New PBS drugs reviewed in NPS RADAR
1 August 2013
The 10th anniversary edition of NPS RADAR contains reviews for new medicines listed on the Pharmaceutical Benefits Scheme (PBS) including rivaroxaban (Xarelto), rotigotine patches (Neupro) and mifepristone (Mifepristone Linepharma) followed by misoprostol (GyMiso).
According to the RADAR review, rivaroxaban for deep vein thrombosis (DVT) and pulmonary embolism (PE) and for prevention of venous thromboembolism (VTE) is an alternative to INR-adjusted warfarin in some people. However, as with all of the newer anticoagulants, managing the risk of bleeding is a primary safety concern with rivaroxaban and prescribers will need to weigh up the bleeding risk before starting treatment.
The review found that rivaroxaban is non-inferior to enoxaparin plus warfarin for preventing VTE recurrence in people with DVT (without PE) and in people with PE (with or without DVT).
However, the review raises some areas of concern, including that further studies are needed to understand the benefits and harms for people aged over 75 years and people with renal impairment. There is no antidote for rivaroxaban and no readily available method of monitoring its activity in a primary care setting, and so routine clinical monitoring is essential.
NPS MedicineWise urges prescribers to take into account that efficacy and safety data for rivaroxaban are limited beyond 12 months, and that bleeding risk may be higher in people with renal impairment
The August edition of NPS RADAR also includes an in depth review of apixaban (Eliquis) – another newer oral anticoagulant for stroke prevention in non-valvular atrial fibrillation (NVAF).
Apixaban is not currently PBS listed for stroke prevention, but the PBAC has recommended its PBS listing for this indication. Anticoagulation is recommended for stroke prevention in people with NVAF with one additional risk factor, which places them at moderate to high risk of stroke. Apixaban is an oral anticoagulant with a twice-daily dosing regimen, and in clinical trials it reduced the incidence of stroke and systemic embolism in people with non-vavular atrial fibrillation with efficacy comparable to warfarin.
The review explains that apixaban may be an alternative for patients who are unable to maintain stable INR or unable to tolerate warfarin or undergo INR monitoring. There are no clinical trials comparing the efficacy and safety of apixaban to the other newer oral anticoagulants rivaroxaban and dabigatran. Like rivaroxaban and dabigatran, the main safety concern with apixaban is bleeding as there is no established way to reverse the anticoagulant effect should bleeding occur.
Without long-term safety and efficacy data and the absence of an antidote, continuing with warfarin may be the best option for people with well-controlled INR.
This edition of NPS RADAR includes full reviews on mifepristone (Mifepristone Linepharma) followed by misoprostol (GyMiso) for medical termination of pregnancy of up to 49 days’ gestation, and rotigotine transdermal patch (Neupro) for Parkinson’s disease.
It also includes In Brief articles on risedronate (Actonel) and its combinations extended to include patients 70 years of older with T-score less than or equal to -2.5, and on brand equivalence – ‘a’ flagging explained.
To read the full reviews go to www.nps.org.au/radar
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