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Janssen's Imbruvica scores PBS listing
Posted 9 October 2017
Janssen's cancer drug Imbruvica (ibrutinib) will list on the PBS in December, almost three years after it was approved by the TGA and after five failed attempts at gaining a PBAC recommendation.
Janssen finally scored a positive recommendation in an out-of-session PBAC meeting in March, with the recommendation reportedly delayed due to the sponsor being unable to reduce the projected cost of the drug sufficiently to satisfy the PBAC.
The committee finally recommended it on the basis it be available "only for use as monotherapy in patients who meet certain conditions" in both relapsed or refractory chronic lymphocytic leukaemia (CLL) and relapsed or refractory small lymphocytic leukaemia (SLL).
Imbruvica will be available from December for CLL/SLL patients in whom the disease has progressed despite treatment with standard therapies and who were not suitable for treatment with fludarabine.
Janssen ANZ managing director Bruce Goodwin described the listing as "an important moment in the treatment of chronic lymphocytic leukaemia which we know will be welcomed by doctors, patients and their families".
"The listing of innovative medicines like Imbruvica is an example of the strategic agreement between Medicines Australia and the government at work," Goodwin said. "Minister Hunt is to be congratulated on reaching this agreement which benefits patients and provides stability to the industry."
Goodwin said more than 900 Australians and New Zealanders had been treated with Imbruvica to date through a patient access program commenced by the company in November 2014.
"This was opened to ensure that over the last three years Australian patients who most needed this medicine could receive it until it is was made available on the Pharmaceutical Benefits Scheme," he said.
Janssen is most likely hoping the second-line listing for its first-generation Bruton tyrosine kinase (BTK) inhibitor will open the door for further access, with Imbruvica already going before the PBAC again next month seeking PBS listing in relapsed or refractory mantle cell lymphoma (MCL) as well.
Imbruvica is approved in Australia in second-line MCL, CLL and SLL as well as first line CLL/SLL. It is also approved for Waldenstrom's macroglobulinaemia and has global approvals in marginal zone lymphoma and chronic Graft-versus-host disease.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 9 October 2017
Janssen's cancer drug Imbruvica (ibrutinib) will list on the PBS in December, almost three years after it was approved by the TGA and after five failed attempts at gaining a PBAC recommendation.
Janssen finally scored a positive recommendation in an out-of-session PBAC meeting in March, with the recommendation reportedly delayed due to the sponsor being unable to reduce the projected cost of the drug sufficiently to satisfy the PBAC.
The committee finally recommended it on the basis it be available "only for use as monotherapy in patients who meet certain conditions" in both relapsed or refractory chronic lymphocytic leukaemia (CLL) and relapsed or refractory small lymphocytic leukaemia (SLL).
Imbruvica will be available from December for CLL/SLL patients in whom the disease has progressed despite treatment with standard therapies and who were not suitable for treatment with fludarabine.
Janssen ANZ managing director Bruce Goodwin described the listing as "an important moment in the treatment of chronic lymphocytic leukaemia which we know will be welcomed by doctors, patients and their families".
"The listing of innovative medicines like Imbruvica is an example of the strategic agreement between Medicines Australia and the government at work," Goodwin said. "Minister Hunt is to be congratulated on reaching this agreement which benefits patients and provides stability to the industry."
Goodwin said more than 900 Australians and New Zealanders had been treated with Imbruvica to date through a patient access program commenced by the company in November 2014.
"This was opened to ensure that over the last three years Australian patients who most needed this medicine could receive it until it is was made available on the Pharmaceutical Benefits Scheme," he said.
Janssen is most likely hoping the second-line listing for its first-generation Bruton tyrosine kinase (BTK) inhibitor will open the door for further access, with Imbruvica already going before the PBAC again next month seeking PBS listing in relapsed or refractory mantle cell lymphoma (MCL) as well.
Imbruvica is approved in Australia in second-line MCL, CLL and SLL as well as first line CLL/SLL. It is also approved for Waldenstrom's macroglobulinaemia and has global approvals in marginal zone lymphoma and chronic Graft-versus-host disease.
Megan Brodie
megan.brodie@lushmedia.com.au
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