NEWS 11
ausdoc . com . au 12 JULY 2024
NEWS 11
‘ Refer for add-on biologics earlier ’
Rachel Fieldhouse PATIENTS with at least two asthma |
effective for some people who have very difficult-to-control asthma , are on high doses of ICS or need frequent courses of oral corticosteroids ,” the Gold Coast GP said .
“ There is a real opportunity now to refer them on to a specialist .”
Four monoclonal antibodies — omalizumab , benralizumab , mepolizumab and dupilumab — are listed on the PBS for adults with severe uncontrolled asthma ; omalizumab and dupilumab are also subsidised for children aged 6-11
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with uncontrolled asthma . Professor Zwar said GPs may not have considered referring such patients to respiratory specialists because , until recently , “ there was not much else you could do ”.
Respiratory physician Professor Peter Wark , from John Hunter Hospital in Newcastle , agreed that patients could be referred earlier .
“ In Australia , people have a tendency to use very high doses of ICS , sometimes in association with LABAs , and people will
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also use prednisone to treat acute exacerbations .
“ If you cannot control a patient ’ s asthma with moderate doses of ICS and people are experiencing frequent exacerbations , they really should be considered for biologic therapy .
“ Continuing on with other ineffective treatments exposes patients to risks of both poorly controlled asthma and risks associated with oral corticosteroids .” Patients no longer needed to
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have taken a specified amount of prednisone in the previous year to be eligible for monoclonal antibodies on the PBS following a PBAC decision in March , he added .
But he acknowledged that access to biologics through a respiratory specialist or allergist could be difficult because of long wait times .
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exacerbations and multiple courses of oral corticosteroids in a year could be eligible for add-on biologics under specialist care , say leading asthma doctors .
Professor Nick Zwar said he wanted to remind GPs that injectable monoclonal antibodies were “ changing the landscape ” of severe asthma management but were under-utilised .
“ Biologic therapies can be very
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Professor Wark disclosed research funding from AstraZeneca , Sanofi and GSK . |
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Bring back items , review tells govt |
Why consider LAGEVRIO ?
Demonstrated efficacy 7 *
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In MOVe-OUT , LAGEVRIO reduced the risk for hospitalisation or death vs . placebo through Day 29 by 30 % ( adjusted relative risk reduction ) in adult patients with mild to moderate COVID-19 7
( 95 % CI : 1 %, 51 %; 6.8 % ( 48 / 709 ] vs 9.7 % ( 68 / 699 ). Adjusted risk difference -3.0% ( 95 % CI -5.9%, -0.1%), p-value not available ). Based on a planned interim analysis of LAGEVRIO vs placebo : The adjusted risk difference was -6.8% ( 95 % CI : -11.3%, -2.4; 7.3 % ( 53 / 377 ) vs 14.1 % ( 28 / 385 ); p = 0.0024 ).
Real-world studies , 10-13 including the local Victorian study published in 2023 , 13 also support the use of LAGEVRIO in treating older vaccinated patients with mild to moderate COVID-19 .
Treatment-related adverse events ≥ 1 % ( MOVe-OUT , LAGEVRIO vs placebo ): 7 Diarrhoea ( 2 % vs 2 %), nausea ( 1 % vs 1 %), dizziness ( 1 % vs 1 %)
A simple † treatment for appropriate patients 7 , 9
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No known drug interactions based on limited data available 7
▼This medicine is subject to additional monitoring in Australia . This will allow quick identification of new safety information . Healthcare professionals are asked to report any suspected adverse events at www . tga . gov . au / reporting-problems .
Selected Safety Information 7
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No dose adjustments required in patients with renal and / or hepatic impairment 7
Scan to access study design for the MOVe-OUT registration trial .
INDICATION : LAGEVRIO has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death . The decision to approve this indication was based on efficacy and safety data from a Phase 3 trial . Continued approval of this indication depends on additional data .
CONTRAINDICATIONS : Hypersensitivity to the active substance or any of the excipients . Hypersensitivity reactions have been reported with LAGEVRIO . If signs or symptoms of a clinically significant hypersensitivity reaction occur , immediately discontinue LAGEVRIO and initiate appropriate medications and / or supportive care .
PRECAUTIONS : Pregnancy Category D : The use of LAGEVRIO is not recommended during pregnancy . In women of childbearing potential , health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test . Contraception : Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO . Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment . Based on animal data , LAGEVRIO may cause foetal harm when administered to pregnant women . Breastfeeding : Based on the potential for adverse reactions on the infant from LAGEVRIO , breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO . Paediatric patients : Use in patients under the age of 18 years is not recommended .
ADVERSE REACTIONS : Common : nausea , diarrhoea , dizziness . The following have been reported in post-marketing experience : hypersensitivity , angioedema , erythema , pruritus , rash , urticaria , vomiting .
Antony Scholefield THE Federal Government should restore telephone items for GPs writing and reviewing chronic disease care plans , the MBS Continuous Review has said .
In a 45-page report , the review has also ditched its original draft recommendation to scrap video telehealth items for initial appointments with non-GP specialists .
It criticised the government ’ s attempt to prioritise video-based telehealth , saying it has “ potentially resulted in inequitable access to telehealth for some populations ”.
The government brought in telephone items for care planning in early 2020 when the COVID-19 pandemic began but scrapped them the following year , deeming them suboptimal .
The review said some consults , such as for paediatric patients or those with binge eating disorders , needed the video element .
But it said Medicare-funded phone consults “ with a known clinician ” were still needed .
This included writing and reviewing GP chronic disease care plans and follow-up consults with geriatricians , paediatricians and psychiatrists .
It stressed that clinicians could still refuse a phone consultation based on their judgement .
“ On the other hand , patients should be able to access telehealth if it is clinically appropriate .”
The report will now be considered by the government .
References : 1 . Australian Bureau of Statistics . COVID-19 mortality in Australia : Deaths registered until 31 January 2024 . https :// www . abs . gov . au / articles / covid-19-mortality-australia-deaths-registered-until-31-january-2024 ( accessed May 2024 ). 2 . Australian Bureau of Statistics . Health conditions prevalence ( 2022 ). Available at https :// www . abs . gov . au / statistics / health / health-conditions-and-risks / health-conditions-prevalence / latest-release ( accessed February 2024 ). 3 . Ross SB et al . JAMA Netw Open 2022 ; 5 ( 7 ): e2220184 . 4 . Shini Rubina SK et al . Diabetes Metab Syndr 2022 Mar ; 16 ( 3 ): 102451 . 5 . University of Liverpool . COVID-19 Drug Interaction Checker . Available at https :// www . covid19- drugintractions . org / checker ( accessed March 2024 ). 6 . Paxlovid ( nirmatrelvir-ritonavir ) Product Information . February 2024 . 7 . LAGEVRIO Product Information . October 2023 . 8 . Australian Government Department of Health and Aged Care . COVID-19 Oral treatments fact sheet . https :// www . health . gov . au / sites / default / files / 2023-01 / covid-19-oral-treatments-fact-sheet . pdf ( accessed May 2024 ). 9 . Pharmaceutical Benefits Scheme . www . pbs . gov . au ( accessed March 2024 ). 10 . Gentry CA et al . J Infect 2023 ; 86 ( 3 ): 248 – 255 . 11 . Lin DY et al . JAMA Netw Open 2023 ; 6 ( 9 ): e2335077 . 12 . Park HR et al . Infect Chemother 2023 ; 55 ( 4 ): 490 – 499 . 13 . Van Heer C et al . Lancet Reg Health West Pac 2023 ; 41:100917 .
Before prescribing , please review the full Product Information available at www . msdinfo . com . au / lagevriopi or by scanning the QR code .
Copyright © 2024 Merck & Co ., Inc ., Rahway , NJ , USA and its affiliates . All rights reserved . Merck Sharp & Dohme ( Australia ) Pty Limited . Level 1 – Building A , 26 Talavera Road , Macquarie Park NSW 2113 . MSDA0137 . AU-ANV-00563 . Issued June 2024 .