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PBAC facing big agenda and tough decisions
Posted 30 June 2017
Spare a thought for the PBAC when it meets next week to consider a July agenda packed with more than 26 major submissions, nine resubmissions, several drugs not yet approved anywhere in the world and a stack of reviews.
One of the toughest decisions is likely to be Vertex's cystic fibrosis treatment Orkambi (lumacaftor/ivacaftor), which the PBAC has twice rejected as too expensive and with questionable efficacy.
Determined to get reimbursement for its strong CF community, Vertex is making a third attempt with what it said could include "creative and practical schemes" to win over the PBAC.
Suggestions included a phase IV trial system whereby Australian patients would get free and immediate access with the government only paying if the trial results were positive.
AbbVie's pan-genotypic HCV combo gelcaprevir/pibrentasvir is yet to be approved in Australia or anywhere else in the world, giving the PBAC no global precedents when it considers the sponsor's application for reimbursement.
Yet with a promise of being effective regardless of genotype, it is an attractive premise for the PBAC despite the HCV market becoming crowded with offerings.
Gilead's HCV combo Epclusa (sofosbuvir/velpatasvir) won a green light in November but has returned with a request the PBAC review a condition that it be treated as interchangeable with other direct-acting antivirals.
Gilead is arguing there are groups of patients "that cannot be treated with all the drugs determined to be interchangeable".
Also challenging will be a decision on Novartis' yet-to-be-approved Kisqali (ribociclib), seeking reimbursement for use in combination with letrozole to treat HR+ and HER2- advanced or metastatic breast cancer in non-premenopausal women.
Fast tracked in the US, Kisqali was FDA-approved in March but is still under consideration in Europe and Australia.
Also before the PBAC is Roche's new lung cancer drug Alecensa (alectinib) for non-small cell lung cancer which was approved by the TGA in March, as well as the company's latest multiple sclerosis treatment Ocrevus (ocrelizumab), which is yet to be listed on the ARTG.
With 26 major submissions and nine resubmissions, the PBAC will have its work cut out getting through the reimbursement and other drug decisions - and that's before it gets to other business.
Also in its papers will be a number of reports from its Drug Utilisation Sub-Committee including on the use of Allergan's Botox (botulinum toxin type A) for migraine and on a number of biologics used to treat Crohn disease; the PBS post-market review of MSD's ezetimibe based products; and vaccine reviews submitted by the Australian Technical Advisory Group on Immunisation.
All in all, it is likely to be a few long days and possibly even late nights for the committee next week.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 30 June 2017
Spare a thought for the PBAC when it meets next week to consider a July agenda packed with more than 26 major submissions, nine resubmissions, several drugs not yet approved anywhere in the world and a stack of reviews.
One of the toughest decisions is likely to be Vertex's cystic fibrosis treatment Orkambi (lumacaftor/ivacaftor), which the PBAC has twice rejected as too expensive and with questionable efficacy.
Determined to get reimbursement for its strong CF community, Vertex is making a third attempt with what it said could include "creative and practical schemes" to win over the PBAC.
Suggestions included a phase IV trial system whereby Australian patients would get free and immediate access with the government only paying if the trial results were positive.
AbbVie's pan-genotypic HCV combo gelcaprevir/pibrentasvir is yet to be approved in Australia or anywhere else in the world, giving the PBAC no global precedents when it considers the sponsor's application for reimbursement.
Yet with a promise of being effective regardless of genotype, it is an attractive premise for the PBAC despite the HCV market becoming crowded with offerings.
Gilead's HCV combo Epclusa (sofosbuvir/velpatasvir) won a green light in November but has returned with a request the PBAC review a condition that it be treated as interchangeable with other direct-acting antivirals.
Gilead is arguing there are groups of patients "that cannot be treated with all the drugs determined to be interchangeable".
Also challenging will be a decision on Novartis' yet-to-be-approved Kisqali (ribociclib), seeking reimbursement for use in combination with letrozole to treat HR+ and HER2- advanced or metastatic breast cancer in non-premenopausal women.
Fast tracked in the US, Kisqali was FDA-approved in March but is still under consideration in Europe and Australia.
Also before the PBAC is Roche's new lung cancer drug Alecensa (alectinib) for non-small cell lung cancer which was approved by the TGA in March, as well as the company's latest multiple sclerosis treatment Ocrevus (ocrelizumab), which is yet to be listed on the ARTG.
With 26 major submissions and nine resubmissions, the PBAC will have its work cut out getting through the reimbursement and other drug decisions - and that's before it gets to other business.
Also in its papers will be a number of reports from its Drug Utilisation Sub-Committee including on the use of Allergan's Botox (botulinum toxin type A) for migraine and on a number of biologics used to treat Crohn disease; the PBS post-market review of MSD's ezetimibe based products; and vaccine reviews submitted by the Australian Technical Advisory Group on Immunisation.
All in all, it is likely to be a few long days and possibly even late nights for the committee next week.
Megan Brodie
megan.brodie@lushmedia.com.au
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