The new listings wrap-up is designed to provide you with information about medicines that have been listed on the PBS for which full NPS RADAR reviews or brief items are not available.
June 2019 sees the listing of:1
- Insulin aspart for diabetes mellitus (new medicine)
- Oxycodone capsules for severe disabling pain (new medicine)
See the PBS Schedule for complete details for each PBS listing described in this article.
A new form of insulin aspart (Fiasp) is now listed on the PBS General Schedule (Section 85) for the treatment of diabetes mellitus.1
What is it?
Insulin aspart (Fiasp) is an ultra-fast acting insulin aspart formulation for subcutaneous administration.2
Fiasp has a faster onset of action compared with the other PBS-listed insulin aspart formulation (NovoRapid).3
Fiasp includes the excipient nicotinamide (niacinamide; vitamin B3). This results in faster insulin absorption, leading to an earlier onset of action and greater early glucose-lowering compared with NovoRapid.2
Onset of action is 5 minutes faster and time to maximum glucose infusion rate is 11 minutes earlier with Fiasp than NovoRapid.2
Who is it for?
Insulin aspart (Fiasp) is PBS listed as an unrestricted benefit for patients with type 1 or type 2 diabetes mellitus.1,3
According to the TGA registered indication, patients are required to be adults with diabetes mellitus.2
At time of TGA approval, there was a lack of safety and efficacy data for use of Fiasp in children. However, clinical data are now available for children with type 1 diabetes mellitus.3
The sponsor advised that it would consider seeking TGA registration of Fiasp in paediatric patients following its listing on the PBS.3
The two PBS-listed insulin aspart formulations (Fiasp and NovoRapid) are not equivalent.3
The earlier onset of action and subsequent increased glucose lowering effect of Fiasp compared with NovoRapid must be considered when prescribing insulin aspart.2
When switching to Fiasp, glucose levels should be closely monitored to allow any necessary dose adjustments.2
One (1) unit of Fiasp corresponds to 1 international unit of human insulin, or 1 unit of other fast-acting insulin analogues.2
Patients switching to Fiasp from a different insulin should be trained on how to administer Fiasp.2
See the insulin aspart (Fiasp) product information for more information.
A generic brand of oxycodone 5 mg, 10 mg, and 20 mg capsules (Oxycodone BNM) is now listed on the PBS General Schedule. The originator brand (OxyNorm) is still available.1,4
What is it?
Oxycodone BNM is a full opioid agonist with affinity for kappa, mu and delta opiate receptors in the brain and spinal cord.5
It is similar to morphine in its mechanism of action.5
Oxycodone also has pharmacological effects in the central nervous system, smooth muscle and cardiovascular system.5
Who is it for?
Oxycodone BNM is indicated for the management of opioid-responsive moderate to severe pain.5
It is PBS-listed for severe disabling pain that is unresponsive to non-opioid analgesics.4
Oxycodone BMN capsules can be substituted with OxyNorm capsules1 but they are not interchangeable with Endone tablets.5
As with any opioids, there is risk of tolerance, abuse and physical dependence with oxycodone.5
An excess of opioid medicines can cause respiratory depression.5
Oxycodone BNM capsules should be swallowed whole and not opened, chewed or crushed. Patients who are taking oxycodone BNM capsules should avoid drinking alcohol.5
Find out more about chronic (non-cancer) pain management and opioid prescribing on the NPS MedicineWise website.
Other key items
Other items listed in May or June 2019 include:1,4,6
- Ferric carboxymaltose for treatment of iron deficiency (General Schedule, Item 11702X)
- Abatacept autoinjector for rheumatoid arthritis (General Schedule, Items 11684Y and 11693K)
- Lacosamide oral liquid for intractable partial epileptic seizures (General Schedule, Item 11694L).
See the PBS Summary of Changes for a complete list of all additions, deletions and alterations.
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (June 2019). Canberra: Australian Government Department of Health 2019 (accessed 1 June 2019).
- Novo Nordisk Pharmaceuticals Pty Ltd. Insulin aspart (Fiasp) product infomation. Sydney: 2017 (accessed 27 May 2019 ).
- Pharmaceutical Benefits Scheme. Public Summary Documents: Insulin Aspart (November 2018 PBAC meeting). Canberra: Australian Government Department of Health, 2019 (accessed 27 May 2019).
- Pharmaceutical Benefits Scheme. PBS Schedule. Canberra: Australian Government Department of Health, 2019. (accessed 1 June 2019).
- Boucher and Muir Pty Ltd. Oxycodone product information. Sydney: 2018 (accessed 28 May 2019).
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of Changes (May 2019). Canberra: Australian Government Department of Health 2019 (accessed 1 June 2019).