Mixed results from scheduling committee

Asthma combination medication to remain a prescription product, but new anti-histamine to be downscheduled, as latest scheduling decisions are released

A proposal to downschedule the asthma combination medicine containing budesonide and formoterol has been rejected by the Therapeutic Goods Administration’s Advisory Committee on Medicines Scheduling (ACMS).

The results of the November hearing of the ACMS were released this week, and saw a proposal for downscheduling budesonide and formoterol to Schedule 3 rejected by the TGA delegate as the “current schedule is appropriate.”

“I acknowledge that recent updated clinical guidance has recommended the use of low dose beta agonist (LABA)/low dose inhaled corticosteroid (ICS) combined reliever medicines, as the primary medication in all but very mild asthma,” the delegate said.

“However, the use of budesonide-formoterol fixed dose combination (FDC) as a PRN medication is very new to Australia and marks a significant change to asthma management.

I am of the view that this proposal is premature and further evidence is required to support the use of this medicine in an over the counter (OTC) setting”.

In its submission to the committee the Pharmacy Guild of Australia said it supports “the Schedule 3 listing for the combination product and further recommends extending the Schedule 3 listing to budesonide-only inhalers”.

However, the ACMS did vote to create a new Schedule 3 listing for the anti-histamine bilastine

The new S3 and Appendix H listing is for “Bilastine in divided oral preparations containing 20 mg or less in adults and adolescents 12 years of age and older”.

“I find that there is sufficient information to support the safety and lower toxicity of bilastine in these preparations,” the delegate said.

“Bilastine has a well-defined safety and tolerability profile, with a wide therapeutic index. The daily dose of 20mg had been determined for adults and adolescents over the age of 12 years of age, noting that 10mg is reported as safe in children (6-11 years) with a body weight of at least 20kg”.

Bilastine is a new second generation non-sedating antihistamine (NSAH), belonging to the same pharmacological class as other Schedule 2 substances such as fexofenadine, loratadine and cetirizine, which are also used for the symptomatic treatment of allergic rhinitis and urticaria.

The initial proposal had been for a S2 listing for bilastine, which was rejected.

This move was backed by the Pharmacy Guild, who said in their submission: “Bilastine is currently not available in the Australian market and Australian consumers are unfamiliar with this product. Self-selection without pharmacist input could lead to confusion and misuse, including doubling up on antihistamines….The Guild proposes listing bilastine as a Schedule 3 medicine.”. 

A proposal to delete the Schedule 2 entry for azelaic acid, allowing general sales, was rejected by the ACMS.

The TGA delegate found “there is insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling. I am not satisfied that at this cut-off azelaic acid can be supplied at the general sales
level with reasonable safety and without any access to health professional advice”.

“It is not clear why Schedule 2 deletion has been proposed by the applicant” the Pharmacy Guild said. “Azelaic acid preparations are used by consumers and are safely sold through community pharmacies. We do not support a scheduling change that would limit consumer access to these preparations”.

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