Determinants of the Cancer Drug Funding Process in Canada

Abstract

Background: Canada has a publicly funded healthcare system with a complex drug funding process. After Health Canada approval to market a drug, the pan-Canadian Oncology Drug Review (pCODR) (now renamed the CADTH reimbursement review) makes a non-binding funding recommendation to the Canadian provinces (except Quebec), which each then decide whether the drug will be publicly funded. We identified the determinants of funding in this process. Methods: We analyzed drugs for advanced lung (n = 15), breast (n = 8), colorectal (CRC) (n = 7), melanoma (n = 10), and neuroendocrine (NET) (n = 3) cancers undergoing the funding decision process from 2011 to 2019. Determinants of funding assessed in the model included list price, cancer type, drug class, and pCODR recommendation. The primary outcome was the correlation between list price and time to funding (TTF: Health Canada approval to first provincial funding). Secondary outcomes included an exploratory analysis of predictors of drug funding. Results: We analyzed 43 drugs: targeted agents 72%, immunotherapy 20%, chemotherapy 7%. A total of 72% were funded in at least one province. Median TTF was 379 days (IQR 203–601). Median list price (28-day course) was CAD 8213 (IQR CAD 5391–9445). Higher list price was not correlated with TTF (correlation coefficient −0.20, p = 0.28). There was no association between list price and pCODR recommendation or the decision to fund in at least one province. A positive pCODR recommendation correlated with the provinces’ funding decisions (p < 0.001), where 89% of drugs with a positive recommendation were funded and 100% of drugs with a negative recommendation were not funded. Tumor type was predictive of TTF (p < 0.001): CRC drugs were the slowest at a median of 2541 days (IQR 702–4379), and NETs were the quickest at a median of 0 days (IQR 0–502). Cancer type predicted decision to fund in at least one province (p = 0.005), with funding for 100% of NET drugs at the high end and 29% of CRC drugs at the low end. Drug class was predictive of TTF (p = 0.01): 465 days (IQR 245–702) for targeted agents, 443 days (IQR 298–587) for chemotherapy, and 339 days (IQR 164–446) for immunotherapy. Conclusions: Determinants of drug funding included cancer type, drug class, and pCODR recommendation but not list price. Factors other than cost were more heavily weighted in the funding decisions of cancer drugs in Canadian provinces.

Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021

“…To investigate the impact of RWE on reimbursement decisions leading to Conditional approvals, CADTH’s critical appraisals of indirect evidence submitted by sponsors (Section 7 of the CADTH review report) on all NOCc products approved between 2019 and 2021 with completed CADTH reviews were descriptively quantified according to a variety of parameters (bias, heterogenicity, inability to adjust known or unknown confounders and other methodology flaws). These parameters were identified previously as having a considerable impact on the validity of the RWE evidence required to support efficacy or safety [ 32 , 33 , 34 , 35 ]. Table 3 and Table S4 list the parameters and provides examples from CADTH appraisals of NOCc products with positive (“reimburse with conditions”) or negative (“do not reimburse”) decisions.…”

“…The accelerated timelines achieved by Health Canada were not mimicked by CADTH as there were no significant differences in review times between oncology drugs with priority, conditional or standard reviews ( Table 2 ). This is not surprising as a previous study that examined CADTH funding between 2011–2020 suggested that, although CADTH did have publicly stated target timelines to provide their recommendations, those targets were met only 50% of the time [ 33 ]. NOCc-approved products are considered to be “higher complexity” reviews by CADTH, so a shorter review time is unlikely [ 21 ].…”

“…A study by Anderson et al [ 36 ] reviewing pCODR decisions on funding of oncology drugs between 2010 and 2017 indicated that conditional authorizations were associated with a recommendation against public funding by CADTH, which is consistent with our findings. Gotfrit et al [ 33 ] while analyzing funding decisions by pCODR on different tumor types, reported that while positive funding decisions differed by tumor type, with the longest for colorectal cancer ( n = 7) and shortest for neuroendocrine tumors ( n = 3) (mean of 2541 days to 0 days), drug cost was not a significant factor for positive funding decisions. Consistent with our findings, the authors commented that the lack of transparent weighting schemes, objective thresholds for assessment and standards required for approval added a high degree of uncertainty to the decision making process.…”

Impact of Systemic Delays for Patient Access to Oncology Drugs on Clinical, Economic, and Quality of Life Outcomes in Canada: A Call to Action

“…These disparities between Canada and other countries are partly attributable to complex, overlapping sequential multi-step regulatory and funding processes involving federal, provincial, and private authorities (Health Canada, PMPRB, HTA organizations (CADTH and INESSS), pCPA, and different provincial and private payers) [ 19 ]. One study investigated the determinants of cancer drug funding decisions and timelines in Canada [ 20 ]. Drugs for advanced lung, breast, colorectal, melanoma, and neuroendocrine cancers undergoing the funding decision process from 2011 to 2019 were analyzed.…”

Access to Cancer Drugs in Canada

“…Gotfrit et al, in their second paper in the issue, highlight factors that are associated with positive provincial listings, concluding that a positive HTA recommendation is crucial, and that cancer type seems to be influential, However, the HTA recommendation does not seem to be influenced by the list price of the drug [ 9 ].…”