(1)   Is it correct that in the 2009-10 Budget the Government has allocated $200 million per year for Lucentis, and that each injection for treating macular degeneration costs (per vial) approximately $2000.

(2)   Is the Minister aware of research and international clinical practice that indicates Lucentis and Avastin provide an equivalent clinical outcome for patients with macular degeneration.

(3)   Has the department, the Therapeutic Goods Administration or the Pharmaceutical Benefits Advisory Committee (PBAC) considered this international experience and research, or done any other investigation as to whether Avastin would deliver an equivalent clinical outcome for patients with macular degeneration as Lucentis at a lower cost; if not, why not.

(4)   Is the Minister aware that Avastin was recommended by New Zealand’s Pharmaceutical Management Agency (PHARMAC) for use in patients with macular degeneration.

(5)   Has the department examined the experience in the United States of America (US), and specifically, is it correct that in the US Avastin is now used twice as often as Lucentis to treat macular degeneration.

(6)   What would be the cost (per vial) for an injection of Avastin for the treatment of macular degeneration in Australia.

(7)   Has the department or the PBAC considered the savings that could be made through the use of Avastin to treat macular degeneration; if not, why not.

(8) (a)   Is the Minister, the department or the PBAC aware of claims that savings of approximately $100 million per year could be made to the Pharmaceutical Benefits Scheme (PBS) expenditure by encouraging the use of Avastin, whilst delivering an equivalent clinical outcome to products already listed on the PBS which are more expensive than Avastin; and (b) what is the view of the Minister, the department and/or the PBAC of this claim.

(1)   The addition of Lucentis® to the PBS was announced in mid-2007. The Government did not allocate $200 million per year for Lucentis® in the 2009/10 Budget. There are two products on the PBS for the treatment of macular degeneration by injection: Visudyne®, at $2246.36 per injection and Lucentis® at $1976.36 per injection.

(2) (3)   , (6), and (7) The supplier of Avastin®, Roche Products, would need to apply to the Therapeutic Goods Administration (TGA) for registration of this product in Australia for macular degeneration. Roche may submit, at any time, an application to the PBAC for PBS subsidy of Avastin® for macular degeneration, provided Avastin® has been registered for treatment of that condition with the TGA. The Pharmaceutical Benefits Advisory Committee (PBAC) has not yet received a submission for the treatment of any other indication with Avastin®. The Government is committed to using sound, evidence-based principles to decide which products should be subsidised through the PBS and under what circumstances. The same requirements for listing medicines on the PBS are applied in all cases to ensure consistency and fairness in the listing process. Avastin® is currently listed on the PBS for bowel cancer at a cost of $534.77 per 100mg vial, and $1866.36 per 400mg vial. The price per vial for any other listings would be determined as part of the PBAC process to assess cost effectiveness.

(4)   Yes

(5)   The Department has not examined the US experience and is unable to comment on the use of Avastin compared to Lucentis.

(8) (a)   No. (b) As no submission has been made to the PBAC for the listing of Avastin® for macular degeneration, it is not possible to comment on the costs and benefits of Avastin® this condition.