pCODR Reimbursement Decision
|Manufacturer||Bristol-Myers Squibb Canada|
|pCODR Indication||Advanced Melanoma|
|pCODR Tumour Type||Melanoma|
|Funding Request||Treatment of advanced melanoma (unresectable Stage III and IV melanoma) in patients who have received prior systemic therapy.|
|Submission Type||New Drug|
|Review Status||Notification to Implement Issued|
|Notification to Implement Date||2012-05-02|
|RD Interpretation of pERC Recommendation||Recommended - conditional on improved cost-effectiveness.|
The pCODR pERC recommends funding ipilimumab (Yervoy) conditional on the cost-effectiveness of ipilimumab being improved to an acceptable level. To be eligible for treatment, patients should have received at least one prior systemic treatment for unresectable stage III or IV melanoma and have good performance status (ECOG ≤ 1). Ipilimumab should be given at a dosage of 3 mg/kg every three weeks for four doses. At the time of disease progression, reinduction may be considered if patients have had stable disease for at least three months duration or have previously experienced a complete or partial response to ipilimumab. The Committee made this recommendation because it was satisfied that there is a net clinical benefit with ipilimumab treatment in this group of patients based on an overall survival advantage compared with no ipilimumab therapy. However, the Committee noted that, at the submitted price and best estimates of the incremental cost-effectiveness ratio, ipilimumab could not be considered cost-effective compared with dacarbazine or other therapies commonly used to treat metastatic melanoma.
Patients with unresectable advanced melanoma (stage III or stage IV disease) who have previously received at least one prior systemic therapy and have a good performance status (ECOG <= 1).
|RD Interpretation of Patient Population Requested vs Actual||
|Summary of pERC Deliberations - Clinical||
pERC discussed the design and results of the Hodi 2010 study and determined that there are net clinical benefits associated with ipilimumab. Overall, the results reported in Hodi 2010 demonstrated a clinically meaningful benefit across multiple relative and absolute measures including hazard ratios for overall survival, median survival time and the proportion of patients surviving at one year and two years. The Hodi 2010 study only included patients with HLA-A*0201 positive melanoma since the gp100 vaccine is specifically designed to target this patient population due to its biologic mechanism. However, pERC agreed that ipilimumab therapy should not be restricted to HLA-A*0201 positive patients after reviewing evidence in previously untreated patients demonstrating that, ipilimumab is effective in both HLA-A*0201 positive and HLA-A*0201 negative patients (Robert 2011).
|Summary of pERC Deliberations - Safety||
pERC also discussed the toxicity profile of ipilimumab as reported in the Hodi 2010 trial. The Committee noted there are serious immune-related side effects associated with ipilimumab but these adverse events are manageable by specialists with the support of other therapies directed at these symptoms and close patient monitoring of adverse events. pERC considered that patients receiving ipilimumab should be managed in specialized cancer treatment centres with the medical expertise required to manage these side effects. However, it was noted that this could impact the feasibility of implementing ipilimumab treatment, and therefore a funding recommendation, as there would likely be additional costs associated with patient management and for adverse event monitoring.
|Summary of pERC Deliberations - Cost-effectiveness||
pERC discussed the cost-effectiveness of ipilimumab at 3 mg/kg in previously treated patients. It was concluded that ipilimumab is not cost-effective using either the EGP's best estimates or the manufacturer's estimates. pERC considered that the price of ipilimumab would need to be reduced substantially in order for it to be considered cost-effective. pERC also discussed the EGP's best estimates of ipilimumab's cost-effectiveness, which were higher than the manufacturer's estimates, primarily due to differences in the time horizon assumed in the economic model. pERC expressed concern that the manufacturer would not publicly disclose the time horizon that was used in the manufacturer's economic model and this information was redacted from the economic guidance report provided to pERC. As a result, pERC considered it challenging to interpret the cost-effectiveness evidence provided by the manufacturer. pERC noted that the time horizon used in the EGP's best estimates was five years and that the EGP indicated this was shorter than the time horizon used by the manufacturer. pERC reviewed the overall survival data from Hodi 2010 and some considered that a time horizon somewhere between five and ten years could be appropriate.
|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.