Dear All:
The attached EU Parliament resolution on Access to Medicines was released today. Broadly, it calls for greater transparency in price setting for medicines and for harmonization of HTA processes. Along the way, AMR gets a couple of specific mentions as does the Adaptive Pathway concept that provides some of the logic behind registering antibiotics with relatively smaller programs.
I encourage everyone to take a few minutes to carefully page through it as reading the text directly gives you an excellent sense of the ebb & flow of the debate. You can really feel the philosophical tension between “We want to support industry as innovative pharmaceuticals have value” and “There’s only so much we can afford and these medicines really save lives.”
Note in particular the language calling for compulsory relative effectiveness (RE) estimates. This is a highly problematic concept for many reasons. Although we can (and should) routinely show comparable activity via non-inferiority studies, RE entails to my ear the implicit goal of clinical superiority. This is very challenging (and arguably not desirable) for new anti-infectives as discussed in slides 7-10 of the deck I used at last week’s FDA meeting on animal models in support of narrow-spectrum agents.
An extended written discussion of the tension between superiority and non-inferiority for anti-infectives will come in a paper that we now have in press at Clinical Infectious Diseases. I’m expecting this paper to become an online preprint very soon and will forward that link when it is released.
That said, it will still be necessary for new antibiotics to show their value. The most obvious way is through true novelty. Inventing a new class of fire extinguisher (metaphorically) is the most obvious such path. But, truly novel mechanisms/classes have always been rare birds and we must also find ways to show the value of products that are more incremental in terms of their advance. There’s lots of debate about this at present and I remain hopeful that we’ll find a path.
Best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx