Raise orphan threshold call
July 30, 2015
To MAKE allowances for
population growth, the threshold
for availability of orphan drugs
should be calculated as a prevalence
number such as 5 in 10,000,
rather than as a fixed number of
“not more than 2000 individuals”,
argued Medicines Australia (MA) in
its submission to the Therapeutic
Goods Administration (TGA)
consultation on the matter.
Other recommendations from MA
focused on incentives for sponsor
companies and include maintaining
the fee waiver to provide incentives
for sponsors to invest in clinical
development for orphan diseases,
as well as developing a priority
review mechanism, strengthening
intellectual property rights and
providing a period of market
exclusivity and tax credits.
The current definition of orphan
drugs was supported by MA as
it allows for the current trend in
targeted treatments to continue to
be recognised as orphans.
Submissions by Novartis,
Bayer, GlaxoSmithKline, Biogen,
Biopharma, AbbVie and a number of
stakeholder groups especially those
with a haematology or oncology
focus, sought related adjustments to the Orphan Drugs Program.
A major theme of most
submissions revolved around
matching global standards in
relation to each of the measures,
along with incentives for sponsors
who may otherwise not have reason
to propose some drugs for rare
diseases to Australia considering the
small population.
CLICK HERE to access the
submissions to the TGA.
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