Positive Recommendations made by the PBAC - December 2008

Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2008 relating to the listing of drugs on the Pharmaceutical Benefits Scheme (PBS).

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Positive recommendations made by the PBAC, December 2008

Drug Name and Sponsor

Drug Use and Type

Listing requested by Sponsor

PBAC Recommendation

ADALIMUMAB, pre-filled syringe, 40 mg in 0.8 mL, pre-filled injection pen, 40 mg in 0.8 mL, Humira®, Abbott Australasia Pty Ltd

ETANERCEPT, injection set containing 4 vials powder for injection, 25 mg and 4 pre-filled syringes solvent 1 mL, injection set containing 4 vials powder for injection, 50 mg and 4 pre-filled syringes solvent 1 mL, injections, 50 mg in 1 mL single use pre-filled syringes, Enbrel®, Wyeth Australia Pty Ltd

INFLIXIMAB, powder for I.V. infusion, 100 mg, Remicade®, Schering-Plough Pty Ltd

Minor submission
Psoriatic arthritis Amend the restriction applying to Treatment of adult patients with severe active psoriatic arthritis to remove the requirement that the psoriatic component be confirmed by a dermatologist or biopsy at any time. The PBAC recommended the removal of the requirement to have the psoriatic component of the disease confirmed by a dermatologist or by biopsy from the current restrictions for adalimumab, etanercept and infliximab for the treatment of psoriatic arthritis.
nab-PACLITAXEL, powder for I.V. injection (suspension), 100 mg, Abraxane®, Specialised Therapeutics Australia Pty Ltd

Minor submission
Breast cancer Treatment of patients with metastatic breast cancer after failure of prior therapy which includes an anthracycline. The PBAC recommended an Authority required listing of nab-paclitaxel on the PBS for the treatment of metastatic breast cancer after failure of prior therapy which includes an anthracycline. This recommendation was on a cost-minimisation basis against solvent-based paclitaxel. The equi-effective doses were 260 mg/m2 of nab-paclitaxel and 175 mg/m2 of solvent-based paclitaxel.