Please find below information relating to new and amended Pharmaceutical Benefits Scheme (PBS) listings implemented on 1st June 2023.

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

Metastatic castration sensitive carcinoma of the prostate

Apalutamide (Erlyand®) (60 mg tablet) is now listed on the PBS for the treatment of metastatic castration sensitive carcinoma of the prostate. Authority applications for initial, grandfather and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Chronic severe dry eye disease with keratitis

Ciclosporin (Cequa®) (eye drops 0.09%, single dose units, 0.25 mL, 60) is now listed on the PBS for the treatment of chronic severe dry eye disease with keratitis. Authority applications for initial and continuing treatments can be made either in real time using the Online PBS Authorities system or by telephone.

Seizures of the Lennox-Gastaut syndrome

Cannabidiol (Epidyolex®) (100 mg/mL oral liquid, 100 mL) is now listed on the PBS for the treatment of seizures of the Lennox-Gastaut syndrome. Authority applications can be made either in real time using the Online PBS Authorities system or by telephone.

Relapsed and/or refractory multiple myeloma

Selinexor (Xpovio®) (20 mg tablet) has had an amendment to include triple therapy with bortezomib and dexamethasone for the treatment of relapsed and/or refractory 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.

Advanced, metastatic or recurrent endometrial carcinoma

Pembrolizumab (Keytruda®) (100 mg in 4 mL injection, 4 mL vial), in combination with lenvatinib (Lenvima®) (capsule 4 mg, 10 mg) is now listed on the PBS for the treatment of advanced, metastatic or recurrent endometrial carcinoma. Authority applications for initial, grandfather and continuing treatments are streamlined.

Smoking cessation therapy for nicotine dependence

Nicotine patches have had a change to their restriction allowing an additional 12 weeks of PBS-subsidised nicotine replacement therapy (NRT) in a 12-month period and to remove the requirement to be used as monotherapy to allow for combinations of NRT patch + short acting formulations to be used concomitantly. Nicotine patches are listed on the PBS as a restricted benefit.

Treatment of bacterial infections

Amoxicillin and clavulanate potassium (Aurobindo®; Micro Labs®) (USP 875 mg/125 mg tablets 20 pack) is now listed on the PBS for the current supply shortage under section 19A. Amoxicillin and clavulanic acid is listed as a restricted benefit and as a streamlined authority.

Phenoxymethylpenicillin (Penopen®) (250 mg/5 mL powder for oral solution) is now listed on the PBS for the current supply shortage under section 19A as an unrestricted benefit.

Cefalexin (Keforal®) (250 mg/5 mL granules for oral suspension) is now listed on the PBS for the current supply shortage under section 19A as an unrestricted benefit.

Severe refractory hypertension

Minoxidil (Roma Pharmaceuticals®) (10 mg tablet) for the treatment of severe refractory hypertension is now listed on the PBS for the current supply shortage under section 19A as a restricted benefit.

Arrhythmia

Disopyramide (Rythmodan® UK, Rythmodan® Canada) (100 mg capsule) for ventricular arrhythmias is now listed on the PBS for the current supply shortage under section 19A as an unrestricted benefit.

Growth Hormone

There is a shortage of Norditropin Flexpro (5mg, 10mg and 15mg) for the treatment of growth hormone. A Serious Scarcity Substitution Instrument for these products will not be possible. Prescribers will need to consider alternative treatment plans, including alternative treatment options.

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

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