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Where is Pfizer's Ibrance?
Posted 24 May 2018
Pfizer says it is "assessing the detail" of a PBAC recommendation for its breast cancer drug Ibrance after it failed to keep pace with direct competitor Kisqali in gaining PBS listing.
Pfizer initally had the jump on Novartis in the CDK4/6 inhibitor class, with Ibrance hitting the ARTG in May 2017 - five months before Novartis' Kisqali.
Ibrance was initially rejected for reimbursement by the PBAC in March 2017 as Kisqali was in July, putting them neck-and-neck as they appeared before the committee again in November then again in March this year.
The pair were positively recommended in March as being non-inferior to each other but at a reduced cost-effective price and with a financial cap.
However, while Kisqali was a surprise inclusion in the 2018-19 Budget papers, gaining PBS listing from July, Ibrance remains out of sight.
In response to questions from Pharma in Focus, a Pfizer spokesperson said the company "firmly believes that Ibrance is an important treatment option for women and men living with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer".
"We are currently assessing the detail of the PBAC recommendation to determine the way forward for Ibrance in Australia," the spokesperson said.
While the PBAC recommendations for Kisqali and Ibrance are remarkably similar, they are not identical and could provide the key as to why Pfizer is yet to strike a listing agreement.
Both CDK4/6 inhibitors were recommended as initial therapy in combination with either letrozole or anastrozole in the same HR-positive, HER2-negative metastatic breast cancer population but Kisqali is restricted to a postmenopausal population whereas Ibrance is not.
The PBAC did note the "effect on overall survival is unknown" for both drugs, supporting Chair Andrew Wilson's recent comments regarding drugs being approved with "less than the ultimate information".
As a result, the PBAC says if the drugs did not impact overall survival "then the observed gain in progression free survival would be at the expense of a reduced time spent in the post-progression state".
While this meant the modelled cost-effectiveness of the two products was "uncertain" for Ibrance and "highly uncertain" for Kisqali, "the committee considered the cost effectiveness of [Kisqali/Ibrance] could be brought into an acceptable range with a reduced effective price in conjunction with financial caps".
With Pfizer still "assessing the detail" as Novartis prepares to launch, its failure to keep pace with its rival has left industry insiders baffled. It possibly suggests Novartis may have been more willing to accept the restrictions for its therapy than Pfizer was for Ibrance, meaning premenopausal women who may benefit from a CDK4/6 inhibitor will have to continue waiting for reimbursed treatment.
Megan Brodie
Posted 24 May 2018
Pfizer says it is "assessing the detail" of a PBAC recommendation for its breast cancer drug Ibrance after it failed to keep pace with direct competitor Kisqali in gaining PBS listing.
Pfizer initally had the jump on Novartis in the CDK4/6 inhibitor class, with Ibrance hitting the ARTG in May 2017 - five months before Novartis' Kisqali.
Ibrance was initially rejected for reimbursement by the PBAC in March 2017 as Kisqali was in July, putting them neck-and-neck as they appeared before the committee again in November then again in March this year.
The pair were positively recommended in March as being non-inferior to each other but at a reduced cost-effective price and with a financial cap.
However, while Kisqali was a surprise inclusion in the 2018-19 Budget papers, gaining PBS listing from July, Ibrance remains out of sight.
In response to questions from Pharma in Focus, a Pfizer spokesperson said the company "firmly believes that Ibrance is an important treatment option for women and men living with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer".
"We are currently assessing the detail of the PBAC recommendation to determine the way forward for Ibrance in Australia," the spokesperson said.
While the PBAC recommendations for Kisqali and Ibrance are remarkably similar, they are not identical and could provide the key as to why Pfizer is yet to strike a listing agreement.
Both CDK4/6 inhibitors were recommended as initial therapy in combination with either letrozole or anastrozole in the same HR-positive, HER2-negative metastatic breast cancer population but Kisqali is restricted to a postmenopausal population whereas Ibrance is not.
The PBAC did note the "effect on overall survival is unknown" for both drugs, supporting Chair Andrew Wilson's recent comments regarding drugs being approved with "less than the ultimate information".
As a result, the PBAC says if the drugs did not impact overall survival "then the observed gain in progression free survival would be at the expense of a reduced time spent in the post-progression state".
While this meant the modelled cost-effectiveness of the two products was "uncertain" for Ibrance and "highly uncertain" for Kisqali, "the committee considered the cost effectiveness of [Kisqali/Ibrance] could be brought into an acceptable range with a reduced effective price in conjunction with financial caps".
With Pfizer still "assessing the detail" as Novartis prepares to launch, its failure to keep pace with its rival has left industry insiders baffled. It possibly suggests Novartis may have been more willing to accept the restrictions for its therapy than Pfizer was for Ibrance, meaning premenopausal women who may benefit from a CDK4/6 inhibitor will have to continue waiting for reimbursed treatment.
Megan Brodie
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