Recommendations made by the PBAC - December 2016

Page last updated: 6 March 2017

Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2016 relating to the listing of drugs on the Pharmaceutical Benefits Scheme (PBS).

Recommendations made by the PBAC - December 2016
DRUG, SPONSOR, TYPE OF SUBMISSION	DRUG TYPE OR USE	LISTING REQUESTED BY SPONSOR / PURPOSE OF SUBMISSION	PBAC OUTCOME
ADALIMUMAB Injection 40 mg in 0.8 mL pre-filled pen Injection 40 mg in 0.8 mL pre-filled syringe Humira^® AbbVie Pty Ltd Change to listing (Major submission)	Hidradenitis suppurativa (HS)	Resubmission to request an Authority Required listing for the treatment of moderate to severe HS. (Deferred by the PBAC in November 2016)	The PBAC recommended the listing of adalimumab on the General Schedule for the treatment of patients with moderate-to-severe HS under certain conditions on a cost-effectiveness basis. The PBAC noted that this is the first treatment for moderate-to-severe HS recommended for listing on the PBS. The PBAC was satisfied that adalimumab provides, for some patients, a significant improvement in effectiveness compared with best supportive care. The PBAC considered that the cost effectiveness of adalimumab for HS was acceptable following the reduction in the requested price and in conjunction with the requested continuation rule and risk sharing measures to provide additional certainty.
CHLORAMPHENICOL Eye drops 5 mg per mL, 10 mL, Chlorsig^® Aspen Pharma Pty Ltd	For treatment of a patient identifying as Aboriginal or Torres Strait Islander	To re-list chloramphenicol 0.5% eye drops, 10 mL on the PBS for Aboriginal or Torres Strait Islander patients.	The PBAC recommended the listing of chloramphenicol 0.5% eye drops, 10 mL as a restricted benefit for Aboriginal and Torres Strait Islander patients.
EVEROLIMUS Everolimus 1 mg tablet, 60 Everolimus 250 microgram tablet, 60 Everolimus 500 microgram tablet, 60 Everolimus 750 microgram tablet, 60 Certican^® Novartis Pharmaceuticals	Maintenance of renal and cardiac transplant	To seek the PBAC’s advice on whether everolimus (transplant indications) should be made Unrestricted to align with sirolimus on the PBS.	The PBAC recommended that the current General Schedule listings for everolimus (Certican^®) for maintenance of renal transplant and maintenance of cardiac transplant be made Unrestricted to align the listings with sirolimus.
GLYCERYL TRINITRATE 300 microgram sublingual tablet, 100 and 600 microgram sublingual tablet, 100 Nitrostat^® Pfizer Australia Pty Ltd	Prevention and treatment of acute angina pectoris	The Minister (delegate) referred the following matters to the PBAC for advice: whether to list a new brand of the listed drug, glyceryl trinitrate, tablets 600 micrograms, 100; and whether to list a new form of glyceryl trinitrate, tablets 300 micrograms, 100.	The PBAC recommended the listing of glyceryl trinitrate, tablets 300 micrograms, 100 and a new brand of glyceryl trinitrate, tablets 600 micrograms sublingual tablets as an alternative to Lycinate and Anginine Stabilised brand glyceryl trinitate 600 micrograms tablets, at the same price as the currently PBS listed 600 microgram tablets. The PBAC advised that these new listings should be consistent with that for the currently listed glyceryl trinitrate 600 microgram sublingual tablets.
NALOXONE Naloxone hydrochloride 1 mg/ mL injection, 1 x 2 mL pre-filled syringe, Prenoxad^® Phebra Pty Ltd	Reversal of opioid overdose	The Minister (delegate) requested that the PBAC provide advice on the following: Request for a General Schedule, unrestricted PBS listing of a pre-filled syringe form of naloxone which is suitable for use in an at home setting.	The PBAC recommended the listing of naloxone in the form of naloxone hydrochloride 1 mg/ mL injection, 1 x 2 mL pre-filled syringe on the basis that there is a high clinical need for naloxone presentations that are suitable for at-home use and use by laypeople. The PBAC recommended that this new listing should be consistent with that for the currently listed naloxone product with the exception that naloxone hydrochloride 1 mg/mL injection, 1 x 2 mL pre-filled syringe not be made available as a prescriber bag item.
PIRFENIDONE Capsule 267 mg Esbriet^® Roche Products Pty Ltd New listing (Major submission)	Idiopathic pulmonary fibrosis (IPF)	Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required listing for the treatment of IPF. (Deferred by the PBAC in November 2016)	The PBAC recommended the listing of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) under certain conditions on a cost-minimisation basis to nintedanib. The PBAC recalled that it previously considered nintedanib and pirfenidone to be similarly clinically effective and that it recommended nintedanib for IPF in November 2016 on a cost effectiveness basis. The PBAC considered that listing pirfenidone, such that the effective daily cost is no higher than that for nintedanib, would be appropriate.
Update of restrictions that currently refer to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition	Various	To seek the PBAC’s advice on updating restrictions which currently refer to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) to the current edition, DSM-V.	The PBAC recommended updating the term ‘autism’ to ‘autism spectrum disorder’ and ‘DSM-IV’ to ‘DSM-V’ in the current restriction for risperidone. In making this recommendation, the PBAC noted that autistic disorder, Asperger’s disorder, childhood disintegrative disorder and pervasive developmental disorder not otherwise specified have been consolidated into autism spectrum disorder in the current DSM-V which in turn made the term ‘autism’ obsolete.