Blockchain: Solution or Snake Oil?
The potential of blockchain to better manage RWE and access makes it an exciting prospect. However, pharma first needs to get its head around the practical application.
To hear Bryan Hill tell it, blockchain technology could one day make his job a lot easier.
As Medical Science Director at Mitsubishi, one of Hill’s various tasks is to identify clinical trial sites. It’s no minor undertaking, he stresses. The process of ensuring a site is fit for purpose often involves huge initial upfront expenses. The chances of then getting even two or three patients involved are slim.
“It needs to be more virtual in nature, which I think blockchain can allow you to do,” he says. “It can allow you to know exactly all the individual characteristics of a particular patient and clinical trial subject and the match them through inclusion-exclusion criteria to a particular trial that you’re trying to recruit for.”
Blockchain, or distributed ledger technology, can no longer be regarded as new-fangled within the pharma space. In recent months and years, much has been posited as to its potential regarding real world evidence and the delivery of value-based healthcare. As a speaker at eyeforpharma’s recent Value Summit in 2018, held in Philadelphia, Hill used his time on the day to examine how blockchain could be used to manage access.
As an intrinsic component of blockchain, Hill believes tokenization could be the answer in allowing pharma to put a value on real world outcomes. In what is essentially “micro-valuation” on any particular therapeutic intervention, companies could be able to assign value to their overall cost systems.
“It really provides hopes that within, say, nine months, you can be compliant and attach a real value to a drug or device product,” he says. “That also really ties into the concept of reputation of particular individuals, from patients and care providers to entire systems being able to properly manage patients.”
According to a recent study conducted by life science NGO Pistoia Alliance, 60% of pharma companies admitted to having toyed with blockchain – compared to 22% in similar survey compiled in 2017. This might suggest pharma is warming to the technology, but stops far short of representing a sea change, with 40% of this year’s respondents claiming to have no plans to implement solutions any time soon.
“There’s been a lot of hype around blockchain, but the uptake is still fairly small,” says Hassan Chaudhury, Director & Co-Founder of Health iQ. “That’s because we’re really starting from a blank slate.”
Chaudhury – who spoke on this very subject at eyeforpharma's 6th annual Real-World Evidence & Access Europe Conference in April – describes blockchain as “a solution looking for a problem”. In other words, a problem first needs to be defined before the hunt for a suitable technological solution.
“I’d say that much of the conversation around blockchain is lopsided,” he says. “For me, blockchain is about transactions. If you don’t have transactions, it’s not the technology for you.”
What Chaudhury is alluding to here is smart contracting, which allows companies to create a digital representation of a physical contracts agreed at a health technology assessment, or in negotiations with private payers for pricing agreements.
This is a service offered by Digipharm, a provider of blockchain platforms with the goal of fairer healthcare pricing.
“At the moment, a lot of outcomes-based contracting involves the administrative burden of processing and tracking patients, made even more cumbersome because patients start treatments at different times,” explains Ahmed Abdulla, the company’s founder and CEO.
“While those agreements have to be manually tracked and reconciliated, with smart processing you can automate the process. It also gives you the ability to have very comprehensive, very detailed pricing agreements regarding specific patient groups. As these agreements are all informed by an API-driven model (a set of functions and procedures that allow the creation of apps which access the features of an operating system), there’s hardly any sort of burden.”
Hill is certain levels of uptake will increase in the near future, as “it’ll be impractical not to,” he says. He cites the oft-referenced $2.6 billion figure attributed to getting drugs to market as evidence of the increasingly unfeasible state of drug development. In allowing drug companies to manage their data much earlier on during the clinical trial process, he believes the widespread application of blockchain is only a matter of time.
“The traditional way of drug development no longer works,” says Hill. “The average of approvals from the FDA in the last 10-15 years has been in the mid-thirties per year, when we need it to be in the thousands. At the same time therapeutic development is heading towards rarer, small clinical trials.
“As there is no longer that ability to throw much money at development, we need synergies, efficiencies, economies of scale. In allowing you to eliminate failures early and open up parts of data early on, blockchain allows you to do that.”
Hill, however, understands there lies a difference between potential and practical application, and that blockchain might be headed for a hundredth-monkey scenario when adoption rates finally get going after more companies have passed “the growing pains stages”.
The “real beauty” of blockchain”, claims Chaudhury, is its ability to act as a conduit of communication in a transaction conducted between two parties “who don’t really trust each other”. This, he says, make it particularly well-suited to RWE.
“RWE is perfect for this area because we want analysis, but we don’t want to know the patient sensitivity. When you are talking about large numbers, you don’t need blockchain, but now we are moving into this area of precision medicine, based around specific genomic profiles. Here blockchain can act as a shield around this information and allows you to control who gets access because it’s transactional.”
Should we even be surprised that companies seem to be content to just dip their toes into the blockchain pool at this current time? Perhaps not. As Abdulla points out, “pharma companies – as all healthcare companies for that matter – are notoriously slow when it comes to pilots for things like this”.
In Digipharm’s experience, the main challenge is in is getting pharma companies to be more proactive in testing their solutions.
“There’s rarely that drive from pharma where we they say, ‘Yes, let’s get to work on this right away,’” says Abdulla. “The problem is that they are dealing with sensitive data that is subject to ethics and approvals, with concerns around compliance and data security and information governance. All the stuff that we aren’t massively fond of, even if it is necessary.”
That said, installing blockchain software is not the main hurdle, insists Abdulla; rather it is the integration of the digital ledger into existing systems that poses the biggest consideration.
“You essentially have to integrate into these health information systems and clinical data registries,” says Abdulla. “The thing about blockchain, in terms of getting the best out of it, is that it won’t benefit you as a stand-alone product. It has to be part of a network, with the payers, pharma and providers all involved.”
Chaudhury agrees that integration can be a problem, although it is ultimately in the hands of the blockchain providers, who are able to do it on behalf of pharmaceutical companies.
“Blockchain isn’t just something that you give to somebody and say, here you go and play with that,” he explains. “It’s something that’s held somewhere – in the cloud, for example – and you have to connect, hence the need for integration and middleware. The problem isn’t the blockchain itself – it’s understanding the point of blockchain.”
According to Abdulla, pharma, while intrigued by blockchain, does not appear to have gotten its head around this yet. How can we affect a step change, one wonders? “The ability to showcase the outcomes from some of our upcoming pilots would help. Other than that, in the case of Digipharm, we are doing lots of standard marketing to try and get the message through.”
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