PBS listing extended for Apixaban (Eliquis)

From 1 August 2015, the PBS listing for the novel oral anticoagulant (NOAC) apixaban was extended to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) — collectively referred to as venous thromboembolism (VTE).^1-3

Before this extension apixaban was available through the PBS for prevention of VTE only in patients undergoing knee or hip replacement.

The Authority Required (Streamlined) listing applies to:

• 2.5 mg tablets as continuing treatment for the prevention of recurrent VTE
• 5 mg tablets for initial and continuing treatment of confirmed, acute symptomatic DVT without symptomatic PE, and initial and continuing treatment of confirmed, acute symptomatic PE.¹

Authorised nurse practitioners may prescribe this medicine as part of a formal care plan with a medical practitioner (Shared Care Model).¹

The Pharmaceutical Benefits Advisory Committee recommended extending the listing at its March 2015 meeting on a cost-minimisation basis (ie, non-inferior efficacy and safety) compared with rivaroxaban, the other NOAC currently PBS listed for this patient population.^{2, 3}

Dabigatran was not considered an appropriate comparator by the PBAC and is not currently PBS listed for the proposed indication.

Both the 2.5 mg and 5 mg twice daily doses of apixaban were determined to be equi-effective to rivaroxaban 20 mg daily.²

As there are currently no clinical trials comparing apixaban with rivaroxaban, indirect comparisons were made using:

• enoxaparin/warfarin as the common comparator for acute treatment of VTE
• placebo as the common comparator for continuing treatment of VTE.³

Apixaban is an oral anticoagulant that directly inhibits factor Xa.⁴ It was first listed on the PBS in January 2012 for the prevention of VTE in people undergoing total knee or total hip replacement surgery.⁵

An additional listing for the prevention of stroke and systematic embolism in non-valvular atrial fibrillation was approved in September 2013.⁶

For more information

For more information about the use of apixaban for postsurgical VTE prevention see the January 2012 NPS RADAR review Apixaban (Eliquis) for preventing venous thromboembolism after knee or hip replacement surgery.

For more information about apixaban for stroke prevention in non-valvular atrial fibrillation see the August 2013 NPS RADAR review Apixaban (Eliquis) for stroke prevention in non-valvular atrial fibrillation.