March 2007 PBAC Outcomes - Subsequent Decision to Defer
March 2007 PBAC Subsequent Decision to Defer - Bortezomib
|Drug and Sponsor||Drug Use and Type||Listing requested by sponsor||PBAC Recommendation|
|Bortezomib, vial, 3.5 mg, (Velcade®)
Janssen-Cilag Pty Ltd
|Anti cancer drug||Authority required listing for multiple myeloma after failure of thalidomide in certain
patients who have progressive disease with a WHO performance status of 2 or less,
who have received at least one prior therapy and who have already undergone or are
ineligible for a primary stem cell transplant, and also in those
who are unsuitable for thalidomide.
Unsuitable for thalidomide treatment is defined according to the following contraindications in the TGA-approved Product Information: known hypersensitivity, pregnancy or breastfeeding, or inability to comply with adequate contraceptive measures in male and female patients of child-bearing age.
|The PBAC decided to defer the submission to allow the sponsor to present a revised version of the modelled economic evaluation, which could be considered as a minor submission. The sensitivity of the economic model to cost offsets associated with the extent of substitution of HDT/SCT was pivotal to the PBAC’s consideration. PBAC noted there is variation in clinical practice on the use of bortezomib and HDT/SCT and concluded that there is divergent clinical opinion on this matter. Thus, the extent of substitution remained unresolved.|
|Sponsor’s comment||In order to assist the PBAC in its consideration of bortezomib for PBS listing at its July 200 meeting, Janssen-Cilag has provided the additional requested sensitivity analyses.|