Data and the Future of the Healthcare Ecosystem
by Elie Khalife, president, KeyCentrix
Data has always been a part of the healthcare ecosystem. Although it’s been collected inconsistently in the past, technology has helped advance the gathering, storing and needs for this data today. For decades healthcare professionals had worked independently to collect and aggregate data, but the calling for advancements in the healthcare industry required better interaction for all of healthcare’s actors including, but not limited to, drug manufacturers, prescribers, pharmacies and patients. Continuous improvements in technology facilitated and promoted this collaboration while providing even better outcomes for the industry and patients alike. These advancements and outcomes in healthcare now grow exponentially, and patient data is the new driving force.
The Need for Data
In 1972, with the distribution of methadone, the first drug was required to have data tracking and controlled distribution from the Food and Drug Administration (FDA). Now fast forward to 2005, an interesting year for drugs and pharmacies in general, the FDA started to demand more data points from drug manufacturers regarding new drug therapies in clinical trials and maintaining patents for existing blockbuster drugs. In turn, drug manufacturers required more process controls and limited the distribution to a select number of pharmacy locations that were capable of handling the collection of the expected data needed. This started a new trend of limited distribution drugs (LLD’s) – limited to a smaller number of specialty pharmacies and wholesalers that could dispense. Through this development, data’s importance continued to grow.
This group of LLD’s traditionally treats conditions that affect a specific and smaller patient population. They may have special and complex dosing requirements that need to be continually monitored for approval by the FDA. Through limited distribution, specialty drug manufacturers can require and ensure those who distribute these medications have proper inventory control and compliance with defined methods while forcing growth in their performance. More data needs to be collected.
Moving forward just a couple of years, the FDA has an estimated 200 requests for orphan drug designated LLD’s pending review. They have seen a steady increase in these even more rare drug requests over a five-year period. The number of requests for this designation in 2016, 568 requests, has more than doubled the number received in 2012. Now imagine today’s increased number of devices, LLD’s and orphan drug LLD’s on the list for the FDA to approve. This increase is growing rapidly each day moving forward. Each request requires a growing number of resources, grants and funding for what may become a patented drug brand, a success as a cure and an extended relief to patients. No matter what role you play, the healthcare ecosystem requires a continually growing amount of data be available and coming together.
Challenges for the Ecosystem
Full transparency is now required from everyone in the ecosystem, while providing data at the point of care through the point of dispensing, to meet patient compliance and best outcomes. This is an intricate task considering the elaborate coordination of drug distribution that rivals patient complexities with their multiple medical conditions and management of chronic diseases – all while monitoring stringent requirements. And this level of complexity is certainly not decreasing.
One of the other greater challenges today is establishing a distribution model. Here’s just a couple of the data factors that need to be considered for inclusion – risk evaluations and mitigation strategies management, inventory control, coordination of care, ability for dosage adjustments, reimbursement handling and patient assistance needs, consideration of the growing size of the patient population, adjusting costs of products, compliance and persistency and patient training.
Let’s also not forget the important piece everyone in the ecosystem must consider – value-based care. It began as a trend a couple of decades ago, but it’s quickly becoming industry standard. Value-based care is an approach designed around patients, making sure they are provided the right care whether preventative, chronic or acute.
Impact of Data Today for Tomorrow
The FDA is approving drugs more rapidly, and pharmacies are collecting data on these new and existing drugs to include outcomes for patients. Data may then be provided to insurance companies to track results of the medications and patient compliance. To best serve patients the healthcare industry needs to continue and improve open and collaborative data sharing from development to diagnosis and dispensing. The intent is a better understanding of how medication helps patients achieve better outcomes. In a world of smart phones and mobile apps, healthcare may soon be facilitated completely through mobile devices making it possible to have interaction between patients and providers. The idea leads to a better understanding of how a particular treatment helps patients, providing an opportunity for even better outcomes – which leads to more data collection.
Is the market ready for a smarter system that collaborates through drug development, distribution, drug dispensing, medical outcomes, pharmacist and nurse counseling, tracking simple daily tasks like biometric data, drug and activity compliance, and most importantly mobile apps facilitating interaction between patients and providers? All participants will need technology connected to a system holding accessible real-time data for the optimum results.
Technology that Delivers
“We’re looking for an all-inclusive system that will service our pharmacy and grow with all of our business data demands,” says every pharmacy – specialty, retail, small and large. These needs are widespread and changes are happening more frequently than expected. Commercially, no one system is capable of handling or successfully maintaining all the components necessary. Fortunately, software does exist like KeyCentrix’s New Leaf Rx. It is an enterprise solution for all of the actors – handling their data and leading them through and towards successful outcome based processes. It can think like a pharmacist and a prescriber, and it can help think for a patient all while providing the data needed for decisions from all roles. In essence… every actor, including this enterprise solution, focuses on contributing what they do best.
The new driving questions become – will third party payers adjust reimbursements to providers, hospitals, physicians and pharmacists, based on expected value-based outcomes? Will Insurance plans become designed on patient health rating and patient compliance – bypassing preexisting conditions? Let’s see how the future continues to develop.