Given the volume of news items heralding the impact of voguish concepts like predictive analytics, blockchain and AI, I often hear questions as to how these new “breakthrough" technologies will “revolutionize” the pharma industry, and particular the field of market access that our company’s expertise lies in. An avowed buzzword sceptic, I’m always tempted to reply that “breakthroughs" in an industry like pharma are first and foremost medical ones. But that’s a cheap retort - we face major operational challenges despite the most innovative drugs ever to reach the market, calls for disruption are valid anywhere from drug development to the value discussion and patient engagement. So - fine, the question posed is an important one.
Having the great daily fortune to work alongside some of world’s leading statisticians and modelers, I have come to appreciate the unique practical affordances of predictive analytics, machine learning or natural language processing, as solutions anywhere from drug development and trial design to the prediction of drivers of effectiveness across real-world populations (as opposed to drug efficiency in RCTs). Those are real applications, and have been employed for a while to address uncertainty in the face of highly complex, multi-layered research questions. And we have discussed their virtues at nausea at conferences and big data forums. But what about the more futuristic end of the buzzword chain?
Blockchain is the new frontier, isn’t it?
To be honest, like most of us, I haven’t had much of a clue. Is it? Well I do know, blockchain is not driving major expenses at any large pharma company outside of the thought leadership and innovation camp - today. But while I am perfectly sure there are no definite guides and answers out there, I’ve found my initial, “safe” response to the question a bit lame and evasive - “Well, there is a lot of smoke out there, a few interesting pilots, but despite the hype we’ll have to wait and see”. Sure, but that’s been true for any major disruptive technology. So, having pushed myself to engage with some thought leaders on the matter this week, let me synthesize 5 observations as to where we are today, and what might lie ahead - a simple primer, but perhaps a place to start at if you’ve comforted yourself to be a hype-sceptic like me.
Speaking broadly, technologies like blockchain have been welcomed as the healthcare ecosystem of the future, driven by full HIE interoperability and trustless collaboration from molecule to market. Andy Coravos landscape summary (above) does a nice job of mapping scope of investment in various areas of healthcare. You might have read that pharmaceutical manufacturers have already begun to embrace the technology to secure their supply chain against counterfeit medicines and track and trace drug distribution (i.a. GSK, Janssen, Merck). Here, blockchain is been actively pursued – no surprise considering the regulatory pressure put on industry such as the 2013 Drug Supply Chain Security Act.
In the future, the proposition of distributed ledgers at the core of blockchain expands to a variety of attractive use cases in pharma, such as for submissions to global regulatory bodies, or managing clinical trials and data sharing across various entities involved in the research (incl. sites, enrollees etc). I don’t know of a single pharma pilot in this space, but I bet someone like Pfizer’s Craig Lipset will be able to talk about a proof-of-concept at an innovation conference soon.
In the field of market access, blockchain lives within its promises: Easy and expeditious trust-building around the authenticity and value of health outcomes, rooted in distributed layers of real-time data, indelible records that are securely and verifiably shared between key stakeholders. At the core, data is written by multiple partners not habituated to data-sharing. Importantly, each record has additive value to the conclusion of the whole and is governed by automated rules, so that the validation need not be re-interpreted by the parties but occurs as the automatic consequence of rules embedded into the platform.
What does this mean, practically speaking? So-called smart contracts – the technical term here - could allow payers to automate reimbursement in exchange for verified real-world, real-time outcomes data. Patients could be remunerated with tokens for their sharing of health data with providers and research partners, immutable information of such value that it could be leveraged as a substantial offset against their personal medical and pharmacy costs. This would ultimately reduce expenditure and certainly be the most precise arbitrator of real-world effectiveness of healthcare interventions. Projects to look out for include public consortia such as Myhealthmydata (EU), as well as private-equity-driven platform products like BlockRx.
Needless to say, blockchain applications in pharma will remain in pilot mode for some time. Serious challenges for maturity emerge with respect to scalability (storage, and energy needs), the expansion into ethically and operationally challenging information categories such as identity and reputation data, or the ability to embed meaningful governance mechanisms and compliance rules within the respective platforms. For pharma, any use exponentially surges once and when patient data is available in a blockchain – which, truth be told, remains a what-if scenario in whitepapers until a number of early-stage companies can move from pioneering to a wider commercial market application.
If this peaks your interest, I’d recommend to take a seat in the cockpit of the blockchain discussion (i.e. watch this video), and follow a conversation between those currently busy defining its frontiers. Like me, you may be a tad surprised that the exponents at the forefront of the discussion are keen to take a much calmer stance than most news reports you find online.
And, if you’re interested in how these technologies affect your day-to-day research operations and decision-making in market access and health economics, let me also tease that we are working on an educational symposium to address some of these questions, presented later in the year at the International Society For Pharmacoeconomics and Outcomes Research’s annual meeting in Barcelona (ISPOR 2018). The attempt will be to break down some of the loftier concepts into day-to-day scenarios - more to be shared soon.
Do you work at the bleeding-edge of automation technologies and HEOR operations? What’s your take on the viability of intelligent automation for decision-making (support) in our field? As we’re building the ISPOR symposium with partners in industry and stakeholders on the provider side, I’d love to hear your experiences - feel free to message me with your thoughts and examples. Thanks!