New Drugs for Australia?

[Euan]

Sipuleucel-T (Provenge®)

FDA approved April 29, 2010 - US$93,000 for a course of 3 treatments

The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Dendreon explained disappointing sales by saying doctors are afraid they won't get reimbursed. Also only about 25% of potential prescribers were aware of a June 30 2011 decision by US Medicare to cover the drug's cost.

Dutasteride/tamsulosin (Duodart®)

FDA approved June 2010. Available on the PBS from 1 September 2011 for men with BPH (also required by men following LDR and HDR brachytherapy). Previously tamsulosin only available on the RPBS.

Denosumab (Xgeva®, Prolia® in Australia)

FDA approved November 18, 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. The median time to first on-study SRE was 20.7 months denosumab vs. 17.1 months zoledronic acid.

The July 2011 PBAC meeting recommended the listing on the basis of acceptable cost-effectiveness compared with zoledronic acid. Cost A$304.87 per injection

Available on the PBS from 1 December 2011 for the treatment of bone metastases from breast cancer and hormone-resistant prostate cancer.

Cabazitaxel (Jevtana®),

FDA approved June 17, 2010 – US$8000 per vial typically 6 vials used.

The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.

The July 2011 PBAC meeting rejected the submission on the basis of a high and uncertain cost-effectiveness ratio. Resubmitted for November 2011 PBAC meeting for treatment of hormone refractory metastatic carcinoma of the prostate previously treated with docetaxel. Rejected again for the same reason.

Abiraterone acetate (Zytiga®)

FDA approved April 28, 2011. A CYP17 inhibitor costing US$5000 month.

Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.

Submitted to the November 2011 PBAC meeting for treatment of metastatic CRPC following docetaxel. The outcome on 21/12/11 was that the PBAC recommendation cannot be made public until the TGA outcome is known.

Viberect

Medical device approved by FDA June 2011 – US$300

Approved for erectile dysfunction and requires prescription

[Mitoxantrone is sometimes spelt mitozantrone]