PBS changes from 1 January 2021

14 Jan 2021

There have been several changes related to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented 1 January 2021 that may be of interest to AMA members. 

This information relates to the administration of these listings by Services Australia. 

Somatropin: a change will be made to the PBS listing of Somatropin for the treatment of severe growth hormone deficiency in adult patients. The restriction changes will allow the GH dose to be reduced in response to an elevated IGF-1 level without having treatment interrupted to normalise the IGF-1 level, providing the patient is being managed by an endocrinologist.  

For initial applications, this item is Authority Required and available for delayed assessment in-writing only via mail or electronic upload). For continuing applications, immediate/real time assessment is available via telephone or online channels.  

Daratumumab: Daratumumab will be listed on the PBS for second line treatment of multiple myeloma in combination with bortezomib and dexamethasone. This item is Authority Required and available for immediate/real time assessment via telephone or online channels.  

Osimertinib: Osimertinib will be listed on the PBS for the first line treatment of Non-small cell lung cancer (NSCLC). Osimertinib will now be accessed as first line treatment for patients with Stage IIIB (locally advanced) or Stage IV (metastatic), epidermal growth factor receptor mutation positive NSCLC.   

The current osimertinib listing for second line treatment of Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) will be changing from Authority Required (written) to immediate assessment for initial applications and to Authority Required (Streamlined) for continuing applications. The first line treatment will also be immediate assessment for initial and streamlined for continuing.  

It should be noted that patients who accessed osimertinib as a first line treatment will not be eligible for PBS subsidy for osimertinib for second line treatment. 

Lenvatinib with sorafenib: the treatment of Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma, will have Initial restrictions updated to include: ‘or Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to atezolizumab/bevacizumab combination therapy’.  

This item is Authority Required (Streamlined). 

Apremilast: Apremilast will be listed on the PBS for the treatment of severe chronic plaque psoriasis. Apremilast will be available for patients who have failed treatment with or who have shown contraindications or intolerance to methotrexate. Patients may be required to trial Apremilast prior to initiating PBS subsidised bDMARD treatment.  

This item is Authority Required (Streamlined). 

Epilepsy medicines: there is a change to the restrictions for epilepsy medicines to allow lamotrigine and levetiracetam to be available for first-line use in women of child bearing age.  

This item is Authority Required (Streamlined). 

Tenofovir with emtrictabine: for the treatment of Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection restrictions will change to include all patients at risk of contracting HIV regardless of age. Patients must be tested for HIV, however the prescriber may provide a prescription for PrEP regardless of whether they have the results of the test or not.  

This item will change from Authority required (Streamlined) to a Restricted Benefit. 

Prescriber Bag items: Oral furosemide 20mg (50 tablets) has been added to the schedule of items available via Prescriber Bag. 

For further information on broader PBS changes, please visit the PBS website