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Posted 20 April 2023 AM
GSK has been blindsided by a decision to restrict PBS access to two of its asthma medications in young children as the fallout from the April catch-up price reductions continues.
Under the new rules introduced this month, Flixotide Junior and Axotide Junior 50mcg, indicated for the prophylactic management of asthma are restricted to patients under six. They can no longer be prescribed by GPs to patients in that cohort who are starting treatment.These patients will need to be seen by a respiratory specialist or paediatrician first after which a GP will be able to prescribe continuing treatment.
The change has been met with alarm by GPs, with concerns the new restrictions will hurt the most financially disadvantaged.
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Since 1 April, if a GP believes a patient in the under six age group needs inhaled steroids they can either prescribe Flixotide Junior and Axotide Junior on a private script or refer the child to a specialist.
The restrictions were introduced after GSK won an exemption from catch up price reductions for the drugs and came without warning.
"GSK sought and received an exemption under Ministerial Discretion from a statutory price cut that would have made Flixotide Junior and Axotide Junior 50mcg commercially non-viable in Australia. GSK sought this exemption due to the lack of TGA-approved alternatives for patients five years and under and the likely impact on care," the company told Pharma in Focus.
"We were surprised to then see that a decision was made without further GSK input that restricted access to this product and required initiation by a specialist. We have shared our concerns with the PBAC and the Government that this approach is not aligned to national asthma guidelines and current clinical practice and may affect outcomes for children with asthma, particularly for concessional patients."
Off-label worry
A scathing article in The Conversation warns the restrictions could drive an increase in off-label prescribing, most likely involving drugs with higher-dose steroids.
"In children over the age of six, several alternative medicines can be prescribed.
"But in children under five, there are no good alternatives, with no other age-appropriate low-dose steroid inhalers approved by the TGA.
"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."
Pharma in Focus asked the Department for comment yesterday but has not yet received a response.
Christine Spiteri
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