Comparing Manufacturer Submitted and Pan-Canadian Oncology Drug Review Reanalysed Incremental Cost-Effectiveness Ratios for Novel Oncology Drugs


Abstract

Background: To determine the magnitude of difference between manufacturer-submitted and pan-Canadian Oncology Drug Review (pCODR) calculated incremental cost-effectiveness ratios (ICERs), incremental cost (ΔC), and incremental effectiveness (ΔE); to examine whether there is a significant difference in the proportion of ICERs deemed cost-effective; to evaluate trends in the ICERs over time; and to identify methodological issues in manufacturer-submitted economic models.

Methods: Economic guidance reports for all drug indications submitted from July 2011-November 2018 were extracted from the pCODR database. Cumulative distribution plots were constructed to compare the manufacturer-submitted economic values with both the pCODR lower- and upper-reanalyzed estimates. The proportion of drug reviews considered cost-effective at varying willingness-to-pay (WTP) thresholds by the manufacturer and pCODR were calculated. Manufacturer changes in ICERs over time from 2012 to 2018 were determined. Recurring methodological issues with manufacturer submissions were tallied.

Results: There were 73 unique indications that were included. Manufacturer-submitted ICERs were consistently lower than pCODR estimates for most indications. Manufacturer-submitted ICERs were generally more cost-effective over a range of WTP thresholds. From 2012 to 2018, manufacturer and economic guidance panel (EGP) lower limit reanalyzed ICERs did not change significantly over time. However, EGP upper limit re-analyses did show decreasing cost-effectiveness (increasing ICERs). The two most common issues identified in the manufacturer-submitted models were related to survival time horizon and utility estimates.

Conclusions: Manufacturers tend to overestimate the cost-effectiveness of their therapies when submitting economic models to pCODR. Although certain methodological issues are still common in manufacturer-submitted models, revision rates are high for most issues raised by pCODR.

Keywords: cost-effectiveness models; drug wastage; incremental cost effectiveness ratio (ICER); pan-Canadian Oncology Drug Review (pCODR); time horizon.

Conflict of interest statement

We have read and understood Current Oncology’s policy on disclosing conflicts of interest and declare that we have none.

Figures

Figure 1
Figure 1
Selection of indications. For certain submissions, multiple indications were reported and only the most appropriate indications as per the pan-Canadian Oncology Drug Review (pCODR) Final Clinical Guidance Reports were included in these cases.
Figure 2
Figure 2
Cumulative distribution plots of manufacturer-submitted and economic guidance panel (EGP)-re-analyzed (A) incremental cost-effectiveness ratios (ICERs), (B) incremental cost, and (C) incremental effectiveness for each indication. EGP—economic guidance panel; LL—lower limit; UL—upper limit; ICER—incremental cost-effectiveness ratio; QALY—quality-adjusted life year.
Figure 3
Figure 3
Histogram of differences between EGP-reanalyzed and manufacturer-submitted ICERs. (Top) EGP lower limit - manufacturer-submitted ICERs; (bottom) EGP upper limit - manufacturer submitted ICERs. Positive differences indicate higher EGP re-analyzed ICERs. Excluded ICERs for all three economic models if one economic model deemed the drug as dominant (1) or dominated (1) and did not provide a numerical ICER value. When comparing the EGP upper limit and manufacturer submitted ICERS (B), four indications had differences greater than $500,000/QALY. EGP—economic guidance panel; ICER—incremental cost-effectiveness ratio.
Figure 4
Figure 4
Percentage of cost-effectiveness indications, at varying willingness-to-pay thresholds, based on incremental cost-effectiveness ratios generated from the manufacturer-submitted and EGP-re-analyzed economic models. EGP—economic guidance panel; LL—lower limit; UL—upper limit; ICE—incremental cost-effectiveness ratio; QALY—quality-adjusted life year.
Figure 5
Figure 5
Common methodological issues in manufacturer-submitted economic models identified and revised by the economic guidance panel.
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