More post-market reviews
April 26, 2016
THE Health Department has
announced post-market reviews for
Pulmonary Arterial Hypertension
(PAH) medicines and bDMARDs
(biological Disease Modifying Anti-
Rheumatic Drugs) for the treatment
of chronic plaque psoriasis.
In the case of PAH drugs the
review has been initiated because
the PBAC’s Drug Utilisation Sub
Committee (DUSC) considered the
PBS restrictions for these medicines
are not consistent with current
treatment guidelines.
The post-market review follows
a submission from the sponsor
of bossentan, epoprostenol
and macitentan to remove the
requirement for patients to be
assessed as having achieved a
response to treatment in order to
continue accessing the medicines.
The submission claimed this PBS
restriction was inconsistent with
best clinical practice.
The PAH review will cover other
medicines too, including iloprost,
ambrisentan, sildenafil and tadalafil.
For the bDMARD review, the PBAC
has noted emerging evidence of
variation in response to TNF-alpha
(Tumour Necrosis Factor-alpha)
inhibitor agents and recommended
a cost-effectiveness review for the
drugs when used to treat severe
chronic plaque psoriasis.
The bDMARD review will cover
adalimumab, etanercept, infliximab
and ustekinumab.
Both reviews are open for
submissions from 02-16 May, with
draft terms of reference now online
at www.pbs.gov.au.
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