Phase III trial of Rituximab may not be required in Australia for listing

[Kenny Banya]

I have had advice from a knowledgeable person in drug trials at Melbourne University's medical science faculty, that if the Norwegian trials are registered with the European Medicines Agency, that will be a sufficient reference point to instigate its application for listing on the Pharmaceutical Benefits Scheme via the Therapeutic Goods Administration. We tend to piggyback off the listings in Europe & America, as we don't have the same population & funding to 'go it alone'.
Unless someone with insight can advise, I am going to contact the relevant parties in Norway to confirm it will be registered, once results are known.
I was advised that we only undertake Phase III trials of new drugs, such as the biosimilar Truxima, or existing drugs for new indications, when there aren't identical trials being conducted in other countries. Obviously cost is the major factor.

 

[alex3619]

I was hoping this would be the case. It may still require effort to get it fast tracked by the TGA, and even more to get it subsidized under the PBS. However its all very doable, with a little time and advocacy.

 

[kiwigirl29]

That's positive. Wonder if it will be similar in NZ since we are a small country here too.

 

[Snow Leopard]

I have had advice from a knowledgeable person in drug trials at Melbourne University's medical science faculty, that if the Norwegian trials are registered with the European Medicines Agency, that will be a sufficient reference point to instigate its application for listing on the Pharmaceutical Benefits Scheme via the Therapeutic Goods Administration. We tend to piggyback off the listings in Europe & America, as we don't have the same population & funding to 'go it alone'.

Yes, this is standard practise for most drugs approved in Australia. Basically a meta-analysis of all the relevant (international) data is submitted to the TGA along with the details about costs etc and it is then reviewed for approval.

 

[Jonathan Edwards]

I don't think there was ever a suggestion that phase 3 trials have to be done in every country that is going to license the drug. The only requirement I have been aware of is that for licensing in Europe and the USA there have been rules about trials on the relevant side of the Atlantic. Japan may have special rules, partly I think because the Japanese have a genetic difference that affects metabolism of many drugs.

I certainly do not think there would be a need for any trials in Australia or New Zealand.

I think the real question is what European and US medicines control agencies will consider necessary in order to approve. Australia and New Zealand may have a particular eye on the UK but not necessarily. And I think this is uncharted territory because it is very unusual for a biologic drug to get this far in trials independent of industry. I have a strong suspicion that formal approval will take quite a while to sort out but that if the Norwegian trial is positive officially off label use may become widespread. The real question will be who pays - and that is not a matter for medicines control agencies anyway - it falls under health service and insurance policy bodies like NICE.