By David Hewitt, Chief Medical Officer, INC Research/inVentiv Health
To improve care, we need more wide-ranging discussions among patients, payers, physicians and pharmaceutical companies
When we talk about access to healthcare in the US, questions often arise about who should shoulder the high costs of hard-to-develop medicines for cancer or orphan diseases. The spotlight rarely lands on drugs for psychiatric illnesses—and the reason is simple. We currently have an abundance of relatively inexpensive generic treatments for illnesses such as depression and anxiety.
Yet, access is more complicated than the list price on a prescription medicine. In recent conversations with a broad swath of mental health advocates, my colleagues at INC Research/inVentiv Health heard a litany of complaints about the obstacles patients encounter—everything from difficultly locating in-network psychiatrists, to high copays or coinsurance, to the lack of diagnostic tools for serious illnesses such as bipolar disorder and schizophrenia.
To gain a better understanding, we decided to speak directly with 15 private health insurers responsible for coverage decisions in mental health. In addition to sharing frank opinions about why so many patients with serious mental illness fall through the cracks, payers representing a total of 59 million covered lives described a need for better communication among key mental health stakeholders, including patient groups, physicians, and pharma companies, as well as the insurers themselves. They noted that a number of new forums for discussion have emerged in recent years. It’s a welcome beginning, but we must do better.
The first-hand reflections of these executives, compiled in a new INC Research/inVentiv Health white paper titled “Mental Health: An Insurance Industry Perspective,” were surprising in a number of respects. For example, payers who spoke with us broadly acknowledged the problem of “network adequacy”—the persistent shortage of psychiatrists in managed care networks, especially in rural areas. However, unlike many mental health advocates, payers don’t believe there are easy or obvious solutions.
Many advocacy groups contend that more medical students would be drawn to the field of psychiatry if insurers raised reimbursement rates for psychiatric care. A few payers we spoke with concurred. Most, however, believed that shortages stem from a variety of conditions—not least, the dramatic disparities in compensation levels among different medical specialties. The latest research on physician compensation by Medscape shows psychiatrists are near the bottom of the pay scale.
Shrinking the compensation gap would require institutional, cultural, and policy changes at a national level. And these changes can’t easily be mediated by regional or national health plans, payers said. Factors that affect physician pay include ownership of the practice that hires the doctor, federal and state regulatory requirements, data from national compensation surveys, and other elements that are not directly related to reimbursement rates.
Network adequacy was just one area where the perspectives of payers and advocacy organizations were out of sync. We also saw stark divergence when the discussion turned to metrics pharma companies employ in drug development and testing.
Many patient organizations believe drug companies should be looking more closely at measures that gauge how patients with mental health conditions feel, emotionally and physically, when participating in a drug trial. Advocacy groups also say trial sponsors should try harder to gauge whether treatments improve quality of life over the long term. Yet when we asked payers what types of evidence they found persuasive, 100% said they had no interest in looking at quality-adjusted life years (QALY) data.
As a neurologist with 22 years of experience in pharmaceutical research, I was intrigued by these responses. Among other surprises, the majority of payers told us they found patient-reported outcome (PRO) measures to be overly “subjective”—even though these research tools have been refined in recent years, and their use is strongly endorsed by regulators in both the US and Europe.
Even where advocacy views and payer opinions converged, I couldn’t help sensing confusion—on both sides—about how clinical trials are designed and conducted in mental health. Both groups said they want to see drug trials lengthened from a few months, as is typical today, to two years or more. Six weeks, they say, is not enough time to judge long-term safety or efficacy.
In fact, to a researcher, two years is a long time for a patient with severe psychiatric complaints to be in a placebo-controlled trial. Yet, in the absence of a placebo, it would be hard to assess the ongoing efficacy and tolerability of the drug. It’s not an easy conundrum to solve, and it’s complicated by the fact that the extended trial might not prove a drug’s efficacy. In cases of serious depression or psychosis, symptoms often wax and wane over time, and a patient’s responses to medicines may change as well. A drug that works well today may not be the treatment of choice two years down the road. Finally, there is the issue of medication adherence in the course of a long trial. Compliance is a challenge in most disease categories and is especially problematic in mental health. All of this argues for striving to increase the number of effective and well-tolerated therapies.
Setting aside the challenges of running multi-year randomized controlled trials (RCT), I’m not surprised that patients and payers yearn for a more complete picture of a drug’s long-term benefits and risks. Fortunately, we are entering an era when researchers can augment the snapshot provided by a traditional clinical trial. Even before a new drug reaches the market, diverse streams of information help us assemble detailed natural histories of an illness. In some cases, health-related social media and other data sources can significantly enhance the demographic or epidemiological resolution of this picture.
Post-marketing research capabilities are also advancing. Prospective studies and analysis of secondary data sources—such as insurance claims and electronic medical record (EMR) databases—may soon provide us with exactly the sort of information mental health advocacy groups and payers say they seek from extended clinical trials. Increasingly, these tools for capturing and interpreting real world evidence (RWE) allow us to track the dynamic responses of patients and subgroups to specific medications over defined periods of time.
Real World Evidence
In this area, I often consult with my colleague, David Thompson, Senior Vice President, Real World Evidence & Insights at Ventiv Health, who described pertinent RWE developments in a recent column on LinkedIn. Whether a pharma company is talking to patient organizations, health insurers or provider associations, “what these players are interested in, above and beyond how [a] product performs in clinical trials, is how it performs in real-world use,” he wrote.
Legislative action in Washington, D.C., last fall is spurring further developments in the area of RWE. For example, language in The 21st Century Cures Act underscores the need for medical professionals to go on collecting RWE data after new drugs are approved. The same trend is likely to enjoy high-level support from regulatory bodies in the US and Europe. President Donald Trump’s pick for FDA commissioner, Scott Gottlieb, has been highlighting the importance of RWE data for years, including in a widely-cited July 2015 column in Forbes.
Consensus on how to define real world evidence (RWE) remains elusive. Nevertheless, in the field of mental health, we can already see how such evidence might give patients and payers what they’re looking for in lieu of longer placebo-controlled clinical trials.
One place where we can examine how new streams of RWE could help address payers’ desires for longer clinical trials, without the liabilities I described above, is on patient-centric social networks such as PatientsLikeMe. (PLM). More than 10 years ago, the site’s Co-Founder and Chairman, Jamie Heywood, envisioned a world where networked patients, aided by medical professionals and advanced data analytics, would be able to design and execute ad hoc post-marketing surveillance studies and patient-centered comparative effectiveness research. Today, PLM’s membership has swelled to greater than half a million. Patients on the site, as well as corporate partners, share information on more than 2,700 conditions, including schizophrenia and bipolar disorder, and PLM’s Mental Health & Behavior Forum has more than 11,400 members.
Forums for Conversation
In many areas of medicine and academic science, excitement about new streams of health-related evidence is on the rise. What’s missing is a consensus on how to interpret and value all the RWE data we will soon be able to capture. Indeed, rifts among payers, patients, physicians and pharma companies—some related to patient privacy, others involving commercial competition—at times overshadow the medical priorities that ought to unite us. That’s why it’s so important to create opportunities for multi-stakeholder discussions.
In our interviews with payers, several individuals noted the emergence of new forums that can help bridge these gaps. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) organizes regular events to help all stakeholders share points of view. Similar gatherings are often on the agenda at the Institute for Economic and Clinical Review (ICER), and other cross-industry organizations.
In the area of mental health, it would be hard to find a trend that matters more than the sharing of information, personal experiences, and frank opinions. By pulling disparate stakeholders under the same roof for no other purpose than hearing all sides, we can start to dismantle barriers to healthcare access. Perhaps we can even start to envision true parity in the treatment of physical and mental health conditions.