Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1^st December 2021. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities System is also attached. 

This information relates to the administration of these listings by Services Australia. For further information on broader PBS changes, please visit the PBS website. Relevant information and authority application forms have been updated and can be accessed through Services Australia website. 

Hereditary angioedema:
Lanadelumab is now PBS listed for hereditary angioedema for patients aged 12 years and older. Authority requests for Initial and grandfather applications must be submitted in-writing only via mail or electronic upload through HPOS form upload function. Authority applications for continuing treatment can be made either in real time using HPOS or by telephone.
 
Pulmonary arterial hypertension:
As of 1 December 2021, ambrisentan, bosentan, macitentan, sildenafil and tadalafil for pulmonary arterial hypertension dual therapy will no longer be PBS subsidised for patients wishing to commence treatment under the grandfathered PBS restrictions.
 
Severe chronic plaque psoriasis:
Etanercept for severe chronic plaque psoriasis for patients under the age of 18 years, has had amendment to the restriction treatment phases. Authority requests for initial, re-treatment, change or recommencing, and course completion applications must be submitted in writing only via mail or electronic upload through HPOS form upload function.
 
Severe active rheumatoid arthritis and Juvenile idiopathic arthritis:
As of 1 December 2021, patients can either continue with the treatment they commenced with the temporary listings due to critical shortage of tocilizumab PBS listed 1 November 2021 or they can switch back to treatment with tocilizumab. Authority requests for change of treatment (from another biological medicine to tocilizumab after resolution of the critical shortage) applications must be submitted in-writing only via mail or electronic upload through HPOS form upload function.
 
Metastatic or unresectable malignant gastrointestinal stromal tumor:
Ripretinib is now PBS listed for metastatic or unresectable malignant gastrointestinal stromal tumor. Authority applications for initial and continuing treatment can be made either in real time using HPOS or by telephone.
 
Acute myeloid leukemia:
Venetoclax is now PBS listed for acute myeloid leukemia. Authority applications for initial and continuing treatment can be made either in real time using HPOS or by telephone.
 
Chronic hepatitis C infection:
Ribavirin 200 mg strength is now PBS listed for chronic hepatitis C infection. Authority applications for initial and continuing treatment can be made either in real time using HPOS or by telephone.
 
Ketogenic diet:
KetoVie® Peptide 4:1, 250ml oral liquid, high fat formula with vitamins, minerals and trace elements, low in protein and carbohydrate, a new listing for an existing condition – Ketogenic diet. Authority applications can be made either in real time using HPOS or by telephone.
 
Follitropin alfa (Ovaleap®):
Follitropin alfa a new Authority Required (Streamlined) PBS listed biosimilar brand of Gonal-f for assisted reproductive technology.

1 December 2021 delisted PBS listings
 
Testosterone undecanoate (Andriol Testocaps ®)
 Undecanoate 40mg capsule, for Androgen deficiency, micropenis, pubertal induction, constitutional delay of growth or puberty, has been delisted from the PBS as the product has been discontinued from the Australian market. The standard 12 months’ “Supply Only” will apply.
 
Desmopressin (Minirin)
 Desmopressin acetate 100mcg/mL nasal drops, has been delisted from the PBS with 6 months “Supply Only” arrangement.
 
Benralizumab (Fasenra)
 Benralizumab 30mg/mL injection, has been delisted from the PBS as the product has been discontinued. The standard 12 months’ “Supply Only” will apply.

To learn more about these updates, please contact Services Australia directly.

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