July 2012 PBAC Outcomes - Reviews

Review of Statin Therapies

CHOLESTEROL LOWERING MEDICINES

Atorvastatin

Pravastatin

Rosuvastatin

Simvstatin

Request for advice from the Minister for Health in relation to the request made in the Senate on   22 November 2010 on any new evidence on whether or not two medicines, rosuvastatin and atorvastatin, should be included in the existing statins therapeutic group.

The PBAC concluded that although there is a large volume of research about the treatment effect and safety of statins, there is a paucity of trials addressing the specific questions being asked by the Terms of Reference of the review.  The PBAC considered that the problems with the exchangeability of trials eligible for inclusion on the mixed treatment comparison, which focused on clinical outcomes given PBAC’s stated preference to assess comparative benefits of drugs in terms of treatment outcomes that are directly discernible and meaningful to patients,  and the small number of events in those trials may be the basis of the results suggesting that there may be no additional benefit of the higher potency statins over lower potency statins.  On the other hand, the CTTC individual patient data meta-analyses of 2010 and 2012 continue to show a consistent relationship between LDL-C lowering and cardiovascular events and overall survival in patients treated with statins. 

Therefore, the PBAC reaffirmed its recommendations of 2005, 2006 and 2007 that atorvastatin and rosuvastatin are more effective than simvastatin in lowering LDL-C, and that atorvastatin and rosuvastatin should continue to be treated as interchangeable on an individual patient basis.  Furthermore, the PBAC considered that the evidence available to date does not change its previous advice to the Minister that a relative price differential of 12.5%, on average, between atorvastatin and simvastatin was acceptable. 

The PBAC reiterated its previous advice that the only basis for judging whether the price relativity could be further increased would be an incremental cost effectiveness analysis based on major cardiovascular events measured directly in randomised trials rather than based on predictions modelled from surrogate outcomes. Overall, the evidence available to date did not enable the PBAC to be satisfied that a greater price differential than the one agreed to in 2005 would be acceptable.

Issues and Options Paper for the Review of Anticoagulation Therapies in Atrial Fibrillation.

ANTICOAGULANT MEDICINES

warfarin, aspirin, and newer therapies such as apixaban, dabigatran and rivaroxaban.

The purpose of the Issues and Options Paper is to collate the issues and options that were identified in submissions to the Review, the on-going literature review, stakeholder consultations and discussions of the reference group.  The PBAC, along with a wide range of stakeholders was asked to provide comment.

The PBAC provided comment on the issues and options paper.