E-drug: Re: Drug approval criteria
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I would like to make a comment about the note from the moderator. Australia
has a two-tier drug approval process. One for drug approval for marketing
purpose and the other for subsidy purpose.
The drug approval process (for marketing) which is done by the Therapeutic
Goods Administration in Australia is still based on safety, efficacy and
therapeutic index etc.
Once the drug is approved to be marketed in Australia, it can be prescribed
by any prescriber. However due to the nature of the Australian Healthcare
system, the new drug is unlikely to capture much of the market share as most
drugs are subsidied by the Commonwealth Government through the
Pharmaceutical Benefits Scheme (PBS). Therefore most pharmaceutical company
will apply to the Commonwealth Government for inclusion of the new drug into
PBS. The use of cost-effectiveness criteria in Australia is for the purpose
of subsidy from the Commonwealth Government. This is required by the
Pharmaceutical Benefits Advisory Committee (PBAC).
Shu Chuen Li, BPharm, MBA, PhD
Senior Lecturer
Department of Pharmacy
National University of Singapore
phalisc@nus.edu.sg
[Note from moderator: Thanks. I think my comment was written whilst half
asleep! Probably all countries with cost-effectiveness requirements use
these for the reimbursement system. In fact, within EU it is a requirement
not to make price part of the approval process. Kirsten Myhr]
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