research reports and media, page-627

Jeepers...a while back I thought to myself when I first heard that PAR might charge $2500 a pop, will a patient really pay that much for our drug?

I have since learnt so much more about how this all works...it's not really the patient that pays, it's more the insurers, the Govt...the system. Yes of course the patient finally does pay indirectly though taxes and all.

So then I thought...how much does this Humira stuff cost anyway?
It's the worlds biggest selling drug...it does give a fairly good amount of relief to suffering patients BUT it comes with its own set of warnings and side affects and quite a lot of potential Adverse Effects...yes it even has a so called 'black label warning'.





_{Humira's Black Label warning - not a great read.}



So with what frequency does one need to jab themselves? Humira is required once a fortnight on average...cost? A massive $1800 or so per month!!! (That's what it costs without insurance)

So how is this relevant to us? Well we are looking at something in the order of $2500 - ONCE off cost, for 12 injections. I suspect it will end up being slightly more...but that's just my thoughts. The big draw card for us is DURABILITY. Our drug has shown to last up to 12 months in a lot of cases...this in itself is so much better than Humira, having a self injection once a fortnight, in our case patients have to endure a course of 12 injections over 6 weeks...yes that's fairly intense but then they have a full 10.5 months on average of pure relief. Many don't even need a booster at the end of 12 months (Happell, you know I'm thinking of you). Of course all of that, as we know, without any AE's to date and limited, if any, minor side effects from iPPS.

$2500 plus is no longer an issue in my mind. Final cost to patient will be a lot less with insurance. Of course it's all subject to the bio-economist's recommendation, Payers, Trial results, Govt and negotiations etc.


FAST TRACK?

The other point I was also thinking about is Fast Track..yes I sorta hoped we might get this designation at Pre Ind or at least part of the minutes...but Fast Track probably isn't all that relevant to us...why? Because the FDA want to test out our drug for durability over 12 months...Fast Track might possibly apply after that but not to much extent...it may speed it up by a couple of months but it is kinda irrelevant if we HAVE to go through 12 months of durability testing anyway!


SO WHAT'S THE UPSIDE?

The BIG upside to the last paragraph is the fact that if we are shown to have durability of an average of 9 to 12 months, this will be BIG NEWS and the payers/insurers will be impressed. Them being impressed will no doubt in my mind have a direct influence on what transpires in the all important negotiation stage which will come after these results are published. You weigh it up, is it better to have 16 months instead of 18 months with Fast Track in a typical Phase III or, is it better to have the longer 22 months but come out with a massive statement that we have durability for around 12 months AND the FDA encourage us to print that on the box, on the label and on that little leaflet you get when you open the box? I know which scenario I would choose and which probably would be worth a few $Billion more over time.


As per usual, my thoughts here, always DYOR, stay safe.


References:
https://rxsolution.net/why-is-humira-so-expensive/
https://www.humira.com/rheumatoid-arthritis/after-starting-treatment
https://www.drugwatch.com/humira/warnings/