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Cost killed Janssen drug at PBAC
Posted 8 March 2017
Despite five attempts to secure reimbursement for cancer drug Imbruvica (ibrutinib), Janssen has not been able to reduce the projected cost enough to satisfy the PBAC, the latest document release shows.
Janssen was rejected when it took the drug before the PBAC for the fifth time last November, even though it offered a revised risk sharing agreement and the PBAC agreed the drug was an effective treatment.
As a swag of new cancer drugs went before the November PBAC, Janssen again tried to have Imbruvica recommended for expanded PBS listing as a treatment for certain patients with either chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL).
The Public Summary Document (PSD) released this week showed the PBAC considered the cost-effectiveness of the drug unsatisfactory, especially when compared with the existing combination therapy of Leukeran (chlorambucil) and Mabthera (rituximab).
Originally submitted in July 2015 then again in November that year followed by March, August and November 2016, Imbruvica met with a string of deferrals and rejections due to what the PBAC considered the high overall cost of reimbursing the drug, which was estimated to be more than $100 million over five years.
Janssen returned to the committee time and again with revised risk sharing agreements and economic modelling, reducing the cost to the PBAC but each time remaining above the $100 million over five-years threshold.
The November 2016 submission contained the same risk-sharing agreement as the August 2016 submission but with a percentage adjustment to the overall cost to government, which was not disclosed in the PSD.
"Although the new submission proposed a reduction in the total expenditure caps for ibrutinib compared to the previous submission", the application was once again rejected on the basis of its cost-effectiveness remaining "unacceptably high and uncertain", the PBAC stated.
Despite recognising that Imbruvica was "an effective treatment for CLL and SLL", the PBAC said the economic model did not prove sufficient benefit over the existing Leukaran/MabThera therapy option.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 8 March 2017
Despite five attempts to secure reimbursement for cancer drug Imbruvica (ibrutinib), Janssen has not been able to reduce the projected cost enough to satisfy the PBAC, the latest document release shows.
Janssen was rejected when it took the drug before the PBAC for the fifth time last November, even though it offered a revised risk sharing agreement and the PBAC agreed the drug was an effective treatment.
As a swag of new cancer drugs went before the November PBAC, Janssen again tried to have Imbruvica recommended for expanded PBS listing as a treatment for certain patients with either chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL).
The Public Summary Document (PSD) released this week showed the PBAC considered the cost-effectiveness of the drug unsatisfactory, especially when compared with the existing combination therapy of Leukeran (chlorambucil) and Mabthera (rituximab).
Originally submitted in July 2015 then again in November that year followed by March, August and November 2016, Imbruvica met with a string of deferrals and rejections due to what the PBAC considered the high overall cost of reimbursing the drug, which was estimated to be more than $100 million over five years.
Janssen returned to the committee time and again with revised risk sharing agreements and economic modelling, reducing the cost to the PBAC but each time remaining above the $100 million over five-years threshold.
The November 2016 submission contained the same risk-sharing agreement as the August 2016 submission but with a percentage adjustment to the overall cost to government, which was not disclosed in the PSD.
"Although the new submission proposed a reduction in the total expenditure caps for ibrutinib compared to the previous submission", the application was once again rejected on the basis of its cost-effectiveness remaining "unacceptably high and uncertain", the PBAC stated.
Despite recognising that Imbruvica was "an effective treatment for CLL and SLL", the PBAC said the economic model did not prove sufficient benefit over the existing Leukaran/MabThera therapy option.
Megan Brodie
megan.brodie@lushmedia.com.au
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