July 2006 PBAC Outcomes - Deferrals

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Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2006 relating to the listing of drugs on the Pharmaceutical Benefits Scheme (PBS)

Drug and Form Drug Use and Type Listing Requested by Sponsor PBAC Outcome and Comment
Diphtheria and tetanus vaccine for adult use, injection 0.5 mL in pre-filled syringe, adsorbed. Diluted for adult use, ADT®

CSL Limited

Minor submission

Vaccine Listing of replacement ADT vaccine for Doctor’s Bag (not as yet TGA registered) which is sourced from a third party. A higher price than for current listing is requested. The PBAC deferred the submission to seek the views of the sponsor and the Australian Technical Advisory Group on Immunisation on the suitability of the adult/adolescent formulation of diphtheria – tetanus-acellular pertussis vaccine for this purpose.
Sponsor’s comment The sponsor needs to clarify the decision with the PBAC.
Dornase alfa, solution for inhalation, 2.5 mg (2,500 units) in 2.5 mL ampoule,


Roche Products Pty Ltd

Minor submission

Treatment for cystic fibrosis A change to the restriction to allow children less than 5 years of age to receive treatment. In view of expert advice received that it is not possible to objectively measure improvements with treatment of patients less than 5 years of age, the PBAC again deferred the submission to seek advice on a possible restriction to target the most severe patients in whom dornase alfa is more likely to be cost-effective. The PBAC expressed sympathy with the request and decided to seek a meeting with the expert clinicians to try and reach an agreed position.
Sponsor’s comment The sponsor agrees with the PBAC decision.
Goserelin acetate and bicalutamide, subcutaneous implant 3.6 mg- tablet 50 mg x 28;subcutaneous implant 10.8 mg-tablet 50 mg x 28, and subcutaneous implant 10.8 mg-tablet 50 mg x 84(Zoladex Plus®)

AstraZeneca Pty Ltd

Minor submission

Prostate cancer Authority required listing for metastatic (equivalent to stage D) prostatic carcinoma in patients for whom a combination of an antiandrogen and a GnRH (LH-RH) agonist is required. The PBAC deferred the submission to seek the sponsor’s comments on concerns about the proposed listing .
Sponsor’s comment AstraZeneca will be responding to the PBAC’s request