pCODR Reimbursement Decision
|Generic Name||Sunitinib Malate|
|Manufacturer||Pfizer Canada Inc.|
|pCODR Indication||Pancreatic Neuroendocrine Tumours|
|pCODR Tumour Type||Gastrointestinal|
|Funding Request||Patients with unresectable locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNETs), whose disease is progressive.|
|Submission Type||New Indication|
|Review Status||Notification to Implement Issued|
|Notification to Implement Date||2012-05-17|
|RD Interpretation of pERC Recommendation||Recommended - conditional on improved cost-effectiveness.|
The pCODR Expert Review Committee (pERC) recommends funding sunitinib malate (Sutent) conditional on the cost-effectiveness of sunitinib being improved to an acceptable level to jurisdictions. Funding should be for the treatment of patients with progressive, unresectable, well-differentiated, locally advanced or metastatic pancreatic neuroendocrine tumours, with Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, until disease progression. The Committee made this recommendation because it was satisfied that there is an overall clinical benefit of sunitinib based on the magnitude of the observed hazard ratio for risk of death and the observed progression-free survival difference between sunitinib and placebo, while noting that sunitinib could not be considered cost-effective at the submitted price and the Economic Guidance Panel's estimates of the range of incremental cost-effectiveness ratios.
Patients with progressive, unresectable, well-differentiated, locally advanced or metastatic pancreatic neuroendocrine tumours, with ECOG status of 0 or 1.
|RD Interpretation of Patient Population Requested vs Actual||
|Summary of pERC Deliberations - Clinical||
pERC discussed the results of Study A6181111 and noted that the trial was stopped upon recommendation from a data safety and monitoring committee due to a greater number of deaths and serious adverse events in the placebo group, as well as a difference in progression-free survival favouring the sunitinib group. Given that the trial was stopped due to the decision of a data safety and monitoring committee, pERC agreed that the early stopping of the trial was appropriate and in patients' best interests, but they also agreed that this likely resulted in an overestimation of the benefit of sunitinib when compared with placebo. It was noted that interpretation of the overall survival results from the trial was challenging because of the early stopping of the trial and the large proportion of patients crossing over from the placebo group to the sunitinib group. pERC further deliberated upon the magnitude of the observed hazard ratio for death and the magnitude of the observed hazard ratio for progression-free survival. The Committee considered that, despite uncertainty in the exact estimates for the risk of death and progression-free survival, the observed magnitude of these effects was clinically meaningful and large enough that the Committee was satisfied that sunitinib is an effective treatment. pERC also noted the stabilization of disease is important to patients and that progression-free survival is one measure of disease stabilization, based on input from one patient advocacy group. pERC also considered that there are no current trials in progress evaluating the effectiveness of sunitinib in pancreatic neuroendocrine tumours to address any remaining uncertainty and that there are unlikely to be further trials specifically addressing this question in the small population of patients with pancreatic neuroendocrine tumours.
|Summary of pERC Deliberations - Safety||
pERC discussed the safety of sunitinib in the context of the grade three and grade four serious adverse events observed in Study A6181111 as well as the most commonly observed adverse events. The Committee considered that both the pCODR Clinical Guidance Panel and input from one patient advocacy group supported that these potential side effects were manageable for clinicians and patients.
|Summary of pERC Deliberations - Cost-effectiveness||
pERC reviewed the results of the manufacturer's submitted economic evaluation and discussed the estimates of cost-effectiveness provided by the pCODR Economic Guidance Panel. It was noted that these estimates were substantially higher than the estimates provided by the manufacturer. The Committee agreed, however, that the assumption underlying the Economic Guidance Panel's estimates, i.e. that the risk of death before tumour progression differs from the risk of death after tumour progression, was more realistic and had more clinical validity than the manufacturer's assumption that the risks are similar.
|Provincial Funding Report:||
pCODR Provincial Funding Summary report
|Final Recommendation Report:||
pCODR-pERC Final Recommendation report
|Final Clinical Guidance Report:||
pCODR Final Clinical Guidance report
|Final Economic Guidance Report:||
pCODR Final Economic Guidance report
†The information referenced on this page is compiled from publicly available documents published by pCODR and is available through the embedded links.