The coronavirus disease 2019 (COVID-19) pandemic has taken a substantial toll on human life, not to mention our way of life. With over 14 million confirmed global cases and the death toll approaching 612,000, it is one of the most significant crises in recent history. In the United States (US), the country with the most cases and deaths, confirmed cases exceed 3.8 million and over 141,000 deaths have been reported as a result of this outbreak. As cases surge in certain parts of the country and the world, safe and effective vaccines and therapies are crucial to combatting this virus.  

Currently, there are no US Food and Drug Administration (FDA)-approved treatments or vaccines for SARS-CoV-2, the virus that causes COVID-19. Over 200 agents are being evaluated to treat the virus. These include new emerging molecular entities as well as approved drugs that are already available to treat other conditions and now being repurposed for COVID-19. According to the World Health Organization (WHO), 24 vaccine candidates have entered human trials and over 140 vaccine hopefuls are in preclinical evaluation.

Scientists around the world are working tirelessly to discover a vaccine for COVID-19. Vaccines candidates go through many stages of study. The average time to develop a vaccine ranges from 10 to 15 years. The Ebola vaccine, newly-minted in December 2019, only took about 6 years to be approved, whereas an HIV/AIDS vaccine has still not come to market after about 40 years. Given this pandemic’s magnitude, extraordinary measures from public and private stakeholders have been introduced to accelerate vaccine development.

COVID-19 has presented us with many challenges. Mitigation measures and safe and effective vaccines and treatments are key to restoring a new normalcy.

Q: What is the cumulative effect on mental health of COVID-19, social distancing and now the protests/riots on African-American and other BIPOC adults, both immediately and in the long term?

A: The COVID-19 pandemic has worsened longstanding ethnicity-based healthcare disparities that have resulted in disproportionate infection, morbidity and mortality rates for BIPOC adults, specifically Black Americans. Black Americans represent approximately 11.9% of the workforce, however they make up 17% of the front-line, essential workforce that is at higher risk for contracting and transmitting the virus[1]. At a time when the pandemic has resulted in an employment loss of 17.8% among Black workers compared to 15.5% among White workers, the risk to individual health safety is compounded by the risk of occupational hazards, job loss and financial insecurity[2]. As such, the compounded crisis of police brutality and increased social awareness of protest movements and civil unrest adds an additional layer of uncertainty, worry, fear, anger and sadness. Studies show that Black Americans are more likely to develop both physical and mental consequences to prolonged exposure to the chronic stress associated with discrimination and socioeconomic status, particularly high blood pressure, asthma, diabetes, depression and anxiety[3] [4]. In the week following the release of the George Floyd police brutality video, the rate of Black Americans experiencing depressive or anxiety symptoms increased from 36% to 41%, and among Asian Americans, the rate jumped from 28% to 34%[5].

Q: Are there unique signs of mental distress in African-American and other BIPOC adults that differ from those presented by Caucasians?

A: Though various forms of mental distress are characterized and diagnosed by commonly reported symptoms and behaviors, it is not unusual for individuals to have unique experiences that don’t look or sound the same, depending on who’s experiencing them. Additionally, cultural and spiritual norms specific to certain ethnic populations can influence the ways in which we communicate our pain, worry, sadness, anger and fear to healthcare providers, which often leads to misdiagnosis and/or ineffective treatment planning for ethnic minorities. Moreover, a 2019 study conducted by Rutgers University, indicates that Black Americans with severe depression are more likely to be misdiagnosed with Schizophrenia, which reveals significant provider bias in overemphasizing psychotic symptoms compared to mood symptoms[6] . In these instances, it appears that Black respondents’ endorsement of mistrust, hopelessness and paranoia due to extenuating sociocultural and political circumstances can result in unique clinical presentations that pose significant obstacles to understanding and healing, and that this effect is heavily influenced by the identity and implicit bias of both the patient and the provider. Ethnic minorities are also more likely to somaticize mental health symptoms, meaning they often report physical complaints like pain, fatigue or headaches, as well as sleeping difficulties as their chief complaints, rather than attributing the combination of symptoms to a mental health condition like depression or anxiety. This dichotomy often leads to further limitations in access to care, weakening of trust in the healthcare system, and escalating feelings of traumatization, oppression and isolation for marginalized demographics.

Q: How can African-American and other BIPOC adults help each other process their thoughts and emotions about the general unrest in our country?

A: It’s often said that there’s strength in numbers, and this is equally true as it relates to emotional support for marginalized communities in times of social unrest and collective trauma. Generational exposure to workplace and community discrimination is a shared experience for many ethnic minorities, and this commonality may make it easier for individuals who are feeling distress to share their thoughts with friends, family and providers who have a firsthand experience with the same issues in our society and across the world. This familiarity may also reduce mistrust within the healthcare system, if BIPOC patients feel they have an opportunity to share their feelings without judgment, misdiagnosis or repetitive traumatization and discrimination. Likewise, ethnic minorities are more likely to rely on spiritual or other cultural leaders for support and guidance in times of stress or civil unrest and are more likely to benefit from clinical behavioral health services when these alternative modalities are considered and integrated as fluidly as possible.

Q: Are there unique barriers to mental health treatment for African-American and other BIPOC adults?

A: Apart from generalized limitations in access to healthcare that have been noted for Americans across the spectrum, behavioral healthcare remains out of reach for millions of people, including those who actually have healthcare coverage. Shortages in available providers, clinics and hospitals means that there are longer wait times for appointments, and fewer resources available for maintenance of chronic mental conditions. Many mental health providers have moved to cash pay only practices, and this may serve as an obstacle for people who don’t have the disposable income available to pay out of pocket for psychotherapy or medication management. Inpatient bed shortages and the lack of long-term behavioral healthcare facilities are also shown to contribute to chronic homelessness, frequent ER visits and more interactions with the criminal justice system, which has become the largest provider of mental healthcare and boarding for chronically mentally ill patients over the last few decades[7]. Finally, stigma remains a very prominent barrier to seeking care for many ethnic minorities. In some cases individuals may fear judgment, mockery, maltreatment or discrimination due to their mental illness, while others may simply lack adequate information about the mental health field due to relatively less cultural reliance on these modalities within certain ethnic groups.

Q: What would you recommend to Caucasian individuals who want to reach out to their BIPOC friends and acquaintances and show their support, but don’t know what to say or are afraid it would not be received well?

A: In times of social division, strife and unrest, marginalized groups who are experiencing emotional distress and traumatization are likely to be concerned about safety, survival and stability. Allies and systems of support outside of ethnic peer groups can be helpful in building trust and solidarity across demographics, and this may aid in the development of healthier coping and conflict resolution strategies. It’s important that friends, family and coworkers be mindful that not every BIPOC person experiences distress or social events the same way and be open to simply listening to how the person feels first, before rushing to offer apologies or solutions that may not be indicated or helpful. MLK said that riots are the language of the unheard, and it is indeed the case that marginalized identities continue to live social and emotional experiences that so often go unnoticed, misunderstood and unaddressed by the ethnic majority. An expression of willingness to hear, care and help despite not knowing all the answers or solutions is sometimes all that’s necessary to convey empathy, sympathy and solidarity.

[1] https://www.epi.org/publication/black-workers-covid/

[2] https://www.epi.org/publication/black-workers-covid/

[3] https://www.ajmc.com/focus-of-the-week/high-levels-of-chronic-stress-high-blood-pressure-linked-in-african-americans#:~:text=African%20Americans%20who%20report%20high%20levels%20of%20chronic,serving%20as%20possible%20catalysts%2C%20according%20to%20study%20findings.

[4] https://www.washingtonpost.com/health/2020/06/12/mental-health-george-floyd-census/?arc404=true

[5] https://www.washingtonpost.com/health/2020/06/12/mental-health-george-floyd-census/?arc404=true

[6] https://ps.psychiatryonline.org/doi/10.1176/appi.ps.201800223

[7] https://www.theatlantic.com/politics/archive/2015/06/americas-largest-mental-hospital-is-a-jail/395012/#:~:text=As%20sheriff%2C%20Dart%20is%20also%20responsible%20for%20Cook,considered%20the%20largest%20mental-health%20facility%20in%20the%20nation

We are excited to re-introduce our Thought Leaders series with Dr. Karen L. Fortuna, one of the world’s leading researchers and activists focused on digital peer support and the role of technology in recovery. As a result of COVID-19, technology-enabled peer support has become the norm and vitally necessary to ensure continuity of care. We hope you enjoy our exclusive, virtual e-interview with Dr. Fortuna as she shares her unique insights about the transformation of peer support.

Dr. Fortuna holds a doctorate in social welfare and a master’s degree in social work. She is an Assistant Professor of Psychiatry in the Geisel School of Medicine at Dartmouth College. Her primary research interest is service delivery strategies for older adults with serious mental illnesses and chronic health conditions. Dr. Fortuna is using community-engaged research methods to develop and implement peer-supported mobile health (mHealth) intervention. Dr. Fortuna was awarded a NIMH K01 award (K01MH117496), a NARSAD Young Investigator Grant from the Brain and Behavior Foundation, the Alvin R. Tarlov & John E. Ware Jr. Award in Patient Reported Outcomes, and the Gerontological Society of America’s AGESW Faculty Achievement Award. Dr. Fortuna served on the International Standards Advisory Committee to develop the first-ever international accreditation standards for behavioral healthcare for older adults. Dr. Fortuna also serves on the American Psychiatric Association expert advisory panel on smartphone apps.

Dr. Fortuna led the development of the first digital peer support curriculum to equip older adult peer supporters with the skills and knowledge to offer digital peer support. The Digital Peer Support Certification was co-produced with Dartmouth scientists and peer support specialists and has been found to be an effective knowledge translation training that has shown to increase peer support specialists’ capacity to use digital peer support in practice (http://digitalpeersupport.org/).

And now, let’s hear from Dr. Fortuna!

Magellan: Dr. Fortuna, thank you so much for your time. Can you share what brought you to this field?

Dr. Fortuna: Thank you! My background is in social work. I went into this field because my dad had multiple sclerosis and he was very sick as I was growing up. People treated him like he was different just because he was in a wheelchair. I would say he was marginalized—but, to me, he was always just my dad—not different—not helpless—one of the most amazing and capable people I have ever known in my life. So here I am. Working with peer support specialists that may have at one point in their life been viewed as “different” or “helpless” and I work with peer support specialists to accomplish things they maybe never thought possible.

Magellan: You are recognized as one of the world’s leading researchers into the area of digitally delivered peer support. What drove your interest in pursuing this topic?

Dr. Fortuna: My initial exposure to mental health services began in the first year of a Masters in Social Work internship at the University of Pennsylvania. During this internship, I provided group-based self-management training to adults with a lived experience of a mental health condition and chronic health conditions. During this experience, I was impressed by the severity of disabilities that continued to be present for adults with a lived experience of a mental health condition despite participation in evidence-based programs. I subsequently pursued a volunteer opportunity with Dr. Mark Salzer to learn about efforts to improve the effectiveness of interventions for people with a lived experience of a mental health condition; in addition to being introduced to community-based research and peer support specialists.

As a result, I have developed an understanding of the history of the peer recovery movement, peer perspectives and theories of service delivery—and I saw recovery for the first time. I was sold! Recovery is real! This experience laid the foundation for my research career focused on digital peer support as an innovative service delivery strategy. Digital peer support is defined as live or automated peer support services delivered through technology mediums.

Magellan: One of the hallmarks of your work has been using a co-design approach, working collaboratively with persons with lived experience to inform your projects. Would you share with our readers what co-design is and why you choose this approach?

Dr. Fortuna: Co-design is a partnership in research that promotes shared decision making in all aspects of the research process. Our model, the Peer and Academic Partnership, supports collaboration, engagement, shared decision-making, principles of reciprocal relationships, co-learning, partnership, trust, transparency and honesty. We use this co-design approach because peer support specialists bring new insights and energy to our research that our team believes will lead to the next discovery in the social sciences. Plus, it’s fun! I have an amazing group across the globe that I work with!

This is an excerpt from the Magellan Healthcare eMpowered for Wellness June newsletter. To read the full article, go here.

In contrast to the conventional drug approval pathway in which drugs are reviewed under a New Drug Application (NDA), approval of a biological product is done under a separate pathway known as the Biologics License Application (BLA). Examples of biologics include therapeutic proteins such as insulin, monoclonal antibodies, vaccines, and blood-derived products. While the NDA and BLA processes are similar, they are not identical. The typical generic drug provisions (e.g., same active ingredient, bioequivalence) do not apply to BLAs. Instead, the single biological product already approved by the United States (US) Food and Drug Administration (FDA) is referred to as the reference product; the new potential biosimilar is then compared to the reference product. For approval as a biosimilar, the manufacturer must demonstrate that the agent is highly similar with no clinically meaningful differences.

In July 2018, the FDA released their Biosimilar Action Plan, described by then FDA Commissioner Dr. Scott Gottlieb, as “aimed at promoting competition and affordability.” Then, in December 2018, the FDA announced the plan to transition biological products that were historically regulated as drugs and approved via NDAs to the biologics pathway, taking effect in March 2020. These products include insulin, human growth hormone, and glucagon, among others. This change was mandated by Congress in the 2009 Biologics Price Competition and Innovation Act, which allowed 10 years for the transition. When considered as drugs under the NDA pathway, it was virtually impossible to develop a generic equivalent due to the nature and the inherent variation in the manufacturing process of these products. On March 23, 2020, the FDA issued a statement noting that this change is now in effect.

However, in the US, even if an agent is determined to be biosimilar, it is not automatically interchangeable (a process by which a product can be substituted for another without the approval of the prescriber). For a biosimilar to be considered interchangeable by the FDA, it must meet even more rigorous requirements and be approved as interchangeable. For products that are biosimilar but not interchangeable, the prescriber still needs to write for the specific product. In addition, even if determined to be interchangeable by the FDA, state pharmacy laws may further regulate what substitutions may be made at the pharmacy level without the approval of the prescriber. Just as a listing of generic equivalents is available through the FDA in their Orange Book, the FDA lists biologics and any respective biosimilars in their Purple Book. Recently converted to an online database format, the Purple Book provides details on reference products, their corresponding approved biosimilars, and whether or not the biosimilar is interchangeable. To date, no biosimilar has been designated as interchangeable.

As described in a previous blog post, the cost of insulin has risen substantially, leading patients to take desperate measures. At a time of economic instability and health uncertainty, these access concerns are even larger. Now that these products have transitioned to the biologic approval pathway, once patent exclusivity has passed, biosimilars can be developed, evaluated, and approved. Moreover, biosimilars can be reviewed further and may be classified as interchangeable, which can further alleviate the burden by allowing substitution at the retail level depending on local laws. This landmark change can promote market competition, potentially driving increased availability and decreased cost. The FDA reports that even having one generic drug on the market can decrease prices to approximately two-thirds of the price without competition. Generally, initial list prices of launched biosimilars have been 15% to 35% lower than their reference products. Most importantly, in their announcement of this change on March 23, the FDA pledged that they are ready to review eligible applications to ensure efficient approval. Ultimately, this revised process will provide an opportunity for other manufacturers to introduce safe and effective product competition without clinically meaningful differences. While this may be challenging in light of the ongoing global pandemic, this change, 10 years in the making, offers hope for patients who use these medications.

When your workplace is disrupted by a tragic event, employees may feel overwhelmed, anxious, insecure, and distracted. Everyone reacts differently to stress events, but tragic workplace events are serious and can cause significant physical, cognitive, and emotional reactions. A team of experienced mental health consultants can help reduce the negative impact of the event and its long-term impact on the organization, speed recovery, and return people to everyday life. Critical event interventions can also prevent post-traumatic stress disorder (PTSD).

Types of traumatic events

Tragedies come in many forms. Typical traumatic events include the unexpected death of an employee, a chronic illness of an employee, an injury at work, robberies, shootings and other acts of violence, criminal attacks, industrial or natural disasters, or even organizational restructuring or dismissal. People who have witnessed the event or know the people affected can experience a number of symptoms of the stress response, such as:

• Insomnia, nausea, dizziness, fatigue, racing heart, headache and loss of appetite
• Nightmares, hyper vigilance, panic attacks, intrusive images and poor concentration
• Feelings of anxiety, guilt, depression, irritability, anger and fear
• Social withdrawal and self-medication with alcohol or other drugs [1]

Critical events can also trigger memories of previous intense stressors.

How Magellan’s Employee Assistance Program Can Help

Magellan’s Critical Incident Response (CIR) team consists of specially trained clinical staff who are available 24 hours a day, 365 days a year. CIR Consultants help employees process and manage the emotional and physical effects of a traumatic event.

The first step is to consult with you about what has happened and assess the situation. Once the situation is assessed and an action plan is developed, we will send a CIR consultant to your workplace within a reasonable and agreed time frame. The CIR consultant will carry out a structured intervention on site to help deal with the incident, if necessary, and will also be available to managers and individual employees if needed. Services are confidential and provide employees with the resources and support they need to cope with the stress and anxiety caused by the event and return to normal life.

Our broad spectrum of CIR services includes management consultancy, telephone crisis support, group and individual support for affected employees, as well as follow-up care.

Critical incidents and tragic events occur in all types of companies and industries. Preparation with an existing CIR program is key to effectively managing the aftermath and associated risks.

[1] https: //www.osha.gov / SLTC/emergencypreparedness/guides/critical.html

Featuring excerpts used with permission from the Magellan Rx Management Medical Pharmacy Trend Report^TM, ©2020. Get a copy of the full report at magellanrx.com/trendreport.

In 2010, plans were just starting to manage drugs on the medical benefit; there were only nine approvals for medical injectable drugs, and biosimilars were talked about but still five years away. Now, the medical benefit is top of mind, and in 2019 alone there were triple that number of approvals—seven of them biosimilars.

For the 10th year in a row, the top five commercial drugs were Remicade, Neulasta, Rituxan, Herceptin, and Avastin. Remicade saw decreases in PMPM due to the introduction of biosimilars Renflexis and Inflectra. We may see similar trends in upcoming data, since all of these top 5 agents now have marketed biosimilars.

How have biosimilars impacted some of the top-spend medical benefit categories?

There are 26 FDA-approved biosimilar products across three different therapeutic categories, of which 17 have been launched. Fifteen of those are oncology or oncology support agents.

Biologic Drugs for Autoimmune Disorders (BDAIDs)

Trend remained relatively flat in this category as Remicade market share decreased, with biosimilars Renflexis and Inflectra beginning to gain market share (market share data for these biosimilars was not available for 2017 and 2018, but we expect to include it in next year’s report).

Oncology & Oncology Support

Oncology spend is a concern for payers, and oncology immunotherapies and gene therapy will continue to contribute to this spend. However, many opportunities for savings are anticipated with the biosimilars for Avastin, Herceptin, and Rituxan.

There are currently several biosimilars on the market in the oncology support category for the long- and short-acting CSFs and the ESAs. The predicted negative forecast growth illustrates their impact. Specifically, Neulasta biosimilars are now on the market, with Fulphila and Udenyca gaining market share.

Payer feedback on current bio-similar strategies

The biosimilars currently on the market proved to have an impact on medical pharmacy strategy, as 40% of plans, based on number of lives, reported they were currently reimbursing based on a maximum allowable cost (equivalent reimbursement for reference and biosimilar). At the time of our survey (summer 2019), there were no oncology bio-similar products on the market, but payers were planning to utilize the same formulary strategies, including step therapy.

What biosimilar strategies should payers be deploying NOW to prepare for the FUTURE?

At Magellan Rx, our 16+ years of total specialty drug management expertise enables us to prepare our customers for what comes next through forward-thinking solutions that keep a pulse on future industry trends. Through successful medical pharmacy management across all sites of service, we can deliver targeted, customized solutions designed to yield substantial drug cost savings while maintaining a high level of clinical quality.

• We’ve seen that health plans can experience a significant shift in utilization to lower-cost biosimilars through implementation of a comprehensive utilization management solution.
• Initial results from our new oncology biosimilar solution show proactive utilization management of oncology drugs via step therapy increases use of less expensive biosimilars. We encourage customers to combine the power of all our oncology solutions—such as utilization management, drug wastage, dose optimization, sophisticated claims editing, enhanced regimen review, site of service management, targeted solutions for oncology immunotherapies and oncology care management—to enhance outcomes and improve member quality of care.

Learn more about our total specialty drug solutions.

Being discharged from the hospital or receiving an unexpected diagnosis can feel lonely and confusing. What’s next? Where do I start? How do I manage all these follow up visits? What was I prescribed?

Data suggests that access to a collaborative team of a pharmacist and care manager can reduce hospital re-admissions by 50 percent. With our data-driven MRx Navigate solution, we are identifying members who might get lost in their care journey, helping to protect them from gaps in care and the risks of non-adherence, and guiding them along their path to wellness.

By fully integrating the many touch points of a member’s health and wellness, our team of clinical professionals works closely together to understand the member’s healthcare needs and assist them to better manage their condition through education, empowerment and specialized support. Our team provides seamless continuity of care and healthcare population management, delivering quality health outcomes and value-based savings.

Jill Anderle, RN, MRx Navigate Care Manager, describes her role by saying, “I care for patients and their loved ones who are often in extremely overwhelming circumstances. By listening closely and validating members’ concerns, I assess gaps in their treatment plan once they are discharged from the hospital. We also teach self-advocacy and connect people to supportive community resources to help prevent unnecessary hospital re-admissions.”

Mental Healthcare Manager Silvia Pantoja considers her role as multifaceted: “I help people who have recently been discharged from a hospital or mental health facility. Besides being a coordinator, educator, facilitator, and advocate, my main focus as a care manager is to empower patients by giving them a greater understanding of their disease.” Silvia helps connect members with therapists, psychiatrists, and other resources and stays in contact with each member to ensure they follow a clear discharge plan.

The MRx Navigate team has connections to extensive resources, helping members with durable medical equipment, like wheelchairs, scheduling follow-up appointments with specialists, and making sure the member’s home is safe and accommodates their new needs. The team’s clinical pharmacists provide drug information, answer questions about new medications, help find options for reducing the costs of drugs, and explain how to take medications appropriately and safely.

The wellness component of MRx Navigate, identifies opportunities for better care and increasing members’ quality of life through educational tools and preventive resources like bio-metric screenings, flu shot clinics, and mobile mammograms. Personal wellness coaches, like Baihly Birdseye, conduct outreach and health coaching. “Focusing on behavior change can not only help resolve illness, but it can also help member s avoid the hospital altogether, possibly preventing even more serious and costly complications. We also want wellness to be fun and engaging,” shares Baihly.

As the COVID-19 pandemic continues, and social distancing becomes the new normal, we have seen rapid expansion of digitally delivered peer and family support. In this post, we explore emerging issues and considerations for using technology to reach others.

The use of technology to offer peer support is a practice that has been around for quite a while. Think about telephonic peer support via peer-operated warmlines. A from December 4, 2019 said this about warmlines:

“Unlike a hotline for those in immediate crisis, warmlines provide early intervention with emotional support that can prevent a crisis.”

Magellan has long been a supporter of peer-operated warmlines and has helped launch warmlines in multiple states.

You can find more information about warmline availability by state at www.warmline.org or by visiting the National Empowerment Center’s directory of peer-run warmlines.

As opportunities for in-person, face-to-face support have decreased, many peer-run organizations, along with traditional mental health providers, have shifted delivery of services to telehealth platforms. Yet, during this unprecedented COVID-19 public health crisis, we see increased demand for support from folks living with anxiety and depression. As more families are impacted by the pandemic, access to peer support is more critical than ever.

Peers have been quick to step up with a national grassroots-driven expansion of support via video conferencing platforms like Zoom. With this rapid expansion, however, we see wide variability in practices. Skills learned by providing in-person peer support do not necessarily translate onto a digital delivery platform. Individuals who are used to seeing a peer supporter in person may have a different experience when it’s offered through technology. In some cases, apps that purport to offer peer support are actually “peer-bots,” with real-time interactions being driven by algorithms and predictive analytics.

Fortunately, solutions to address the nuances of digital peer support have been developed. One of the most beneficial is training in digital peer support. Magellan partnered with Dr. Karen Fortuna to provide specialized training to our team members who provide peer and family support. Many other organizations and agencies have completed this training as well. It’s an important and necessary step to take as we navigate this new normal.

If you want to learn more about the state of practice relevant to digitally delivered peer support, check out this article from the April 2020 Journal of Medical Internet Research by Dr. Fortuna, Digital Peer Support Mental Health Interventions for People With a Lived Experience of a Serious Mental Illness: Systematic Review.

As we learn more about what works and what could be improved with peer support services via telehealth, we are paving new ground. What we do over the coming weeks and months will set the trajectory for digitally delivered peer support.  Let’s make sure we get to where we want to go safely, respectfully and responsibly.

This is an excerpt from the full eMpowered for Wellness May newsletter. To read the full article, go here.