PBAC backflips on GP fluticasone restriction

5 minute read

Haggling over price was behind the committee’s decision to restrict PBS scripts of fluticasone propionate 50mcg.

The most contentious aspect of recent changes to a children’s asthma drug have been reversed, meaning GPs can once again write PBS scripts for fluticasone inhalers.  

Introduced in April, the new restrictions meant fluticasone propionate 50mcg/actuation inhalation, 120 actuations (Axotide Junior, Flixotide Junior) were restricted to children under six and had to be initiated by a specialist paediatrician or respiratory doctor.  

It also became an Authority Required (telephone/online) medicine.  

After public outcry and a polite request to review the decision from Health Minister Mark Butler, the PBAC elected to walk back some of the changes at its intracycle meeting last week.  

Mr Butler, who himself admitted that asking the PBAC to reconsider its own recommendation was a “pretty unusual decision”, said he had done so because the changes didn’t appear to be in line with asthma management guidelines.  

Effective some time in the next few weeks, the restrictions on prescriber type will be removed and patients who initiate fluticasone and are stabilised on the treatment before six years of age will be allowed continued PBS access beyond six years.  

While it will continue to be an Authority Required drug, it will be moved to Authority Required (STREAMLINED) category, removing the need to phone or email Services Australia prior to writing the script. 

“The PBAC acknowledged … concerns, including that the current listings may create difficulties in patient access, particularly for those in rural or remote areas, those unable to secure timely respiratory specialist appointments, and those who cannot afford private consultations or the private cost of the medicine,” it said.  

“The PBAC noted this had not been the intended effect of its previous advice.” 

The revised changes still mean that patients over the age of six cannot be initiated on fluticasone.  

Instead, the PBAC recommended switching to budesonide, beclomethasone dipropionate or ciclesonide.  

It will review the decision and its impact on medicine usage in two years.  

The new PBAC decision also sheds light on the reason it introduced fluticasone restrictions in the first place, which had thus far remained somewhat of a mystery. 

It confirmed that the original advice had been “provided in the context of the sponsor’s request for Ministerial Discretion to avoid the 1 April 2023 catch-up statutory price reductions”.  

The catch-up statutory price reduction was a one-time measure that applied to virtually all medicines that had been PBS listed for 15 years or more and had not already taken a price-disclosure-related PBS price reduction. 

Under this provision, the PBS could essentially renegotiate prices, reducing the amount it paid for each drug by a maximum of 37%.  

If drug sponsors disagreed with the pricing, they could threaten to delist the medicine from the PBS.  

From the wording in last week’s PBAC decision, it appears that this may have been what happened.  

“The PBAC recommended that fluticasone could return to an unrestricted listing if the price for patients aged six years and above were reduced as per the legislated 1 April 2023 catch up reduction,” it said.  

“The PBAC considered that the cost effectiveness of fluticasone propionate 50mcg would be acceptable under these circumstances, where the price would be more consistent with the alternative therapies.” 

Asthma Australia research and evaluation manager Anthony Flynn said the revised PBAC restrictions would be “more user friendly” for Australians.  

“Asthma needs to be treated quickly and decisively to avoid harm, so it was really a welcome announcement,” he told The Medical Republic.  

The PBAC announcement does not specify how long children who are stabilised on fluticasone can continue to receive repeat scripts of the medicine for after turning six.  

“We’re still unclear on the criteria applied to families of children six and over who will face some difficulties when they’re forced to change medicines,” Mr Flynn said. 

The committee did note that an unrestricted listing would provide the greatest patient access but said that accepting a price consistent with the legislated catch up reduction would be “a commercial decision” for the medicine’s sponsor, GlaxoSmithKline.  

Whether the drug sponsor eventually accepts the lower price offered by the PBS or not, there’s some damage that cannot be undone.  

“I think we are accustomed to seeing rationale and reason under underneath [these decisions], especially in the environment where we’re seeing great efforts being made to reduce the cost of medicine,” Mr Flynn said.  

“Families [are] … trying to manage their lives, their cost of living and their management of chronic conditions in their households. The change was really confusing.” 

The RACGP – which was not consulted prior to the suite of changes in April – welcomed the reversal, calling it a learning experience for the PBAC.  

“The RACGP is unaware of any inappropriate prescribing of fluticasone propionate in young children, so the clinical need for this change was always unclear and that is why we pushed back so strongly against it,” college president Dr Nicole Higgins said.  

According to Dr Higgins, the changes were particularly severe for rural and regional patients, who may have comparatively more challenges in accessing non-GP specialists.  

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