trial results reported that stereotactic radiotherapy (SABR) may impr... more Background: Recent clinical trial results reported that stereotactic radiotherapy (SABR) may improve survival for patients with oligometastatic (OM) cancer. Given that these results come from a phase II trial, there remains considerable uncertainty about this finding, and about the cost-effectiveness of SABR for patients with OM cancer. In this analysis, we estimate the cost-effectiveness of SABR for oligometastatic cancer patients. Methods: A probabilistic time-dependent Markov model was constructed to simulate treatment of oligometastatic cancer patients over five- and ten-year time horizons. The primary data source was the phase II, Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastases (SABR-COMET )trial and supplemented with data from the literature. We estimated the effect of SABR and the standard of care (SoC) using quality-adjusted life-years (QALYs). Costs were measured from a provincial payer perspective (2018 Canadian dollars). Results: In t...

Journal of Cancer Policy, 2021

Journal of Cancer Policy, 2021

Abstract Introduction Several chimeric antigen receptor (CAR-T) T-cell therapies have been approv... more Abstract Introduction Several chimeric antigen receptor (CAR-T) T-cell therapies have been approved for use for haematological malignancies. Despite known safety, access, and cost issues, little is known about how patients and caregivers understand novel treatments such as CAR-T and their associated uncertainties. Methods We gathered data from Reddit, an online public social media site. We performed a keyword search in three relevant subreddit threads: r/cancer, r/lymphoma, r/leukemia. We systematically extracted threads and associated comments and reviewed against our inclusion criteria. Results We identified a total of 186 posts and 87 were included in the qualitative analysis from March 1, 2013, to April 15, 2021. Qualitative content analysis was used to identify themes. Of those excluded, 88 contained discussions of other immunotherapies and 11 were scientific profiles. We identified four themes: 1) navigating uncertainty with community, 2) finding a cure, 3) managing treatment-related uncertainties, and 4) overcoming uncertainties related to access. We found patients experience numerous barriers when seeking access to novel therapeutics, such as CAR-T therapies. Conclusions The perceptions and struggles of patients and their families are relevant for developing technology assessments that are sensitive to patient experiences, as well as to inform policies for equitable resource allocation. Policy summary Our study underscores the importance of balanced decision making between patients and physicians to ensure patients understand the risk and benefits of cancer treatments. Study investigators might evaluate trial participants based on patient demographics to ensure equitable access to studies for individuals in settings where internet access is less common.

Journal of Nuclear Medicine, 2021

Rationale: The objective was to assess the cost-effectiveness of staging positron emission tomogr... more Rationale: The objective was to assess the cost-effectiveness of staging positron emission tomography/computed tomography (PET/CT) in early-stage follicular lymphoma from the Canadian health care system perspective. Methods: The study population was FL patients staged as early-stage using conventional CT imaging and planned for curative-intent radiation therapy (RT). A decision analytic model simulated the management after adding a staging PET/CT vs. using staging CT alone. In the no-PET/CT strategy, all patients proceeded to curative-intent RT as planned. In the PET/CT strategy, PET/CT information could result in an increased RT volume, switching to a non-curative approach, or no change in RT treatment as planned. Subsequent disease course was described using a state-transition cohort model over a 30-year time horizon. Diagnostic characteristics, probabilities, utilities and costs were derived from the literature. Baseline analysis was performed using quality-adjusted life years (QALYs), costs (2019 Canadian dollars, CAD$) and the incremental cost-effectiveness ratio. Deterministic sensitivity analyses were conducted, evaluating net monetary benefit at a willingness-to-pay threshold of 100,000/QALY.Probabilisticsensitivityanalysisusing10,000simulationswasperformed.CostsandQALYswerediscountedatarateof1.5100,000/QALY. Probabilistic sensitivity analysis using 10,000 simulations was performed. Costs and QALYs were discounted at a rate of 1.5%. Results: In the reference case scenario, staging PET/CT was the dominant strategy, resulting in an average lifetime cost saving of 100,000/QALY.Probabilisticsensitivityanalysisusing10,000simulationswasperformed.CostsandQALYswerediscountedatarateof1.53,165 and a gain of 0.32 QALYs. In deterministic sensitivity analyses, the PET/CT strategy remained the preferred strategy for all scenarios supported by available data. In probabilistic sensitivity analysis, the PET/CT strategy was strongly dominant in 77% of simulations (i.e., reduced cost and increased QALYs), and was cost-effective in 89% of simulations (i.e., either cost-saving or with an incremental cost-effectiveness ratio below $100,000/QALY). Conclusion: Our analysis shows that the use of PET/CT to stage early-stage FL patients reduces cost and improves QALYs. Patients with early-stage FL should undergo PET/CT prior to curative-intent RT.

PharmacoEconomics, 2021

Patients and physicians want rapid access to novel cancer therapies, particularly for advanced ca... more Patients and physicians want rapid access to novel cancer therapies, particularly for advanced cancers with poor prognoses. However, many purported novel therapies are associated with considerable uncertainty and are only available at a substantial cost to health systems [1, 2]. In oncology, clinical trials often form the evidence base that informs drug approvals and reimbursement decisions; however, methodological limitations mean these studies introduce a significant amount of uncertainty into decision-making and thus the healthcare system. Further, recent studies have indicated that anticancer drugs enter the clinical space on the basis of early-phase clinical trials, which introduces even more uncertainty because of methodological limitations such as non-randomization and non-comparative designs [3]. Uncertainty associated with clinical trials can be exacerbated by accelerated approval pathways. While these processes are intuitively attractive, the result is that decision makers are often forced to make reimbursement decisions that can have significant implications for a publicly funded health system on the basis of immature evidence. The US FDA, the European Medicines Agency (EMA), and Health Canada (HC) all have pathways to accelerate and facilitate patient access to novel therapies. Research into the Canadian process of providing accelerated approval (with conditions) for promising new therapies has reported that manufacturers often do not adhere to these non-binding conditions [4]. As early-phase clinical trials (i.e., phases I and II) receive more attention concurrently with the use of mechanisms for accelerated approval, there is also a growing scepticism of the benefit of these new cancer drugs [2]. Since the clinical benefit of new therapeutics is rarely reassessed post-approval, this means ineffective drugs might continue in clinical use, incurring opportunity costs because other treatments cannot be funded or researched. In Canada, after receiving HC approval, cancer drugs are evaluated by the Canadian Agency for Drugs and Technologies in Health (CADTH), specifically the pan-Canadian Oncology Drug Review (pCODR). The pCODR assesses the value of a new therapy through a deliberative framework that includes clinical evidence, economic evidence, patient input, and adoption feasibility (additional details of this process can be found online: www.cadth .ca/pcodr ). These assessments are typically based on a ‘pivotal’ clinical trial that has demonstrated some measure of clinical benefit, and is almost exclusively driven by manufacturers, who are required to submit supporting clinical and economic evidence. These submissions are evaluated by pCODR and then reviewed by the pCODR expert review committee (pERC). After the review, the pERC provides provincial and territorial decision makers with recommendations for whether the drug should be reimbursed. The objective of this study was to determine the frequency with which early-phase clinical trials are used as the primary source of evidence in the submission for reimbursement to pCODR in Canada. * Adam J. N. Raymakers araymakers@bccrc.ca

BMC Cancer, 2020

Background Treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) is a well-e... more Background Treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) is a well-established therapy for advanced Hodgkin’s lymphoma (HL). However, the recently completed ECHELON-1 trial showed potential net clinical benefit for brentuximab vedotin (BREN+AVD) compared to ABVD as frontline therapy in patients with advanced Hodgkin’s lymphoma. The objective of this analysis is to determine whether, on current evidence, BREN+AVD is cost-effective relative to ABVD as frontline therapy in patients with advanced HL. Methods We constructed a probabilistic Markov model with two arms and six mutually exclusive health states, using six-month cycle lengths, and a 15-year time horizon. Time-dependent transition probabilities were calculated from ‘real-world’ data collected by the BC Cancer’s Centre for Lymphoid Cancer database or from the literature for ABVD. Time-dependent transition probabilities for BREN+AVD were taken from the ECHELON-1 trial. We estimated the incremental cos...

European Respiratory Journal, 2020

The study used population-based administrative data from the province of Quebec, Canada, to evalu... more The study used population-based administrative data from the province of Quebec, Canada, to evaluate the association between inhaled corticosteroid (ICS) exposure and lung cancer risk in patients with COPD. The results of the study indicated that ICS use was not associated with lung cancer risk in this patient population.

Journal of Clinical Oncology, 2018

94 Background: For health technologies, and cancer treatments specifically, economic evaluation i... more 94 Background: For health technologies, and cancer treatments specifically, economic evaluation is often used to assess the value of new treatments. The preferred approach to economic evaluation is often cost-utility analysis (CUA). In CUA, incremental costs and benefits of a new treatment and a standard of care are calculated with benefits quantified using the quality-adjusted life-year (QALY); the QALY attempts to account for the quantity and quality of life (using a utility weight). The utility weight often comes from a generic, preference-based measure of health-related quality of life (HRQoL), such as the 5-dimension EuroQol measure (EQ-5D). Many submissions for reimbursement by manufacturers, and indeed many clinical trials, still do not include HRQoL data which may result in lower quality submissions and thus, sub-optimal decisions. Methods: We reviewed submissions to the pan-Canadian Oncology Drug Review (pCODR), the body charged with making reimbursement recommendations in ...

Healthcare Management Forum, 2019

Expenditure on cancer therapies is rising rapidly in many countries, particularly for cancer drug... more Expenditure on cancer therapies is rising rapidly in many countries, particularly for cancer drugs. In recent years, this has stimulated a global debate among the public, patients, clinicians, decision-makers, and the pharmaceutical industry on value, affordability, and sustainability propositions relating to cancer therapies. In this article, we discuss some recent developments in evidence-based approaches to priority setting and resource allocation in Canadian cancer systems. These developments include new methods for deliberative public engagement, generating and using real-world evidence, multi-criteria decision analysis, and handling uncertainty with evidence for gene therapies.

Health Policy and Technology, 2019