PBS changes from 1 December 2020

New and amended PBS listings include: 

Maximum allowable quantities and repeats: Several medicines will have amendments made to the maximum allowable quantity and repeats, to align with the TGA approved Product Information recommended dosing. These medicines are available through the Online PBS Authority System for a real time result. The system will allow approval of the maximum allowable quantity and repeats, if required.  

Ankylosing spondylitis: Ixekizumab will be listed on the PBS for the treatment of ankylosing spondylitis. This is an additional bDMARD that has been made available to the existing ankylosing spondylitis program. This item is Authority Required (Written), except for balance of supply which can be accessed in real time via the Online PBS Authorities system (OPA). 

Pulmonary Arterial Hypertension (PAH): Ambrisentan has been listed on the PBS as an additional agent that may be used in dual therapy for the treatment of PAH. This is in addition to the agents listed on 1 October 2020. Dual therapy is limited to a combination of an ERA (ambrisentan, macitentan and bostentan monohydrate) and a PDE-5i (sildenafil citrate and tadalafil) only.  

• These items are Authority Required (In Writing) for initial applications and Authority Required (Telephone/Electronic*) for continuing applications. The patient must be treated by a physician with expertise in the management in PAH and the applications for authority approval must also be made by a physician with expertise in the management in PAH. 

Spinal Muscular Atrophy (SMA): The listing of Nusinersen for the treatment of spinal muscular atrophy has been expanded to include the indication of pre-symptomatic SMA patients before the age of 36 months. This item is Authority Required (In Writing) for initial applications and Authority Required (Telephone/Electronic*) for continuing applications. The two indications (symptomatic and pre-symptomatic) are separate and will require selection of the correct PBS item and restriction codes.  

Chronic Lymphocytic Leukaemia (CLL): Venetoclax for the treatment of chronic lymphocytic leukaemia (CLL), used in combination with obinutuzumab, will be made available as first-line treatment of patients with CLL who have co-existing conditions and are unsuitable for fludarabine based chemotherapy. This item is Authority Required (Telephone/Electronic*). 

HIV treatment: Dovato (Dolutegravir + Lamivudine) for the treatment of HIV will be made available. This is a combination treatment and patients currently being treated with the individual medicines will be able to access them as a combination product. This item is Authority Required (Streamlined). 

Cerebral Palsy: Clostridium Botulinum type a toxin-haemagglutinin complex (Botox) will have a new brand –Dysport – listed on the PBS. This listing will be expanded to include treatment of focal spasticity of the upper limb. This item is Authority Required (Streamlined). 

Asthma: Fostair (beclometasone dipropionate+formoterol) is a new fixed dose combination of an ICS and a LABA for the maintenance treatment of asthma that will be PBS subsidized. This will now include new fixed dose combination therapy for maintenance therapy only. This item is Authority Required (Streamlined). 

Coronary artery disease (CAD) and peripheral artery disease (PAD): A new strength of rivaroxaban (2.5mg) will be subsidised on the PBS in combination with aspirin for the treatment of coronary artery disease (CAD) and peripheral artery disease (PAD). The item is Authority Required (Streamlined). 

Buruli Ulcer: Rimycin (rifampicin) indications will be expanded to include the treatment of mycobacterium ulcerans infections (Buruli ulcer). This item is Authority Required (Telephone/Electronic*).  

Palliative care: Paracetamol suppositories for the management of mild to moderate pain in palliative care will be supplied in a new pack size, which is subsidised on the PBS. This item is a Restricted Benefit on the PBS. 

*Authority Required (Telephone/Electronic)  

Authority Required (Telephone/Electronic) means you can now request an Authority using the Online PBS Authorities system. The electronic system allows you to easily request a PBS Authority and obtain an approval or rejection straight away. You can use the Online PBS Authorities system to:  

• Request an Authority and receive a real time assessment result (for most PBS Authority medicines 

• Reduce the waiting periods for authority requests 

• Submit the authority request 24/7 

• Cancel or amend approved applications not already dispensed 

Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities System are available in this article.

For more information, please visit the PBS website.