PBAC recommends RU486
April 29, 2013
THE Pharmaceutical Benefits
Advisory Committee late on Friday
afternoon released the outcomes
of its March meeting, including
a positive recommendation for
abortion drug RU486 (mifepristone)
and misoprostol.
The PBAC recommendation is for
an Authority Required listing for
use in women of childbearing age
“for the termination of an intrauterine
pregnancy of up to 49 days
gestation,” with the decision made
on the basis of similar effectiveness
and lower cost when compared
with surgical abortions.
The government will now review
the RU486 recommendation, with a
decision due in the coming months.
Marie Stopes International is the
sponsor of the drug which was TGA
approved last October.
MEANWHILE other outcomes
from the meeting included
recommendations for the PBS
listing of novel anticoagulants
rivaroxaban, dabigatran and
apixaban.
This was the result of the Review
of Anticoagulation Therapies
in Atrial Fibrillation, with the
committee considering updated
analyses of the newly developed
alternatives to warfarin.
Rivaroxaban has been
recommended for a PBS listing
as an Authority Required
(Streamlined) benefit for the
prevention of stroke in patients
with non-valvular atrial fibrillation,
at the price proposed in the
submission on a cost-effectiveness
basis in comparison with warfarin.
Similar approvals for dabigatran
and apixaban were recommended,
but for all three medications the
proposal includes a risk sharing
arrangement between the sponsors
and the government.
This will see 100% of expenditure
on the novel anticoagulants above
the agreed estimates rebated to
the government.
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