Source: IQVIA Institute for Human Data Science
A digital health progress report by IQVIA Institute for Human Data Science, formerly known as the QuintilesIMS Institute, shows a maturation of the sector. The number of digital health apps has doubled in recent years to 318,000. Increased clinical validation has led to wider adoption by pharma companies and healthcare systems to remotely monitor patients and quantify medication adherence for clinical trials. It also notes that the digital health tools are being used to monitor disease progression but wider adoption requires overcoming significant barriers such as malpractice liability and
Here’s a roundup of the most interesting findings from the report:
“We are seeing an increase in the number and sophistication of sensors to see how patients are responding to medications,” said Murray Aitken, IQVIA Institute for Human Data Science Executive Director in a conference call with reporters Friday. He pointed to the adoption of smart inhalers to track asthma and COPD medication adherence. There has been widespread collaboration between device developers such as Propeller Health, Adherium Health and Qualcomm Life with big pharma companies such as Novartis, Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline.
About 82 percent of the 850 clinical trials using apps were sponsored by universities, hospitals, health systems and other patient care institutions. Duke University, the University of California San Francisco, and the University of Pennsylvania are the primary institutions doing the majority of digital health clinical studies.
Digital biomarkers
The use of sensors and apps to track disease progression with biomarkers that set parameters and correlate to disease severity has attracted a great deal of interest. They’ve been used to assess behavioral health for depression and anxiety to tracking and detecting seizures. A digital version of the “six-minute walk test” has been used to spot gait changes such as for Alzheimer’s disease, juvenile fibromyalgia, geriatrics, heart failure, multiple sclerosis, Parkinson’s disease, pulmonary disease, osteoarthritis, spinal cord injury, and stroke.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A study by Roche and Prothena Biosciences used a smartphone app in a Phase I Parkinson’s trial to continuously measure symptoms such as tremors, balance, gait, standing up/sitting down transitions and turns.
Clinician adoption is still limited, but…
Only 26 percent of clinicians recommend patient engagement technologies and 13 percent use remote patient monitoring technologies according to an American Medical Association (AMA) survey cited in the report. Among the turnoffs for clinicians are privacy, security and malpractice liability, financial incentives, and workflow integration.
That’s why there have been efforts to develop a way to standardize curation for app formularies that would enable physicians to “prescribe” to patients. Examples include Mount Sinai’s app prescription platform RxUniverse.
Some health systems are developing their own apps to quantify adherence such as the patient reported outcome app Cleveland Clinic developed — a Multiple Sclerosis Performance Test. It is intended to measure neurological and neuropsychological impairment and disability to be a precise, valid measurement of MS severity.
The clinical trial endpoint dilemma
Digital health apps and sensors enable patient experience data to be gathered over the span of a clinical trial.
Despite the clinical validation of many different apps and sensors, pharma companies are still reluctant to include data generated by sensors in clinical trials lest it jeopardizes a drug’s approval. Instead, most trials are using digital health tools to incorporating these as exploratory endpoints for commercial Phase IV trials on marketed drugs, where risk and regulation are lower.
That point was underscored in the report by Marc Sebes, the vice president of product management at data aggregator and integrator Validic, who said:
On the pharmaceutical side… there’s certainly a lot of experimentation going on during the trial process and before the trial process, but where we’re seeing things start to actually happen is after the drug is out there [on the market]. They are saying, ‘Let’s have more interaction with this patient and how they take the medication. Let’s learn more about the real world use of this drug while it’s out in the wild … rather than jump straight to the more challenging aspect — at least from a regulation side — of how to incorporate all this into a[n approval] trial…’”
A small number of drug developers do use digital tools with new drugs or for gathering primary and secondary endpoints.
To address the endpoint quandary, there is the Clinical Trials Transformation Initiative, a public-private partnership of pharma companies, academics, and regulators, including the FDA. CTTI released guidelines earlier this year for selecting novel endpoints.
The overall body of clinical evidence on app efficacy has grown substantially and now includes 571 studies, including 234 randomized controlled trials and 20 meta-analysis studies.
Quantifying downloads
Just 41 apps with over 10 million downloads each account for nearly half of all app downloads while over 85 percent of all health apps have fewer than 5,000 installs.
Health apps that have focused on wellness management only make up 60 percent of total apps compared with 73 percent in 2015. On the other hand, there has been a 48 percent increase in the share of apps focused on health condition management. The number of apps that focused on specific diseases have increased from 10 percent in 2015 to 16 percent of all apps. Medication reminders have inched up from 7 percent to 11 percent.
Digital health and the future of value-based care
The Trump administration’s healthcare policies, including the decision by the Centers for Medicare and Medicaid to halt reimbursement to providers for virtual coaching on weight management for the Medicare Diabetes Prevention Program, came up on the conference call and how it would impact the shift to value-based care.
“While there may be a slowing of efforts by the administration for value-based care, that is not the case with the private sector,” said Aitken
