November 2006 PBAC Outcomes - Deferrals

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Drug and Form

Drug Use and Type

Listing Requested by Sponsor

PBAC Recommendation

Amino acids- synthetic formula, EleCare Vanilla®, and EleCare®, Abbott Australasia Pty Ltd
Minor submission
Nutritional Supplement Extend authority required listing to include the treatment of eosinophilic oesophagitis in children and adolescents. The PBAC decided to defer consideration of this matter following advice from the Nutritional Products Working Party that it wished to investigate further the appropriate use of this product for treatment of eosinophilic oesophagitis in children and adolescents.
Sponsor’s comments The sponsor looks forward to working with the PBAC to resolve this issue.
Trastuzumab, powder for I.V. infusion, 150 mg, Herceptin®, Roche Products Pty Ltd
Minor submission
Treatment of breast cancer Amend authority required restriction to allow sequential therapy to chemotherapy. The PBAC considered that a major submission is required to address the effectiveness and cost-effectiveness of the sequential to chemotherapy use of trastuzumab, and that such a submission needs to include data from the sequential arm of the N9831 trial, as well as the HERA trial.
Sponsor’s comments The sponsor will be considering its position regarding any future course of action.