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Vertex Pharmaceuticals: Kalydeco Update In Australia

August 24, 2013

As reported in a recent Blog Post, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has deferred making a decision on the Government subsidization of orphan drug Kalydeco (Ivacaftor), for Cystic Fibrosis (CF) patients with the G551D mutation. The PBAC recommendation can be read on the Pharmaceutical Benefits Scheme website :

“ …the Pharmaceutical Benefits Scheme (PBS) is the most appropriate mechanism for subsidizing Ivacaftor for Australian patients, but that, at the price proposed in the submission, the cost per Quality Adjusted Life Year (QALY) is too high and too uncertain … to allow the sponsor the opportunity to consider the Committee’s views and to submit a new price proposal for PBS listing ….”.

Vertex Pharmaceuticals responded that they:

“ …. Look forward to meeting with the PBAC to find a rapid and practical solution to achieve equitable access to Kalydeco through the appropriate funding mechanism …”.

Kalydeco is approved in Australia in July 2013 and evaluated during PBAC’s July 2013 meeting.

Vertex Pharmaceuticals (Australia) announces the presentation of data from Kalydeco studies at the 10th Australasian CF Conference in Auckland, New Zealand, August 17 – 20, 2013 :

  1. “Significant and sustained benefits in children, adolescents and adults receiving twice-daily Kalydeco” (ACFC Oral Abstract 05)
  2. “Kalydeco efficacy and safety sustained for up to 96 weeks” (ACFC Poster Abstract P9)
  3. “Kalydeco improved lung function in people with early-stage and severe CF” (ACFC Poster Abstract P8).

Please Note: “Icon Announcer” by Orion 8 [Public domain] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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