PBS Changes from 1 December 2022

Information relating to the new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st December 2022 can be found below. For further information, please download the Frequently Asked Questions.

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.  

Paroxysmal nocturnal haemoglobinuria
Pegcetacoplan (Empaveli®) (solution for subcutaneous infusion 1080 mg in 20 mL) is now listed on the PBS for the treatment of paroxysmal nocturnal haemoglobinuria. Authority applications for initial and continuing treatment can be made in writing.

Pulmonary arterial hypertension
Ambrisentan, bosentan, epoprostenol, iloprost, macitentan, riociguat, sildenafil and tadalafil (various brands) have had a change to the available dual therapy and triple therapy combinations and to the authority level for the treatment of pulmonary arterial hypertension. Authority applications for initial monotherapy, dual therapy or triple therapy treatment of pulmonary arterial hypertension in an untreated patient can be made either in real time using the Online PBS Authorities system or in writing. For previously treated patients, all treatment applications including changing from monotherapy to dual or triple therapy can be made either in real time using the Online PBS Authorities system or by telephone.

Growth hormone deficiency (Adult)
Somatropin (Genotropin Goquick®, Norditropin FlexPro®, NutropinAq®) has had amendments made to the prescriber instructions. Authority applications for somatropin for initial treatment of growth hormone in adults can be made either in real time using the Online PBS Authorities system or in writing. Continuing treatment applications can be made either in real time using the Online PBS Authorities system or by telephone.

Rheumatoid arthritis and severe active juvenile idiopathic arthritis
Tocilizumab (Actemra®) has had the temporary listings due to critical shortage removed as the critical shortage has been resolved. Patients wishing to change biological drugs under these programs must qualify under the change or recommencement criteria of the relevant drug. 

Primary mediastinal B-cell lymphoma, Hodgkin lymphoma, urothelial cancer and colorectal cancer
Pembrolizumab (Keytruda®) (solution concentrate for I.V. infusion 100 mg in 4 mL) has had an amendment to the existing listings for the treatment of primary mediastinal B-cell lymphoma, Hodgkin lymphoma, urothelial cancer and colorectal cancer. Authority applications for pembrolizumab for initial and continuing treatment of primary mediastinal B-cell lymphoma and Hodgkin lymphoma is streamlined. Authority applications for pembrolizumab for initial and continuing treatment of urothelial cancer and colorectal cancer can be made either in real time using the Online PBS Authorities system or by telephone. 

Hereditary angioedema Types 1 or 2
Lanadelumab (Takhzyro®) (300 mg/2 mL syringe) has had a change to remove the grandfather restriction.

Chronic heart failure
Vericiguat (Verquvo®) (tablet 2.5 mg, tablet 5 mg, tablet 10 mg) is now listed on the PBS for the treatment of chronic heart failure. Authority applications for vericiguat for initial treatment of chronic heart failure can be made either in real time using the Online PBS Authorities system or by telephone. Continuing treatment is streamlined.

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer
Lorlatinib (Lorviqua®) (tablet 25 mg, tablet 100 mg) has had an amendment to the existing listing. Authority applications for lorlatinib for initial and continuing treatment of Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer can be made either in real time using the Online PBS Authorities system or by telephone. 

Hypercholesterolaemia
Evolocumab (Repatha®) (injection 140 mg in 1 mL single use pre-filled pen, injection 420 mg in 3.5 mL single use pre-filled cartridge) has had an amendment to the existing listing. Authority applications for evolocumab for initial treatment of hypercholesterolaemia can be made either in real time using the Online PBS Authorities system or by telephone. 

Multiple sclerosis
Natalizumab (Tysabri®) (solution concentrate for I.V. infusion 300 mg in 15 mL) has had an amendment to the existing listing. Authority application for natalizumab for treatment of multiple sclerosis is streamlined.

Treatment of bacterial infections
Amoxicillin and clavulanic acid USP (Aurobindo) (875 mg/125 mg tablets 20 pack) is now listed on the PBS for the current supply shortage under section 19A. Authority applications for amoxicillin and clavulanic acid for treatment of bacterial infections is streamlined.

Amoxicillin (Kent) (250 mg/5 mL oral powder for suspension 100 mL) is now listed on the PBS for the current supply shortage under section 19A as an unrestricted benefit.

Central precocious puberty
Leuprorelin acetate (Eligard®) (suspension for subcutaneous injection (modified release) containing 45 mg of leuprorelin acetate) is now listed on the PBS for the treatment of central precocious puberty. Authority applications for initial and continuing treatment is listed as a restricted benefit.

Detrusor overactivity
Oxybutynin (Niche Generics Limited) (5 mg tablets 84 pack) is now listed on the PBS for the current supply shortage under section 19A as a restricted benefit.

Unrestricted benefit
Bevacizumab (Abevmy®) (solution for I.V. infusion 100 mg in 4 mL, solution for I.V. infusion 400 mg in 16 mL) is now listed on the PBS as an unrestricted benefit. 

1 December 2022 delisted PBS listings 

Hypertension
Pindolol (Barbloc®) (5 mg tablet) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.

Multiple sclerosis
Interferon Beta-1A (Rebiff 44®) has been delisted from the PBS with “Supply Only” arrangement until 1 April 2023.

Anticoagulant
Dipyridamole with aspirin (Diasp SR®) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.

Heparin (Pfizer Australia) (5000 IU in 5 mL 50 pack) has been delisted from the PBS with “Supply Only” arrangement until 1 December 2023.

Treatment of bacterial infections
Ampicillin (Alphapharm) (1 g vials) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.

Depression
Doxepin (Deptran®) (10 mg and 25 mg capsules, 50 mg tablet) has been delisted from the PBS with “Supply Only” arrangement until 1 June 2023.

Selecting the correct restriction in the Online PBS Authorities system

Balance of Supply (BoS) restrictions are available through the Online PBS Authorities system. New questions and answers (Q&As) have been applied against BoS restrictions for multiple medicines listed on the PBS for multiple Authority Required (Written) programs to ensure prescribers are selecting the correct restriction and treatment phase to determine their patient’s eligibility. These Q&As will also ensure prescribers are using the correct authority submission channel for the required treatment phase to avoid post compliance activities.