IMPORTANCE Cancer drugs approved by the US Food and Drug Administration have come under scrutiny for marginal clinical benefits; however, the clinical benefits of cancer drugs recommended for reimbursement in Canada have not been adequately studied.OBJECTIVE To assess the differences in the clinical evidence and benefit of cancer drugs that received a positive vs a negative recommendation for provincial reimbursement in Canada. DESIGN, SETTING, AND PARTICIPANTSThis cohort study obtained publicly available regulatory documents from the pan-Canadian Oncology Drug Review (pCODR) and corresponding clinical trial documentation. All cancer drugs with a solid tumor indication that were submitted from the inception of the pCODR (July 2011) to February 2020 were evaluated. To be included, submissions had to have a final reimbursement recommendation; submissions that were incomplete, were withdrawn, or had a pending decision were excluded. EXPOSURES A completed reimbursement recommendation decision from the pCODR. MAIN OUTCOMES AND MEASURES Final reimbursement recommendation (positive vs negative); trial characteristics; and relevant clinical outcomes (ie, overall survival [OS] and progression-free survival [PFS]), including the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scores available at the time of pCODR assessment.RESULTS Between 2011 and 2020, the pCODR issued 104 reimbursement recommendation decisions for cancer drugs with a solid tumor indication. Among these drug submissions, 78 (75.0%) received a positive recommendation, of which 72 (92.3%) were conditional. Drugs that received a positive recommendation compared with those with a negative recommendation were more likely to have phase 3 randomized clinical trial design (92.3% [72 of 78] vs 53.8% [14 of 26]; P < .001) and have substantial benefit according to the ESMO-MCBS scores (61.5% [48 of 78] vs 19.2% [5 of 26]; P < .001). The most common primary end points associated with the successful submissions were PFS (53.9%) and OS (32.1%). Overall, 39 of 78 submissions (50.0%) that received a positive recommendation had shown OS benefit, with median (interquartile range) OS gains of 3.7 (2.7-6.5) months.CONCLUSIONS AND RELEVANCE This cohort study found that, although the pCODR takes into account the magnitude of clinical benefit, only half of the cancer drugs that received a positive recommendation had evidence of improved OS and the survival gains were usually modest. These results suggest that, although the pCODR helps filter out some cancer drugs with low quality of evidence and low magnitude of benefit, cancer drugs without meaningful patient benefit continue to enter the Canadian market; these findings are important for making reimbursement policy decisions globally.

PURPOSE: Many oncologists have relationships with industry. Previous work has shown that these payments are usually modest; however, there exist a subset of medical oncologists who receive more than $100,000 US dollars (USD) annually. Here, we describe the characteristics of these physicians. METHODS: This retrospective cohort study used the Open Payments data set to identify all US-based medical oncologists/hematologists who received $100,000+ USD in general payments linked to cancer medications in 2018. Open Payments and a web-based search were used to identify physician characteristics, demographics, research profile, and leadership positions. RESULTS: One hundred thirty-nine medical oncologists received > $100,000 USD in general payments. The median payment was $154,613 USD, and the total payment was $24.2 million USD. These high-payment physicians represent 1% of all US medical oncologists (N = 10,620) yet account for 37% of all industry payments in 2018. Sixty percent (84 of 139) and 21% (29 of 139) of these high-payment physicians hold hospital and specialty association leadership roles, respectively. One quarter (24%, 33 of 139) serve on journal editorial boards, and 10% (14 of 139) have authored clinical practice guidelines; 72% (100 of 139) hold faculty appointments. CONCLUSION: A small number of medical oncologists receive very high payments from the pharmaceutical industry. These physicians hold major leadership roles within oncology. Further work is needed to understand the extent to which these conflicts of interest may shape clinical practice and policy.

BACKGROUND: Over the past 2 decades there has been a substantial increase in the number of new cancer medicines; this has been accompanied by a dramatic rise in drug costs. It is unknown how these trends impact the revenue of the pharmaceutical sector. METHODS: Retrospective cohort study to characterize temporal trends of revenue generated from cancer medicines as a proportion of total drug revenue among 10 large pharmaceutical companies from 2010 to 2019. Itemized product-sales data publicly available through company websites or annual filings were used to identify annual drug revenue. Revenue data were adjusted for inflation and converted to 2019 US dollars. RESULTS: During the study period, cumulative annual revenue generated from cancer drugs

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6505 Background: In the past decade there has been a 70% increase in the number of clinical trials for cancer drugs. During this time, there has also been a substantial increase in the price of cancer drugs. It is unclear how these trends have changed the revenue landscape of major pharmaceutical companies. In this study we characterize temporal trends in cancer drug revenue relative to non-cancer drugs. Methods: This retrospective cohort study used publicly available global sales data from the 10 pharmaceutical companies with the highest annual revenue in 2019; Abbvie (AB), AstraZeneca (AZ), Bristol Myers Squibb (BMS), GlaxoSmithKline (GSK), Johnson & Johnson (JJ), Merck (M), Novartis (N), Pfizer (P), Roche (R) and Sanofi (S). We quantified the contribution of cancer drugs to net revenue for each company from 2010 – 2019 using consolidated annual financial reports (i.e. 10-K or 20-F forms). Cancer drugs were defined as those with an FDA-approved indication for anti-cancer effect or supportive care. All sales data were converted to USD and adjusted for global inflation. Trends in the percentage of company revenues accounted for by cancer drugs were assessed with the Kendall-Mann test. P-values were adjusted for multiple hypothesis testing using the Benjamini-Hochberg method. Results: During 2010-2019, cumulative annual revenue generated from cancer drugs in our cohort of companies (n = 10) increased by 96%, from $52.8 billion to $103.5 billion. The cumulative revenue from non-oncology drugs decreased by 19%, from $342.5 billion to $276.9 billion. The proportion of total revenue generated from cancer drugs grew over time; from 13% in 2010 to 27% in 2019 (p < 0.001). During 2015-2019, annual revenue for the study cohort grew by 12%: from $339.7 billion to $380.4 billion. During this period non-oncology revenues remained stagnant (mean $278.9 billion, range 276.9 – 281.9), while oncology revenues grew by 66%; from $61.4 billion to $103.5 billion. Six companies (AB, AZ, BMS, JJ, N, and P) saw substantial increases in the proportion of revenue attributable to cancer drugs. R had both the highest net revenue ($23.9 billion), and highest proportion of revenue (57%) from cancer drugs in 2010 among the cohort, similar to 2019 ($27.7 billion, 57%; p = 0.37). While not reaching significance over the total study period, M saw increases in oncology revenue from $1.5 billion in 2015 to $12.3 billion in 2019 (4% to 30% of total revenue); driven almost exclusively by sales of Pembrolizumab. Conclusions: Amongst the world’s largest pharmaceutical companies, sales revenue from cancer drugs have increased by 96% over the past decade, while revenues from non-cancer drugs have decreased by 19%. Revenues from cancer drugs accounted for 27% of company revenues in 2019. Further work is needed to understand if this massive increase in sales revenues has translated into proportional improvements in patient and population outcomes.