December 2003 PBAC Outcomes - Deferrals

 

DRUG AND FORM DRUG USE AND TYPE LISTING REQUESTED BY SPONSOR PBAC RECOMMENDATION
AZITHROMYCIN tablet 500 mg Antibiotic Unrestricted listing The PBAC agreed that on clinical grounds, listing could be recommended for adults with respiratory tract infections. However, given that the Government now requires that all PBAC applications must be referred to the Expert Advisory Group on Antimicrobial Resistance (EAGAR) for comment on resistance, the PBAC deferred its decision on listing, pending receipt of a resistance risk assessment by EAGAR.

Sponsor's comment:

The sponsor looks forward to working with the PBAC to resolve the situation.

INFLIXIMAB powder for injection
100 mg, RemicadeĀ®
Schering-Plough Pty Ltd
Used to treat inflammatory diseases, such ankylosing spondyltis, rheumatoid arthritis and Crohn's disease Section 100 for "Initial treatment by a rheumatologist of adults with confirmed active ankylosing spondylitis according to specific criteria.
Continuing treatment by a rheumatologist of adults with confirmed active ankylosing spondylitis who demonstrate an adequate response to treatment with infliximab."
The PBAC accepted the submission's claims for clinical effectiveness and cost-effectiveness, but deferred its final decision to allow consultation between the stakeholders to address uncertainty regarding the wording of the restriction for PBS listing, for consideration at the March 2004 PBAC meeting.

Sponsor's comment:

Schering-Plough is looking forward to working with the PBAC and other stakeholders to clarify and finalise the wording of the restriction for the timely PBS listing of Remicade for AS.