A robust and comprehensive evidence base is critical in health care decision making. This has been recognized as a key element in explaining why the US health care system, comprising over 20% of the US economy, not only delivers health care at a higher per capita cost than in comparable developed economies but delivers outcomes for the population that lag behind those achieved in countries that spend far less. Shortfalls in the evidence base are seen in a number of areas. Two of the most significant are:

  1. a lack of access on the part of health system decision makers to information that would enable them to monitor and validate, including replicate, the claims made by manufacturers for pharmaceutical products and devices in target patient populations;
  2. limited access to information by patients that would enable them to avoid choosing unnecessarily high cost providers in favor of providers who offer high value and cost-effective treatment.

This situation cannot continue. Health systems face escalating costs, driven in part by the pricing policies of manufacturers, which threaten system viability and are factored into mergers with their reduction in competition between providers. Unfortunately, in the present environment with major information asymmetries there seems little hope that manufacturers will adopt different pricing strategies. The situation is made more intractable from a cost perspective with government agencies such as CMS barred from negotiating prices.

The increasing attention being given to blockchain technology offers one way forward through empowering patients to own, tokenize and monetize their encrypted and secure health data. There are two aspects to consider: first, enforcing property rights allows patients to capture ‘data value’ in respect of its potential utilization by third parties and not, as in the present, surrendering value to information vendors and, second, to provide a framework not just for the monetization of data collected as part of the electronic medical record but to add value to these data by utilizing the blockchain technology to establish evidence platforms that assemble data from patients and physicians over the course of treatment to evaluate outcome claims.

In respect of property rights, the decision as to whether or not to give access to their data rests with the patient. At the same time the patient can decide whether or not they want to add to the value of their data by participating in platforms specific to their health treatment profile. Patients with chronic pain, for example, may wish to engage, with their treating physician, in a platform that allows the patient and the physician to track response to therapy, evaluating the merits of treatment choices and determining the most effective therapy pathway at the individual level.

The chronic pain platform would include validated instruments such as reported outcomes in pain and functional status, assessments of drug choice and risks in potential medication abuse (notably opioids), resources utilized to support therapy, red flags for adverse events and regular assessments of the overall efficacy of the intervention against therapy targets. While the objective for any platform is to encourage high value and cost-effective interventions, platforms allow also a framework for physicians to evaluate their compliance with guidelines including those presently in place for opioid utilization and the medical necessity of therapy choice.

Once sufficient patients have been enrolled and tracked within specific platforms, the evidence base is in place for establishing ‘value’ benchmarks. Health systems, for example, who may have underwritten a specific platform for target patient groups with agreed patient monetization, could utilize these data to set practice parameters for therapy options, resource utilization and outcomes based and cost-effective treatment targets. This would address directly the issue of practice pattern variability, not solely in terms of costs but from the perspective of a comprehensive and flexible evidence base linked to monitoring outcomes over the course of treatment.

The issue of target populations is also important. There may be priority targets, such as older patients, who present with multiple comorbidities and who typically incur a high proportion of overall health system costs. This is one group where information on therapy choices, costs and outcomes is severely limited. It would be possible to build linked blockchain platforms to treatment options and outcomes across a range of comorbidities. Health care systems and individual practices would have a particular interest in these groups as Medicare reimbursements are becoming more limited, yet there are a range of outcome quality metric incentives that could accrue at the practice level as well as though accountable care organizations.

Blockchain enabled platforms have a further role to play in product, disease area and therapeutic class reviews. All too often, formulary committees have to take at face value claims made for competing products, claims that are all too often based upon limited clinical trial data often with protocols that give them little in the way of external validity (e.g., older patient populations, presence of comorbidities). Access to a blockchain would allow formulary committees to require manufacturers to undertake blockchain based observational studies to support claims. Patients would be incentivized to participate, together with physicians, in an agreed study protocol agreed providing feedback to the formulary committee in real time. The same approach could be utilized for disease area and therapeutic class reviews for comparator products with the results factored into pricing and tier placement decisions.

In summary, the adoption of a blockchain ecosystem has a potential transformative role in health system information flows and decision making. The Timicoin/TimiHealth blockchain ecosystem has such potential. It empowers patient health data property rights together with the options for tokenization and monetization of the blockchain to support value added activities. With the TimiCoin/TimiHealth blockchain ecosystem, we have, for the first time, not only a secure encrypted database for a patient’s health data, but the opportunity to create additional value for the patient by enabling the creation of disease specific platforms. The net result is a major addition to the information at our disposal to monitor in real time therapy interventions, to evaluate practice patterns in respect of costs and outcomes and a framework to challenge the claims, pricing proposals and the formulary position of pharmaceutical products.

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