Dx Launch Risks
This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker's market progress, but to ...
Peter Keeling of Diaceutics discusses competition in companion diagnostic markets and suggests that diagnostic adoption rules learned only recently will not be so dependable.
We all knew it was coming, we just didn’t know when. Specifically, the shift into an era of unpredictable diagnostic market events derived from pharma-fuelled test battles, sample access battles, quintupling of disease-based molecular testing costs and rapid stakeholder bewilderment. This era will illustrate that just recently learned diagnostic adoption rules will not be so dependable.
We all knew it was coming because the last decade of personalized medicine and CDx introduction, principally in oncology, has been conducted for the most part in a market model of every man for himself, or rather, every asset team within pharma, for itself.
Decisions about specific biomarker commercialization could be taken in isolation of the broader market landscape because there wasn’t any competitive rivalry. Of course, HER2 testing served Herceptin and Tykerb, EGFRm testing served IRESSA and Tarceva, KRAS testing served Erbitux and Vectibix, however these were single biomarkers with binary treatment choices. Driving test adoption and managing the often naïve infrastructure gaps around reimbursement and regulatory grey zones have been frustrating, but surmountable. In short, we have all deployed the classic ‘work arounds’ to remove testing hurdles to ‘right drug – right patient’. At the same time, the consequence of this rather myopic real estate grab has been an increasingly fragmented and fragile diagnostic marketplace.
Yet, it is into this very same fragmented and fragile companion testing market, where patient, physician and pathologist/laboratorian and payer confusion are now well-established[i], that the collective personalized medicine community is just about to launch some serious CDx weaponry. Take NSCLC as an example; currently in the US  we have four commercial biomarkers[ii] competing for physician, patient, pathologist and payer attention. Within 36 months, this could treble[iii]. If every one of these biomarkers is priced at $200 a pop and deserves a first line testing status, we will have moved the potential cost of efficiently testing the NSCLC patient community in the US from $52 million to $150 million in the blink of an eye.
Laboratories are already creaking under the gaps in sample management[iv], with up to 30 per cent of diagnostic accuracy at risk in the pre-analytical sampling handling steps alone. Remember, diagnostic companies have no incentive to focus on these pre-analytical steps! Yet, it is to underdeveloped quality infrastructure that we will add a myriad of biomarkers on different platforms. Take the much-vaulted therapy arms race underway in PD-L1. There are 4 to 6 different drugs, 4 to 6 different tests (each potentially with different cut-off points) and 4 to 5 different diagnostic companies marching forth into the market. A significant question for us should be, ‘How do we collectively avoid the impending confusion?’.
Up until now, pharma has somewhat disregarded the biomarker confusion profusion triggered by the ‘every asset for itself approach’. After all, doctors are used to testing, so what is one more in the mix? But listen to the recent real words from one high prescriber in the US who told us, “I feel like there is a biomarker juggernaut coming towards us and nobody cares”.
Actually, she was wrong in this statement! We, at Diaceutics, are pretty sure pharma does care about the confusion profusion, but caring and cooperating to prevent are two wholly different things.
Consider flying from Seattle to Frankfurt, where you traverse four international air spaces. The ‘freedom of the skies’ agreement born of a mature air travel market allows different airlines to compete on service and target marketing but cooperate to create an air traffic control infrastructure which serves all. The diagnostic infrastructure in personalized medicine deserves some similar cooperative structures. However, I am pretty sure we will have to live through a decade of disruptive rivalry before we have our very own ‘freedom of the biomarker’ agreements.
[i][php snippet=34 param=”title=Physicians’ Lag in Understanding of Personalized Medicine: Pharma’s Opportunity&id=999″]
[ii]In NSCLC therapies are currently targeting EGFRm, ALK, BRAF EGFR
[iii]In NSCLC pipeline therapies are targeting PDL1,ROS 1 mTOR,, PIK3a, AKT1, PTEN, FGFR1, β-catenin, RET and DDR2
[iv][php snippet=34 param=”title=A Dose of Reality: Laboratories Need to be A Key Priority in Companion Diagnostics&id=1019″]