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PBAC to reassess PrEP in Dec
Posted 5 October 2017
The PBAC will consider additional economic analyses and utilisation scenarios prepared by the Kirby Institute as Gilead and Alphapharm continue their push to have Truvada and its generic substitute PBS-listed for Australians considered at high risk of contracting HIV.
In response to a request from the PBAC at its July meeting, Gilead and Alphapharm have submitted the additional economic modelling to a special December meeting of the PBAC scheduled specifically to handle an overflow of submissions from November.
The combined submission is one of six on the PBAC's December agenda which chair Professor Andrew Wilson recently told Pharma in Focus was a "one-off" resulting from a bumper 42 major submissions being put forward for November consideration.
"Arrangements were subsequently made for the PBAC to consider these submissions at its special meeting in December 2017," the PBS website says.
"The sponsors of five of the six deferred submissions accepted the opportunity to have their submission evaluated and considered at the December 2017 Special PBAC meeting."
In one of the six submissions, Gilead and Alphapharm continue to push for Truvada (tenofovir disoproxil/emtricitabine), ARTG registered in 2005, and a genericised version to be PBS-listed for HIV pre-exposure prophylaxis (PrEP).
Also on the December agenda is Ipsen's Cabometyx (cabozantinib) making its first appearance on Australia's regulatory scene seeking a second-line PBS-listing in stage IV clear cell variant renal cell carcinoma (RCC) following treatment with a tyrosine kinase inhibitor. FDA-approved for RCC last year, Cabometyx is yet to appear on the ARTG.
GSK's triple combination therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) also makes its first regulatory appearance in Australia with the company seeking PBS-listing in moderate to severe chronic obstructive pulmonary disease (COPD).
Approved in the US last month and recommended for approval in Europe, Trelegy Ellipta is yet to appear on the ARTG and, along with Cabometyx, is being considered under parallel processing.
Rejected by the PBAC in November last year and deferred by the PBAC at its July meeting is Celgene's Istodax (romidepsin) seeking reimbursement in relapsed or refractory peripheral T-Cell lymphoma. Celgene is asking for a Section 100 (Efficient Funding of Chemotherapy) Authority Required PBS listing.
Novartis' Afinitor (everolimus) is also on the agenda looking for PBS reimbursement in refractory seizures associated with tuberous sclerosis complex in combination with other anti-epileptic medications.
The PBAC will also consider a submission from AbbVie for an alternative formulation of Humira (adalimumab) to be added to all its existing PBS subsidised indications. Considered to be an attempt by AbbVie to extend the patent life of its immunology blockbuster, the new formulation is designed to reduce injection site pain and reduce injection volume.
While Wilson says the additional December meeting is an outlier, the Department apportioned at least part of the blame to what it saw as industry misusing the parallel processing system. Two of the six December submissions are for products yet to appear on the ARTG.
MAJOR SUBMISSIONS
Indication
Drug
Sponsor
Submission type
Request
All current subsidised indications of adalimumab on the PBS
ADALIMUMAB, Humira
AbbVie
New listing
To request Authority Required listings for an alternative formulation of adalimumab, for all existing PBS subsidised indications.
Chronic obstructive pulmonary disease (COPD)
FLUTICASONE FUROATE WITH UMECLIDINIUM AND VILANTEROL, Trelegy Ellipta
GSK
New listing
To request an Authority Required (STREAMLINED) listing for the treatment of patients with moderate to severe COPD (FEV
Clear cell variant renal cell carcinoma (RCC)
CABOZANTINIB, Cabometyx
Ipsen
New listing
To request an Authority Required (STREAMLINED) listing for the treatment of Stage IV clear cell variant RCC in patients previously treated with a tyrosine kinase inhibitor (TKI).
Tuberous sclerosis complex
EVEROLIMUS, Afinitor
Novartis
Change to listing
To request an Authority Required listing for the treatment of patients with refractory seizures associated with tuberous sclerosis complex in combination with other anti-epileptic medications.
Relapsed or refractory peripheral T-Cell lymphoma (PTCL)
ROMIDEPSIN, Istodax
Celgene
New listing
Resubmission to request a Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for the treatment of relapsed or refractory PTCL.
Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP)
TENOFOVIR with EMTRICITABINE, Truvada, Tenofovir Disoproxil Emtricitabine Mylan
Gilead, Mylan
Change to listing
To provide the PBAC with additional economic analyses and utilisation scenarios prepared by the Kirby Institute, as requested by the PBAC when it deferred the submissions for PrEP at its July 2017 meeting.
Megan Brodie
megan.brodie@lushmedia.com.au
David Rowley
david.rowley@lushmedia.com.au
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 5 October 2017
The PBAC will consider additional economic analyses and utilisation scenarios prepared by the Kirby Institute as Gilead and Alphapharm continue their push to have Truvada and its generic substitute PBS-listed for Australians considered at high risk of contracting HIV.
In response to a request from the PBAC at its July meeting, Gilead and Alphapharm have submitted the additional economic modelling to a special December meeting of the PBAC scheduled specifically to handle an overflow of submissions from November.
The combined submission is one of six on the PBAC's December agenda which chair Professor Andrew Wilson recently told Pharma in Focus was a "one-off" resulting from a bumper 42 major submissions being put forward for November consideration.
"Arrangements were subsequently made for the PBAC to consider these submissions at its special meeting in December 2017," the PBS website says.
"The sponsors of five of the six deferred submissions accepted the opportunity to have their submission evaluated and considered at the December 2017 Special PBAC meeting."
In one of the six submissions, Gilead and Alphapharm continue to push for Truvada (tenofovir disoproxil/emtricitabine), ARTG registered in 2005, and a genericised version to be PBS-listed for HIV pre-exposure prophylaxis (PrEP).
Also on the December agenda is Ipsen's Cabometyx (cabozantinib) making its first appearance on Australia's regulatory scene seeking a second-line PBS-listing in stage IV clear cell variant renal cell carcinoma (RCC) following treatment with a tyrosine kinase inhibitor. FDA-approved for RCC last year, Cabometyx is yet to appear on the ARTG.
GSK's triple combination therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) also makes its first regulatory appearance in Australia with the company seeking PBS-listing in moderate to severe chronic obstructive pulmonary disease (COPD).
Approved in the US last month and recommended for approval in Europe, Trelegy Ellipta is yet to appear on the ARTG and, along with Cabometyx, is being considered under parallel processing.
Rejected by the PBAC in November last year and deferred by the PBAC at its July meeting is Celgene's Istodax (romidepsin) seeking reimbursement in relapsed or refractory peripheral T-Cell lymphoma. Celgene is asking for a Section 100 (Efficient Funding of Chemotherapy) Authority Required PBS listing.
Novartis' Afinitor (everolimus) is also on the agenda looking for PBS reimbursement in refractory seizures associated with tuberous sclerosis complex in combination with other anti-epileptic medications.
The PBAC will also consider a submission from AbbVie for an alternative formulation of Humira (adalimumab) to be added to all its existing PBS subsidised indications. Considered to be an attempt by AbbVie to extend the patent life of its immunology blockbuster, the new formulation is designed to reduce injection site pain and reduce injection volume.
While Wilson says the additional December meeting is an outlier, the Department apportioned at least part of the blame to what it saw as industry misusing the parallel processing system. Two of the six December submissions are for products yet to appear on the ARTG.
| MAJOR SUBMISSIONS | ||||
| Indication | Drug | Sponsor | Submission type | Request |
| All current subsidised indications of adalimumab on the PBS | ADALIMUMAB, Humira | AbbVie | New listing | To request Authority Required listings for an alternative formulation of adalimumab, for all existing PBS subsidised indications. |
| Chronic obstructive pulmonary disease (COPD) | FLUTICASONE FUROATE WITH UMECLIDINIUM AND VILANTEROL, Trelegy Ellipta | GSK | New listing | To request an Authority Required (STREAMLINED) listing for the treatment of patients with moderate to severe COPD (FEV |
| Clear cell variant renal cell carcinoma (RCC) | CABOZANTINIB, Cabometyx | Ipsen | New listing | To request an Authority Required (STREAMLINED) listing for the treatment of Stage IV clear cell variant RCC in patients previously treated with a tyrosine kinase inhibitor (TKI). |
| Tuberous sclerosis complex | EVEROLIMUS, Afinitor | Novartis | Change to listing | To request an Authority Required listing for the treatment of patients with refractory seizures associated with tuberous sclerosis complex in combination with other anti-epileptic medications. |
| Relapsed or refractory peripheral T-Cell lymphoma (PTCL) | ROMIDEPSIN, Istodax | Celgene | New listing | Resubmission to request a Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for the treatment of relapsed or refractory PTCL. |
| Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) | TENOFOVIR with EMTRICITABINE, Truvada, Tenofovir Disoproxil Emtricitabine Mylan | Gilead, Mylan | Change to listing | To provide the PBAC with additional economic analyses and utilisation scenarios prepared by the Kirby Institute, as requested by the PBAC when it deferred the submissions for PrEP at its July 2017 meeting. |
Megan Brodie
megan.brodie@lushmedia.com.au
David Rowley
david.rowley@lushmedia.com.au
Yajun Ma
yajun.ma@lushmedia.com.au
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