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Manufacturers and the Mental Health Crisis: How Data and Education Can Improve Patient Access

According to the National Institutes of Health (NIH), nearly one in five U.S. adults (approximately 52 million) live with some form of mental illness. Unfortunately, those struggling with a mental health disorder often aren’t getting the treatment they need, and when undertreated, can have considerable economic impact on national healthcare budgets due to the cost of hospitalization for patients with worsening conditions.   

Barriers to Mental Healthcare 

Despite the prevalence of mental health disorders, recent data from the Substance Abuse and Mental Health Services Administration (SAMHSA) show that in 2020, over 30% of people living with serious mental illness did not receive treatment (counseling or prescription medication) for their condition.  

Reasons for patients not accessing care are wide-ranging and may include:  

  • Cost of therapies (including lack of insurance coverage or therapies not covered for insured patients) 
  • Stigma and misconceptions about mental health conditions, or a lack of confidence in therapies (such as drug misinformation, poor response from previous trials, misdiagnosis resulting in inappropriate prescriptions and undesirable side effects) 
  • Complexity of accessing care (in-network specialty provider requirements, prior authorization requirements and multistep product requirements to access newer therapies) 
  • Marketing based on data that may not account for social or cultural factors, like a mistrust of healthcare providers among historically stigmatized ethnic groups  

In 2008, the Mental Health Parity and Addiction Equity Act (MHPAEA) determined that insurance coverage for mental health conditions, including substance use disorders, shouldn’t be more restrictive than insurance coverage for other medical conditions. Yet despite the MHPAEA Act, demonstrated clinical efficacy for many mental health therapies, and digital therapeutics on the market, some plans have struggled to meet the complex components of the law that govern how they design and apply managed care practices, such as prior authorization, reimbursement rate setting and network design, among many others.  

As a result, the Consolidated Appropriations Act (CAA) enacted in December 2020 requires insurers and health plans to perform comparative analyses showing that they comply with the managed care provisions of MHPAEA, and must now make these analyses available to state regulators and the U.S. Department of Labor upon request.  

How Manufacturers Can Improve Mental Health Coverage 

Despite these major legislative steps forward, pharmaceutical manufacturers still have a long way to go when it comes to ensuring adequate coverage. Payers often cite a lack of long-term data, or challenges with the quantity or quality of the existing studies, when deciding which therapies to cover. Here’s what manufacturers can do to help overcome these hurdles to patient access:  

  1. Invest in data. Pricing of newer products needs careful consideration in a crowded field where generic options are readily available and branded agents face stiff competition vying for preferred position on payer formularies. By investing in market data for currently available therapies, manufacturers will be better equipped to anticipate how their products will fare among payers post-launch. 

    Additionally, manufacturers should analyze big data sources to stay abreast of trends in drug development. Looking ahead and being proactive can help determine what sorts of products they should be developing for specific patient populations. For example, if a manufacturer sees that more patients than ever are getting diagnosed with ADHD, the company could focus their R&D efforts in that therapeutic area.  

  2. Communicate the right clinical trial data. In addition to FDA approval, of course, quality trials are essential for manufacturers seeking to convince payers to cover their products. Effectively communicating the efficacy of a particular drug will boost the chances of it getting covered by the payer. When considering newer therapies, especially when cost is reasonable compared to conventional therapy, payers will want to know that clinical improvement has been demonstrated, and that significant side effects are low or reasonable compared to standard therapy. 
  3. Increase awareness and education. Manufacturers should include disease state education for payers as part of their launch strategy. Using data and research, they can provide a payer with insights about the ever-evolving mental healthcare landscape, such as the recent changes to the DSM, and then highlight where their product stands out or fits in the current landscape. Payers may consider this information when deciding which treatments to cover for certain mental health diagnoses. 

Many stakeholders now recognize poor mental health as a public health concern. Prioritizing mental healthcare is essential for improved societal wellbeing (think reduced hospitalizations, fewer missed school or workdays and greater reported quality of life). Continued improvement in mental health therapies and access to such therapies will play a major role in mitigating the mental health crisis and improving patient care.  

By Tonna Alimole, PharmD 

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