mHealth and wearables – taking your health home with you
The Access to Medical Treatments (Innovation) Bill and the Accelerated Access Review here in the UK are important recent contributions to the bid to get drugs to patients with unmet need quicker. However, in the area of orphan drugs and rare diseases, any solution ultimately needs to be considered at a global level
This is not only in terms of identifying the necessary number of patients for taking part in clinical trials, but also for commercialising the drug after. This means that all country specific initiatives need to be in line with all the regulatory, governance and reimbursement requirements in partnering countries too. Quite the challenge even in this digital age!
At a European level, one such important initiative seeking to address these global considerations is ADAPTSMART (www.adaptsmart.eu).
ADAPT SMART is an IMI funded platform enabling the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities. MAPPs is an extension of adaptive pathways, which seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion – i.e. gets medicines to patients as soon as practically possible.
MAPPs gives full recognition to the fact that access for patients to new drugs is determined by a chain of decision makers, including drug developers, regulators, HTA bodies, payers, prescribers and patients. MAPPs considers this chain in the round.
An inevitability of MAPPs’ approach is that approval decisions are made in an iterative process, based on a smaller amount of initial data to allow that early drug availability to patients. Whilst this does increase the amount of uncertainty at the initial assessment, it should not be considered as lowering the approval standards. Greater emphasis and expectation is placed on restricting prescribing to the target population and the on-going real world data collection once the drug is made available. Essentially this shifts post-marketing surveillance from reactive reporting to proactive monitoring, something that the Empower campaign has been championing for a number of years.
Rapid advances in technology mean that mobile health (mHealth) and wearable technology is set to transform the way that drugs introduced under the MAPPs agenda can be monitored for both safety and efficacy. In essence mHealth means that patients can now be monitored continuously, passively and in real time in their own homes (and out and about).
Patients facing life limiting and life threatening diseases are invariably the most informed people about the impact of their disease. They are therefore the most motivated and empowered to provide the meaningful data that describes their health.
Hospital based tests used to analyse disease severity in a medical setting only provide a sterile, snapshot view of the patients’ overall health and wellbeing; The data generated therefore does not provide a comprehensive understanding about the physical health and emotional wellbeing of patients.
This means that patients are currently the most under-utilised resource in terms of understanding disease pathways and response to therapy.
By providing patients with the platforms to provide their data in a passive manner (i.e. not in a medical setting), and in a user friendly way for both patients and busy physicians, we can drastically improve the quality of post-marketing surveillance. Add in the safeguards to provide peace of mind that the data used complies with data protection and privacy laws, and we will go a long way towards providing the quality data necessary to demonstrate both the efficacy and effectiveness of innovative drugs for patients.
Elin Haf Davies is an Associate Fellow at CASMI and the Founder and CEO of aparito (a digital health start up delivering wearables and disease specific for orphan diseases).