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FP 50 restriction sparks prescribing authority debate


Matt Woodley


1/05/2023 4:57:40 PM

GPs have questioned why some medications can only be prescribed by certain specialties, calling differential access to the PBS ‘utterly illogical’.

Graphic representing GP script being rejected
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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Dr Mary Louise Miller   2/05/2023 6:14:13 AM

The most ridiculous thing is that Fluticasone 100mcg does not have the same restrictive criteria as the 50mcg formula does…..go figure!


Dr Clare Lydia Roczniok   2/05/2023 7:08:19 AM

If the government is serious about improving access to treatment and cost cutting it should provide public outpatient clinics that can provide specialist input in a timely fashion and consider capping specialist Medicare rebates for services provided in private settings The private/public mix made the system work and with the underfunding and collapse of the public system our health service is becoming one that only benefits the wealthy.


Dr Jimmy Tseng   2/05/2023 9:38:06 AM

Strictly speaking this article isn’t accurate. We can’t prescribe Flixotide Junior 50 under PBS, though we can prescribe privately. I wouldn’t say that this patient needs to see a respiratory physician just to get $9 off each script.

Secondly, the majority of children under 6 years old are not asthmatic, rather having viral wheeze. GPs and paediatricians overprescribe FP50, and so having some friction in prescribing FP50 in my opinion is only a good thing.


yo   2/05/2023 9:55:03 AM

Regulatory bodies are made up of people with overinflated egos who like to tell others what to do. They inherently lack common sense and experience in these matters. This is not just a stupid decision, its expected of them. We need a revolution in healthcare. I call on GPs to strike - stop working. Watch the health system entirely collapse overnight.


Dr Philip Ian Dawson   2/05/2023 10:17:22 AM

current waiting times to see a paediatrician in Northern Tasmania are over a year in public, and a number have closed their books in private, mainly due to the large and increasing volume of behaviour disorder referrals. getting an asthmatic child reviewed by a paediatrician is impossible! Also illogical is that other formulations of steroid inhalers, such as those combined with a LABA ar not restricted! Why has there been no message to GPs and Paediatricians from the PBS committee about its reasoning?


Dr Guy Stephen Vaughan Davies   2/05/2023 10:34:10 AM

Fluticasone 50 available on private script at same price as PBS unless patient is concession


Dr Henry Arthur Berenson   2/05/2023 2:16:24 PM

My bugbear is ADHD regulations. I cannot find out why GPs are not trusted to prescribe for this common condition.


Dr Sean Carroll   3/05/2023 12:03:29 AM

Didn’t know we should have been proud to be called “the doctors down the corner that people go to for some cough medicine”…now we’re not even capable of this!


SD   3/05/2023 1:25:24 PM

It makes me wonder that a pharmacy can sell Nexium over the counter while a GP has to pass restriction criteria for an OTC medication.
The steroid puffer does not need a specialist visit.


A.Prof Christopher David Hogan   3/05/2023 2:32:00 PM

Do they want to destroy General Practice or save the health system & have GPs work at the peak of their capabilities?
This is a binary choice.
If GPs are specialist GPs they are specialists & are just as responsible as doctors in the other disciplines.
Or is this just defunding of the health system by stealth?