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By Christiane Truelove

As the danger of the COVID-19 pandemic continues to fade, healthcare systems around the world find themselves grappling with a new crisis—that of mental health, as conditions such as depression, anxiety, and mental health-related substance abuse skyrocket. According to Mental Health America’s 2023 State of Mental Health survey, 21% of adults in the United States—50 million people—are experiencing at least 1 mental illness and 55% of adults with a mental illness have not received any treatment. Of the adults with mental illness, 5.44% are experiencing severe mental illness. Additionally, more than 12.1 million adults (4.8%) have reported serious thoughts of suicide—and this figure more than doubled among adults who identify as 2 or more races.

And with more people reporting mental health concerns, only 28% say they were able to find the care they needed. Some of the most common barriers to finding and getting mental health care include a lack of affordable options, reported by 42% of respondents and lack of awareness about where to go for services, according to 27% of respondents; 19% of the respondents reported that they had no time to get treatment.

The World Health Organization (WHO) reports that in 2021, more than 150 million people in the WHO European Region lived with a mental health condition, and only 1 in 3 people living with depression received the care they needed. In response, WHO/Europe launched the Pan-European Mental Health Coalition, with the goal of transforming mental health services and by integrating mental health into emergency response and recovery efforts, as well as promoting mental health and preventing mental ill health across the life course.

With the urgent need for new and better ways to treat mental health conditions, the field of health economics and outcomes research (HEOR) needs to turn its attention to studies that validate (or disprove) the value of new and current treatment paradigms. The information can help policy makers determine what is effective and what should be funded—and it will take concerted efforts from all stakeholders, including HEOR scientists, patient advocates, and manufacturers, to come up with solutions that policy makers can use. But there are several challenges yet to overcome.

 

The Gap Between HEOR Studies and Policy Making
“One of the things to recognize is that policy works in a different rhythm than research and is much less tractable,” says Sherry Glied, PhD, MA, Dean of New York University's Robert F. Wagner Graduate School of Public Service. “So, policy makers are understandably reluctant and appropriately reluctant to change what they're doing based on one study. One study is one study. And especially in an area like mental health, where there are so many variations in how things work out, I don't think it is realistic to imagine that policy makers are going to turn on a dime because somebody shows that some program has been cost-effective.”

 

“One of the things to recognize is that policy works in a different rhythm than research and is much less tractable.” 
— Sherry Glied, PhD, MA

 

According to Glied, this is a reasonable attitude to have because there are “real differences” between programs—and even medications—when they're administered in the context of a study versus when they're administered in real life. “The first thing we need to do as researchers is to temper our expectations a little bit and to recognize that making a change in Medicaid policy is a big effort; it's a big lift. It's going to take not just one study. One study does not constitute evidence for policy making no matter how wonderful that study is.”

One thing health services researchers need to consider when designing studies to examine mental health programs is how to translate their research into the kind of evidence that policy makers can understand and implement. “Policy makers want to be able to answer the question, ‘If I do X—where X is a policy like a payment change or authorization for something—what's going to happen?’ And that's often not what we produce,” Glied says. “As researchers, we need to think about how we assemble studies in a way that actually gives that kind of evidence to policy makers so that they can sensibly act upon it.”

But a significant stumbling block in making evidence-based policy making for mental health “is that our measures of mental health are terrible,” Glied says. “We have a huge problem of defining what is wrong with somebody or if there's something wrong with what the condition is, how much it has improved. We don't have measures of severity or anything that comes close to the kind of measures that many physical health conditions do. I think that creates the concern among policy makers that funding things will be gamed, as we've seen with risk adjustment.”

 

“As researchers, we need to think about how we assemble studies in a way that actually gives that kind of evidence to policy makers so that they can sensibly act upon it.” 
— Sherry Glied, PhD, MA

 

One of the inherent limitations in doing HEOR in mental health is that the nature of the conditions makes it harder to draw conclusive findings and to argue that they are universal, Glied points out. “In fact, we have a very complicated relationship with the idea of universal and mental health. We're not absolutely persuaded that the same program or medication is going to work for everybody with a particular set of symptoms because our measures are so lousy. So that, again, is an ill fit with policy making.”

The lack of good measures for the effectiveness of mental health treatments is also coupled with a dearth of studies of these treatments in general. “From my own perspective, another thing that we've done poorly in mental health services research is that we rarely focus on some of the costliest interventions that we don't understand very well,” Glied says.

For example, even though a majority of mental health spending goes to inpatient hospital care, “no one's ever done a study on what constitutes appropriate inpatient hospital care,” Glied says. “How long should an inpatient stay be? Does it matter if hospital stays are shorter or longer? This is not a thing we study. We probably could not do it as a randomized trial, but we probably could study it somehow.”

 

Coordinating With Patient Advocates and Industry
As HEOR experts figure out how to viably measure mental health advancements and translate them in ways that policy makers can actually use them, patient advocacy groups can offer an important resource.

Phyllis Foxworth, BS spent 10 years working in Peer and Policy Advancement for the Depression and Bipolar Support Alliance, a peer-focused organization for people living with mood disorders. As part of her work there, she started an initiative called Transforming the Definition of Wellness for People Living With Mood Disorders. The initiative was designed to address the fact that while patients understood the purpose of the scales of symptom-based skills used in clinical trials, they were concerned that what was being measured was not the treatment outcomes that they were seeking.

”At the end of the day, what we ended up with was a patient-focused drug development meeting with the FDA [US Food and Drug Administration] to share the insights that we were learning,” Foxworth says.

Another goal of the initiative was creating a new clinical outcome assessment  for depression and wellness. The group had identified 3 domains for the clinical outcome assessment : resiliency (eg, being able to adapt to changes, identify how to stay or become well); self-awareness (eg, recognizing having a chronic condition and understanding the impact it has on life); and positive focus (eg, having goals and a purpose). “Getting a clinical outcome assessment that focuses on depression wellness that can be used by health economists is really a step forward,” Foxworth says.

“Getting a clinical outcome assessment that focuses on depression wellness that can be used by health economists is really a step forward.” 
— Phyllis Foxworth, BS

 

Patient advocates and health economists may not have the same goals, but Foxworth believes both need to work together. “I will always say upfront, ‘I recognize the tension between the two groups—we don't need to be adversaries.’” “In some ways, there is an adversarial relationship going on here. But we are respectful of each other and we try to understand each other's points,” Foxworth says.

Foxworth does see a problem in the common measure—the quality-adjusted life year (QALY)—used in HEOR  when it comes to mental health outcomes research. While the QALY focuses on what lengthens or improves patient lives, Foxworth has heard repeatedly from patients with mood disorder that they would rather have a smaller number of years of quality life rather than living for a much longer time, “because living with a mental health condition is so debilitating and so painful.”

 

“We all want the same thing. Let’s find a way that we can work together so that we’re measuring the outcomes that are important to patients and that we’re applying sound health economics to measuring those outcomes that are important to patients.” 
— Phyllis Foxworth, BS

 

And in some cases, the medication a patient treated for mental health is taking can interact quite badly with medications taken for other chronic issues. “Many people living with PCOS [polycystic ovary syndrome] also live with bipolar disorder—there's a connection, but the research isn't being done,” Foxworth says. “But the problem for these women is that often the treatment for PCOS interferes with the treatment for the bipolar disorder.” One patient flatly told Foxworth that she was stopping her PCOS treatment because she could not live with the pain of the mental health condition.

HEOR scientists would call this woman “noncompliant,” but Foxworth says, “she's not noncompliant. It's the medical healthcare system that's noncompliant because it hasn't given her a treatment option.”

Foxworth points out that the average individual with a mood disorder dies 25 years sooner than the average population. "That’s not because of suicide, but because of comorbidities,” she says, adding that when HEOR studies look at the cost-effectiveness of a treatment based on the QALY, these comorbidities are not taken into consideration.

“We all want the same thing. Let's find a way that we can work together so that we're measuring the outcomes that are important to patients and that we're applying sound health economics to measuring those outcomes that are important to patients,” Foxworth says.

At the same time, throwing the entire task of determining new measurement guidelines at the feet of patient advocacy organizations does not work either because that’s not their core competency.

For companies that are trying to bring new mental health treatments to market, the challenge will be showing that these treatments work and should be funded. Compass Pathways is a 7-year-old company focused on finding new treatments that bring better outcomes for patients living with serious mental illness. The company is testing psilocybin, the active chemical in magic mushrooms, for the treatment of severe treatment-resistant depression—typically for patients who have failed to respond to 2 or more treatments.

According to Kabir Nath, MBA, MA, CEO of Compass Pathways, in the populations the company has studied, nearly 70% had at some point experienced suicidal ideation or thoughts of suicide in the past. “This is a very large, chronically ill population that doesn’t just suffer from depression, but possibly also from the inability to work, anhedonia, and all sorts of other personal issues,” he says.

 

“A lot of the data and the insights generated around the costs and burdens of serious mental illness—to individuals, to caregivers, to society—have to be used to transform some of our approaches to dealing with people living with serious mental illness.” 
— Kabir Nath, MBA, MA

 

Bringing this treatment to market and getting it accepted by payers poses many challenges, Nath points out. “Many systems, both in the United States and Europe, tend to evaluate the effectiveness of treatments on a very narrow basis, just around an economic cost basis and so on.”

But in mental illness, which comes with the burden of so many comorbidities, looking at the whole patient is important. “We need to look at some of these patient-reported outcomes. We need to look beyond just the economic cost of the system,” Nath says. “That said, even the economic costs of patients living with chronic severe depression are very substantial, especially when you consider the cost of the healthcare system, the costs on the family and the caregivers, and so on.”

Nath says Compass is using its outcomes research disciplines to understand what happens to a patient over the course of their illness because many patients cycle in and out of treatments like selective serotonin reuptake inhibitors, cognitive behavioral therapy, and other forms of therapies. “We're using our ability to look at big data sources to understand the patient journey much better and why the outcomes are poor.”

Nath also realizes that mental health outcomes are poor not just because of the failure of  therapies, “it's the fact that the entire system of care for people living with serious mental illness does not operate effectively. If somebody breaks their leg, you know what to do: You know to go to the ER and what happens next. If somebody has a psychotic break, you have no idea what to do. Do you go to the ER? Do you call the police? Do you call some other first responder?

“So again, a lot of the data and the insights generated around the costs and burdens of serious mental illness—to individuals, to caregivers, to society—have to be used to transform some of our approaches to dealing with people living with serious mental illness.”

Compass is not only testing psilocybin, but also testing the way the drug is administered, which entails a 3-part process. First, a patient receives counseling from a therapist to know what to expect. Then, the patient is given a 25-milligram dose and is observed in a 6- to 8-hour session, where they receive “psychologic support” from a therapist. A week or so later is the “integration” session, where the patient talks with a therapist about what they experienced.

The company has already taken steps to ensure that providers can administer the therapy and payers are able to account for it, Nath says. “We've already done the work to obtain a specific CPT [Current Procedural Terminology] tracking code that will enable physicians and healthcare to prepare primary care physicians to start tracking the work put into the administration session because no such code existed. Demonstrating that the whole cost—including the 6 to 8 hours—is actually economically viable is going to be fundamental.”

 

The Future of Mental Health Care
As the economic burden of mental illness grows, HEOR will have a crucial role to play in determining the effectiveness and value of treatments. This will take revamping the models used to evaluate mental health interventions, designing studies with outcomes that can be understood and implemented by policy makers, and working with patient advocates and industry.