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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.

Background There are no randomized control trials (RCTs) comparing gemcitabine and nab-paclitaxel (Gem-Nab) and fluorouracil, folinic acid, irinotecan, oxaliplatin (FOLFIRINOX) for advanced pancreatic cancer (APC). Although it is well known that RCT-based efficacy often does not translate to real-world effectiveness, there is limited literature investigating comparative cost-effectiveness of Gem-Nab vs FOLFIRINOX for APC. We aimed to examine the real-world cost-effectiveness of Gem-Nab vs FOLFIRINOX for APC in Ontario, Canada. Methods This study compared patients treated with first-line Gem-Nab or FOLFIRINOX for APC in Ontario from April 2015 to March 2019. Patients were linked to administrative databases. Using propensity scores and a stabilizing weights method, an inverse probability of treatment weighted cohort was developed. Mean survival and total costs were calculated over a 5-year time horizon, adjusted for censoring, and discounted at 1.5%. Incremental cost-effectiveness ratio and net monetary benefit were computed to estimate cost-effectiveness from the public health-care payer’s perspective. Sensitivity analysis was conducted using the propensity score matching method. Results A total of 1988 patients were identified (Gem-Nab: n = 928; FOLFIRINOX: n = 1060). Mean survival was lower for patients in the Gem-Nab than the FOLFIRINOX group (0.98 vs 1.26 life-years; incremental effectiveness = −0.28 life-years [95% confidence interval = −0.47 to −0.13]). Patients in the Gem-Nab group incurred greater mean 5-year total costs (Gem-Nab: $103 884; FOLFIRINOX: $101 518). Key cost contributors include ambulatory cancer care, acute inpatient hospitalization, and systemic therapy drug acquisition. Gem-Nab was dominated by FOLFIRINOX, as it was less effective and more costly. Results from the sensitivity analysis were similar. Conclusions Gem-Nab is likely more costly and less effective than FOLFIRINOX and therefore not considered cost-effective at commonly accepted willingness-to-pay thresholds.

ObjectivesThe pan-Canadian Oncology Drug Review (pCODR) evaluates new cancer drugs for public funding recommendations. While pCODR's deliberative framework evaluates overall clinical benefit and includes considerations for exceptional circumstances, rarity of indication is not explicitly addressed. Given the high unmet need that typically accompanies these indications, we explored the impact of rarity on oncology HTA recommendations and funding decisions.MethodsWe examined pCODR submissions with final recommendations from 2012 to 2017. Incidence rates were calculated using pCODR recommendation reports and statistics from the Canadian Cancer Society. Indications were classified as rare if the incidence rate was lower than 1/100,000 diagnoses, a definition referenced by the Canadian Agency for Drugs and Technologies in Health. Each pCODR final report was examined for the funding recommendation/justification, level of supporting evidence (presence of a randomized control trial [RCT]), and time to funding (if applicable).ResultsOf the ninety-six pCODR reviews examined, 16.6 percent were classified as rare indications per above criteria. While the frequency of positive funding recommendations were similar between rare and nonrare indication (78.6 vs. 75 percent), rare indications were less likely to be presented with evidence from RCT (50 vs. 90 percent). The average time to funding did not differ significantly across provinces.ConclusionRare indications appear to be associated with weaker clinical evidence. There appears to be no association between rarity, positive funding recommendations, and time to funding. Further work will evaluate factors associated with positive recommendations and the real-world utilization of funded treatments for rare indications.

Background Although increasing evidence has suggested that an efficacy-effectiveness gap exists between clinical trial (CT) and real-world evidence (RWE), to the authors' knowledge, the magnitude of this difference remains undercharacterized. The objective of the current study was to quantify the magnitude of survival and toxicity differences between CT and RWE for contemporary cancer systemic therapies. Methods Patients receiving cancer therapies funded under Cancer Care Ontario's New Drug Funding Program (NDFP) were identified. Landmark CTs with data regarding survival and adverse events (AEs) for each drug indication were identified. RWE for survival and hospitalization rates during treatment were ascertained through Canadian population-based databases. The efficacy-effectiveness gap for each drug indication was calculated as the difference between RWE and CT data for median overall survival (OS), 1-year OS, and generated hazard ratios (HRs) with 95% CIs from Kaplan-Meier OS curves. Toxicity differences were calculated as the difference between RWE of hospitalization rates and CT serious AE rates. Results Twenty-nine indications from 20 systemic therapies were included. Twenty-eight of 29 indications (97%) demonstrated worse survival in RWE, with a median OS difference of 5.2 months (interquartile range, 3.0-12.1 months). Lower effectiveness in RWE also was demonstrated through a meta-analysis of an OS hazard ratio of 1.58 (95% CI, 1.39-1.80). The median difference between RWE for hospitalization rates and CT serious AEs was 14% (95% CI, 9%-22%). Conclusions An efficacy-effectiveness gap exists for contemporary cancer systemic therapies, with a 5.2-month lower median OS observed in RWE compared with CT data. These data supports the use of RWE to better inform real-world decision making regarding the use of cancer systemic therapies.

Background Advanced pancreatic cancer (APC) patients often have substantial symptom burden. In Ontario, patients routinely complete the Edmonton Symptom Assessment Scale (ESAS), which screens for nine symptoms (scale: 0‐10), in cancer clinics. We explored the association between baseline patient‐reported outcomes, via ESAS, and overall survival (OS). Methods Advanced pancreatic cancer patients with ESAS records prior to receiving publicly funded drugs from November 2008 to March 2016 were retrospectively identified from Cancer Care Ontario's administrative databases. We examined three composite ESAS scores: total symptom distress score (TSDS: 9 symptoms), physical symptom score (PHS: 6/9 symptoms), and psychological symptom score (PSS: 2/9 symptoms); Composite scores greater than defined thresholds (TSDS ≥36, PHS ≥24, PSS ≥8) were considered as high symptom burden. Crude OS was assessed using Kaplan‐Meier method. Hazard ratios (HRs) were assessed using multivariable Cox models. Analysis was repeated in a sub‐cohort with Eastern Cooperative Oncology Group (ECOG) status and metastasis. Results We identified 2199 APC patients (mean age 64 years, 55% male) with ESAS records prior to receiving chemotherapy. Crude median survival was 4.5 and 7.3 months for high and low TSDS, respectively. High TSDS was associated with lower OS (HR = 1.47, 95% CI: 1.33, 1.63). In the sub‐cohort (n = 393) with ECOG status and metastasis, high TSDS was also associated with lower OS (HR = 1.34, 95% CI: 1.04, 1.73). Similar trends were observed for PHS and PSS. Conclusions Higher burden of patient‐reported outcome was associated with reduced OS among APC patients. The effect was prominent after adjusting for ECOG status., In a cohort of advanced pancreatic cancer patients, we observed that higher burden of patient‐reported symptoms at baseline is associated with reduced overall survival. The association remained significant after accounting for performance status and type of treatment.

In response to an increase in COVID-19 infection rates in Ontario, several systemic treatment (ST) regimens delivered in the adjuvant setting for breast cancer were temporarily permitted for neoadjuvant-intent to defer nonurgent breast cancer surgical procedures.To examine the use and compare short-term outcomes of neoadjuvant-intent vs adjuvant ST in the COVID-19 era compared with the pre-COVID-19 era.This was a retrospective population-based cohort study in Ontario, Canada. Patients with cancer starting selected ST regimens in the COVID-19 era (March 11, 2020, to September 30, 2020) were compared to those in the pre-COVID-19 era (March 11, 2019, to March 10, 2020). Patients were diagnosed with breast cancer within 6 months of starting systemic therapy.Estimates were calculated for the use of neoadjuvant vs adjuvant ST, the likelihood of receiving a surgical procedure, the rate of emergency department visits, hospital admissions, COVID-19 infections, and all-cause mortality between treatment groups over time.Among a total of 10 920 patients included, 7990 (73.2%) started treatment in the pre-COVID-19 era and 7344 (67.3%) received adjuvant ST; the mean (SD) age was 61.6 (13.1) years. Neoadjuvant-intent ST was more common in the COVID-19 era (1404 of 2930 patients [47.9%]) than the pre-COVID-19 era (2172 of 7990 patients [27.2%]), with an odds ratio of 2.46 (95% CI, 2.26-2.69; P .001). This trend was consistent across a range of ST regimens, but differed according to patient age and geography. The likelihood of receiving surgery following neoadjuvant-intent chemotherapy was similar in the COVID-19 era compared with the pre-COVID-19 era (log-rank P = .06). However, patients with breast cancer receiving neoadjuvant-intent hormonal therapy were significantly more likely to receive surgery in the COVID-19 era (log-rank P .001). After adjustment, there were no significant changes in the rate of emergency department visits over time between patients receiving neoadjuvant ST, adjuvant ST, or ST only during the ST treatment period or postoperative period. Hospital admissions decreased in the COVID-19 era for patients who received neoadjuvant ST compared with adjuvant ST or ST alone (P for interaction = .01 for both) in either setting.In this cohort study, patients were more likely to start neoadjuvant ST in the COVID-19 era, which varied across the province and by indication. There was limited evidence to suggest any substantial impact on short-term outcomes.

Aims To examine the real-world safety of adding bevacizumab to first-line irinotecan-based chemotherapy for patients with metastatic colorectal cancer (mCRC). Materials and methods Patients diagnosed with CRC in three Canadian provinces (Ontario, Saskatchewan and British Columbia) who received publicly funded bevacizumab and/or irinotecan from 2000 to 2016 were identified from cancer registries. Propensity score 1:1 matching (PSM) and inverse probability of treatment weighting (IPTW) were performed to contemporaneous and historical controls, adjusting for baseline demographic and clinical characteristics. Safety end points evaluated during first-line treatment plus 30 days included mortality within 30 days and all-cause-, chemotherapy- and bevacizumab-related hospitalisations. Chemotherapy- and bevacizumab-related visits were defined as hospitalisations for specific conditions commonly associated with chemotherapy (e.g. infections) or bevacizumab (e.g. arteriovenous thromboembolism) using most responsible diagnosis codes. In PSM and IPTW-weighted cohorts, we assessed event frequencies using odds ratios from logistic regressions and event rate ratios using negative binomial regression models. The results from each province and comparison were pooled using random-effects meta-analysis. Results We identified 16 250 mCRC patients who received first-line irinotecan-based treatment. In PSM cohorts, bevacizumab was associated with fewer deaths within 30 days of treatment compared with contemporaneous (pooled odds ratio = 0.62; 95% confidence interval 0.50–0.75) and historical controls (pooled odds ratio = 0.73; 95% confidence interval 0.58–0.93). Hospitalisations were more frequent among patients treated with bevacizumab compared with historical controls but similar to contemporaneous controls. As patients receiving bevacizumab were exposed to a longer average treatment duration, across their full treatment duration, patients receiving bevacizumab had significantly lower rates of hospitalisations (contemporaneous pooled rate ratio = 0.56; 95% confidence interval 0.47–0.67; historical pooled rate ratio = 0.73; 95% confidence interval 0.56–0.95). Similar trends were observed for chemotherapy- and bevacizumab-related hospitalisations and in IPTW-weighted cohorts. Discussion We did not observe any increase in rates of hospitalisation or death within 30 days of treatment among mCRC patients treated with bevacizumab plus chemotherapy versus chemotherapy alone; these findings should be interpreted with caution due to the risk of residual confounding.

PURPOSE: Take-home cancer drugs (THCDs) have become a standard treatment of many cancers. Robust guidelines have been developed for intravenous chemotherapy drugs, but few exist for THCDs with a focus on decentralized models. Hence, Ontario Health (Cancer Care Ontario) established the Oncology Pharmacy Task Force (OPTF) to develop consensus-based recommendations on best practices for THCDs to ensure that patients receive safe, consistent, high-quality care in the community once they leave the cancer center/practice with a prescription. METHODS: The OPTF included 34 members with comprehensive representation. Guidance from leading authorities was extracted through literature review, thematically analyzed, and synthesized to develop 29 recommendations. The consensus process (> 70% agreement) included a three-step modified Delphi method followed by an extensive review process. RESULTS: Sixteen recommendations were developed: training and education for providers (2), drug access (1), prescribing (4), patient and family/caregiver education (3), communication (1), dispensing (3), monitoring for patient adherence and adverse effects (1), and incident reporting (1). CONCLUSION: Through a rigorous methodology, the OPTF derived a robust set of recommendations similar to the ASCO/Oncology Nursing Society and ASCO/National Community Oncology Dispensing Association guidelines, further validating and strengthening the applicability across multiple jurisdictions, including those with decentralized models. Unique aspects in a decentralized model include the need for two pharmacy professionals, with one doing cognitive verification of the script and the other dispensing the medication; moreover, they optimize interprofessional communication between community providers and the cancer center/practice health care team.

Background For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment’s real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW). Results We identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4–8.3) and 4.95 (4.3–6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27–41%), 20.6% (15–27%), and 15.2% (9.6–21%) for ipilimumab and 17.1% (11–23%), 7.1% (2.9–11%), and 4.7% (1.2–8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR = 0.62; 95% CI: 0.49–0.78; p Conclusions This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.

529 Background: Currently, there are no direct randomized control trials (RCTs) comparing gemcitabine and nab-paclitaxel (Gem-Nab) and FOLFIRINOX for advanced pancreatic cancer (APC). Thus, previous model-based cost-effectiveness analyses were based on indirect comparisons of RCT data. While it is well known that RCT-based efficacy does not often translate to real-world effectiveness, there is limited literature investigating the comparative cost-effectiveness of Gem-Nab versus FOLFIRINOX for APC in the real-world. The objective of this study is to examine the real-world cost-effectiveness of Gem-Nab versus FOLFIRINOX in patients with APC in Ontario, Canada. Methods: This population-based retrospective cohort study compared all patients treated with first-line Gem-Nab or FOLFIRINOX for APC with ECOG performance status 0-1 in Ontario from April 2015 to March 2019. Patients were linked to administrative databases to identify key characteristics and costing data. Using propensity scores and a stabilizing weights method, an inverse probability of treatment weighted cohort was developed. Mean survival and total costs were calculated over a 5-year time horizon, adjusted for censoring and discounted at 1.5% (per Canadian guidelines). Incremental cost-effectiveness ratio and net monetary benefit were computed (measured in life-years and quality-adjusted life years) to estimate cost-effectiveness from the public healthcare payer’s perspective. A sensitivity analysis was conducted using the propensity score matching method. Results: 1,988 patients were identified (Gem-Nab: 928, FOLFIRINOX: 1,060). Mean survival was lower for patients in the Gem-Nab group than the FOLFIRINOX group (0.98 versus 1.26 life-years, incremental -0.28 (95% confidence interval -0.47, -0.13)). Patients in the Gem-Nab group also incurred greater mean 5-year total costs (Gem-Nab: $103,884, FOLFIRINOX: $101,518). Key cost contributors include ambulatory cancer care, acute in-patient hospitalization, and systemic therapy drug acquisition. Gem-Nab was dominated by FOLFIRINOX, as it is less effective and more costly. Results from the sensitivity analysis were similar. Conclusions: In routinely treated unselected patients, Gem-Nab is likely more costly and less effective than FOLFIRINOX and therefore, not considered cost-effective at any commonly accepted willingness-to-pay threshold.

Key Points Question Are drug-funding reimbursement decisions associated with uptake of new therapies and survival outcomes for patients with advanced pancreatic cancer? Findings In this population-based cohort study of 5465 patients with advanced pancreatic cancer receiving first-line chemotherapy within a universal health care system, reimbursement decisions were associated with uptake of new treatment options over time. Uptake of both FOLFIRINOX and gemcitabine combined with nab-paclitaxel were associated with improvements in survival for patients with pancreatic cancer. Meaning These findings suggest that drug-funding reimbursement decisions are associated with uptake of new cancer therapies and improvements in survival for patients with advanced pancreatic cancer., This cohort study investigates whether there is an association of sequential drug-funding approvals and overall survival of patients with advanced pancreatic cancer., Importance Gemcitabine-nab-paclitaxel (GEMNAB) and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) both improve survival of patients with advanced pancreatic cancer when compared with single-agent gemcitabine in clinical trials. Objective To describe changes in the survival of patients with advanced pancreatic cancer associated with sequential drug-funding approvals and to determine if there exist distinct patient populations for whom GEMNAB and FOLFIRINOX are associated with survival benefit. Design, Setting, and Participants This population-based, retrospective cohort study examined all incident cases of advanced pancreatic cancer treated with first-line chemotherapy in Ontario, Canada (2008-2018) that were identified from the Cancer Care Ontario (Ontario Health) New Drug Funding Program database. Statistical analysis was performed from October 2020 to January 2021. Exposures First-line chemotherapy for advanced pancreatic cancer. Main Outcomes and Measures The main outcomes were the proportion of patients treated with each chemotherapy regimen over time and overall survival for each regimen. Cox proportional hazards regression models were used to compare overall survival between treatment regimens after adjustment for confounding variables, inverse probability of treatment weighting, and matching. Results From 2008 to 2018, 5465 patients with advanced pancreatic cancer were treated with first-line chemotherapy in Ontario, Canada. The median (range) age of patients was 66.9 (27.8-93.4) years; 2447 (45%) were female; 878 (16%) had prior pancreatic resection, and 328 (6%) had prior adjuvant gemcitabine. During the time period when only gemcitabine and FOLFIRINOX were funded (2011-2015), 49% (929 of 1887) received FOLFIRINOX. When GEMNAB was subsequently funded (2015-2018), 9% (206 of 2347) received gemcitabine, 44% (1034 of 2347) received FOLFIRINOX, and 47% (1107 of 2347) received GEMNAB. The median overall survival increased from 5.6 months (95% CI, 5.1-6.0 months) in 2008 to 2011 to 6.9 months (95% CI, 6.5-7.4 months) in 2011 to 2015 to 7.6 months (95% CI, 7.1-8.0 months) in 2015 to 2018. Patients receiving FOLFIRINOX were younger and healthier than patients receiving GEMNAB. After adjustment and weighting, FOLFIRINOX was associated with better overall survival than GEMNAB (hazard ratio [HR], 0.75 [95% CI, 0.69-0.81]). In analyses comparing patients treated with GEMNAB and gemcitabine, GEMNAB was associated with better overall survival (HR, 0.86 [95% CI, 0.78-0.94]). Conclusions and Relevance This cohort study of patients with advanced pancreatic cancer receiving first-line palliative chemotherapy within a universal health care system found that drug funding decisions were associated with increased uptake of new treatment options over time and improved survival. Both FOLFIRINOX and GEMNAB were associated with survival benefits in distinct patient populations.

In Canada, requests for public reimbursement of cancer drugs are predominately initiated by pharmaceutical manufacturers. Clinician-led submissions provide a mechanism to initiate the drug funding process when industry does not submit a request for funding consideration. Although such requests are resource-intensive to produce, Cancer Care Ontario (cco) has the capacity to facilitate clinician-led submissions. In 2014, cco began developing a cancer drug prioritization framework that allocates resources to systematically address a growing number of clinician-identified funding gaps with clinician-led submissions. Cancer site&ndash, specific drug advisory committees established by cco consist of health care practitioners whose roles include identifying and prioritizing funding gaps. The committees submit their identified gaps to a cross-cancer-site prioritization exercise in which the requests are ranked based on a set of guiding principles derived from health technology assessment. The requests are then sequentially allocated the resources needed to meet submission requirements. Whether the funding gap is of provincial or pan-Canadian relevance determines where the submission is filed for assessment. Since its inception, the cco framework has identified 17 funding gaps in 9 cancer sites. In 4 prioritizations, the framework supported 6 submissions. As of June 2018, the framework had contributed to the eventual funding of more than 9 new drug&ndash, indication pairs, with more awaiting funding consideration. The cco prioritization framework has enabled clinicians to effectively and systematically identify, prioritize, and fill funding gaps not addressed by industry. Ultimately, the framework helps to ensure that patients can access evidence-informed and cost-effective therapies. The framework will continue to evolve as it encounters new challenges, including funding requests for rare indications.

60 Background: Multiple myeloma represents less than 1.5% of new cancer cases in Canada. Currently, the estimated median overall survival is at least 5-6 years, primarily driven by therapeutic advances over the past decade. As treatment protocols routinely use doublet and triplet combinations, there are increasing concerns about the ability of health systems to afford growing costs of treatment. To inform system planning in Ontario, we examined trends in costs and utilization of myeloma drugs funded by Ontario’s New Drug Funding Program (NDFP) and the Ontario Drug Benefit program (ODB). Methods: NDFP primarily funds IV cancer drugs while ODB funds take-home cancer drugs (THCD). Treatment volumes and government costs, including drug costs and pharmacy fees where applicable, were obtained from ODB and NDFP claims data. Based on the available data, trends were examined from the 2010/11 to the second quarter of the 2019/20 fiscal year. Results: A total of 7 myeloma drugs (3-IV cancer drugs, 4-THCD) were examined. Over 9 years (2010/11 - 2018/19), spending on publicly-funded myeloma drugs increased by 303% while treatment volumes increased by 116%. Between 2014/15 and 2018/19, bortezomib spending decreased by 72%, largely due to generic pricing policies, while lenalidomide spending increased by 158%, likely due to new indications. By 2018/19, these 7 drugs accounted for 17% of the total cancer drug costs under Ontario's publicly funded programs. NDFP spending on IV cancer drugs by the second quarter of 2019/20 has surpassed the annual expenditures in 2018/19 due to the addition of daratumumab. Conclusions: Since 2010/11, growth in Ontario's public expenditures on myeloma drugs has outpaced savings from pricing policies and this growth is mainly driven by the high cost of the novel agents.

The association between obesity and survival in non-Hodgkin lymphoma is unclear. Using the Ontario Cancer Registry we conducted a retrospective analysis of incident cases of aggressive-histology B-cell lymphoma treated with a rituximab-containing regimen with curative intent between 2008-2016. 6246 patients were included. On multivariable analysis the rate of all-cause mortality was lower for the overweight body mass index (BMI 25-29.9 kg/m

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services - things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues - issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This article aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

We critically examined long-term cardiovascular (CV) outcomes and overall survival (OS) of breast cancer (BC) patients who had cardiotoxicity during adjuvant trastuzumab treatment requiring discontinuation in a population-based sample. This was a retrospective cohort of early-stage BC patients diagnosed before 2010 and treated with trastuzumab in Ontario. Patients were stratified based on trastuzumab doses received: 1-8, 9-15, ≥16 (therapy completion). Time-dependent multivariable Cox models were used to analyze primary endpoint OS, and the following composite endpoints: hospitalization/emergency room visit for heart failure (HF) or death; non-HF CV (myocardial infarction, stroke) or death; and clinically significant relapse (palliative systemic therapy initiation >90 days after last trastuzumab dose) or death. Of the 3134 women, 6, 10, and 85 % received 1-8, 9-15, and ≥16 doses, respectively. Over 5-year median follow-up, early trastuzumab discontinuation was associated with more HF/death [1-8 doses hazard ratio (HR) 4.0, 95 % confidence interval (CI) 2.7-6.0; 9-15 doses HR 2.97, 95 % CI 2.1-4.3], non-HF/death (1-8 doses HR 4.3, 95 % CI 3.0-6.1; 9-15 doses HR 3.1, 95 % CI 2.2-4.4), clinically significant relapse/death (1-8 doses HR 3.1, 95 % CI 2.2-4.4; 9-15 doses HR 2.4, 95 % CI 1.8-3.3), and importantly lower OS (77, 80, 93 %; P

Evaluate inter-country variability in the reimbursement of publically funded cancer drugs, and identify factors such as cost containment measures that may contribute to variability. As of February 28, 2010, licensed indications for 10 cancer drugs (bevacizumab, bortezomib, cetuximab, erlotinib, imatinib, pemetrexed, rituximab, sorafenib, sunitinib, and trastuzumab) were obtained from the drug registries of 6 licensing authorities corresponding to 13 countries or regions: Australia, Canada (Ontario), England, Finland, France, Italy, Germany, Japan, New Zealand, the Netherlands, Scotland, Sweden, and the United States (Medicare Parts B and D). Number of licensed indications reimbursed by public payers and the use of cost containment measures were obtained by survey of health authorities involved in reimbursement and through public documents. The 48 identified licensed indications varied between agencies (range: 36&ndash, 44 indications). Finland, France, Germany, Sweden, and the United States reimbursed the highest percentage of indications (range: 90%&ndash, 100%). Canada (54%), Australia (46%), Scotland (40%), England (38%), and New Zealand (25%) reimbursed the least. All 5 countries with the lowest rate of reimbursement incorporated a cost-effectiveness analysis into reimbursement decisions and rejected submissions for reimbursement mainly because of lack of cost effectiveness, in New Zealand, lack of cost effectiveness was the second leading cause of rejection after excessive cost. In 9 countries, risk-sharing agreements were used to contain costs. Indications initially not recommended for reimbursement (9 in Australia, 5 in Canada, and 3 in England, New Zealand, and Scotland) were subsequently approved with risk-sharing agreements or special pricing arrangements. Reimbursement of publically funded cancer drugs varies globally. The cause is multifactorial.

205 Background: Advanced pancreatic cancer (APC) patients often have a substantial symptom burden. In Ontario, patients visiting cancer clinics routinely complete the Edmonton Symptom Assessment Scale (ESAS), which screens for 9 symptoms (scale: 0-10). Using ESAS, we explored the association between baseline patient-reported outcomes and overall survival (OS). Methods: APC Patients with ESAS records prior to receiving publicly-funded drugs from November 2008 to March 2016 were identified from Cancer Care Ontario’s New Drug Funding Program and Symptom Management databases. We examined 3 baseline composite ESAS scores: Total Symptom Distress Score (TSDS: all 9 symptoms), Physical Symptom Score (PHS: 6/9 symptoms), and Psychological Symptom Score (PSS: 2/9 symptoms); Composite scores greater than a threshold (defined as number of symptoms in composite score multiplied by clinically relevant score (≥4)) were categorized as High Symptom Burden (TSDS ≥ 36, PHS ≥ 24, PSS ≥ 8). The primary endpoint, OS, was assessed using Kaplan-Meier. Multivariable Cox models were used to adjust for age, gender, income, prior therapies (surgery, adjuvant gemcitabine, radiation), and Charlson's comorbidity. Analysis was repeated in a sub-cohort with identifiable ECOG status and stage. Results: We identified 2,199 APC patients (mean age 64 years, 55% male) with ESAS records prior to receiving gemcitabine (54%), FOLFIRINOX (40%) or gemcitabine/nab-paclitaxel (6%). Crude median survival was 4.5 and 7.3 months for patients with high and low TSDS burden, respectively (HR = 1.50, 95% CI: 1.36, 1.66). After adjustment with multivariable Cox model, high TSDS burden was associated with lower OS (HR = 1.47, 95% CI: 1.33, 1.63). Similar trends were observed for PHS and PSS. When adjusting for both PHS and PSS in a Cox model, only the effect of PHS remained significant. In the sub-cohort (n = 393), high TSDS burden (HR = 1.34, 95% CI: 1.04, 1.73) was associated with lower OS, after adjusting for ECOG and stage. Conclusions: Among APC patients, a higher burden of patient-reported symptoms, via ESAS, at baseline was associated with reduced OS. The effect was prominent for physical symptoms, even after adjusting for treatment, stage and ECOG.

103 Title: Impact Of Novel Chronic Lymphocytic Leukemia Drugs On Public Spending Background: Chronic lymphocytic leukemia (CLL) is a common hematologic malignancy that mainly affects the elderly. Over the past five years, the treatment pathway for CLL has dramatically changed with the emergence of multiple novel agents. In Ontario, Canada, the Ontario Drug Benefit (ODB) program and the New Drug Funding Program (NDFP) primarily provide public coverage for CLL drugs. Given advances in treatment, we evaluated utilization trends for publicly-funded CLL drugs over a five year period (fiscal years 2012/13 to 2016/17). Methods: Drugs with primary CLL indications funded under the two public funding programs (i.e., ODB and NDFP) by 16/17 were included (n = 6). Claims and costs data were obtained from the Institute for Clinical Evaluative Sciences and Cancer Care Ontario‘s datasets. Results: Over five years, expenditures on CLL drugs have increased approximately ten-fold (1000 percent), reaching nearly CAD 43 million (i.e., USD 32.8 million) in 16/17. In the front-line setting, spending on rituximab remained consistent over the five years. Spending on single agent bendamustine decreased with the introduction of obinutuzumab which became the main cost driver by 16/17. In the previously-treated CLL population, ibrutinib has dominated expenditures since it was funded in July 2015. By 16/17, ibrutinib accounted for approximately ninety eight percent of spending in the previously-treated population. Conclusions: In the past five years, public spending on CLL drugs increased rapidly and substantially with the introduction of four novel agents, and may continue to evolve as Canadian provinces consider funding additional indications or newer agents. These findings warrant exploring whether the incremental spending is providing survival benefit or improvement in patients’ quality of life in a real-world setting. Declaration of funding: None

246 Background: Take-home cancer drugs (THCD) have become a standard treatment for many cancers and present opportunities and challenges for patients, providers and administrators. Ontario’s system has been described as two-tiered, with intravenous cancer drugs (IVCD) viewed as more comprehensive, organized, safer, and more patient-centred. Cancer Care Ontario (CCO) is the Ontario government’s principal cancer advisor. In April 2017, CCO established an Oncology Pharmacy Task Force to develop consensus-based recommendations on best practices for THCD to ensure that all patients are receiving consistent high-quality care regardless of the method of delivery of treatment. Methods: The Task Force included 34 members with representation from patient advocacy groups, pharmacy and pharmacist associations, regulatory and standard setting organizations, and subject matter experts. Standards, guidelines and recommendations from leading authorities were extracted by CCO’s Evidence Search and Review Service and synthesized by a core working group to develop 29 statements. The consensus process included a three-step modified Delphi method with two electronic surveys and a face-to-face meeting. Seventy percent agreement was required to include a recommendation. Thereafter, an extensive review process was conducted with relevant CCO programs and committees as well as subject matter experts, stakeholders and standard setting bodies at the local-regional and national levels. Results: Sixteen consensus-based recommendations were developed: training and education for providers (2); drug access (1); prescribing (4); patient, family/caregiver education (3); communication (1); dispensing (3); monitoring for adherence, identification and management of symptoms/adverse effect (1); and incident reporting (1) . This guidance will have most relevance for patients receiving THCD that require routine monitoring and for clinicians involved in delivering systemic treatment, and associated medications. Conclusions: Through the rigorous use of the Delphi technique, the Task Force developed a robust set of recommendations for THCD delivery in Ontario. Further work will be required to understand implementation enablers and barriers

6581Background: Often, when counseling patients on therapy, we utilize CT survival and toxicity data to help inform decision-making. While it is commonly believed CT data, derived from highly selec...

It's the not-so-distant future. A new patient tells you that he's been reading reviews of your pharmacy online. He suffers from a chronic disease and your pharmacy's specialty services were recommended in an article by a local blogger. Later that day, while you're talking with a new mom about the safety of routine immunizations for her children, she references Facebook, YouTube and something she calls “mommy blogs” when discussing concerns over autism and seizure disorders. After work, you're introduced to a local physician at the gym who has just opened a new practice. You ask for her business card, and she replies, “I'm on LinkedIn.” That night, the local news reports the results of a huge research trial. Anticipating phone calls and questions when you get to work tomorrow morning, you wonder where you can quickly find some of the experts' thoughts on this new data. Welcome to Pharmacy 2.0.

327 Background: FOLFIRINOX (FFX), gemcitabine+nab-paclitaxel (GnP) and gemcitabine monotherapy (Gem)) are universally funded as first-line chemotherapy regimens for advanced pancreatic cancer (APC) in Ontario, Canada. However, there is scarce real-world data on factors that may influence choice of chemotherapy regimens in APC. Methods: Patients who received first-line chemotherapy for APC between April 2015-March 2016 in Ontario were identified from CCO’s New Drug Funding Program database and linked to the Ontario Cancer Registry and other provincial databases to ascertain baseline factors. Multinomial logistic regressions were used to examine the associations between the prescribed chemotherapy regimen and baseline factors. Results: 546 patients were identified, with a mean age of 65 and 43.6% female. 9.9% and 9.7% had received adjuvant gemcitabine and radiation treatment respectively. 17.6% had previous pancreatic resection. 68.3% had zero Charlson score and 30.6% had ECOG performance status (PS) of 0. 72.7% had metastatic disease. The majority of the patients received FFX (52.4%) compared to GnP (35.7%) and Gem (11.9%). Age and ECOG PS were strongly associated with choice of chemotherapy regimens. (See Table) Conclusions: In Ontario, increased patient age and worse ECOG PS are strongly associated with choice of Gem compared to GnP and FFX. Previous treatments and stage of disease also impact chemotherapy choice. Understanding how providers choose chemotherapy in APC aids in comprehending our practices. Odds ratio (OR) and p value from multinomial logistic regressions. [Table: see text]

375 Background: FFX has been universally publicly funded in Ontario, Canada, for metastatic pancreatic cancer (mPC) and unresectable locally advanced pancreatic cancer (uLAPC) since 11/2011 and 04/2015, respectively. GnP has been publicly funded for uLAPC and mPC (APC) since 04/2015. We examined the real world comparative effectiveness and safety of implementing funding of FFX and GnP for patients with APC. Methods: Patients with APC who received first-line FFX, GnP, or G from 01/2008-03/2016 were identified in CCO’s New Drug Funding Program database and divided into 3 periods: 01/2008-10/2011 (P1), 11/2011-03/2015 (P2), and 04/2015-03/2016 (P3). Data were linked with the Ontario Cancer Registry and others to ascertain demographics, comorbidities, and outcomes. Matching weights of propensity score to simultaneously compare three periods were generated using multinomial logistic regression. Crude and adjusted survival analyses were conducted to assess overall survival (OS) using Kaplan-Meier and weighted Cox regression methods.Weighted negative binomial models were used to estimate rate ratios (RR) for all-cause hospitalization (H) and ED visits. Results: We identified 3696 patients (1250 in P1, 1891 in P2, 555 in P3) (overall mean age 65, female 46%). In P2, 49% received FFX. In P3, 53% received FFX and 35% received GnP. Median OS was 5.7, 7.0, and 7.5 months for P1, P2, and P3, respectively. Median OS for FFX and GnP in mPC were 8.8 and 5.5 months, respectively. OS was improved in P2 vs. P1 (HR = 0.84, 0.78-0.90) and in P3 vs. P2 (HR = 0.82, 0.73-0.92). ED visits were similar compared P2 vs. P1 (RR=1.02, p = 0.75) and P3 vs. P2 (RR=1.04, p = 0.48), and H was reduced in P2 vs. P1 (RR = 0.86, p = 0.01), but similar in P3 vs. P2 (RR = 0.98, p = 0.78). H for febrile neutropenia (FN) was increased in P2 vs. P1 (RR = 2.18, p = 0.04) but not in P3 vs. P2 (RR = 1.32, p = 0.45). Conclusions: Implementation of universal public funding of FFX for mPC improved OS and reduced the rates H overall, but increased FN-related H. Funding of FFX for uLAPC and GnP for APC improved OS without increased in ER and H.

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services - things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues - issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This article aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

186 Background: Clinical trials (CTs) are a key component of a quality cancer care system. When funding for systemic therapy services in Ontario transitioned in 2014 from a one-time payment for new cases to bundled payments for specific care activities (consultation, therapy, well follow-up, supportive care), a policy was developed to address public funding for systemic therapy in CTs. Methods: Treatment facilities receive funding from the Systemic Treatment-Quality Based Program (ST-QBP) for treatment with evidence-informed regimens inclusive of inexpensive drug, preparation and delivery costs. Under the new CT policy, randomized CTs with a standard of care comparator arm receive funding for all arms of the trial from the ST-QBP for older inexpensive drugs and all treatment administration costs at the band level for the disease type and stage. Non-randomized CTs are funded at the level of best supportive care or other appropriate band level. CT costs over and above the standard of care must be negotiated with industry sponsors. New and expensive drugs in CTs may be funded through separate provincial drug reimbursement programs if used according to publicly approved funding indications. Weekly joint reviews of new CT submissions by staff of the ST-QBP and drug reimbursement programs ensures timely communication to investigators concerning policy alignment and public funding and addresses potential concerns with regard to downstream access to expensive drugs. Results: As of January 29, 2016, 121 CT applications have been assessed (Phase 0 = 1, Phase I = 26, Phase II = 31, Phase III = 39, Phase IV = 1 and Multi-Phase = 23). Almost all CTs are aligned with the new policy and were assessed in a timely fashion. Assessments are posted on Cancer Care Ontario’s website within 1 week of review to allow all Ontario investigators access to this information. Conclusions: A clear CT funding policy and timely reviews support patient and investigator access to new and innovative therapies within an evidence-informed public funding model in Ontario, Canada. [Table: see text]

394 Background: Data regarding the benefits of FFX and GnP in patients (pts) with initially uLAPC is limited. FFX and GnP have been universally publicly funded for first-line uLAPC in Ontario, Canada, since April 2015. The aims of this study are to determine (1) the overall survival (OS) of pts receiving FFX and GnP, (2) the surgical conversion rate of FFX and GnP, and (3) whether resection is associated with better OS in pts with uLAPC in an unselected, real world population. Methods: All pts in Ontario who started first-line FFX, GnP or gemcitabine (G) for uLAPC between April 2015 and March 2016 were identified in Cancer Care Ontario’s New Drug Funding Program database. They were linked to the Ontario Cancer Registry and other population-based databases to ascertain baseline characteristics (age, sex, performance status (PS), locating of tumor, income quintile, and rural residence) and outcomes (pancreatic cancer resection and vital status). Crude and adjusted models of OS were generated using Kaplan-Meier the method and Cox regression. Surgical resection was modelled as a time-dependent variable to examine its association with OS. Results: We identified 147 pts with uLAPC (mean age = 65, 44% female, 31% ECOG PS 0, 61% PS 1, 60% pancreatic head). Ninety (61.2%), 40 (27.2%) and 17 (11.6%) patients were treated with FFX, GnP and G, respectively. With a median follow-up of 7.5 months, median OS was not reached. The 6-month OS rate was 87.8%, 75.1% and 76.4% for FFX, GnP and G, respectively (p = 0.33). Resection occurred in 12 (8.2%) patients, with 10 (11.1%) and 2 (5.0%) treated with FFX and GnP, respectively ( p= 0.34). Surgical resection after initial chemotherapy was not associated with better OS in multivariable analysis (HR 0.26, 95%CI 0.03-1.98, p= 0.19). Conclusions: Pts with uLAPC treated with FFX and GnP appeared to have a reasonable OS in the real world, with > 75% of pts alive at 6 months. Surgical conversion rate in this unselected population appeared to be less than other single institutional studies. The current findings do not appear to show an early surgical benefit, but longer follow-up will be required to assess the potential long-term benefit of surgery.

Background: The late cardiac effect of adjuvant trastuzumab and its potential interaction with anthracycline have not been well-studied on a population level. Methods: In this retrospective population-based cohort study, female breast cancer patients in Ontario, diagnosed between 2003 and 2009, were identified by the Ontario Cancer Registry and linked to administrative databases to ascertain demographics, cardiac risk factors, comorbidities, and use of adjuvant trastuzumab and other chemotherapy. Patients with pre-existing heart failure (HF) were excluded. The main endpoint was new diagnosis of HF. Analyses included KaplanMeier (KM) survival analysis, multivariable piecewise Cox regression, and competing risk and propensity score analyses. All statistical tests were two-sided. Results: Nineteen thousand seventy-four women with breast cancer treated with adjuvant chemotherapy were identified, of whom 3371 (17.7%) also received adjuvant trastuzumab. Anthracycline use was 84.9% overall. After a median followup of 5.9 years, patients treated with trastuzumab and chemotherapy were more likely to develop HF than patients on chemotherapy alone (5-year cumulative incidences of 5.2% vs 2.5%; log-rank P < .001). After adjusting for confounders, adjuvant trastuzumab remained independently associated with incident HF in the first 1.5 years (HR = 5.77, 95% CI = 4.38 to 7.62, P < .001), but not thereafter (HR = 0.87, 95% CI = 0.57 to 1.33, P = .53). Anthracycline use did not increase the risk of HF with trastuzumab synergistically, neither within ( P interaction = .92) nor beyond 1.5 years ( interaction = .23). Conclusion: Adjuvant trastuzumab was associated with increased risk of new incidence of HF in breast cancer survivors during the period of adjuvant treatment but not thereafter. Routine intensive monitoring may not be necessary after completing adjuvant therapy.

Background Current treatment of diffuse-large-B-cell lymphoma (DLBCL) includes rituximab, an expensive drug, combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. Economic models have predicted rituximab plus CHOP (RCHOP) to be a cost-effective alternative to CHOP alone as first-line treatment of DLBCL, but it remains unclear what its real-world costs and cost-effectiveness are in routine clinical practice. Methods We performed a population-based retrospective cohort study from 1997 to 2007, using linked administrative databases in Ontario, Canada, to evaluate the costs and cost-effectiveness of RCHOP compared to CHOP alone. A historical control cohort (n = 1,099) with DLBCL who received CHOP before rituximab approval was hard-matched on age and treatment intensity and then propensity-score matched on sex, comorbidity, and histology to 1,099 RCHOP patients. All costs and outcomes were adjusted for censoring using the inverse probability weighting method. The main outcome measure was incremental cost per life-year gained (LYG). Results Rituximab was associated with a life expectancy increase of 3.2 months over 5 years at an additional cost of $16,298, corresponding to an incremental cost-effectiveness ratio of $61,984 (95% CI $34,087‒$135,890) per LYG. The probability of being cost-effective was 90% if the willingness-to-pay threshold was $100,000/LYG. The cost-effectiveness ratio was most favourable for patients less than 60 years old ($31,800/LYG) but increased to $80,600/LYG for patients 60–79 years old and $110,100/LYG for patients ≥80 years old. We found that post-market survival benefits of rituximab are similar to or lower than those reported in clinical trials, while the costs, incremental costs and cost-effectiveness ratios are higher than in published economic models and differ by age. Conclusions Our results showed that the addition of rituximab to standard CHOP chemotherapy was associated with improvement in survival but at a higher cost, and was potentially cost-effective by standard thresholds for patients

New "social" information and communication technologies such as social media and smartphones are allowing non-experts to access, interpret and generate medical information for their own care and the care of others. Pharmacists may also benefit from increased connectivity, but first there needs to be an understanding of how pharmacists engage with social media. A scoping review methodology was used to describe pharmacist and pharmacy student participation in social media networks and to describe the gaps in research. Three themes that emerged from reviewing social media use in pharmacy education were student engagement, boundaries and e-professionalism. For pharmacists, the themes of liability and professional use were prominent. Few pharmacy leadership organizations are providing guidance on social media but that appears to be changing. As the control of medical knowledge shifts from health professionals to the larger social community, pharmacists need to be present. Social media use and training in undergraduate programs is promising but experienced pharmacists also need to join the conversation.

10093Background: There is little information on cardiovascular (CV) outcomes and survival of breast cancer (BC) pts who had cardiotoxicity during adjuvant trastuzumab (Tmab) treatment requiring dis...

38 Background: One of the challenges facing Ontario relates to managing the rising costs of cancer drug treatments. The annual growth rate of cancer drug spending has increased by 10-20% since 2010, exceeding other therapeutic categories and is expected to continue to grow significantly faster than expenditures in other areas. Paradoxically, the price of a drug seems to have little relation to its demonstrated efficacy ( http://www.asco.org/practice-research/cancer-care-america-2015/focus-cost ). The Cancer Quality Council of Ontario (CQCO) and Cancer Care Ontario (CCO) embarked on a journey to systematically address this challenge. Methods: The CQCO and CCO focused on identifying and reviewing the critical success factors of a sustainable drug reimbursement program with international, pan-Canadian and internal input. Recognizing that drug funding sustainability is a challenge faced by health systems worldwide, the scope of this work was broadened from a provincial focus to one that was relevant across the Canadian context. Results: Ultimately, this work resulted in CQCO providing a core set of recommendations for CCO that may also be relevant to other reimbursement programs, in order to maximize the effectiveness of cancer drug use and support overall system sustainability in a patient-centred way. The recommendations to address drug funding sustainability included: (1) Transparency in drug funding decisions; (2) development of process to incorporate current best evidence to support system sustainability; (3) development of a consistent approach to gathering and analyzing real world evidence (RWE); (4) development of a consistent process for disinvestment and renegotiation of prices with buy-in from public, patients and clinicians; (5) development of a provincial process to maximize harmonization in cancer drug funding coverage decisions; (6) refinement of the algorithm and priority setting for review of drug submissions; and (7) incorporating RWE into funding decisions and downstream re-evaluation. Conclusions: CCO is determining an action plan based on the above recommendations and developing partnerships to support successful implementation to improve sustainability in regards to cancer drug funding.

242 Background: There is uncertainty regarding the optimal systemic treatment for patients with SBA and AA due to the limited available evidence for these uncommon malignancies and conflicting recommendations in existing guidelines. However, on the basis of biologic similarities between SBA, AA and colorectal cancer (CRC), common practice is to use the same systemic therapies as for CRC. We compared the utilization of chemotherapeutic agents for SBA and AA to that of CRC patients in Ontario, Canada. Methods: The provincial tumour registry in Ontario, Canada was used to identify patients diagnosed with SBA, AA or CRC from 2010-2014. Subsequent chemotherapy utilization and costs were captured from single-payer government administrative databases. We studied the use of oxaliplatin, irinotecan, capecitabine, bevacizumab, cetuximab, panitumumab, and raltitrexed, which are funded for CRC treatment. Patients were excluded if they had multiple primary cancer sites, morphology codes inconsistent with adenocarcinomas, or missing identification data. Statistical analyses were used to report and test patterns of utilization and average costs per patient. Results: Our cohort consisted of 30,946 patients over a 5-year period. On average, 160 and 80 patients were diagnosed annually in Ontario with SBA and AA, respectively, together representing less than 4% of the total diagnoses each year. Among SBA and AA patients, 30-40% initiated therapy with the selected systemic therapies, similar to the proportion in CRC. SBA and AA patients were less likely to receive adjuvant oxaliplatin (SBA 9%, AA 13%) compared to CRC (18%) patients, but more likely to use first and second-line oxaliplatin or irinotecan for metastatic disease. Bevacizumab was added to first-line therapy for SBA and AA patients in fewer cases than CRC (SBA 29%, 45% AA, 72% CRC). Third-line EGFR inhibitors panitumumab and cetuximab were used infrequently in all groups ( < 2% of those diagnosed). Average per patient costs were similar across disease sites (p > 0.05). Conclusions: On a population level, SBA and AA patients appear to be managed similarly to CRC patients and at similar cost. Future research will evaluate survival outcomes.

39 Background: Ontario hospitals are reimbursed for IV chemotherapy through Cancer Care Ontario’s (CCO) New Drug Funding Program (NDFP). By 2009, 54 indications (annual budget $195MM) were managed through largely paper based processes. A new web based system (eClaims) was developed focusing on clinic workflow and integration to chemotherapy ordering systems. Interfaces were developed for CCO’s OPIS and commercial systems (HL7v3). eClaims provides users with clinical best practice, pre-approval, immediate adjudication and simple means of tracking outstanding claims. The benefits and challenges are described. Methods: Evaluation used several strategies: debriefs after each deployment; post-go live user surveys and lessons learned workshops. Results: eClaims was deployed in 80 hospitals over two years. At most sites (50/80) treatment data flows from CPOE systems to eClaims in near real time. Over 50% of claims are machine adjudicated. Newly approved indications can be posted within hours. The main learnings during the deployment process were the need to understand and adjust for hospital specific factors and the unique business relationships among clusters of hospitals. Survey responses were received at a 19% response rate. The later deployment groups reported greater satisfaction than earlier adopters with more positive responses in all categories. Workshop key theme was the need to match complex clinical workflows with design/build processes. Secondly, evaluation of historical data before migration is necessary. Conclusions: Introducing an application into complex, varied clinical workflows is difficult. The phased approach to deployment and evaluation worked, allowing for increasingly smooth go lives. Future work revolves around balancing user needs through eClaims modifications vs simplifying clinical processes to make the tool more usable.

46 Background: The delivery of systemic cancer therapy has expanded from primarily intravenous (IV) treatment, delivered in cancer centres, to include significant use of take-home cancer therapies (THCT) (e.g., oral medications). An industry pipeline survey suggests half of new cancer drugs are expect to be THCT. While IV treatments administered in hospitals are publicly funded for Ontario residents, public funding of THCT is dependent on age, socioeconomic status, and other factors. The delivery of these therapies may also take place outside the cancer centre. While the lack of universal funding is cited as a significant barrier to access, the growing use of THCT has introduced other system delivery questions. Cancer Care Ontario recently hosted a “Think Tank” to inform public policy recommendations for system change to enhance the delivery of THCT in the province. Methods: The day was highly interactive with health professionals and patient participants, and was structured around a case study of a patient receiving both IV and THCT. Approaches taken with THCT in other Canadian provinces were examined. Participants used a multi-dimensional framework (safety and quality; reimbursement and distribution; data and information) to develop recommendations across pre-defined “checkpoints” in the patient’s treatment journey. Pre-assigned groupings of participants with common professional/patient backgrounds developed recommendations that were subsequently prioritized by reassigned multidisciplinary groups. Results: Over 80 stakeholders developed and prioritized more than 180 recommendations. Major themes included education, technology levers, and drug access model reform. This advice will inform system planning and next steps in defining opportunities for system change. The majority of participants (84%) felt the event broadened their understanding of THCT delivery issues. Conclusions: The strategic design of the “Think Tank” facilitated the development of robust recommendations for improving the delivery and reimbursement of THCT. These recommendations, along with the lessons learned from other provinces, will provide the foundation for potential policy and system changes to enhance the quality of THCT delivery in Ontario.

9504 Background: The late cardiac effect of adjuvant trastuzumab (T) and its potential interaction with anthracycline in the general population have not been well studied. The purpose of this retrospective population-based cohort study was to determine the long-term risk of heart failure (HF) associated with adjuvant T and chemotherapy, compared to chemotherapy alone. Methods: Female breast cancer patients in Ontario, diagnosed between 2003 and 2009 were identified by the Ontario Cancer Registry and linked to administrative databases to ascertain demographics, cardiac risk factors, comorbidities, and use of adjuvant T and other chemotherapy. Patients with pre-existing HF were excluded. The main endpoint was new diagnosis of HF, obtained using an algorithm of admission and physician claims data. Group differences were assessed by the Kaplan-Meier (KM) method and multivariable piecewise Cox regression. Competing risk analysis using the Fine and Gray method and propensity score matching analysis were perform...

e11569 Background: Less is known about the benefits vs risks of adjuvant H in women with small ( 1cm as the former were largely excluded from random...

192 Background: Chemotherapy drug shortages are common and unpredictable. The causes are multifactorial and the negative effects on patients and practitioners have been well described. In an effort to mitigate the impact of this problem, Cancer Care Ontario (CCO) has developed a coordinated approach to the management of chemotherapy drug shortages. Tactics have included a system level strategy to promote communication through a virtual collaborative workspace for providers to network and share management strategies and inventory, where feasible. Disease site experts have also developed clinical guidance for the management of specific drug shortages which have then supported public funding decisions that enabled the use of substitute chemotherapy agents in a number of instances. Methods: The impact and management of a recent shortage of liposomal doxorubicin (LD), a publically funded drug for patients with platinum refractory ovarian cancer is described for both new chemotherapy starts and for prevalent LD treated cases. Expert clinical guidance supported a funding policy amendment so patients already on treatment could switch to a recognized substitute drug, topotecan (TT). This also became the preferred funded option for new platinum refractory patients. Results: LD was in short supply between August 2011 and December 2012. In the quarter prior to shortage, 83 new platinum refractory patients started on LD and 1 on TT. During that time, the average number of monthly prevalent LD and TT treated cases was 80 and 4 respectively. For the first quarter post shortage, 20 new patients started on LD and 34 patients started on TT. The average monthly prevalent treated cases were 49 and 21 respectively. Funding for the switch from LD to TT was requested in only 7 cases. Therefore, the total number of new and prevalent treated cases on either preferred therapy dropped post LD shortage. This decline worsened with each subsequent quarter and immediately returned to baseline when the shortage resolved. Drug procurement costs were lower during the period of shortage. Conclusions: Drug shortages have a significant impact on patients and providers. Even when appropriate substitutes are available, quality of care may be affected.

128 Background: A recent study suggests that cardiotoxicity from adjuvant trastuzumab (T-mab) is associated with inadequate cardiac monitoring (Ng et al. SABCS 2012). Few studies have examined the impact of centre or physician (MD) case volume (vol) on the quality of care in systemic therapy, including the adequacy of cardiac monitoring during T-mab treatment. Methods: All breast cancer patients treated with adjuvant T-mab in Ontario between 2003-2009 were identified through a provincial drug funding program. Patient demographics, hospitalizations, cardiac risk factors, cardiac imaging, comorbidities, treatment centres and MDs were ascertained. Annual case vol was calculated as the number of patients treated per year with adjuvant T-mab by each MD and centre. Cumulative case vol was calculated as the total number of patients treated with adjuvant T-mab. Centre and MD vol were divided into terciles (T1, T2 and T3) by the year of diagnosis. Inadequate cardiac monitoring was defined as per recent guidelines and per Ng et al. Hierarchical multivariable logistic regression models were constructed to examine factors associated with inadequate cardiac monitoring. Results: Our cohort consisted of 3,777 patients, 214 MDs and 68 centres. Of the total patients, 16.5% were over age 65; 30.3%, 9.4%, and 1.2% had previous diagnoses of hypertension, diabetes, and heart failure (HF), respectively; 24.3% did not receive adequate cardiac monitoring. Inadequate cardiac monitoring was associated with lower cumulative MD vol (T1: 27.9%, T2: 23.3%, T3: 20.8%, p < 0.0001) and lower annual centre vol (T1: 32.5%, T2: 19.7%, T3: 20.7%, p < 0.0001) in univariate analyses, and remained significant after adjusting for age, comorbidities, previous HF, socioeconomic status based on income, rural residence and calendar period. After adjusting for patient clustering at the MD, centre, and regional levels, lower cumulative MD vol (p=0.012), but not annual centre vol, remained a significant predictor for inadequate cardiac monitoring. Conclusions: Our findings suggest improved cardiac monitoring with greater MD experience, supporting the notion of centralization of systemic therapy to high vol MDs to optimize outcomes.

6050 Background: The cost of cancer treatments are rising globally. We examined access to new cancer therapeutics among various countries to identify innovative strategies to increase reimbursement...

11534 Background: Ontario, a province of 13 million, has a single payer system for new IV cancer drugs, the New Drug Funding Program (NDFP) of Cancer Care Ontario. Trastuzumab (T) is an NDFP drug with funding for both adjuvant (adj) and metastatic (met) breast cancer. Each patient (pt) is registered as adj, or met with line of treatment (tx). Adj T is funded for pts who receive adj chemotherapy (chemo) for node+ disease or node-, >1cm. Methods: Pts who received T were identified in the NDFP from 1999–2007. Funding for met disease was from 1999 onwards and for adj tx from 7/2005 (tx allowed for those whose adj chemo ended after 10/2004). For adj T, records of further chemo were identified for pts treated in Integrated Cancer Programs, for whom complete tx information is available, 50% of all adj pts. Results: About 5,300 cases of breast cancer are diagnosed annually in ON. 1,799 patients have received met T since 1999. Initially met tx was 1st, 2nd and 3rd line, including single agent T. Since 2005 tx is m...