FP 50 decision reversed

The Pharmaceutical Benefits Advisory Committee (PBAC) has reversed its decision to recommend tighter prescribing controls on an important preventive asthma medication for children.
 
As first reported by newsGP, restrictions imposed from 1 April have removed GPs’ ability to initiate PBS-subsidised prescriptions of fluticasone propionate 50 mcg (FP 50), leading to health equity concerns related to cost and access.
 
The recommendation sparked a flurry of advocacy, with the RACGP joining other medical organisations, including the National Asthma Council, in protesting the changes. This eventually led the PBAC to revisit its decision at a recent intracycle meeting, where many of the changes were rescinded.
 
GP Dr Tim Senior, a member of Asthma Australia’s Professional Advisory Council, was one of the first to speak out against the restrictions and told newsGP he is pleased that the PBAC has reversed its decision.
 
‘It means GPs will again be able to prescribe the low dose of fluticasone on a streamlined authority, and patients won’t need to see a paediatrician,’ he said.
 
‘The PBAC has taken on feedback from a wide range of professional and patient organisations regarding the unintended consequences of its decision, which had potentially profound implications for the ability of children with asthma to get appropriate management.
 
‘This recognises that GPs are able to manage asthma in young children, and that paediatricians are available for the patients they most need to see.’
 
RACGP President Dr Nicole Higgins also advocated against the change and last month wrote to PBAC Chair Professor Andrew Wilson to explain the likely impact on young patients. She described the reversal as a win for Australian families at a time of high cost of living pressures.
 
‘The original changes were bad news in terms of equity of access, particularly since fluticasone propionate is the mainstay of asthma management for children and teenagers,’ she said.
 
‘It was particularly disadvantageous to rural and regional patients who struggle to access non-GP specialist care at the best of times.
 
‘There were also additional costs to the broader health system in terms of unnecessary consultations with paediatric respiratory physicians and paediatricians. The RACGP is unaware of any inappropriate prescribing of fluticasone propionate in young children, so the clinical need for this change was always unclear and that is why we pushed back so strongly against it.’
 
The PBAC has said its original recommendation came about following a request for advice on clinical alternatives to FP 50 after the medication’s sponsor, GlaxoSmithKline (GSK) Australia, sought Ministerial Discretion to avoid a 20.83% drop in the approved ex-manufacturer price (AEMP).
 
The reduction, due to come into effect from April as part of standard catchup statutory price reductions, would have seen the AEMP for FP 50 drop from $6.89 to $5.45.
 
In response, the PBAC proposed beclomethasone and budesonide as relevant alternative therapies that would remain available under the existing conditions and recommended that restrictions be placed on FP 50.
 
According to the outcome summary from its most recent meeting, it also noted that FP 50 is the only metred aerosol for use in patients under six years of age and the only low dose metred aerosol registered for use in Australia, and therefore advised there is a clinical need to retain it on the PBS for this cohort.
 
It is not clear whether this assessment was provided as part of the initial advice to the Federal Government, or subsequently after ‘strong concerns … had been raised by clinicians and professional organisations regarding the restriction changes’.
 
Nonetheless, the PBAC outcome said the committee has ‘acknowledged these concerns’.
 
‘The current listings may create difficulties in patient access, particularly for those in rural or remote areas, those unable to secure timely respiratory specialist appointments, and those who cannot afford private consultations or the private cost of the medicine,’ the meeting outcome stated.
 
‘The PBAC noted this had not been the intended effect of its previous advice.’
 
Federal Health and Aged Care Minister Mark Butler also welcomed the reversed decision, having reportedly written to the PBAC last month to ‘take another look at’ issues raised by health organisations.
 
‘The original recommendation led to unintended consequences for GPs and families and young children who have limited access to alternative asthma treatment,’ he said.
 
However, while the PBAC decision has been met with near-unanimous approval, some concerns remain.
 
Dr Kerry Hancock, Chair of RACGP Specific Interests Respiratory Medicine, was a vocal opponent of the initial decision and told newsGP the reversal is a win for patients – but lamented a lack of detail regarding when the recommendation will be acted upon.
 
‘We still don’t know when the latest changes will be implemented, which is frustrating,’ she said.
 
‘It also seems that children over six years who require inhaled corticosteroids via the PBS will need to be initiated on an alternative medication unless they had already been on FP 50 prior to turning six.
 
‘This unnecessary restriction could impact on practitioners seeking to prescribe the most appropriate medication and inhaler device for their patient, and I would urge the PBAC to reconsider.’

The committee outcome indicated FP 50 could return to an unrestricted listing, but only if the price for patients aged six years and above was reduced.
 
‘While the PBAC considered an unrestricted listing would provide the greatest patient access and reduction in administrative burden for prescribers, it noted that accepting a price consistent with the legislated 1 April 2023 catch up reduction would be a commercial decision for the medicine’s sponsor,’ it stated.
 
In response, a spokesperson for GSK Australia told newsGP the drug company had sought an exemption from the statutory price cut as it would have made FP 50 ‘commercially non-viable in Australia’.
 
‘Managing these unintended consequences for patients was the reason the Ministerial Discretion process was established,’ they said.
 
‘There is no requirement on the Government to add access restrictions to products where discretion has been granted. Other discretion requests have been granted with no limits placed on their prescribing.
 
‘The new arrangements announced on Friday are a far more reasonable outcome under the circumstances and we welcome the PBAC’s prompt response to patients’ and doctors’ concerns.’
 
The Department of Health and Aged Care has said it will work with GSK Australia to finalise the revised listing details, after which the Government will make further announcements.
 
In the meantime, Dr Higgins has said the PBAC’s original decision – and its reversal – should be used as a learning experience.
 
‘The RACGP was not aware of any open consultation on this issue before the changes were announced by the PBAC,’ she said.
 
‘In future it’s important to listen to all voices on such important decisions and that includes GPs and practice teams.’
 
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