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FP 50 restriction sparks prescribing authority debate
GPs have questioned why some medications can only be prescribed by certain specialties, calling differential access to the PBS ‘utterly illogical’.
GPs have questioned why the type of specialist impacts prescription eligibility for evidence-based treatments listed on the PBS.
A recent decision to limit who can initiate PBS-subsidised prescriptions of fluticasone propionate 50 micrograms (FP 50) has prompted a wider conversation among GPs about prescriber restrictions.
Announced last month following a Pharmaceutical Benefits Advisory Council (PBAC) recommendation, the decree has meant children with asthma now need to be referred to a respiratory physician or paediatrician in order to access the medication.
In lieu of an explanation from either the PBAC or the Department of Health and Aged Care (DoH) behind why the restriction was imposed, the RACGP wrote to the Committee’s Chair Professor Andrew Wilson asking that GP prescriber rights be reinstated to their previous level.
But Professor Mark Morgan, Chair of RACGP Expert Committee – Quality Care, has taken an even broader view and questioned why many of these restrictions exist in the first place.
‘It seems utterly illogical to have differential access to PBS depending on whether the script was written by a GP or non-GP specialist,’ he told newsGP.
‘Either the treatment is appropriate and evidence-based or not. That does not change because of who prescribes it.’
Professor Morgan highlighted a number of medications and interventions that currently require non-GP specialist input that he believes could be safely managed within general practice, including:
- isotretinoin (sold as Roaccutane)
- fluticasone
- testosterone
- ADHD treatments
- some severe mental illness treatments
- some disease modifying medicines for inflammatory conditions
- MRI scans.
According to Professor Morgan, compelling patients see non-GP specialists in these instances is adding a costly and time-consuming step as a form of ‘hidden rationing of healthcare’.
‘Some clinical management that falls well within GP capabilities requires unnecessary visits to specialists,’ he said.
‘As professionals, GPs make a judgement about their individual scope of practice all the time and refer when necessary. It is unfortunate that some bureaucratic historical barriers exist in which patients need to see specialists to access treatments and investigations.
‘Given
multi-year delays have now come to light, these barriers should be removed immediately.’
When asked about the clinical rationale behind making certain medications, such as isotretinoin ‘specialist-only’, the DoH cited the
Therapeutic Goods Poisons Standard, stating that it ‘outlines decisions on the classification of medicines into Schedules and recommendations about other controls, including prescriber types’.
‘Complete information on the scheduling of any medicine registered in Australia, including isotretinoin, is available at
legislation.gov.au/Details/F2023L00067,’ the spokesperson said.
All three warning statements contained in the Poisons Standard for isotretinoin relate to the potential for birth defects and the need to avoid use of the medication while pregnant, while
NPS MedicineWise states it is restricted to dermatologists due to it having some ‘serious adverse effects’.
However, other medications that can result in birth defects, such as
molnupiravir – a drug that has been
prescribed more than 500,000 times in the past year – are not similarly restricted. GPs in New Zealand have also
been able to prescribe isotretinoin since 2009.
Dr Tim Senior, the GP who first raised concerns about the FP 50 change, told
newsGP limited access to particular medications via prescribing restrictions is part of a pattern experienced by GPs and patients that can compromise care and result in worse outcomes.
‘Some can only be prescribed by a non-GP specialist, such as dupilumab,’ he said. ‘I know of at least one patient who responded really well to this for their severe eczema, but can’t afford to see the dermatologist again, so can’t continue the drug.
‘Meanwhile,
restrictions on diagnosing and prescribing for ADHD essentially mean that any publicly funded health service has opted out of ADHD management entirely.’
Dr Senior also lamented restrictions on MRI scans and the inability to certify that someone has a mental health condition for in order to access the Disability Support Pension or the NDIS.
‘This is at a time when other non-medical professions are being encouraged to work “top of scope”, even as GP scope is limited,’ he said.
When asked, the DoH spokesperson did not say whether the department would consider relaxing some of these restrictions to improve access to care and instead deferred to the PBAC.
‘The Australian Government requires advice from the PBAC about the listing of medicines on the PBS – including any restrictions on use and prescribing – and cannot list a medicine on the PBS unless the PBAC recommends its listing,’ the spokesperson said.
‘Similarly, the Government relies on the advice of the PBAC for changing the circumstances of PBS listings, such as a change to the clinical criteria including the prescriber type.’
The spokesperson went on to say that PBS listings ‘reflect the evidence that has been considered by the PBAC to date’, without providing the specific rationale relied on to restrict FP 50 prescriptions.
‘When considering a medicine proposed for PBS listing, the PBAC is required by that legislation to give consideration to the cost and clinical safety and effectiveness of the medicine, including by comparing the effectiveness and cost with that of alternative treatments,’ the spokesperson said.
‘The PBAC consideration may also include the clinical complexity of the disease a medicine is used to treat and how the medicine is administered in the clinical setting. Based on such considerations, the PBAC may indicate which specialty would be appropriate to prescribe a medicine through the PBS.’
FP 50 has been subsidised on the PBS
since 2001, with more than 85,000 prescriptions issued last year at cost of
nearly $1.2 million, but no explanation was provided when the updated listing was
announced on 1 April.
And while there has been
some speculation that the restriction came into force due to the PBAC and the medication’s sponsor not being able to agree on a new price as part of a scheduled reduction, Professor Morgan has urged the committee to provide its reasoning so that clinicians and patients have clarity around why the choice was made.
‘FP 50 use stats suggest a lot of patients will be inconvenienced or going untreated,’ he said. ‘The PBAC needs to be clear whether this is a rationing decision, or a decision based on a new interpretation of published evidence.
‘These specialists are just not able to provide timely services unless the patient is wealthy enough to pay privately.
‘The impact … may not have been adequately assessed before the changes were made.’
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