AF review sparks new delays
December 19, 2012
A FIFTEEN month review of
Anticoagulation Therapies in Atrial
Fibrillation has set a stumbling
block on the road to PBS listing for
new anticoagulant therapies such
as Boehringer Ingelheim's Pradaxa,
with its recommendation that the
PBAC review its previous
recommendations of new (or novel)
oral anticoagulants (NOACs).
Penned by Emeritus Professor
Lloyd Sansom, the review stated
that “while warfarin will retain a place
in the management of stroke risk in
patients with atrial fibrillation (AF),
NOACs offer an important clinical
benefit in reducing the incidence of
intracranial haemorrhages in AF
patients who receive anticoagulants
and offer patients who are unable to
take warfarin an effective alternative”.
“However, the net overall benefit
of NOACs in clinical practice and the
subsequent impact on costeffectiveness
is uncertain at this
stage, given the further information
about dabigatran use that has
become available since the
PBAC decision regarding this NOAC
in 2011,” the review added.
As such, the review recommended
that the PBAC consider the
establishment of a managed entry
scheme for the PBS availability of
NOACs which would take into
account the identified uncertainties
while acknowledging the need for
effective alternatives to warfarin.
“In considering a managed entry
scheme, PBAC should evaluate the
entry price that addresses the
uncertainties and what ‘fit for
purpose’ evidence would be
required to address these to ensure
that acceptable,” the review said.
In addition, the review advised
the PBAC to consider the PBS listing
of NOACs as a restricted benefit for
patients unable to tolerate warfarin
therapy and/or who are unable to
obtain satisfactory INR control
despite specific measures.
“There would need to be a
definition of ‘satisfactory INR control’
together with a price–volume
arrangement which addresses the risk
to the Government of use beyond
any restriction,” the review said.
The review has unsurprisingly
drawn the ire of Boehringer
Ingelheim, which responded to the
report by saying it “is extremely
concerned that a new delay in the
form of yet another PBAC review
will further postpone patients’
access to new treatment options”.
“Today is a sad day for many
atrial fibrillation patients and their
families,” the company added.
MEANWHILE the PSA has
welcomed the review, in particular
its recommendations for shared
care and collaboration between
health professionals in the
management of anticoagulation
therapy in patients with AF.
One such recommendation was
the use of point-of-care testing for
the measurement of INR values,
which determine appropriate
dosing, as an option for warfarin
management, particularly in the
community setting.
The report also pointed to the
need for the development of
resources to improve the health
outcomes of patients with AF.
“Pharmacists could potentially
become more involved in the
identification of people with AF,
helping to implement guidelines,
educate patients, improve the use
of anticoagulant medications and
monitor patients,” the PSA said in a
statement.
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