PBS restriction changes on fluticasone propionate 50mcg/actuation metered dose inhaler

The Pharmaceutical Benefits Scheme has made changes to the access and prescribing of fluticasone propionate (FP) 50mcg/actuation metered dose inhaler (Flixotide Junior, Axotide Junior), that came into effect on 1 April 2023. 

The National Asthma Council Australia (NAC), including the Australian Asthma Handbook Guidelines Committee, is concerned about changes that include: 

• initial authority prescription being required by a respiratory physician or paediatrician for patients aged under six, after which a GP or nurse practitioner can prescribe continuing treatment.  
• fluticasone propionate 50mcg no longer being PBS-subsidised for children aged six years and older. 

The NAC’s Australian Asthma Handbook, Australia’s national guidelines for asthma management, recommends a regular low-dose inhaled corticosteroid (ICS) for children aged one to six years for preschool wheeze e.g. those who have recurrent symptoms between viral respiratory infections. In addition, a preventer medication is indicated if the child has had a moderate-severe flare up requiring oral corticosteroids. Fluticasone propionate 50mcg is the only metered dose inhaler registered on the Australian Register of Therapeutic Goods (ARTG) for this age group. 

Debbie Rigby, pharmacist and NAC’s clinical executive lead said in AJP, “This means that children under six years of age stabilised on FP 50mcg MDI who require ongoing PBS-subsidised ICS treatment will need to see a respiratory physician or paediatrician for initiation of therapy. General practitioners (GPs) and nurse practitioners may prescribe FP 50mcg MDI for continuing treatment. 

“If FP 50mcg MDI is initiated by a GP, the inhaler is not funded by the PBS and would be a private script. Whilst FP 50 as a private script is under the general co-payment, the change will disadvantage those on concessional subsidy and CTG, and a private script will not count towards the safety net limit. 

“These PBS changes may increase out-of-pocket expenses for families, at a time when the government is committed to making medicines more affordable.” 

The PBS changes will cause significant access, cost, health outcome and equity issues particularly for socially disadvantaged and vulnerable populations, who have the highest rates of asthma.  

Professor Nick Zwar, chair of the NAC’s Australian Asthma Handbook guidelines committee said in AusDoc, “It’s just not practical for people to get kids to see a respiratory physician or a paediatrician at a cost they can afford and in a timely way.”  

Dr Louise Owens and Dr Brett Montgomery, members of the NAC’s Australian Asthma Handbook Guidelines Committee, and Dr Shivanthan Shanthikumar said in The Conversation, “The use of private scripts will certainly hurt families who rely on concessions or safety nets, including Aboriginal and Torres Strait Islander children and those from low socioeconomic backgrounds who are disproportionately affected by asthma. Requiring referral to a specialist also has many detrimental consequences. There are already bulging waitlists for these services, leading to delays in care. In many parts of Australia there are no bulk-billing specialists, which makes it hard for vulnerable families to access these services.” 

The NAC has written to the Pharmaceutical Benefits Advisory Committee (PBAC) Secretariat outlining the following concerns: 

• It will be difficult for families to see a respiratory physician or paediatrician promptly to obtain the medication they require. In Victoria, the average wait time to see a specialist in the public system is 256 days. For patients in rural and remote areas, it can be more than a year. Long wait times may result in under-treatment. 
• Additional costs will be incurred by patients needing to access a respiratory physician or paediatrician and this will particularly impact low-income families. Limited access to specialists, particularly for those in rural or remote areas will lead to the need for private scripts, at additional cost for concessional patients. 
• Limited access due to both cost and availability of fluticasone propionate and ability to see a specialist is likely to result in inadequate asthma care for young children. Children in this age group should not stop taking an ICS without medical advice and an updated asthma action plan. 
• GPs and nurse practitioners may prescribe Flixotide 125 instead of Flixotide Junior, because this can be prescribed without restrictions. The change may result in a switch to a higher dose fluticasone propionate or ICS/LABA combination product, which may not be clinically indicated and is associated with increased risk of adverse effects. Guidelines recommend the consideration of stepping down the dose of therapy when asthma has been stable and well controlled for six months in children. 
• Alternate ICS MDI products are not registered by the TGA for children under six years. A dry powder inhaler is PBS-subsidised as an unrestricted benefit and TGA registered with no age restrictions; however, young children may not be able to effectively use this device. 
• The increased PBS restrictions may lead to over-reliance on short-acting relievers for asthma symptoms, use of oral corticosteroids for acute exacerbations and unnecessary use of higher dose ICS in children over six years. 
• Untreated asthma may place additional burden on the health system due to increased presentations to GPs, emergency departments and hospitalisations. Public patient waiting times to see a specialist will increase and put pressure on public clinics, potentially also affecting more patients with complex needs. 

The changes will also impact: 

• Pharmacists - risk of dispensing an invalid prescription and additional workload confirming initiation by a respiratory physician or paediatrician and explanations to parents. Pharmacists will need to refer patients back to their GP for review and continued treatment.  
• Respiratory physicians or paediatricians - more referrals, increased waiting times and additional burden on the public health system.  
• GPs - more regular review of asthma in children and increased referral to respiratory physicians or paediatricians. Increased referral for young children may reduce inappropriate use of ICS in this age group.  

The NAC, along with several peak bodies, is urging the PBAC to maintain GPs’ fluticasone propionate 50mcg prescribing rights for children aged one to six years and maintain availability of fluticasone propionate 50mcg for patients six years and over. If authority prescribing is a priority for the Department, make it authority streamlined, in line with the policy underpinning the prescription of every other preventer class medicine for asthma in Australia, such as montelukast and fixed dose combination inhaler. 

Prescribing fluticasone propionate 50mcg is an important part of asthma management for children. Limiting access to it due to both medication/specialist cost and availability issues will result in poorer health outcomes for disadvantaged and vulnerable Australian children, particularly Aboriginal and Torres Strait Islander people, resulting in under-treatment and suboptimal of asthma and exposing them to unnecessary health risks. 

References 
Haggan, M (2023) The problem is they're just going to get Ventolin, AJP. Available at: https://ajp.com.au/news/the-pr...  

Fieldhouse, R (2023) PBS abruptly restricts GP prescribing of kids' asthma inhaler, AusDoc. Available at: https://www.ausdoc.com.au/news... 

Montgomery, B, Owens, L and Shanthikumar, S (2023) New asthma medicine restrictions will hurt the poorest children the most, The Conversation. Available at: https://theconversation.com/ne...