The TGA has rejected a bid to improve access to a medical cannabis spray for MS spasticity symptoms by down-scheduling it from Schedule 8 to Schedule 4 status.
The nabiximols oromucosal spray (Sativex) is licensed by the TGA as a prescription (Schedule 8) medicine for the treatment of adults with spasticity due to multiple sclerosis, but its availability is restricted due to onerous pharmacy storage requirements. The product has to be refrigerated, and as a restricted S8 drug it must be stored in a separate locked fridge away from other medicines that can only be accessed by a pharmacist.
A submission from MS Australia supported an application for down-scheduling to S4 status, which the group said would have made the spasticity treatment more accessible for people with MS in regional areas.
“We understand that by down-scheduling nabiximols and deleting Appendix D, that prescribing, storing, transporting and distributing nabiximols will be easier, resulting in potential cost savings for consumers. Nabiximols is not currently listed on the PBS and we understand that it is currently priced at around $745 for a 6-8 week supply, so any potential cost savings will make an enormous difference to consumers,” it said.
“Easy-to-use medications for MS are also of great benefit for people living with MS in rural and regional settings where the need for hospital and clinic visits can be minimised or not needed at all,” it added.
In its evaluation of the application, the TGA acknowledged that there was evidence for the efficacy of medical cannabinoids for symptoms of MS and pain, but said the effects were modest (for pain, around 20 patients needing to receive cannabinoids for one to benefit). The TGA also concluded there was potential for dependency and misuse of the product.
“The risk of misuse and abuse of nabiximols preparations in the Australian context is difficult to accurately quantify on the basis of the current evidence, and therefore the loss of regulatory controls over prescribing for those with a drug dependency issue would seem premature,” it stated.
The TGA also noted that down-scheduling of nabiximols was not supported by the AMA or by professional pharmacology and therapeutics special interest groups.
And since down-scheduling of nabiximols would be inconsistent with the current S8 status of other medical cannabis products such as THC, the TGA made the interim decision not to amend its current scheduling.