Australian Doctor 14th June Issue | Page 4

4 NEWS

14 JUNE 2024 ausdoc . com . au

‘ Butler ’ s drug ban is a mistake ’

Dr Nick Coatsworth .

Antony Scholefield FORMER deputy chief medical officer Dr Nick Coatsworth says the Federal Government ’ s looming ban on compounded semaglutide fails to recognise the life-changing effect of the drug .

Minister for Health and Aged Care Mark Butler announced last month that pharmacists would be prevented from compounding

semaglutide and other GLP-1 receptor agonists from 1 October .

It is estimated that around 20,000 patients are currently using compounded semaglutide off-label for weight loss .

But with some patients reporting haematemesis , peripheral neuropathy and other side effects , Mr Butler said the safety risks were too high .

ARE YOUR PATIENTS STILL WAITING FOR ASTHMA CONTROL ?* * TRELEGY ELLIPTA IS INDICATED FOR MAINTENANCE TREATMENT OF ASTHMA IN ADULT PATIENTS NOT ADEQUATELY CONTROLLED ON ICS / LABA 1

200 fluticasone furoate / umeclidinium / vilanterol PBS LISTED FOR SEVERE ASTHMA 2

Trelegy Ellipta showed superior improvement in lung function ( trough

FEV 1

) vs FF / VI ( ICS / LABA ) * 3

* Change in trough FEV 1 at 24 weeks ( primary endpoint ): Trelegy Ellipta 200 / 62.5 / 25mcg vs FF / VI 200 / 25mcg 92mL ( 95 % CI 49,135 ), p < 0.0001 ; Trelegy Ellipta 100 / 62.5 / 25mcg vs FF / VI 100 / 25 mcg 110mL ( 95 % CI 66 , 153 ), p < 0.0001 . 3

TRELEGY Ellipta is generally well tolerated . The most commonly reported adverse events were nasopharyngitis , headache and upper respiratory tract infection . 1 , 3 TRELEGY Ellipta 200 PBS listed for severe Asthma 2

Trelegy Ellipta 100 is indicated but not PBS listed for asthma . 1 , 2 FF 100mcg is medium dose and FF 200mcg is high dose ICS . 4

Study design : The CAPTAIN study was a 24-to-52 week , randomised , double-blind , active-controlled , parallel-group , study that evaluated efficacy and safety of TRELEGY Ellipta vs FF / VI in 2436 adult patients whose asthma was inadequately controlled while receiving ICS / LABA . The primary endpoint was mean change from baseline in trough FEV 1 at week 24 . The key secondary endpoint was annualised rate of moderate / severe exacerbations

FEV 1

, forced expiratory volume : FF , fluticasone fuorate ,: ICS , inhaled corticosteroid ; LABA , long-acting beta 2

-agonist : PBS : pharmaceutical benefit scheme :

VI , vilanterol

References : 1 . TRELEGY Ellipta Approved Product Information 2 . www . pbs . gov . au ( accessed on 18th April 2023 ) 3 . Lee et al . Lancet Respir Med 2021 ; 9 : 69-84 4 . National Asthma Council Australia . Australian Asthma Handbook . National Asthma Council Australia , Melbourne , 2023

For more information on GKS products or to report an adverse event involving a GSK product , please contact GSK Medical Information on 1800 033 109 . GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 , Melbourne , VIC . Trelegy Ellipta Trade marks are owned by or licensed to the GSK group of companies © 2023 GSK group of companies or its licensor . PM-AU-FVU-ADVT-230002 ( Date of approval : April 2023 )

PBS Information : Severe asthma ( 200 / 62.5 / 25 mcg presentation only ); Authority Required ( Streamlined ). Criteria apply . Refer to PBS for full information .

Dr Coatsworth acknowledged patients had been harmed by compounded semaglutide from some pharmacies .

But he said others were about to lose out on life-changing benefits .

“ We are not talking about yet another PPI or the 12th statin that ’ s come onto the market ,” he told Australian Doctor .

“ These drugs have a profound influence , profound benefits for people .

“ You have to ask the question : Is there harm caused by patients missing out on this ?

“ If the answer is yes , then it is incumbent on the government to facilitate alternatives if they exist .”

Dr Coatsworth is on the clinical governance committee for Eucalyptus , the telehealth company

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING

Contraindications : Severe milk-protein allergy or hypersensitivity to any of the ingredients . Pregnancy : Category B3 . Dosage : One inhalation once daily . After inhalation , rinse mouth with water without swallowing . whose doctors prescribe compounded semaglutide as part of its commercial weight loss program .

He said neither the government nor TGA had attempted to show that all semaglutide compounding was unsafe .

“ I ’ m not saying what the government is doing is unreasonable … My suggestion is merely that there ’ s not just one choice .

“ This is about the patients who will have a cardiovascular event in the next year without semaglutide .”

He added that Ozempic maker Novo Nordisk clearly wanted to protect its multibillion-dollar blockbuster drug , although he stressed he had not personally faced any warnings or approaches from the company .

‘ Is there harm caused by patients missing out on this ?’

Asked to explain his involvement with Eucalyptus , he said he had initially been hugely sceptical about the rise of weight loss clinics , sharing the concerns of the RACGP about fragmented care .

He was then contacted by Eucalyptus via LinkedIn , who explained the care model .

His decision to join them was based on his understanding that such clinics were “ here to stay ” and his involvement would minimise patient safety risks by ensuring clinical governance was in place . Dr Coatsworth said the main risk from corporate telehealth clinics focused on single conditions was the conflict of interest when companies controlled both prescribing and dispensing .

However , what the clinical governance committee could do was review how often individual doctors at Eucalyptus were prescribing or refusing treatments , he said .

“ I think it is vital to measure the refusal rate for these models of care ,” he said .

“ And when you measure it , it can ’ t be something like 0.1 %.”

AUSDOC POLL

Should compounded semaglutide be banned ?

Ban it . Patients are at risk . 47 %

Don ’ t ban it . Patients with obesity need this treatment option . 44 %

I don ’ t know . 9 %

n = 252