The wonderful thing about blockchain is that it’s such a resilient and futureproof technology and we are really only now beginning to imagine its potential in biopharmaceuticals. So, at present in healthcare, while its use is primarily around supply chain transparency, security and real time monitoring, its immutability is an obvious application. There are potentially a huge number of other applications if you take a step back and look at the use of blockchain outside of healthcare. For example, its use in financial tech software and famously in cryptocurrencies could point to some low hanging fruit in health settings. The ability to handle large volumes of payments as seen in crypto and applying the use of smart contracts could bring tremendous benefits in the complex payment systems often prevalent in healthcare.
So, I will breakdown the three core areas, before diving deeper, that blockchain should become the de rigueur standard in, namely: supply chain monitoring, digital regulation and smart contracts for multistakeholder therapy reimbursement schemes.
One application we are particularly excited about is helping simplify the relationships between payors, hospitals and innovators. One of the ongoing challenges here is managing all the partners in terms outcomes for the patient. Even in the simplest approaches, there is still a great deal of paperwork needed from the hospital to the payor (insurer in the USA or the NHS in the UK) and to the innovator for the therapy but then equally between the innovator and the payor. The next result is great deal of expensive and administrative burden on the healthcare system. But taking this a step further, and particularly in areas like cell and gene therapies and in newer (more expensive) mAbs, we are seeing payors looking to switching towards milestone payment models. This means paying initially for the therapy but then paying supplementary amounts on positive clinical outcomes – for example, after one year or three years. When you factor in who decides upon the clinical outcomes and when they have achieved, it is likely to be extremely time consuming and complex.
Understandably, many innovators are hesitant to switch form a payment as a service model and worry that this will create greater challenges in securing timely reimbursement. But equally, payors want to be sure that these expensive therapies – many of which are still very new – have the longevity of clinical effects.
A solution to this is to use a blockchain based system for smart contracts that all partners can plug into. This removes all the complex paper-based approvals and replaces it with a more secure digital solution, but it also means we can create digital triggers for payments as milestones are met. To give a working example from the United States, that would essentially enable the hospital to trigger the payments automatically once the conditions (clinical outcomes) for payment have been met. This therefore means the innovator will receive payment faster. But, it also provides advantages for both the hospital and payor in reducing the burden of cross-checking medical records, and what a specific plan covers or not in terms of treatment, while also greatly increasing transparency – as their will be a single record of the therapy from ordering and tracking to outcome. We are already working on a model to add this service into our advanced therapeutic medicinal products (ATMPs) (Haatali), which is obviously the most complex of supply chains for partners with therapies needing to go in both directions between innovator and patient.
One other area we see tremendous potential applications is in simplifying some of the more onerous regulatory requirements. For example, biopharmaceutical facilities need to meet very rigorous standards of build quality. Consequentially, many parts of the facility need to be checked that they comply with these standards. To give just one example, each of the wealds within any clean room or biomanufacturing facilities pipework needs to have regulatory paperwork. So, you end up in a situation where a relatively cheaper weald is made incredibly expensive by the accompanying compliance component (often many times the cost of the weald itself). Blockchain is perfect solution for this type of certification, whereby the compliance is simply digitally certified on the chain rather than filing separate paperwork for each.
And of course, there is the supply chain management of biologics and cell and gene therapies for which we are already providing a transformative solution for innovators. Again, the great benefit is the inherent immutability, but of course, with a blockchain we can add layers of checks and real-time monitoring – so that means everything from its location, to its temperature, its storage conditions and even who exactly has ownership of the product at any given moment. It means not only are therapies unable to escape the distribution network, but it also creates clear boundaries and responsibilities should something go wrong in transit or storage. But most crucially, it provides far greater protection to ensure that nothing does go wrong in the handling of these pressure and expensive therapies. From a patient point of view, it also provides reassurance and certainty around when and where treatment will be taken. In a space like cell and gene therapies where supply chain challenges and site access are critically slowing both trials and patient availability we expect to see rapid growth in adoption.
The real question for biopharma is not if blockchain will make an impact, but how quickly it will be adopted as it will undoubtedly help circumvent many of the issues holding back bringing more of the therapies to patients.
