PBAC reverses decision: Access to essential asthma medications to be restored

Pharma News: In a significant development for young asthma sufferers across the country, the Pharmaceutical Benefits Advisory Committee (PBAC) has revisited its earlier decision and recommended a change in restrictions for GlaxoSmithKline’s Axotide Junior and Flixotide Junior (fluticasone propionate 50 mcg) inhalers. This move comes after mounting pressure from health professionals and advocacy groups who raised concerns about limited access to these medications.

The initial restrictions, which required specialist prescriptions, posed challenges for families living in rural and remote areas, as well as clinicians. In response to concerns raised by health professionals and advocacy groups including National Asthma Council Australia (NAC), Mark Butler MP, Minister for Health and Aged Care wrote a letter to the PBAC urging them to review their initial stance.

“I wrote to the PBAC in May – after health professionals and advocacy groups raised concerns with my office – and asked them to take another look at these issues,” Minister Butler stated. “I am pleased that the PBAC has now reconsidered its advice about Fluxotide Jr and Axotide Jr, and now patients will be able to get their prescription from their GP.”

The previous recommendation had inadvertently created unintended consequences for GPs and families, particularly for young children who have limited access to alternative asthma treatments. The PBAC acknowledged this and emphasised the necessity of retaining Axotide Junior and Flixotide Junior on the Pharmaceutical Benefits Scheme (PBS) for patients under the age of 6. While there are other choices such as Pulmicort, Qvar and Alvesco for children over the age of six, GSK’s Axotide Junior and Flixotide Junior inhalers are the only registered low-dose aerosol available in Australia for children in this age group, making it a vital medication.

Dr Tim Senior, a member of Asthma Australia’s Professional Advisory Council, was one of the clinicians that expressed his concerns over the changes, including higher out-of-pocket costs and the substantial wait to be seen by a paediatrician.

“There are real health equity consequences where the cost of seeking care and the cost of prescriptions will prevent some people from getting appropriate treatment – and that has consequences,” he said.

Recognising the concerns voiced by clinicians and professional organisations regarding the restriction changes implemented in April 2023, the PBAC has taken steps to alleviate the impact on patient access. The committee recommended a series of changes to the existing restrictions, including removing the requirement for treatment initiation by a respiratory physician or paediatrician and streamlining the authority approval process. Additionally, patients who start and stabilise treatment before the age of 6 will now be able to continue accessing the medication through the PBS beyond that age.

The PBAC recommended that Axotide Junior and Flixotide Junior could return to an unrestricted listing if the price for patients aged 6 years and above were reduced as per the legislated 1 April 2023 catch up reduction. The PBAC considered that the cost-effectiveness of Axotide Junior and Flixotide Junior would be acceptable under these circumstances, where the price would be more consistent with the alternative therapies. To monitor the effects of these changes, the PBAC has recommended conducting a utilisation review after two years.

RACGP President Dr Nicole Higgins welcomed PBAC’s reversal.

“This is a win for Australian families at a time of high cost of living pressures. Following our advocacy and calls from health professionals and other professional groups, the Minister for Health and Aged Care Mark Butler wrote to PBAC respectfully asking them to review their decision. Thankfully, they have reversed course and reviewed the initial recommendations so now patients will once again be able to receive a prescription for these drugs from their regular GP. This is a great result for patient care, and I applaud Minister Butler for raising this with PBAC and making it a priority,” she said.

With the PBAC’s recommendations in place, the Department of Health and Aged Care officials will collaborate with GlaxoSmithKline to finalise the revised listing details. The government has promised to provide further updates once an agreement has been reached.

This recent development marks a significant step forward in addressing the concerns raised by health professionals and advocacy groups, ensuring that young asthma patients receive the necessary care and support they deserve.

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