July 2006 PBAC Outcomes - Deferrals
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,
Pulmozyme®, 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 |
