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New and amended PBS listings and FAQs (February 2024)

Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 01 February 2024. Frequently Asked Questions (FAQs) relating to access and use of the Online PBS Authorities system are 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 the Services Australia website.  

Advanced (unresectable or metastatic) uveal melanoma
Tebentafusp (Kimmtrak®) (100 microgram/0.5 mL injection, 0.5 mL vial) is now listed on the PBS for the treatment of advanced (unresectable or metastatic) uveal melanoma. Authority applications for initial treatment (day 1) can be made either in real-time using the Online PBS Authorities system or by telephone. Prescriptions for initial treatment (day 8, day 15) and continuing treatment are Authority Required (STREAMLINED).

Chelation of elevated copper levels
Trientine (Trientine Dr.Reddy’s®) (trientine dihydrochloride 250 mg capsule is now listed on the PBS for the treatment of chelation of elevated copper levels. Authority applications can be made either in real-time using the Online PBS Authorities system or by telephone.

Clinically definite relapsing-remitting multiple sclerosis 
Natalizumab (Tysabri®) (150 mg/mL injection, 2 x 1 mL syringes) is now listed on the PBS for the treatment of clinically definite relapsing-remitting multiple sclerosis. Prescriptions for treatment are Authority Required (STREAMLINED).

Unresectable Stage III or Stage IV malignant melanoma
Nivolumab + relatlimab (Opdualag®) (nivolumab 240 mg/20 mL + relatlimab 80 mg/20 mL injection, 20 mL vial) is now listed on the PBS for the treatment of unresectable Stage III or Stage IV malignant melanoma. Prescriptions for initial and continuing treatments are Authority Required (STREAMLINED).

Major depressive disorders and obsessive-compulsive disorder
Fluoxetine (Medreich®) (10 mg capsule) for the treatment of major depressive disorders and obsessive-compulsive disorder is now listed on the PBS for the current supply shortage under Section 19A. Fluoxetine is listed as a restricted benefit.

Hypercholesterolaemia
Colestyramine (Cholestyramine-Odan®) (Colestyramine 4g powder for oral liquid,  30 sachets) for the treatment of hypercholesterolaemia is now listed on the PBS for the current supply shortage under Section 19A. Colestyramine is listed as a restricted benefit/unrestricted benefit.

Asthma and chronic obstructive pulmonary disease
Salbutamol (pms-Salbutamol®) (Salbutamol 2.5 mg/2.5 mL inhalation solution, 20 x 2.5 mL ampoules) for the treatment of asthma and chronic obstructive pulmonary disease is now listed on the PBS for the current supply shortage under Section 19A. Salbutamol is listed as a restricted benefit.

1 February 2024 delisted PBS listings 

Pyridoxine non-responsive homocystinuria
Amino acid formula with vitamins and minerals without methionine (HCU gel®) has been delisted from the PBS with no supply only arrangement. 

Maple syrup urine disease
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine (MSUD gel®) has been delisted from the PBS with no supply only arrangement.

Tyrosinaemia
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine (TYR gel®) has been delisted from the PBS with no supply only arrangement.

More information

For more information about the Online PBS Authorities system visit www.servicesaustralia.gov.au/hppbsauthorities.

Services Australia has a broad range of educational resources on the Health Professional Education Resources website. This includes simulations, podcast and an infographic on the Online PBS Authorities system. Visit https://hpe.servicesaustralia.gov.au/pharmaceutical-benefits-scheme.html.

Visit servicesaustralia.gov.au/hpwrittenauthoritydrugs on the Services Australia website to find the most up to date authority application form for each drug, program or condition.

Use the Health Professional Online Services upload function to submit your completed written authority application forms and any supporting documents or evidence. You’ll get a faster processing response using HPOS and will avoid any postage delays.

For more information go to servicesaustralia.gov.au/hpos.

FREQUENTLY ASKED QUESTIONS

Update to Continued Dispensing Arrangements – Emergency Measures

A Continued Dispensing Emergency Measure National Health (Continued Dispensing – Emergency Measure) Determination 2023 has been put in place from 22 December 2023 to temporarily support patients, affected by the flooding disaster in Far North Queensland, to continue to access their PBS subsidised medicines. Until this Emergency Measure ceases on 1 March 2024, it will provide access to a wider range of PBS medicines than under the normal Continued Dispensing arrangements, covering most medicines on the General Schedule of the PBS. Further information is available at legislation.gov.au/legislative-instruments.