As we recognize Mental Health Awareness Month, I had the opportunity to connect with PhRMA board member Barry Greene, CEO of Sage Therapeutics, about the company’s efforts to address mental health.
Q: We continue to have conversations about the mental health crisis, but we’re seeing limited progress when it comes to innovative approaches to treatment. Can you talk about how Sage is working to address this?
A: Depression is the leading cause of disability worldwide and has a far-reaching generational impact, particularly given the growing prevalence in young adults. Among other contributing factors, we can credit social stressors, academic pressure, social media and the burden and loneliness of the pandemic. An analysis by the Kaiser Family Foundation shows that half of young adults have reported anxiety and depression symptoms in 2023, compared with about a third of adults overall. Even more devastating — one in seven college students said that they had suicidal ideation according to a 2021 survey by the Healthy Minds Network. We cannot sit by and continue to let this happen.
For so many of us, this is personal, as we see it in our loved ones, in our communities, and in the devastating consequences of an overburdened treatment system that is often conditioned by a treat-to-fail mentality allowing far too many people to fall through the cracks. This is unacceptable and at Sage we fundamentally believe that people deserve better.
I’m hopeful that the personal connection we all have to mental health will be a catalyst for much needed change and consensus. We are seeing that policymakers from across the political spectrum agree that the mental health crisis is impacting employers in their states and further devastating the communities that they serve — and they feel a sense of urgency to foster change.
This is where we come in. We recognize that there has not been meaningful innovation in depression in decades. Sage is dedicated to advancing the way depression is viewed and treated by targeting different pathways in the brain that, if we’re successful, could significantly transform care. We must also have a seat at the table with payors, policymakers, health care providers and patients to achieve improved, equal and sustainable care.
Q: There’s no denying that our industry is currently confronted with policies like government price setting that could impede scientific progress. What’s most concerning to you regarding these policies and the impact they’ll have on patients with mental illness?
A: Fundamentally, policy should be a catalyst to improve and reward innovation and not suppress and punish it. Ideally, policymakers should be working hand in hand with other stakeholders to ensure that patients are supported and getting the care that they need. I am deeply concerned that recent legislation threatens the opportunity for current and future innovations to reach the patients who need them the most.
The business model for biopharmaceutical research and development is unique. Investments in novel innovations come with strategic risk and long approval horizons. Innovation often comes from early-stage biopharmaceutical companies who require significant capital to achieve success. As an industry, we’ve come to rely on our ability to de-risk the drug discovery and development process so that we can substantially reduce time delays and costs of advancing scientific breakthroughs. This entire process could be compromised by the Inflation Reduction Act (IRA).
Simply put, the IRA establishes a form of price setting that undermines investment incentives, which then impacts innovation and ultimately has implications for patient care. This plays out specifically in the aspect of the law that favors biologics over small-molecule drugs. While small-molecule drugs may have a set price imposed nine years after initial FDA approval, biologics are protected for 13 years. And I’ll note, both the nine- and 13-year government price setting time periods are typically sooner than expiration of intellectual property protection on these compounds.
Clinical research that leverages both small and large molecules is important as it can target different conditions and disease areas. This is particularly true in the case of mental health, where many of the novel therapies in development are small molecule medicines that pass through the blood-brain barrier. To advance small molecule innovation, the timeline should be at parity with large molecules, and both should have at least 13 years until a new government set price is imposed.
Q: Public policy should keep pace with innovation by reducing access barriers for patients. Are there examples of state implemented policies that should also be considered at the federal level?
A: People with mental health conditions often face a patchwork of archaic policies that interfere with provider-patient relationships and in many cases delay life-saving treatments.
Many payors have utilization management policies in place, such as step therapy, that restrict access and create barriers for patients. This practice makes patients fail on multiple products before they can access the one their physician determines is most appropriate, which is especially problematic in therapeutic areas that haven’t seen as much innovation and have mostly generic options. Ultimately, these policies create a system that leaves patients to accept a status quo approach with substandard outcomes. Public policy can and should be implemented to ensure that patients are getting the treatments prescribed by their trusted providers.
We are finally seeing states act on utilization management. Varying levels of protection have been passed in more than 20 states. Michigan most recently enacted a law streamlining prior authorizations for commercially insured patients, reducing wait time and administrative burden for both patients and providers.
Further, access to newly approved products within some state Medicaid programs can take much longer than commercial plans. To address this, some states are beginning to implement policies that require timely review of newly approved products. We hope to see these patient-centric policies expand across the country, and potentially influence reform on the federal level too.
Click here to learn more about the IRA’s impact on mental health.