Amino acid formula with vitamins and minerals without phenylalanine (ADD INS®)
Scientific Hospitals Supples c/- Nutricia Australia
Minor submission
|
Nutrient for inborn error of metabolism |
Listing as a restricted benefit for phenylketonuria |
The PBAC decided to defer consideration of this item for use in the dietary management
of phenylketonuria following advice from the Nutritional Products Working Party that
it wished to investigate further the absence of inositol and choline from Add Ins.
|
| Sponsor’s comment |
Nutricia looks forward to working with the PBAC to resolve this issue. |
Mupirocin, cream 20 mg per g (2%), ointment 20 mg per g (2%), Nasal Ointment 20 mg
per g (2%) (Bactroban®)
GlaxoSmithKline Australia Pty Ltd
Minor submission
|
Topical antibacterial |
Listing as an authority required benefit for the treatment of mild impetigo (ointment
and cream), and for the elimination of nasal carriage of staphylococci (nasal ointment)
in Aboriginal and Torres Strait Islander persons.
|
The PBAC deferred consideration of this submission pending the reconsideration of
the listing request by the indigenous health Advisory Panel, in light of the concerns
expressed by the Expert Advisory Group on Antimicrobial Resistance.
|
| Sponsor’s comment |
The sponsor looks forward to working with the PBAC to resolve this issue. |
Strontium ranelate, sachet for oral susp, 2 g, (Protos®)
Servier Laboratories (Australia) Pty Ltd
Minor submission
|
To treat osteoporosis |
Requesting an extension to the authority required listing to include women aged 70
years or older with low bone mineral density (BMD) T-score of -3.0 or less and without
prevalent fracture.
|
The PBAC considered that the analyses of the indirect comparison in this minor submission
required evaluation by the Pharmaceutical Evaluation Section and therefore deferred
the submission for this to occur.
|
| Sponsor’s comment |
No comment |
Sunitinib malate, capsules, 12.5 mg, 25 mg and 50 mg (Sutent®)
Pfizer Australia Pty Ltd
Major submission
|
Anti cancer drug |
Authority required listing for the treatment of advanced renal cell carcinoma (RCC) |
The PBAC deferred consideration of this item pending the provision of further economic
analyses to demonstrate that sunitinib is a cost effective treatment for renal cell
carcinoma.
|
| Sponsor’s comment |
The sponsor is working with the PBAC to resolve the issues. |
Sunitinib malate, capsules, 12.5 mg, 25 mg and 50 mg (Sutent®)
Pfizer Australia Pty Ltd
Major submission
|
Anti cancer drug |
Section 100 special authority required listing for the treatment of gastrointestinal
stromal tumour (GIST) after failure of imatinib mesylate due to resistance or intolerance.
|
The PBAC decided to defer consideration of the submission pending the provision of
further information to demonstrate that sunitinib is a cost effective treatment for
gastro-intestinal tumour after failure of imatinib.
|
| Sponsor’s comment |
The sponsor is working with the PBAC to resolve the issues. |
