Abstract
Digipharms’ solutions aim to accelerate the much needed restructuring of healthcare delivery systems to a value-based approach. The inherent flaws of current global healthcare infrastructure result in substantial inefficiency, wastage and sub-optimal health outcomes for the most important stakeholder; the patient. In healthcare today, there is a lack of incentive for health systems and providers to focus on mutually beneficial collaboration and the maximisation of patient outcomes.
Digipharm aims to utilise innovative blockchain technology to overcome barriers to patient access and innovative pricing, reduce costs for all stakeholders, and bypass infrastructural limitations to drive value improvement, incentivise innovation and expedite the transformation to personalised healthcare.
Vision
Digipharms’ vision is to be ‘the pioneer of value-based healthcare delivery, innovative evidence generation and patient empowerment across the healthcare industry’ using revolutionary blockchain technology.
Problem
Barriers to innovative pricing and ‘paying for performance’
Healthcare systems are often required to make the difficult decision of whether to reimburse costly pharmacological therapies and provide access for patients while taking into account their limited resources. Innovative pricing approaches have the ability to overcome the challenges faced by healthcare systems when assessing the funding of new drugs, to enable the implementation of ‘flexible’ pricing schemes to assess the price of treatment in relation to the benefits it delivers.
Limitations of conventional real world evidence
Real world evidence (RWE) is playing an increasingly influential role in informing decision making within the healthcare industry and is crucial to informing value-based healthcare. Yet the delay of RWE outputs, the expenses of data access and the current methods of data collection negate many of the benefits of utilising these rich data resources.
Solutions
Reimburse
The Reimburse platform harnesses the benefits of automated ‘smart contracts’ and blockchain technology; facilitating the application of truly dynamic innovative pricing solutions between healthcare systems and manufacturers, in a secure and compliant fashion with minimal administrative burden.
Insights
The Insights platform will extract anonymised patient level data from the Reimburse platform and health information systems to the world’s first ‘live’ RWE database. Insights will provide a symbiotic solution with Reimburse to complement the progressive transformation towards value-based healthcare delivery systems.
A paradigm shift in healthcare
Innovative pricing and value-based healthcare
The digitisation of healthcare is a key element to improving patient outcomes, their quality of life and reducing the intense burden on health systems worldwide. The healthcare industry is experiencing a paradigm shift to value-based care due to growth in demand, aging populations, chronic diseases and unsustainable levels of health related expenditure.
Personalised medicine
As the fields of diagnostics, molecular medicine and data capture methods develop over time, it is anticipated that tailored or targeted therapies will become widespread across most disease areas ushering in a new era of personalised healthcare. Such developments will significantly transform current industry models for research and development, treatment pathways and healthcare funding.
Data security & privacy
Utilising blockchain technology for Digipharms’ platforms promotes the development of a decentralised health information infrastructure that is ubiquitous, transparent and security conscious. In May 2017, The National Health Service (NHS) in the UK was subject to one of the largest ransomware attacks in history, crippling almost 50 NHS trusts, leaving confidential data at risk and the halt of numerous services which only added to the misfortune of patients. Such vulnerabilities of the current IT infrastructure could be mitigated by the use of an additional layer of immutable, decentralised, cryptographically encrypted platforms that are able to bypass single points of failure and continue functioning as normal.
Current infrastructural limitations to innovative pricing
In order to be implemented effectively, innovative pricing or value-based pricing models require up-to-date and accurate data to track patient progress and treatment related outcomes, and to be able to report these criteria in a compliant and validated manner. In developed countries, the clinical infrastructure to measure treatment outcomes is currently sufficient, however such resource intensive pricing models are under-utilised due to barriers in data interoperability and lack of capable infrastructure in place at administrative levels (Husereau et al 2011).
Accelerated access
Recently there has been an increased number of proposals at regulatory level with regards to providing therapies that extend life and address a large unmet need at an earlier stage. The FDA will consider accelerated approval by measuring efficacy based on surrogate endpoints or something that is thought to predict clinical benefit, for example this could be based on radiographic imaging or blood biomarkers (Chuk et al 2017; Cohen et al 2003).
Genomic profiling
The drive towards personalised healthcare, supported by genomic profiling, is identifying new drugs that aim to deliver increased benefits to very specific and small patient populations (for example, instead of giving a new medicine to all breast cancer patients, the most benefit may be achieved in a subset of patients whose cancer has a specific genetic mutation).
Market potential
The Reimburse platform has huge potential for uptake, with the possibility of being the premier platform for innovative pricing solutions for every therapy that receives regulatory approval. There is currently no comparative platform available that can provide the scalable dynamic pricing solutions to facilitate funding solutions between manufacturers and payers
As pharmaceutical innovation develops further, it is expected that hundreds of novel agents will be approved over the next 5 years. There are over 7,000 drugs in clinical development across the world, more than ever seen before (PhRMA 2017); with over 450 new clinical trials starting in 2017 alone (Reuters 2017).
The Insights platform
The Insights platform will extract anonymised patient level data from the Reimburse platform and electronic patient records to the world’s first ‘live’ real-world evidence (RWE) database, that is accessible by subscribed users at real time (Figure 5). Uniform and standardised inputs to smart contracts which are encapsulated within the Reimburse platform and the architecture of Digipharms’ bespoke integration solutions to health information systems promptly address several of the limitations that are observed with conventional RWD collection and database generation, thus expediting the time to availability of consistent and ‘ready to use’ RWE outputs.
The availability of ‘live’ RWE will provide payers, manufacturers and providers with ‘real time intelligence’ with which they can inform strategic decisions, product development and anticipate treatment pathways. The generation of tangible, timely and consistent data at a fraction of current costs with no delay, will encourage the increased utilisation of RWE and eliminate the reluctance of all stakeholders from accessing such data. As health insurers move away from a business planning approach towards a flexible data-driven iterative approach, the ability to test, model and receive feedback from a live intelligence source within a landscape that is progressing to personalised medicine could prove to be invaluable.
Market potential
The use and reliance on RWE is growing and will have huge impact in supporting clinical research, trial execution and decision making in healthcare. There is a clear need for the provision of timely and readily accessible RWD to inform industry, policy makers, providers and payers of product performance. Regulatory bodies and HTA agencies are fully supportive of its use. Pharmaceutical companies and health insurers regularly purchase aggregates of RWD or sponsor RWE studies for substantial amounts of money, often collecting data that is not required or valuable resulting in a waste of resources.
Pipeline projects
The future projects outlined in section 5 represent ideas for the future. Their implementation is strongly dependent on permissibility under applicable laws.
MyHealth, incentivising patients for superior outcomes
There is a growing body of research demonstrating the benefits of financial incentives for patients in healthcare. Despite the strong evidence showing that incentives for patients with chronic diseases result in improved health outcomes, the act of incentivising patients with their healthcare management it is extremely underutilised.
Evolve, supporting early medical innovation
Ensuring funds are consistently available for research and development activities for some manufacturers is becoming increasingly difficult due to reductions in the long term profitability of newly launched drugs as a result of shortened exclusivity, biosimilar threat, smaller eligible patient populations for targeted therapies and the competitive landscape of drugs targeting the same disease area.
Technological considerations
Overview
In anticipation of the challenges presented by integrating Digipharms’ platforms with existing IT infrastructure within national health systems or large primary care networks, agile API integration studies of such diverse and complex systems will be performed prior to the development of our bespoke integration engine.
Potential for further development
The successful integration and development of the digipharm ecosystem will enable the possibility for health related decentralised applications to be affixed as application layers on the Digipharm platform.
Blockchain technology & smart contract application
Blockchain is a distributed database technology, most recognized for being the backbone of digital currency platforms such as the Bitcoin and Ethereum networks. Smart contracts are self-executing pieces of code that digitally facilitate, verify or enforce the terms of a predetermined agreement.
Additional services
Private blockchain technology has many benefits to its use when dealing with healthcare and other personal related data. When considering the best architecture to build a secure and scalable solution, private blockchain technology is the best solution for the below reasons:
- Integration support
- Toolkit for payers, providers, manufacturers and private insurers
- Strategic pricing review and strategic advice
- Reimbursement process review and collaboration with payers/providers
- Process review for clinical and industrial clients - automation and digitisation of health services
- Health economic modelling and forecasting
- Advanced data analytics
DPH health economy
Health economy stakeholders
The Digipharm platforms will be built to support all stakeholders seamlessly, utilising task
automation via smart contracts wherever possible. It will be architected with security, data
protection and regulatory compliance at the forefront of the design.
The health economy will involve the following participants:
- Patients
- Payers
- Manufacturers
- Providers
- Digipharm Platforms
Digipharm tokens (DPH)
DPH token use
DPH token sale Information
Funding usage and token distribution
Commitment to charitable causes
0.5% of ICO proceeds will be allocated to the Digipharm charitable foundation (to be established) with the goal to develop sustainable health related services in third world countries. Digipharm will further commit 2.5% of net profits per annum towards the charitable foundation. If the foundation cannot be established due to regulatory or legal reasons, Digipharm intends to allocated the above mentioned funds to a third party foundation with similar goals.
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