Jared Kaltwasser

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A new report underscores the benefits of obstructive sleep apnea therapy for people with cardiovascular disease, but it also highlights the critical role of treatment adherence in order to activate those benefits.

The links between obstructive sleep apnea (OSA) and cardiovascular disease have been widely reported. Disruptions in oxygen associated with the sleep disorder can put strain on a patient’s heart and blood vessels, and, over time, increase the risk of a serious cardiac event.

The primary method of treatment for OSA is continuous positive airway pressure (CPAP) therapy. Previous studies have suggested that CPAP therapy can reduce long-term healthcare costs among people with OSA. Yet, such benefits only accrue if patients utilize their devices on a consistent basis.

, Ph.D., of the University of Maryland School of Medicine, and colleagues, wanted to see what impact it would have if patients with both heart disease and sleep apnea consistently used their CPAP devices following hospitalization.

“Cardiovascular disease is the number one killer of older adults in the world,” Albrecht said, in a press release. “Older adults with comorbid cardiovascular disease and obstructive sleep apnea are a vulnerable population at high risk for hospital readmission.”

Albrecht and her co-authors retrospectively examined a sample of 1,301 Medicare beneficiaries who were at least 65 years old, had both OSA and cardiovascular disease, were hospitalized, and initiated CPAP use. The data covered the period of 2009-2013. The median age of enrollees was 73 years, and a slim majority (53%) were men. The authors tracked those patients for 25 months, using the number of times patients charged their CPAP machines as a proxy for adherence. Patients were then subdivided into three adherence categories: non-adherent, partially adherent, or highly adherent. When the investigators compared those adherence categories to 30-day hospital readmission rates, they found a significant divergence between patients who used the CPAP device regularly and those who did not. Their results were 

“Our data show that successful treatment of obstructive sleep apnea can greatly reduce the risk of 30-day hospital readmission,” Albrecht said.

Specifically, the study found that people in the “highly adherent” category of CPAP use had an odds ratio of readmission of just 0.41  compared with those with low adherence. In other words, those with high adherence were 60% less likely to be rehospitalized within 30 days.

Though the study demonstrated the value of adherence, it also showed why clinicians cannot take for granted that patients will be adherent to CPAP therapy. Less than 1 in 3 patients (28.5%) were in the “highly adherent” category. One-third (33%) had low adherence, and the rest were categorized as partially adherent.

When investigators examined specific cardiovascular conditions, they found that CPAP had a significant benefit among those with heart failure, but not among those with other cardiovascular diseases.

Albrecht said the study is further evidence that CPAP devices can improve patients’ quality of life and also drive down healthcare costs, since readmissions are a major driving factor in the high cost of healthcare. However, she said such benefits rely not only on patient adherence to CPAP machines, but also on the identification and diagnosis of people with sleep apnea.

“If patients show signs of obstructive sleep apnea, such as snoring, daytime sleepiness, or poor sleep quality, they should talk to their doctor, and doctors should ask about sleep, especially when caring for older adult patients with cardiovascular disease,” she said.

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But less than one-third of patients are highly adherent to continuous positive airway pressure therapy, researchers found.

  CPAP Use — and Adherence — Can Cut Risk of Hospital Readmission in People with OSA, CVD

While many digital therapeutics firms are startups based on the technology side of the industry, many established pharmaceutical industry players are also embracing digital tools.

Last month Biogen made digital health tools a centerpiece of their research presentations at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Amsterdam. The data presented at the conference aligns with a number of deals that the Cambridge, Massachusetts, pharmaceutical company has struck in recent months that are aimed at embedding a significant digital health component into the company’s overall multiple sclerosis (MS) portfolio.

, M.D., Ph.D., head of science for Biogen Digital Health, said in a press release that digital tools are a critical part of the company’s vision for MS care.

“Biogen is working to realize a future where multidimensional data are leveraged to better characterize and monitor MS disease progression and to predict therapy response at an individual level,” Belachew said.

Among the presentations at the ECTRIMS meeting were interim data from Biogen’s 

, which is designed to test the efficacy of a self-administered assessment of motor and cognitive function using the smartphone-based application Konectom. The test aimed to evaluate the cognitive processing speed (CPS) of people with multiple sclerosis and healthy controls. The company reported that the application’s CPS scores and response times were able to meaningfully discriminate between patients with MS and healthy controls. In addition, the company released data related to the design of the CPS tests. For now, Konectom is only available in limited research settings, the company said.

The company also said a technology-enabled version of the nine-hole peg test was able to calculate manual dexterity in a way that appeared to correlate with changes in disability level and quality of life in people with MS. Those data were based on more than 3,500 patients.

In addition to tracking changes in a patient’s disease, Biogen is also working on digital tools to predict treatment response in patients. The company presented data from a precision medicine model that they said might eventually be able to predict individual patient responses to treatment in clinical practice, thereby making it easier for clinicians to help guide patients to the best possible treatments.

“This year’s ECTRIMS presentations represent our ongoing digital health research and highlight progress in developing advanced measurement methods that aim to enhance drug development and personalized care for better patient outcomes,” Belachew said.

These latest data follow a number of partnerships Biogen has announced with digital therapeutic makers. In May, Biogen said 

it had entered into a licensing agreement

 with the digital therapeutics maker MedRhythms to develop and commercialize a prescription digital therapeutic for gait deficit in people with MS. The therapeutic candidate, 

, uses rhythmic-auditory stimulation to synchronize the auditory and motor regions of the brain in order to improve a patient’s gait. The device includes sensors that track real-time gait data, thus providing feedback to improve the product’s performance. The technology is also being deployed to treat other neurological conditions.

 with Twill (formerly Happify Health)  to provide a patient education and engagement tool for people with multiple sclerosis. That product is designed to leverage Biogen’s MS research with Twill’s artificial intelligence systems to provide personalized intervention for patients.

The company has made digital health a major focus of its research pipeline in multiple sclerosis.

  Biogen Highlights Digital Focus in MS Care at ECTRIMS

As Americans head to the polls for the midterm elections tomorrow, they must consider a barrage of important issues, ranging from gas prices to abortion to climate change to public safety.

But for the digital therapeutics industry, the most important issue in the midterms may be how the outcome of the elections tomorrow will affect the fate the Access to Prescription Digital Therapeutics Act. The act would expand Medicare coverage so that it includes coverage for prescription digital therapeutics.

When she introduced the bill in March, Senate co-sponsor 

, a Republican from West Virginia, said the bill was an essential step to “harness the power of innovation in medicine.”

“Our bill ensures these prescription digital therapeutics are covered by Medicare so more patients, including seniors, have access to the cutting-edge care they deserve,” 

 Capito, who is not up for reelection until 2026. The House sponsor is 

, a Northern California Democrat who is likely to be reelected.

The bipartisan support may be a good sign, but neither the 

Andy Molnar, chief executive of the Digital Therapeutics Alliance (DTA), and Sara Elalamy, M.A., the organization’s director of government affairs, told 

that they and other DTA representatives have been “pounding the pavement” to advocate for the bill.

“We have been working closely with the committees of jurisdiction and remain hopeful there will be movement on the bill this year,” Molnar and Elalamy said, in an email interview.

The legislation is seen as critical by the industry. Although a growing number of private insurers and other organizations have begun offering coverage of digital therapeutics, the lack of Medicare coverage means millions of potential customers do not have access to the digital treatments, affecting the overall market for the industry. What’s more, Medicare coverage tends to influence the coverage decisions of insurers who sell to businesses.

Molnar and Elalamy noted that digital therapeutics have advantages over other types of therapy because they can easily be administered via digital devices, even to patients who live in remote areas or areas with low access to healthcare.

“Digital therapeutics offer particular value to Medicare populations, leveraging advancements in technology to provide interventions to patients regardless of geographic location, condition severity, socioeconomic status, or the social drivers of health that contribute to disparities and inequitable care,” they said.

Digital therapeutics range in price. They don’t tend to have the high price tags of blockbuster cancer drugs or disease-modifying biologics.

Molnar and Elalamy said that as a practical matter, many patients will not be able to benefit from the kinds of evidence-backed digital therapies their members market unless Medicare covers the therapies.

“Accessibility is key to realizing the value of digital therapeutics and without Medicare coverage, only those who can pay out of pocket or lucky enough to be covered by a forward-thinking health plan will be able to benefit from these treatments, moving us further from the goal of advancing more equitable care,” they said.

Molnar and Elalamy said there has been “broad and increasing” support for the Access to Prescription Digital Therapeutics Act legislation, and said they are optimistic about its prospects in the new congress.

“We are looking forward to continuing to advocate for expanded coverage and access to digital therapeutics in the coming year and with the headway made on education efforts this year, we see a lot of momentum to build even more support in the 

The  Access to Prescription Digital Therapeutics Act has bipartisan support.

  Digital Therapeutics Makers Push for Medicare Coverage

The makers of a prescription digital therapeutic designed to treat migraines and pain have reached a deal to launch a one-year pilot program with a Massachusetts-based health insurer.  

, a company focused on using digital tools to treat neurological pain, announced an agreement with 

, the parent company of the Harvard Pilgrim Health Care and the Tufts Health Plan, last month.

Under the terms of the deal, Points32Health will make Theranica’s Nerivio therapeutic available to its commercial insurance members for 12 months. Nerivio is a wearable device that fits on a patient’s upper arm and is controlled by a smartphone application. It is meant to treat chronic and episodic migraines in people 12 years and older.

, M.D., MBA, M.S., Point32Health’s executive vice president and chief medical officer, noted that migraines affect an estimated 10% of the population.

"We are excited to work with Theranica to offer Nerivio as a drug-free solution to our members experiencing acute migraines and recurring attacks,” he said, in a press release. “This pilot highlights our commitment to offering access to a wide range of medical devices and tools that support healthy living.”

Nerivio has been cleared by the FDA as a migraine treatment and is available on a prescription basis. The therapy is drug-free. Instead of drugs, the device uses remote electrical neuromodulation to stimulate an endogenous analgesic mechanism in the patient. The process, known as “conditioned pain modulation” can be initiated at the onset of a migraine in order alleviate symptoms, the company said. 

 use of the therapy as a preventative tool to decrease the number of migraines a patient experiences.

Sait Ashina, M.D., an assistant professor of neurology at Beth Israel Deaconess Medical Center and Harvard Medical School, said the expanded availability of Nerivio is important because it broadens the potential treatments available to patients.

“Many of my patients have found Nerivio to be highly efficacious for them,” Ashina said, in the press release. “Given the multifaceted complexity of migraine, it’s essential that patients have access to a wide range of therapies, both pharmacological and drug-free.”

Theranica said the device can be used as a standalone treatment or in combination with other therapies.

Once prescribed, the company delivers the armband device directly to patients’ homes. The device is good for 12 treatments, after which it can be recycled, and a new device can be dispensed.

The deal with Point32Health is the latest agreement Theranica has reached to increase the availability of Nerivio. In June, the company announced that Costco would add Nerivio to its member prescription program. Last year, the company signed an agreement with the Department of Veterans Affairs to allow veterans to access the therapy.

“We are dedicated to making Nerivio accessible to people with migraine who seek cost-effective, chemical-free therapies to manage this debilitating disease,” said 

, Theranica’s CEO. “We look forward to working with Point32Health and with the healthcare providers participating in this pilot, and to forging additional strategic collaborations to ensure wide scope access to this disruptive-technology therapy.”

Members who receive healthcare through Point32Health Inc.’s programs will now be able to access a device called Nerivio.

  Theranica’s Inks Migraine PDT Deal with Massachusetts Health Insurer

As SCAN Health Plan worked to boost medication adherence among members, it made a startling discovery. The Medicare Advantage plan used the CMS’ Star Ratings system to self-assess their program.

“We saw that we were a 4½-star plan overall,” says Sharon Jhawar, Pharm.D., MBA, the chief pharmacy officer at SCAN Health, a Southern California-based Medicare Advantage insurer. That was the good news.

When they dug deeper, they found bad news. “When you look at it by race, we were not a 4½-star plan for our Black and our Latinx populations.”

Although the health plan had been analyzing its own data for years and working to identify barriers to patient medication adherence, it found that the benefits were not accruing to all patients equally.

“We’ve been applying all these normal techniques that you do to help an individual adhere to their medications,” she says, “and we weren’t sure why there was still this big gap.”

 Personalized Solutions Boost - Medication Adherence

They quickly ruled out cost as the main driver of the disparity. They had already developed and launched interventions to help address that issue. So they decided to start holding conversations with members in demographic groups disproportionately linked with nonadherence.

When they did, they found that cultural issues had a major impact. For Spanish-speaking members, having a person who could speak their language and with whom the patient was comfortable asking questions was key.

For instance, one patient who was not taking diabetes medications as directed was doing so because she wanted to control her disease with diet and exercise. A pharmacist was able to explain to her that it was still important to take her diabetes medication daily. However, the pharmacist was only able to identify and solve the problem by speaking in Spanish with the patient.

“And then what we saw with our African American members was trust was important — getting recommendations from trusted sources,” Jhawar says, noting that a significant amount of medical literature suggests a historic lack of trust between some Black patients and their healthcare providers. “That trust hadn’t been built with health professionals.”

Solving those problems has not been easy, but she said an individualized approach has paid off. Some patients just need a reminder, a few are annoyed, but most appreciate the check-in. For some, it’s the difference between adherence and nonadherence.

“We’ve finessed the art of reaching out and communicating with them,” she says.

As SCAN Health Plan worked to boost medication adherence among members, it made a startling discovery. 

SCAN Tackles Major Disparities in Adherence

When Yossi Bahagon, M.D., meets with healthcare firms to pitch his company’s treatment-adherence solution, he doesn’t spend much time detailing the problem his company is trying to solve.

“In our slide deck, we don’t have a slide saying, ‘Oh, 50% of patients are not adherent,’ ” says Bahagon, co-founder and chairman of the digital health firm Sweetch, an Israeli company. “They know that better than we do.”

Nor does the academic community require a lesson on the problem.

“For the past 20 to 25 years, the data (have) fairly consistently shown that, overall, of people who have been prescribed long-term medications, about half of those patients are not going to take them as prescribed,” says Todd Ruppar, Ph.D., a professor in the College of Nursing at Rush University in Chicago.

Half is not a good proportion when it come to medication adherence. Ruppar says the trend is headed in the wrong direction. “It’s not getting better,” says Ruppar.

Modern medicine has brought about a host of treatments that can contain — and sometimes cure — harmful medical conditions, many of them killers were it not for the treatments standing in their way. But as many experts and clinicians have pointed out, all those awe-inspiring scientific advances are just jogging in place if people do not take the medications. It is threadbare but true: A medication can only work if the patient actually takes it and, depending on the drug and the condition, takes it as prescribed. Decades of data have made it clear that a large proportion of patients will fail to do so.

 SCAN Tackles Major Disparities in Adherence

Now a swarm of new companies like Sweetch say new technology can put a dent in the adherence problem, not so much because of the technology but because the software they are selling is sophisticated enough to take a tailored approach to patient management.

Historically, patient adherence has been assessed using a rather blunt measurement. Since the 1970s, the figure of 80% has typically been used as the dividing line between adherence and nonadherence, Ruppar explains. The problem, Ruppar says, is that the 80% figure is rather unscientific.

“Eighty percent may be enough for some conditions, but it’s definitely not for others,” he says. “For antiretrovirals for HIV, or for immunosuppressives for people who have had organ transplants, you need to be at, like, 99 (%) to 100%.”

The fact that half of patients with chronic diseases do not reach 80% adherence affects healthcare costs. Low adherence leads to lower rates of disease control and invites a host of comorbid health problems. Adherence also has a financial dimension for pharmaceutical companies. The more reliably patients take medications as prescribed, the larger companies’ sales will be.

But in the larger healthcare picture, lack of adherence can start a downward spiral, says Scott Taylor, CEO and co-founder of Perx Health in Sydney, Australia, another patient engagement firm. If not taking a medication leads to the worsening of a condition or the occurrence of related conditions, other medications may need to be added. The more complicated a regimen becomes, the more difficult it is to follow and the greater the chance of nonadherence increase. “It becomes a bit of a compounding issue over time,” says Taylor. For patients with chronic conditions — especially multiple chronic conditions — nonadherence translates into tens of thousands of dollars in avoidable healthcare costs each year, Taylor says.

One reason adherence is such a thorny problem for patients and providers is that its origins tend to be a messy combination of factors. Lack of adherence can be both unintentional and intentional, Ruppar notes. Some people forget to take their medications. Others are affected by the many twists and turns of the social determinants of health: the pharmacy is miles away, child care cannot be arranged, out-of-pocket costs compete with other expenses.

Sharon Jhawar, Pharm.D., MBA, the chief pharmacy officer at SCAN Health Plan, a Southern California-based Medicare Advantage insurer, says cost can be a factor even when prescriptions are made available for free. She notes that some high-cost medications are available to SCAN members without a copay, but only if they get their prescriptions from pharmacies in SCAN’s preferred network or through mail-order pharmacies. But some members don’t realize that there is a preferred network and wind up paying high out-of-pocket costs. As her health plan began working to boost medication adherence, it began reaching out to individual members to ensure they knew about the availability of lower-cost drugs and where to get them, says Jhawar. “By simply switching to the pharmacy that’s just on the next corner, that could be an opportunity (to save money),” she says.

Ruppar says some patients are deliberately nonadherent. “People may be suspicious of pharma,” he says, “or they may not understand how the medication works and that they need to take it every day, even when they feel OK.”

Given the complex and varied drivers of the adherence problem, a wide range of solutions have been developed. They range from the personal to impersonal, from low-tech to high-tech options. Ruppar speaks up for the low-tech measures. “The cheapest, most effective thing for remembering to take medications is generally that seven-day pillbox,” he says. It’s a visible, tangible reminder to take your medication and also an easy way to know if you’ve already taken it. Ruppar says some younger patients recoil at the idea, which they associate with older adults, but he says it works for any age.

Jhawar says her health plan has emphasized communication. In addition to phone calls from the health plan, she says providers and pharmacists also need to rethink when and how they communicate medication information to patients. She notes that in a typical doctor’s visit, the first person a patient interacts with in the examination room is the nurse: “You tend to converse a lot more and share a lot more and ask a lot more questions.” Next comes the physician, but Jhawar says some patients do not feel as comfortable asking questions of the physician. If they don’t have that comfort level, their questions may go unanswered because the patient may not have another chance to speak to the nurse.

Adding a follow-up conversation with a nurse or other provider can give patients a better chance to raise questions, Jhawar says. Those conversations can also take place with a pharmacist, whether that is the retail pharmacist dispensing the medication or a health plan pharmacist checking up on a patient. The key, she says, is making sure each link in the chain sees their role as critical to achieving patient adherence. “What we have found with medication adherence is it takes this village,” she says. “...It takes continual reinforcement that helps to drive the right healthcare behavior.”

That reinforcement does not necessarily have to come from a human. At least, that is the premise under which a wave of new startups are operating. Sweetch, Perx, and other competitors are using artificial intelligence (AI) to boost patients’ treatment adherence by tailoring approaches to each patient. Bahagon says Sweetch might use a mix of behavioral, location, and schedule information to prompt a patient to sneak in a quick walking workout between meetings. The app could deliver a notification saying something like, “It’s 45 minutes before the next meeting. It’s raining outside. So grab your umbrella and go pick up a coffee from the nearest Starbucks at this address.” If that patient acts in response to such a prompt, they will likely receive similar ones in the future. If they do not, Bahagon says, the software will recalibrate and try a different approach. “If you ignored it in the past, sending it to you again not only won’t create a trigger to action, it will frustrate you,” he says.

By using this type of AI-enabled “precision engagement,” Sweetch says 70% of its notifications are acted upon. Moreover, 6 in 10 users who start using Sweetch are still using it a year later, several times higher than the industry average for mobile health apps, which Bahagon says ranges from 10% to 15%.

“From our perspective, we prefer to achieve gentle, gradual, sustainable responses over the long term,” Bahagon says.

Taylor, who studied behavioral economics before starting Perx Health, says one important aspect of his company’s approach is building upon “wins.” “If we’ve got someone engaged to take their medication, and they need to complete their physical therapy at some point that day, the best time to do that is when they’re already engaged,” he says.​​

One of Perx’s techniques is offering incentives, such as gift cards, to boost adherence, but he notes that 20% to 30% of users who earn such rewards never claim them. Those patients may be more motivated by different kinds of incentives, such as maintaining a long adherence streak or contributing to a community goal. The key, he says, is to have the right mix of incentives and prompts to drive an individual patient’s behavior.

The strategy seems to be working. Perx says 90% of its notifications are acted upon. One client, the health insurer QBE, found the healthcare costs of members who used Perx were about $6,000 less per year than for patients not using the tool, Taylor said. However, results like that should be taken with a grain of salt because people who elect to use health-related apps may also be more inclined to adopt cost-saving behaviors.

Neither Bahagon nor Taylor sees their software as a panacea. Even if the software can incorporate feedback and deliver personalized approaches, sometimes those approaches work best in partnership with human interaction. Bahagon and Taylor say that informing providers about which patients they need to check up on is one use of the information generated by apps. Rather than simply noting that a patient did or did not refill his medication, a physician whose patient uses one of these tools might be able to notice trends, such as the fact that a patient might forget most often to take a medication when he is at work.

Ruppar says one hurdle to improving adherence is that many of the interventions that produce positive results in clinical trials flop when they are outside of that controlled context because they are too time consuming or difficult to use. That’s why companies like Perx and Sweetch are pricing their products in the midrange — less expensive than relying entirely on humans making phone calls and personal visits but more expensive than pillboxes or many wellness apps.

Will that middle course be the way to go? It’s too soon to say. But what is clear is that medication adherence is a costly problem and solutions to costly problems are almost never free. Bahagon says the current era of precision medicine is built on the premise that high-priced drugs can provide value despite the staggering costs. That will not happen, though, without improved patient adherence. “The most sophisticated medication that the pharma company invested $5 billion in, or the most sophisticated medical device … no matter how much technology and effort we put into it, if the patient doesn’t do the final last-mile action, it won’t work,” he says.

“For the past 20 to 25 years, the data has fairly consistently shown that, overall, of people who have been prescribed long-term medications, about half of those patients are not going to take them as prescribed,” says Todd Ruppar, Ph.D., a professor in the College of Nursing at Rush University in Chicago.