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pCODR Reimbursement Decision




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  Votrient
Generic Name Pazopanib Hydrochloride
Manufacturer GlaxoSmithKline Inc.
pCODR Indication Soft Tissue Sarcoma
pCODR Tumour Type Sarcoma
Funding Request Adult patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Funding is not requested for patients with GIST and adipocytic soft tissue sarcomas.
Submission Date 2012-06-04
Submission Type New Indication
Review Status Notification to Implement Issued
Recommendation Date 2012-11-29
Notification to Implement Date 2012-12-14
RD Interpretation of pERC Recommendation Not recommended - clinical benefit insufficient/unclear and cost-effectiveness insufficient/unclear.
pERC Recommendation

The pCODR Expert Review Committee (pERC) does not recommend funding pazopanib (Votrient) for patients with soft tissue sarcoma. The Committee acknowledged the need for more effective treatments for patients with STS, however, it made this recommendation because, as compared with placebo, pazopanib conferred only a modest preogression-free suvival benefit, no overall survival benefit, no measured improvement in quality of life and was not shown to be cost-effective.

Patient Population

Patients with advanced soft tissue sarcoma (STS).

RD Interpretation of Patient Population Requested vs Actual

Same

Summary of pERC Deliberations - Clinical

pERC deliberated upon the results from the PALETTE study in the context of patient values. Overall survival and quality of life improvements were not observed, although pazopanib, as compared with placebo, provides some clinical benefit for patients in terms of delaying progression. pERC discussed that the magnitude of the absolute benefit in progression-free survival was modest for pazopanib compared with placebo (median 4.6 months versus 1.6 months, respectively). pERC noted that the difference in measured overall survival between pazopanib and placebo was small and not statistically significant. pERC also considered that global quality of life measures were similar between pazopanib and placebo at 12 weeks. pERC further discussed the uncertainty associated with these quality of life results because of the large proportion of patients who had dropped out of PALETTE prior to its measurement at 12 weeks, particularly in the placebo group, which may have biased the results. pERC reconsidered its Initial Recommendation based on feedback from the manufacturer concerning the results of the PALETTE study. While the Committee acknowledged there is a clinical effect of pazopanib, given the modest benefits observed, the absence of a survival benefit or robust quality of life data, and the potential for toxicities, pERC reiterated that it could not conclude that there was an overall net clinical benefit. pERC expressed interest in obtaining more quality of life data but it was noted that the manufacturer had indicated there was no additional quality of life information publicly available on pazopanib for patients with STS.

Summary of pERC Deliberations - Safety

pERC also discussed the side effect profile of pazopanib based on the results of PALETTE and in the context of side effects with other treatments commonly used for patients with STS. It was noted that there may be serious adverse events with all these options, however, pERC considered it challenging to interpret the toxicity profile of pazopanib as it was compared with placebo and not with therapies that may be used in clinical practice.

Summary of pERC Deliberations - Cost-effectiveness

pERC discussed the cost-effectiveness of pazopanib and noted that the high quality of the manufacturer's submitted economic evaluation allowed the pCODR Economic Guidance Panel to have some certainty in the range of estimates provided . However, pERC concluded that pazopanib was not cost-effective based on the range of estimates provided.

Provincial Funding Report: pCODR Provincial Funding Summary Report  pCODR Provincial Funding Summary report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-provfund_votrient-sts.pdf
Final Recommendation Report: pCODR-pERC Final Recommendation report  pCODR-pERC Final Recommendation report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-votrientsts-fn-rec.pdf
Final Clinical Guidance Report: pCODR Final Clinical Guidance Report  pCODR Final Clinical Guidance report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-votrientsts-fn-cgr.pdf
Final Economic Guidance Report: pCODR Final Economic Guidance report  pCODR Final Economic Guidance report
https://www.cadth.ca/sites/default/files/pcodr/pcodr-votrientsts-fn-egr.pdf

†The information referenced on this page is compiled from publicly available documents published by pCODR and is available through the embedded links.


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