New dementia drug review
June 29, 2012
THE Pharmaceutical Benefits
Advisory Committee has
announced a post-market review
of all anti-dementia drugs listed on
the Pharmaceutical Benefits
Scheme (PBS) for the treatment of
Alzheimer’s disease.
The review has been called in the
wake of an initial study on
Alzheimer’s drugs in 2010-11,
carried out by the Drug Utilisation
Sub-Committee of the PBAC and
published in the Australasian
Journal on Ageing, which indicated
that these medicines were being
prescribed to a much larger
population for longer periods of
time than was originally
agreed as cost-effective by the PBAC.
The review, which assessed
cholinesterase inhibitors by data
linkage using the PBS Authority
database and other health
databases, found that there was an
unexpectedly high continuation
rate for cholinesterase inhibitors in
Alzheimer’s patients beyond six
prescriptions.
Findings in the report included
the fact that 18,000 people
commenced cholinesterase
inhibitors during 2004, and that
adherence was 79.4% while the
medication possession ratio was 0.88.
In addition, the report showed
that around 70.3% of people filled
all six scripts for the initial trial
period of therapy, whilst around
57.3% of evaluable patients
accessed funding beyond six
prescriptions, a finding which
indicated that their GPs had
declared that there was a twopoint
or more greater
improvement in the Mini-Mental
State Examination.
Despite the high rate of
continuation beyond 6 months,
the report found that rates of
institutionalisation and death were
no different to those reported in
clinical trials.
The new study, according to the
Department of Health, will look at
donepezil; rivastigmine;
galantamine; and memantine, and
will review recent Australian
utilisation data on patient
initiation and continuation rates to
cholinesterase inhibitors and
memantine.
The review will also look into
whether the two point
improvement in Mini-Mental State
Examination continues to be an
adequate surrogate for measuring
improvement in patients with
dementia treated with these
medicines; and if there are other
more reliable measures of patient
relevant outcomes?
In addition, the review will
investigate if there is more recent
evidence on the safety and efficacy
of these medicines that would
inform the PBAC about their costeffectiveness,
and will also look at
the current PBS restriction
continuation rule and the likely
effect it has on cost-effective
utilisation of these medicines.
To this end the PBAC is now
calling for submissions from
interested parties and individuals
which address the report’s terms
of reference.
Submissions must be received by
06 July 2012, see www.pbs.gov.au.
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