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Report: More drug innovation necessary for mental health

Friday, April 7, 2017

As the healthcare industry looks to make good on a promise of patient-centricity, advocacy groups and regulators have increased their focus on earlier patient involvement in clinical trials, with particular attention on so-called patient-reported outcome (PRO) measures. However, according to new research looking at payer perspectives on mental health, use of PROs that track patients’ wishes and experiences in their own voices, unamended by clinicians, may not help manufacturers make a more persuasive case about a new drug when talking to insurers. The research, released by inVentiv Health, found that 92% of private payers do not wish to see wider use of such measures in clinical trials.

In addition to harboring reservations about PROs that capture the patient’s unfiltered point of view, many payers express skepticism when it comes to health economics and outcomes research (HEOR) that is carried out by or paid for exclusively by the drug’s manufacturer. Sixty-nine percent of payers interviewed would not place much stock in HEOR generated solely by a product marketer without corroboration by an impartial organization or institution.

The data come from inVentiv Health research conducted on the U.S. payer perspective from November 2016 through January 2017. This research draws on extensive interviews with executives who are responsible for reimbursement and formulary decisions about regional and national health plans representing more than 59 million lives. The research results are described in a white paper titled, “Mental Health: An Insurance Industry Perspective.”

The white paper is a follow-up to “An Advocacy Rx for Progress in Mental Health,” a report based on in-depth interviews with advocacy and mental health experts across Europe and the U.S. aimed at better understanding the barriers to advancements in the field of mental health. When asked to describe their top priorities, many advocacy groups said they would like their pharmaceutical partners to develop more advanced screens and assays for early detection and diagnosis of mental health conditions.

“This is one of the most important challenges for bringing the treatment of mental health on par with the treatment of other important health conditions, such as cardiovascular disease and diabetes,” said David Hewitt, chief medical officer of inVentiv Health. “Identifying usable biomarkers and developing reliable assays would be a great benefit to patients. In addition to producing better medical outcomes, earlier diagnosis would be cost effective.”

Though advocacy groups and payers disagree on the exact role of the patient voice in drug development, they are in solid agreement on at least one subject: both groups are deeply concerned about what will happen to many patients in need if Medicaid expansion programs are halted due to a repeal of, or substantial changes to, the Affordable Care Act.

“The uncertainty facing the healthcare industry right now is causing incredible concern, particularly for the mental health community,” said Jeanine O’Kane, president, U.S. Public Relations, inVentiv Health. “Advocacy groups will be playing a more important role than ever in facilitating conversations between key stakeholders like pharma, payers and government,” continued O’Kane.

One in five Americans will experience a mental health condition this year. In their most serious forms, these illnesses shorten patients’ life expectancy by 25 years, on average, yet more than half of the people affected receive no treatment at all. Such access issues are a matter of concern both for advocacy organizations and health insurers. Approximately 85% of payers say that “network adequacy” problems exist in their areas, including shortages of psychiatrists and psychologists. But payers point out that this is not something unique to mental health and that societal shifts, not necessarily reimbursement rate increases, will be needed to address the problem.

Both payers and advocacy groups agreed that more forums are needed for patient advocates, pharmaceutical executives, physicians and policymakers at state and federal levels to have frank discussions.

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