Delay in PBS listing of dabigatran

Published in NPS Direct

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– A new oral anticoagulant for stroke prevention in atrial fibrillation

An announcement on18 December 2012 by the Australian Minister for Health, the Hon Tanya Plibersek MP, indicated that the Pharmaceutical Benefits Advisory Committee (PBAC) decision recommending listing of dabigatran should be reviewed.

The announcement recommended that more work was needed before new oral anticoagulants (NOACs) could be listed on the Pharmaceutical Benefits Scheme (PBS) for stroke prevention in atrial fibrillation (AF).[1]

“The [PBAC] Committee has advised me that based on the new information that has arisen about this drug‘s use in clinical practice, it is now concerned about whether dabigatran represents value for money at the price offered by the company.”[1]

“Because of this, the PBAC has now advised me that it is of a mind to rescind its March 2011 recommendation for dabigatran.”[1]

The announcement was in response to the release of the report from Prof Lloyd Sansom’s Review of Anticoagulation Therapies in Atrial Fibrillation.[2] The report was commissioned following a recommendation by the PBAC in March 2011 for listing dabigatran (Pradaxa) on the PBS for the prevention of stroke or systemic embolism in high-risk patients with non-valvular AF on the basis of acceptable cost effectiveness.

Prof Sansom’s report recommended:

"In view of the uncertainties identified in the Review regarding the magnitude of any incremental clinical and cost-effectiveness benefit of NOACs over other therapies when introduced into widespread clinical practice, and the high total predicted cost, it is recommended that the Minister for Health asks PBAC to review its previous recommendations of NOACs."[2]

While the PBAC previously recommended listing of dabigatran for stroke prevention in AF, at its meeting in March 2012 the PBAC rejected an application for PBS listing of rivaroxaban (Xarelto) as a treatment alternative for warfarin for stroke prevention in AF.

For further review of dabigatran and rivaroxaban for this indication see the NPS RADAR review on dabigatran and the NPS RADAR review on rivaroxiban. These reviews conclude that for patients who are well-controlled on warfarin, there may be no clinical benefit in switching to a NOAC.

NPS MedicineWise welcomes the recommendations of the Review of Anticoagulant Therapies in Atrial Fibrillation as it prepares to launch an educational program on good anticoagulant practice in early 2013.