Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1^st September 2022. This information may be of interest to your members.

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.

Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)

Risdiplam (Evrysdi®) (750 microgram/mL and powder for oral liquid, 80 mL) has had a change to remove the grandfather treatment.

Spinal muscular atrophy (SMA)

Nusinersen (Spinraza®) solution for injection 12.6 mg in 5 mL has had a change to extend the current Section 100 Highly Specialised Drugs Program Authority Required (Written) listing to include paediatric patients with Type 3b/c SMA. Authority applications for nusinersen for initial treatment can be made in writing. Continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Severe Crohn's disease

Vedolizumab (Entyvio®) (subcutaneous 108mg/0.68mL injection and 2 x 0.68 mL pen devices) has had a change to remove the grandfather treatment.

Ulcerative Colitis

Vedolizumab (Entyvio®) (subcutaneous 108mg/0.68mL injection and 2 x 0.68 mL pen devices) has had a change to remove the grandfather treatment.

Acute myeloid leukaemia

Gilteritinib (Xospata®) 40 mg tablet is now listed on the PBS for the treatment of acute myeloid leukaemia. Authority applications for gilteritinib for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

High grade epithelial ovarian, fallopian tube, or primary peritoneal cancer

Niraparib (Zejula®) 100 mg capsules are now listed on the PBS for the treatment of high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Multiple myeloma

Selinexor (Xpovio®) 20 mg tablet is now listed on the PBS for the treatment of multiple myeloma. Authority applications for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Familial heterozygous hypercholesterolaemia

Alirocumab (Praluent®) 75 mg/mL & 150 mg/mL injection, 2 x 1 mL pen devices has had a change to remove the grandfather treatment.

Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer

Pembrolizumab (Keytruda®) 100mg/4mL injection, 4 mL vial has had a change to remove the grandfather treatment.

SARS-COV2 infection

Molnupiravir (Lagevrio®) & nirmatrelvir+ritonavir (Paxlovid®) have had an amendment to the clinical criteria within the restriction to provide clarity regarding hospitalisation due to COVID. Authority applications for molnupiravir & nirmatrelvir+ritonavir are streamlined.

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Atezolizumab (Tecentriq®) has had a change to remove the grandfather treatment.

Ketogenic diet

Medium chain triglycerides (K.Quik®) is a new brand to replace the currently listed Betaquik® brand. Authority applications for medium chain triglycerides is streamlined.

Prostate cancer

Cabazitaxel (Cabazitaxel Ever Pharma) 60 mg in 6 mL injection is now listed on the PBS for the treatment of prostate cancer. Authority applications for cabazitaxel is streamlined.

Chronic kidney disease

Dapagliflozin (Forxiga®) 10 mg tablet is now listed on the PBS for the treatment of chronic kidney disease. Authority applications for dapagliflozin is streamlined.

Multiple sclerosis

Glatiramer (Copaxone®) 40 mg in 1 mL single dose pre-filled pen device is now listed on the PBS for the treatment of multiple sclerosis. Authority applications for glatiramer is streamlined.

Severe dry eye syndrome

Polyethylene Glycol 400 with Propylene Glycol (Systane®) eye drops 4mg-3mg per mL for the treatment of severe dry eye syndrome has had a change in the pack size, from a pack of 28 x 0.8 mL unit doses to 30 x 0.8 mL unit doses. Authority applications for polyethylene glycol 400 with propylene glycol is streamlined.

Severe chronic plaque psoriasis

Apremilast (Otezla®) tablet has had an amendment to the PBS listing to allow general practitioners to prescribe maintenance treatment. Authority applications for apremilast is streamlined.

Rituximab

Rituximab (various brands) 500mg/50mL injection, 50 mL vial, 100mg/10mL injection, 10mL vial has had a change of authority level to unrestricted for all indications. There will be new item codes listed under S100 HSD and S100 EFC special arrangements. Existing item codes will be made supply only for the duration specified on the PBS website.

Detrusor overactivity

Oxybutynin (Pro Pharmaceuticals Group Pty Ltd) 5 mg tablets supply shortage under section 19a.

1 September 2022 delisted PBS listings

Eptifibatide (Integrilin®) 20mg/10mL and 75mg/100mL injection for the treatment of coronary artery disease has been delisted from the PBS.

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 medicines listed on the PBS for multiple Authority Required (Written) programs. This is 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.

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

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