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PBS changes from 01 December 2020

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings from 01 December 2020. 

Maximum allowable quantities and repeats
As of 01 December 2020, a variety of medicines treating several conditions 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.Please refer to the FAQ’s for more information about the Online PBS Authorities System. 

Ankylosing spondylitis
As of 01 December 2020, 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). All patients who are currently PBS subsidised with bDMARD treatment for ankylosing spondylitis will have their treatment cycle reset as a result of this change. 

Pulmonary Arterial Hypertension (PAH)
As of 01 December 2020, 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)
From 01 December 2020, 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 from 01 December 2020 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 on the PBS from 01 December 2020. 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 from 01 December 2020. This listing of this item 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 subsidised from 01 December 2020. 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 from 01 December 2020 to include the treatment of mycobacterium ulcerans infections (Buruli ulcer).  This item is Authority Required (Telephone/Electric*).

Palliative care
Paracetamol suppositories for the management of mild to moderate pain in palliative care will be supplied in a new pack size from 01 December 2020, 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: /p>

  • 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 the access and use of the Online PBS Authorities System can be downloaded below. For further information on broader PBS changes, please visit the PBS website.



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