Replies to post #171586 on Biotech Values

[biotech_researcher]

ENTA- "It's logical to assume that in real life the increased pill burden will lead to reduced compliance and hence reduces SVR rates. "

I hadn't model that into my analysis, but it clearly should be included. The unknown is how to model it.. Are there any examples?

[DewDiligence]

GILD/ABBV/ENTA—I doubt that the “real world” difference in compliance between the two regimens will be material. Moreover, it may not be deleterious if someone on ABBV/ENTA’s 3-DAA regimen forgets to take the second daily dose of ABT-333 insofar as ABBV/ENTA have shown some compelling phase-2 data for the 2-DAA regimen of ABT-450 + ABT-267 (which are combined in a qD pill).

[dewophile]

It's logical to assume that in real life the increased pill burden will lead to reduced compliance and hence reduces SVR rates

I don't think the pill burden will factor in at all when it comes to what insurers decide to cover. It's not on the PBMs to factor in non-compliance as long as they have an equally effective and safe treatment. An example is the duopoly that exists with recombinant gonadotropins. One may be easier to use or teach and affect compliance - doesn't matter you will use whichever your insurance plan negotiates with the pharma.
I also don't think you can necessarily conclude in any way shape or form affects SVR in the real world. who really knows what the effect of missing pills does to SVR in a real world setting in the GILD vs ABBv regimen. Picture an 8 week GILD regimen and someone goes on an overnight trip and misses a dose. We know from ph 2 a 6 week regimen with ribavirin failed. there could be a narrow window here where some missed doses really matter. This could crimp SVR more than one missed day of an ABBV 12 week regimen for all we know

The stronger argument that i think GILD will make to doctors is that one can never know when a pt won't tolerate a regimen or need dose reduction or elimination of ribavirin for anemia. if you know your regimen does well with shortened duration and/or lack of rib then you can TRY and argue it may perform better in a real world setting. I don't think this argument will force the hand of insurers given you have trial results with exactly the same efficacy on an ITT basis