The market model for traditional pharmaceuticals, which is based on formulary positioning and prescriptions given by doctors, has been under pressure, giving rise to an end-user and consumer-driven approach. In addition to this, changes in payment models have been linked to positive patient outcomes, otherwise known as 'payment by results'.
For pharmaceuticals, the concept of patient centricity is a major trend, where industry trends - including more defined clinical/regulatory approaches, an increased number of biologic drugs, higher-drug specificity and treatments linked to diagnostic data - are combining with a subsegmentation approach that concerns patients and where drugs can be most effective. While efficacy and safety are still fundamental for gaining drug approval, it is also important to note that exploring and understanding the care journey provides valuable insight into the needs of stakeholders, as well as the basis for defining services that are essential for stakeholders and patients in subsegments. A service model that is dedicated to the drug will be able to meet individual and segment needs, including secondary disease measures, monitoring, and adherence and compliance services.
Smooth interaction with stakeholders is important for deriving value from this drug/service differentiation. This change in the stakeholder/patient engagement equation evidences that bespoke connected health services are proving to be vital tools.
Connected health services could make significant changes to the market as an advocate of direct interaction with end users. In other sectors, end-user ownership equates to market leadership and it is questionable if this will be the case in healthcare, where regulatory and compliance issues, such as safety, efficacy and pharmacovigilence, could be significant entry barriers. Nevertheless, major players that are focused on user needs - including Google and Apple - are working alongside health service platforms to provide value-added services, with the aim of influencing market conditions.
Risk sharing with payers leads to the use of different models that are more finance and data driven. Real-life data has been introduced - in relation to evidence development and situations that concern conditional approval conditions - as a result of remaining clinical uncertainty, where pharamaceutical companies have comitted to delivering post-market data in order to prove secondary measures or outcomes. Doctors will continue to be the main prescribers of drugs, but patients will be able to take an active role in their care journeys by using a combination of drugs, smart devices and services associated with the treatment. Those who take responsibility for the connected health interaction and data flow will control the end-user interaction to some extent, transforming pharmaceutical companies into simple drug suppliers in a service-driven environment - unless the companies decide to take on this service responsibility.
The pharmaceutical industry has a long history with risk management, and works in a tightly controlled and regulated environment. It is not surprising that it has a culture of focusing on challenges rather than opportunities that arise out of new connected health technology. Most concerns centre on security and data privacy, which are extremely important and manageable. Since the launch of smartphones, a greater number of people want to stay connected; other industries have used this to improve consumer insights and knowledge. As long as it manages the risks appropriately, the pharmaceutical sector has a prime opportunity to fulfill its patient centricity claims, as well as a desire among patients to lead their own care journey and disease management by using the connected health opportunities that smartphones and related technologies provide.
Delivering a system requires key strategic considerations and basic rules to be successful. Understanding specific stakeholder needs and challenges related to disease management creates the foundation for identifying potential value drivers. Everything must be assessed in a disease and care journey-specific context, as no disease, care journey or patients are equal.
Designing and developing a smart device and connected health solution, therefore, requires a high degree of flexibility and individual adoption options to ensure engagement, which is vital for delivering value through the patient engagement equation.
The BETACONNECT electronic auto-injector, and its associated myBEATAapp regulated connected health platform, is the first fully connected solution available in the market, which supports Bayer's MS patients and their HCPs along every step of the care journey. This device, and the service combination product set-up, underwent regulatory assessment and has been globally approved; first in EU and most recently in the US.
Smart devices are designed to meet specific needs, compared with off-the-shelf and one-size-fits-all devices; however, this does not mean that timelines to market need to be extended beyond those of an off-the-shelf device. Having a set-up of core technologies that have been tested and proved in other devices, and are what some call 'off-the-shelf' technologies, provides options that help to form a specific and bespoke solution. Similarly, these can be developed for the market around the same time as off-the-shelf solutions, and provide the opportunity to design and assemble bespoke device solutions that deliver features specifically for stakeholder needs, including connected health options. The roll-out of connected health solutions is also possible prior to the lauch of a device, particularly when early interaction from stakeholders adds value. This is made possible by the underlying hardware, security, integration interfaces and analytics becoming part of a standardised platform. The drug and disease specific parts of a connected health solution are primarily software and app-interface development, and there is a short lead time of 12-18 months to compare the development times of smart devices with connected health services.
There are additional costs associated with smart devices and connected health service solutions; however, significant value can be added when establishing a stronger market position and long-term relationships with stakeholders that are vested in the therapy. The move into using smart devices and connected health services has to be seen as a market transformation, and business cases have to be verified. On top of focusing on the drug, it becomes important to address its value from different parameters, including the move away from 'pure' treatments to preventive care models, a learning loop with end users and expanding market opportunity by using connected health as a differentiator. The pharmaceutical market need to envision its future in diseases, making one where it embraces its position as a provider of drugs and a solution to total disease management.
The user focus that is occurring in other sectors is starting to impact the pharmaceuticals industry, where the need for greater patient centricity and alternative payment schemes are key trends. There is little doubt that smart devices and connected health services will play a significant role by influencing the pharmaceutical market.
Technologies and solutions are already available that create a higher degree of interaction with stakeholders along the care journey, and more solutions are being launched. Realising the value that these services can provide, and acting to implement these solutions, is an important fact that the pharmaceuticals sector needs to face by starting to understand that there are bespoke solutions that do not require the 'reinvention of the wheel'. Instead, they need a smarter way to bring existing and proven technologies together, in order to deliver low-risk solutions that add value and successfully compete with off-the-shelf solutions regarding how long it takes to reach the market.