Hypertension — or high blood pressure — affects about 120 million adults in the U.S. and can lead to heart disease, stroke and chronic kidney disease. There is also a higher prevalence of hypertension among Black people, men and seniors. High blood pressure costs the U.S. about $131 to $198 billion a year, according to the CDC.
Numerous digital hypertension solutions have emerged to ostensibly help better manage the disease and control costs, but are they truly clinically and economically effective? That’s what the Peterson Health Technology Institute (PHTI) set out to uncover in its third report analyzing digital health solutions. The organization launched last year with the goal of providing much-needed evidence on the proliferation of digital health companies that have surfaced in recent years. It has already provided results on diabetes solutions (largely unfavorable) and musculoskeletal solutions (largely favorable). PHTI was created by the Peterson Center on Healthcare with a $50 million commitment and functions as an independent non-profit. It doesn’t accept other outside funding for its work.
Unlike the previous two reports, Monday’s report on hypertension solutions produced mixed results. It found that medication management companies have clinically meaningful outcomes with long-term cost savings. However, blood pressure monitoring companies and behavior change solutions were found to be less effective.
Given that buyers of technology are constantly looking for ways to stem costs associated with hypertension, the report can offer clues on which solutions they should be investing in.
The findings
To conduct its analysis on hypertension solutions, PHTI reviewed 2,498 articles, 31 of which were submitted by the companies included in the analysis. In total, it looked at 11 companies across three categories:
Blood pressure monitoring (companies that offer home monitoring and provide data back to the healthcare provider): AMC Health, Health Recovery Solutions and VitalSight
Medication management (companies that provide virtual care teams and offer medication adjustments to supplement the patient’s primary care team): Cadence, Ochsner Digital Medicine and Story Health
Behavior change (companies that provide educational content, alerts, reminders, coaches or care teams): Dario, Hello Heart, Lark, Omada and Teladoc
When looking at the clinical benefits, PHTI found that blood pressure monitoring companies have “slightly greater, but not clinically meaningful,” reductions in systolic blood pressure compared to usual care. Medication management solutions had more “rapid declines” in systolic blood pressure compared to usual care, therefore creating more clinically meaningful results. Behavior change companies had “limited incremental declines” in systolic blood pressure. However, these solutions could help close equity gaps, the report noted.
On the economic front, savings from blood pressure monitoring approaches do not currently offset the increased healthcare spending related to remote patient monitoring reimbursement. Medication management increases costs in the first three years but could lead to long-term savings by preventing cardiovascular events. Behavior change solutions are cheaper but fail to deliver enough health improvements to justify their costs.
“I think this idea of medication management solutions is so interesting because it’s really like expanding access,” said Caroline Pearson, executive director of PHTI, in an interview. “Primary care practices are busy, [so] getting someone back every four to six weeks to do medication adjustments is really hard. The notion that you can, as a primary care doctor, partner with one of these digital companies to help with doing some of those medication adjustments, I think is a really compelling use of digital solutions.”
The backlash
PHTI has received some pushback on its report from some of the companies whose solutions were deemed ineffective. Omada Health, for example, noted to MedCity News that it has published outcomes using an “evidence-based approach in line with best practices endorsed by the [American Heart Association] and [American Medical Association].” One study found that its program including hypertension education, at-home monitoring and behavior change support was effective for self-managing hypertension over 12 months.
“We believe that the latest PHTI assessment inadequately groups companies with very different offerings, narrowly focuses on select clinical metrics (i.e. blood pressure), and presents virtual care providers as point solutions, which is inconsistent with buyer and member needs,” said Dr. Carolyn Bradner Jasik, chief medical officer of Omada Health, in an email. “We believe the AMA’s Return on Health framework provides a more holistic and relevant approach, and we encourage the digital health industry to join us in adopting it.”
Omada Health was also included in PHTI’s previous reports on diabetes and musculoskeletal solutions. The former found that the company was not very effective, while the latter found that it was.
Hello Heart, meanwhile, applauded PHTI’s efforts to assess digital health tools, but argued its “data collection, analysis, and results are majorly flawed, which led to misinformed recommendations.” The company’s senior vice president of medical affairs, Dr. Edo Paz, said PHTI did not take into account its peer-reviewed studies published in JAMA and JAHA, which found that Hello Heart users experienced a 21 mm Hg average reduction in systolic blood pressure in high-risk members over three years.
“Unfortunately, PHTI did not include these outcomes, and instead estimated only a 1 mm Hg improvement over usual care for the Behavior Change category as whole,” Paz argued. “Additionally, PHTI’s economic impact analysis is limited and does not rely on actuarial best practices or real-world claims costs. While avoidance of heart attack and stroke are one driver of cost savings for solutions like ours, the claims analyses we conducted demonstrate that reduction of inpatient hospitalizations is also a driver of lower costs.
“PHTI did not use our independently validated cost reduction data in their analysis. Hello Heart is shown to reduce costs by 17% per participant per year in one study of 5,651 Hello Heart users from 11 clients,” Paz added. “Hello Heart users also had 3.8 fewer inpatient days in the hospital, while non-users had an increase of nearly 10 days (both per 1,000 member months).”
Pearson of PHTI addressed Hello Heart’s clinical evidence, noting that there were some methodological flaws. She said Hello Heart used single arm studies, meaning everyone in the trial receives the same treatment without comparing to a control group. In addition, patients opted into the study.
“Another piece is that actually, that study only reports results for patients who saw improvements in their hypertension. In every other study that we feature in our report, we’re looking at … basically the whole study cohort,” Pearson said. “Some people get better and some people don’t. And that’s always the nature of these studies. You’re looking at averages, and some patients really outperform that and some patients don’t. But in a study where we only know what the subset of patients who actually saw improvements were, and we don’t know what percentage of patients those were, it’s very hard to know whether those results are representative.”
Pearson also responded to the overall pushback PHTI has received. One criticism is that the organization’s assessment methodology is too focused on clinical outcomes and economic impact and not enough on patient experience and patient-reported outcomes.
“We view clinical outcomes as table stakes,” she said. “I think patients expect that clinically-focused digital solutions are improving their health. … We can talk about competing on user experience, on other patient-centric measures that are super important, but we need to prove that they work. We feel strongly that that’s what health plans and employers are looking for, [and] also what patients and families are looking for.”
Another complaint that PHTI sees is that digital health solutions are receiving greater scrutiny than traditional care. Pearson argued that PHTI believes high quality is important in all care. However, in digital health, “these are solutions that employers and health plans and provider practices are paying extra for, and so I think it is fair that we expect that they also deliver extra value,” she said.
Not surprisingly, a company that received favorable results from the Institute — Story Health — had more positive things to say about the report.
“We are pleased to see that PHTI recognized Story Health as the leader in digital hypertension management,” said Tom Stanis, co-founder and CEO of Story Health. “Medication management, a cornerstone of our product differentiation, is a key strategy with strong, evidence-based results, indicating meaningful improvements in hypertension management.”
Implications for investors and purchasers
PHTI’s findings have important implications for purchasers and investors, who are finding themselves increasingly overwhelmed by a plethora of digital health solutions.
“Employers and purchasers writ large haven’t had access to an independent assessment of evidence around the clinical and financial aspects of vendors in the space,” said Christina Farr, a managing director with Manatt Health, a consulting group. “So this is valuable work and I am hearing on the ground that it’s having an impact with purchasers. From an investor [point-of-view]it’s also providing guidance in areas of opportunity based on clinical models that are delivering the most value, particularly at a time of point solution fatigue.”
Farr disclosed that some of her colleagues at Manatt Health work with PHTI on the research.
Another industry expert — Doba Parushev, the head of Healthworx, the innovation arm of the payer CareFirst BlueCross BlueShield — stated that the PHTI hypertension report offers data on something that has been known (or at least suspected) for a while: “Broad-based, low-touch, digital solutions struggle to generate the population engagement and clinical impact they promise.”
He added that this is positive on two fronts. One, it shows a higher expectation around “outcomes-driven thinking from startups.” He anticipates seeing more scrutiny on how companies show and track their impact. Two, the report highlights the challenges that payers, providers and employers have historically faced in choosing and evaluating point solutions due to limited research, which is what PHTI is trying to solve.
“This is a conversation that has been brewing over the past few years as payers, employers, providers, and even individual consumers grew the number of disparate point solutions they choose to work with – and are now grappling with both unwieldy portfolios and an unclear strategy for the future,” Parushev said.
He added that he’s noticed a trend in the past half-decade across payers, providers and employers in picking and championing point solutions on their own. In the future, he hopes to see more collaboration in the procurement process, such as joint program design among these three stakeholders.
What’s ahead for PHTI
Now that three expensive conditions and health tech tools addressing those have been evaluated, the Institute is focusing on the next condition that has attracted a lot of capital and attention during the pandemic: The company is working on a mental health assessment of therapy options for mild to moderate anxiety and depression.
Pearson added that she’s starting to see more people within digital health recognize the need for better evidence.
“What’s been really interesting for us at PHTI since our first couple of reports have come out, is how much it feels like we’ve sort of met the moment where the industry is ready to mature,” she said. “It grew really quickly … but we need the evidence and the proof to catch up. And it’s been nice to see that actually, that message is resonating with people. People may or may not agree with everything that’s in the report, but everybody actually agrees that it’s time to be really clear on how digital solutions are working clinically.”
Photo: Natali_Mis, Getty Images
