Mometasone to remain a mostly prescription product after downscheduling application is knocked back
TGA regulators have rejected a proposal to move the corticosteroid mometasone to become a Schedule 3 product.
It was decided that diagnosis, management and monitoring of the medical condition was such that it required medical intervention before mometasone was used.
Mometasone remains an S2 product only when in “aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms and when packed in a primary pack containing 200 actuations or less, for the short termprophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over”.
The March 2019 meetings of the Advisory Committee on Medicines Scheduling, recommendations for which were released late last week, discussed the proposal.
The ACMS delegate recommended only one change to the S2 listing, adding ‘when packed in a primary pack containing 200 actuations or less’.
“Prior to this change, there was no limit on the number of actuations supplied for treatment of up to six months. Whereas this amendment means that the Schedule 2 supply will have a limit requiring return of the patient to a pharmacy for resupply and possible consultation with a pharmacist,” the delegate said.
For the treatment of adults, the usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total daily dose 200 micrograms).
“It is recommended that the dose is reduced to one spray in each nostril (total daily dose 100 micrograms) for maintenance treatment. A delivery device containing up to 200 actuations would permit fifty days of prophylaxis and treatment and/or 100 days of maintenance”.
The delegate said the down-scheduling of mometasone would not necessarily offer any additional benefit to the community given that existing provisions allow for 3 days emergency supply for a previously diagnosed condition in the absence of a prescription at the time of supply.
“From my understanding of the data, the mild corticosteroids in Schedules 2 and 3 appear to be supplied and used appropriately. I have not identified evidence from either pharmacists or consumers of any demand for, or unmet need for, a higher potency corticosteroid to be available without prescription”.
It was also decided to not add mometasone to Appendix M.
At the same meeting the delegate also ruled against any downscheduling or pack size increase for the allergic rhinitis treatment cetirizine.
“The arguments made by the Applicant in this respect focus on accessibility, consumer convenience and affordability, and I am not satisfied that these factors would result in a public health benefit which outweighs my concerns regarding delaying seeking advice from a health professional,” the delegate said.