Have you heard that the world of cervical cancer therapy is evolving? There are two players who recently stepped onto the field of oncology for the treatment of recurrent, metastatic, or persistent disease. In 2021, FDA approval moved Keytruda® (pembrolizumab) from second-line to first-line therapy in PD-1 positive patients. Tivdak™ (tisotumab vedotin-tftv) also obtained FDA approval as second-line and subsequent therapy in the same space.

Why is the approval of two therapies in the same year significant? Since the 2014 approval of bevacizumab, no new first-line therapy for cervical cancer has hit the oncology market, and prior to bevacizumab, the last new approval in the category was the combination therapy with topotecan and cisplatin in 2006. So Keytruda and Tivdak are possible game-changers for patients!

From 1975-2010, new diagnoses of cervical cancer have decreased by more than 50% due to screening. With the introduction of the HPV vaccine in 2006, there was hope that HPV infection prevention would lead to decreased cervical cancer cases. In 2020, a Swedish study published in the New England Journal of Medicine found that the quadrivalent HPV vaccination was associated with a significant reduction in the risk of invasive cervical cancer. In 2018, there were 293,394 women living with cervical cancer in the U.S. As cervical cancer cases decline, according to SEER data, there were an estimated 14,480 new cases and 4,290 deaths reported in 2021. The total annual medical cost of cervical cancer care is estimated to be $1.6 billion. Due to its move from second to first-line, Keytruda will likely demonstrate a net neutral effect on the budget. A forecasted cost impact model for Tivdak is demonstrated below:

Do psilocybin, MDMA, LSD, ketamine, and cannabis sound familiar as medication therapy to help treat mental illness? It goes without saying that the pandemic has intensified mental health symptoms in the United States (US), turning an urgent matter into a crisis. One in 5 American adults suffers from mental illness, with young adults ages 18 to 25 years reporting the highest prevalence. These numbers speak volumes. Some treatment options do not adequately treat patients with mental illness and are associated with significant side effects. This underscores the need for more effective treatments. Because of these factors, psychedelics and other psychoactive substances are gaining momentum as possible alternatives.

Psychedelics are a “mind-manifesting” hallucinogenic class of psychoactive compounds that affect perception. They have been used by ancient civilizations for medicinal purposes and religious rituals for thousands of years. There is a renewed interest in using psychedelics to treat mental disorders driven by global research, influencers, education, and patient voices. Philanthropy has been the main funding source for psychedelics. However, a recent federal grant to Johns Hopkins Medicine to study psilocybin for tobacco addiction may signal a sea change in federal funding of psychedelic research.

While small-scale clinical trials have been promising, for psychedelics to become mainstream, large-scale randomized controlled trials are needed to fully evaluate their safety and efficacy. Studies are underway through several leading centers including MAPS – the Multidisciplinary Association for Psychedelic Studies – a non-profit dedicated to psychedelic research.

Psychedelics are not currently approved as prescription medications. Notably, the US Food and Drug Administration (FDA) has given Breakthrough Therapy designation to two psychedelics – MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) and psilocybin-assisted therapy for treatment-resistant depression (TRD) and major depressive disorder (MDD). FDA’s Breakthrough Therapy is designed to “expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.” As clinical trials progress, 2023 could bring regulatory approval for the MAPS’ MDMA-assisted psychotherapy for PTSD, a potential turning point in the mental health treatment paradigm.

Patients with mental health illnesses deserve to heal and restore balance to their lives without stigma and judgment and deserve treatments that are safe and efficacious. Step into Magellan’s Clinical Insights for the role of psychedelics in treating mental health conditions. This industry-first paper explores the current evidence, regulatory, and legislative landscape for psychedelics and shares Magellan’s four pillars on emerging therapeutic frontiers. We are guided by four principles:

• Education and thought leadership for patients, payers, providers, and stakeholders while addressing the stigma around mental health
• Evidence-based clinical recommendations and coverage
• Patient safety by advocating for quality standards
• Access that is responsible and sustainable

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.

Twenty twenty-two is here, with all its possibilities and opportunities. You may be wondering how you will achieve all of your personal and professional goals this year. Your mental health in 2022 may hold the key to success. Read on for tips from Magellan Healthcare’s behavioral health experts to help you prioritize your mental health in the new year.

1. Spread out New Year’s resolutions over the year – At the beginning of the year, people usually try to accomplish too many resolutions all at once. They are quickly overwhelmed and give up. Instead, create a list of resolutions, or goals, to implement–one per month–over the year. Spreading out goals and focusing on one at a time will feel more consistent with lifestyle change than the usual New Year’s start and stop. – Candice Tate, MD, MBA
2. Plan things to look forward to – Having a daily routine is important for our mental health. It limits the chaos and helps us feel grounded. But it can get boring, especially during COVID-19 when we are closed in. Schedule things to look forward to for the upcoming weeks and months. Maybe schedule a day trip on a weekend, a few hours in the evening to watch a movie, or a phone/Zoom call with an old friend, make a reservation at your favorite restaurant or plan to place a delivery order. Choose things that make you feel good. – Linda Evans, MD, FAPA
3. Limit screen time and media exposure – Social media has been a much needed lifeline for so many of us during the pandemic, but it’s essential that we remember to limit our screen time and exposure to content that can be emotionally distressing or traumatizing. Make a habit of putting your mobile device down and stepping away from your computer to enjoy the people, plants or pets in your environment. Go outside, take a walk, and get some fresh air and sunlight. – Rakel Beall-Wilkins, MD, MPH
4. Learn that “no” is a complete sentence – You cannot pour from an empty cup. Saying yes to every request asked of you when you are already limited on time, energy or resources can increase stress levels. Putting your needs on the backburner is not healthy for you. Being a “yes” person sometimes equates to saying “no” to your own mental health. Recognize not only when to say no, but that you don’t have to feel guilty about it… It’s all about saying yes to you! – LaShondra Washington, MD, DFAPA
5. Measure something – Our perceptions often do not match the reality of a situation but picking something to measure that is related to a concern can help better align our perceptions to reality. And if the results of the measurements indicate that indeed perception and reality are aligned, then continued measurement, after an intervention, can determine the usefulness of the intervention on the measure. In other words, take steps to find out if what is bothering you is really a problem, and if it is, then make a change and reassess. – Louis Parrott, MD, PhD
6. Engage in journaling – Journaling is an effective way to manage stress and feelings. It can be cathartic to write about feelings and experiences. It is also a way to monitor your inner self and when it may be necessary to seek professional help. – Samuel Williams, MD, MBA, FAPA
7. Practice gratitude – Share gratitude with others and write three things you are grateful for every day. According to Jon Kabat-Zinn, PhD, an internationally known mindfulness advocate, we should ask ourselves three questions each day that relate to our relationships with family, friends, and co-workers: What have I received from __? What have I given to __? What troubles and difficulties have I caused? – Doris Lebischak, MD
8. Establish an attainable plan for regular physical activity and stick to it – Start with one or two days of exercise a week. Plan the days, times, and activities and commit to making it happen. Exercise is proven to reduce depression, anxiety, and negative mood.[1] – Greg Dicharry, CPRP
9. Consider expanding your exercise routine – As we age, our muscles must be challenged to maintain strength. Including strength training, stretching and physical activity that raises the heart rate in our workouts will have an immediate impact as well as long-term benefits for the body and mind. – Paula Hensley, MD
10. Eat a balanced diet with as many unprocessed foods as possible – Include colorful fruits and vegetables and prepare food in healthier ways like steaming and roasting rather than frying. If applicable, include children in meal selection and preparation, and eat at least one meal per day as a family. Try not to place food into strict bad and good categories, and understand that you are not–accordingly–bad or good depending on what you eat. It’s important to eat a balanced diet for your lifestyle. – Misty Tu, MD
11. Prioritize sleep – Push through busy schedules and life’s distractions to maintain eight hours of sleep each night and experience how it helps you think more clearly, feel better and be better able to creatively juggle the multiple demands of family, work, and beyond. – Barbara Dunn, LCSW, ACSW
12. Develop a cue that ends your workday – Whether it is pausing to watch the sunset, moving your body for 20 minutes, or ceremonially closing the door to your workspace, disconnecting from work to focus on rest, joy, or family responsibilities is a necessary way to prioritize mental health in 2022. – Dana Foglesong, MSW, NCPS, CRPS
13. Make sure to prioritize yourself – In a time when kids are home, work is piling up, and there is growing uncertainty in and outside of our homes, it’s unfortunately easy to get lost in all we have going on. But it’s vital we prioritize ourselves. Whether it’s going on a walk or other exercise, meditation, talk therapy, weekly dinner with friends or family… don’t ever forget to put yourself first because your mental health is wealth. – Yagnesh Vadgama, BCBA
14. Ask for help when you need it – Recognize that no one person can do everything. Family, friends, and neighbors can be great resources, so ask for what you need and offer help to them when you can. – Kathryn Kvederis, MD, DFAPA
15. Remember that you are not alone – One in five American adults has a mental illness and one in 18 American adults has a serious mental illness; one in six American youth has been diagnosed with depression.[2] Despite all of the glittery images we may see and our perceptions that others have it better, it’s likely that we have family members, friends, and co-workers who are right there with us when we aren’t feeling our best. – Keith Brown, MD

As we sail into a bright new year, with 2021 in the rear-view mirror, let’s remember to prioritize ourselves and our mental health. We have all experienced the trials and tribulations of a tumultuous previous two years. If we have learned anything, it’s that our mental health in 2022 is what will keep us strong and poised for happiness and success.

Visit MagellanHealthcare.com/BH-Resources for free information and tools to address mental/behavioral health needs and spread awareness to reduce stigma. Stay tuned here and on our calendar for updates on our virtual events throughout the year.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1470658/

[2] https://www.samhsa.gov/data/release/2020-national-survey-drug-use-and-health-nsduh-releases

We made it through Thanksgiving – hopefully emotionally unscathed. But for many, managing mental health during the holidays is not easy. Whether you deal with anxiety for months leading up to the holiday, your family is plagued with arguments or more subtle discomfort during get-togethers, and/or you are mourning the loss of a loved one and have an empty seat at the table – the holidays can be tough. In fact, in a 2021 survey, 44% of Americans said that preparing for the holidays is stressful and 39% said that family gatherings during the holidays are stressful.[1]

Holiday anxiety

Anxiety is defined by the National Institutes of Health as “a feeling of fear, dread, and uneasiness.”[2] And why might we feel anxious leading up to what one might consider a wonderous and magical occasion, such as Thanksgiving or a December holiday, with our family? The reasons are endless. It could be a difficult family member we are not looking forward to seeing. It could be that we are not feeling particularly good about ourselves and want to face others. Maybe we are hosting a holiday gathering and worried about getting everything done in time, how much everything will cost and whether everyone will have a good time.

We are barraged with media images of what the perfect holiday looks like, and we may sometimes feel pressure to be happy and festive and live up to expectations.

When we dread an upcoming holiday, it puts a damper on more than merely just that day or specific gathering, but the days, weeks, or even months leading up to it. It is almost like the reverse of excitement or anticipation. But whether we are excited or anxious about something, the actual event often does not live up to our expectations. In the case of holiday anxiety, if we can remember that it may actually end up being better than we think and simply try not to care as much, our anxiety time may be reduced. We can let go of others’ expectations of us and do what truly makes us happy.

Family arguments during the holidays

Yes, most families argue – even during the shiny holidays and behind the scenes of the happy pictures we post on social media. And just when our typical bickering was not enough, our country has become increasingly divided, and it has seeped into our very own families. There are things we can do to prevent the arguments and deal with them in a healthier way when they occur.

You have probably heard the phrase “communication is key.” A lot has changed over the past couple of years and continues to change at a rapid pace. We may think we know how a loved one would like to celebrate the holidays, for example. But their preferences, and our own, may have changed just like so much else has changed.

It’s a good idea to initiate respectful conversations – early in the holiday planning process – with our family and friends to understand where they are coming from on certain issues. It can be a way to identify the topics that should be off-limits during the upcoming holiday gathering and prevent arguments.

During these early conversations and when we’re all together for the holidays, our family members may inevitably do or say something that rubs us the wrong way. At that moment, our reaction will set the course for what comes next. As our feelings come together to form that reaction, why not assume goodwill and the best intentions of the offending person. It may be that their actions and comments reflect the way they feel about themselves and not the way they feel about you.

With so much to disagree about these days, there is also a lot we can agree on. Try to focus on the latter, agree to disagree when possible, and assume that others are coming from a place that is genuinely meaningful to them.

Grief and missing a loved one during the holidays

The pandemic has taken so much from us, including the lives of precious loved ones. The holidays have always been a difficult time to bear when we cannot share them with a lost family member or friend. During this holiday season, you can uphold and honor memories of those you have lost in many ways: Look through photographs of the person and reminisce about holidays of the past; do things you used to do with a lost loved one during the holidays, like cooking or baking a certain recipe, a craft, or decorating; and journaling or talking with others about your feelings.

It can be hard to move on without a person we love, but they would want you to be happy. We will always have their memories during the holidays and beyond, as we carry on with old and new traditions.

We can all agree that it has been another tough year. But we have endured, and it is time to let go of expectations and focus on our mental health during the holidays and how the holidays can be a time to do what makes us happy, spend quality time with those who are important to us and cherish the memories of those we have lost.

Visit MagellanHealthcare.com/Holidays for additional information and resources on holiday emotional wellbeing and how to find peace and moments of joy with family and friends this holiday season.

[1] Collage Group Holidays and Occasions Survey, May 2021

[2] https://medlineplus.gov/anxiety.html

Candice Tate, MD, MBA, serves as a medical director at Magellan Healthcare. Dr. Tate’s treatment philosophy includes a strong physician-patient therapeutic alliance and safe, responsible medication management. Dr. Tate joined Magellan in 2017. She has years of experience in psychotropic medication management for a variety of psychiatric conditions in inpatient and outpatient settings. During her graduate medical training, Dr. Tate was extensively trained in psychodynamic psychotherapy and was supervised by experienced psychoanalysts. She is also familiar with cognitive-behavioral therapy (CBT), interpersonal therapy (IPT), and dialectical behavior therapy (DBT). Dr. Tate graduated from the University of Tennessee Medical School in Memphis and completed her graduate medical education in General Psychiatry at Northwestern University’s Feinberg School of Medicine in Chicago, IL. Dr. Tate is a board-certified psychiatrist by the American Board of Psychiatry and Neurology.

The holidays can be a joyous time—a time to spend with family and friends, reflect, and be thankful. Yet, for many people, the holiday season can bring on the blues, including feelings of anxiety, stress, worry, and sadness. These feelings may even be worse for those who have experienced divorce, lost a loved one, or are living far away from family and friends.

The holiday blues

A 2014 survey conducted by the National Alliance on Mental Illness (NAMI) found that the holidays contribute to feelings of sadness or dissatisfaction. Of those surveyed:

• 63% reported there was too much pressure
• 57% stated they had unrealistic expectations
• 66% reported experiencing loneliness
• 50% were unable to be with loved ones
• 55% found themselves remembering happier times in the past contrasting with the present
• 68% reported feeling financially strained

While the holiday blues are different from mental illness, it can lead to clinical anxiety and depression. It is important that we do not ignore these feelings, especially as we all continue to deal with changes wrought by the COVID-19 pandemic but deal with them in a proactive and healthy manner.

Tips for beating the holiday blues

1. Throw guilt out the window. Try not to put unreasonable pressure on yourself to be happy or enjoy the holidays and avoid overanalyzing your interactions with others. Give yourself an emotional and mental break this holiday season.
2. Be realistic and try not to expect the “ideal” holiday. Keep expectations for the holiday season manageable by not trying to make the holiday “the best.” Be truthful to yourself and others about what you can and cannot do. And remember, nobody has a perfect holiday or perfect family.
3. Give to others. Volunteering somewhere, like a soup kitchen, food bank, children’s group home or facility for the elderly can fill you with feelings of love and pride. You will spend time with others and immerse yourself in the true spirit of the holiday season.
4. Stay connected. Schedule phone calls or virtual gatherings with your favorite folks where you can open gifts together, sing songs and reminisce. Spending time with those who love and value you can be very comforting and help ground everyone involved.
5. Acknowledge the past yet look toward the future. Change is a constant part of life. If your holidays are not like they used to be, it is OK. Cherish the memories and remember everything does not have to be like past holidays for you to enjoy the season.
6. Make a budget. Budgeting at the start of the season for holiday shopping and expenses is one of the most effective ways to alleviate stress. It helps prevent accidental overspending and allows you to manage expectations.

Want more tips for beating the holiday blues?

Visit the Magellan Healthcare holiday emotional wellbeing website for resources to help you find peace and moments of joy this holiday season here.

The United States (US) Food and Drug Administration (FDA) recently authorized the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 years old. The Centers for Disease Control and Prevention (CDC) also recommended the vaccine in this age group. There are 28 million children in the US ages 5 to 11 years old. This age group makes up 39% of COVID-19 cases in those under the age of 18 years. While children are less likely to develop severe COVID-19 than adults, severe illness, hospitalization, and death have occurred in younger ages. Now that there is a COVID-19 vaccine option for ages 5 to 11 years, here are answers to vaccine questions that are top of mind for many parents.

1. How effective is Pfizer’s vaccine in children ages 5 to 11 years?

• According to results from the ongoing study in ages 5 to 11 years, the vaccine has been 90.7% effective in preventing COVID-19 measured 7 days after the second dose. The study has been going on with delta as the prevalent strain.
• Immune responses in this age group were comparable to 16 to 25-year-olds.

2. What are the common side effects?

• The most common side effect was injection site pain (sore arm). Some of the other common side effects include fatigue, headache, redness and swelling, fever, chills, and muscle pain.
• Side effects were generally more common after the second dose. Side effects were mostly mild to moderate, started within 2 days of the second dose, and resolved within 1 or 2 days.
• There have been no cases of myocarditis (heart inflammation) reported in this age group.
• The study is ongoing, and the FDA and CDC will continue to monitor for vaccine safety and look for rare or serious side effects.
• The vaccine should not be given to anyone who has a history of anaphylaxis (severe allergic reaction) to any part of Pfizer’s vaccine.

3. How is Pfizer’s vaccine dosed in ages 5 to 11 years? What type of vaccine is it?

• The dose for 5 to 11-year-olds is a two-dose regimen of 10 mcg given 21 days apart.
• It is a messenger RNA (mRNA) vaccine, but the dose is one-third of the adolescent and adult doses (30 mcg).

4. Can the flu and COVID-19 shots be given at the same visit?

• COVID-19 vaccine can be given at the same visit as routine childhood immunizations, including flu.

5. Where is Pfizer’s vaccine available?

• Pfizer’s vaccine for ages 5 to 11 years is available in pediatrician offices, pharmacies, health departments, hospitals, and other sites.  Vaccines.gov lists vaccine availability at different locations.

Disclaimer: The content in this blog article is NOT a substitute for professional medical advice. For questions regarding COVID-19 vaccines, any medical condition, or if you are in need of medical advice, please contact your healthcare provider. Given the fluid nature of the pandemic, information in this article is subject to change and may not be current.

Sources

• VRBPAC FDA Briefing Document. October 26, 2021. https://www.fda.gov/media/153447/download
• Pfizer EUA Press Release. October 29, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use-0.
• FDA Press Release. October 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
• CDC Interim Clinical Considerations. November 3, 2021. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#children
• Pfizer EUA Fact Sheet. Revised October 29, 2021. https://www.fda.gov/media/153714/download
• AAP Policy Statement. November 2, 2021. https://www.aap.org/en/pages/covid-19-vaccines-in-children-and-adolescents-policy/
• Vaccines.gov.

The COVID-19 pandemic has had a profound affect on everyone, particularly children with emotional health concerns. Many support structures in place prior to the pandemic to help children thrive have disappeared or been changed significantly, resulting in increased pressure on caretakers and overwhelming stress for children. New and innovative solutions are needed to meet these challenges. Magellan Healthcare’s Emotional Health for Kids by Mightier is a clinically proven video game solution that helps children build emotion regulation skills through play and caregivers build emotionally healthy homes.

Developed at Boston Children’s Hospital and Harvard Medical School, Mightier helps children ages 6 to 14 who are struggling with emotional health concerns, such as irritability, aggression, and anger, as well as children diagnosed with oppositional defiant disorder, attention deficit-hyperactivity disorder, autism spectrum disorder (ASD) and general anxiety disorder.

Mightier’s impact on children’s emotional health

In a pilot program, Magellan provided members access to the Mightier program for a period of twelve weeks during the COVID-19 pandemic. Families were recruited and randomized into a group that received Mightier in addition to applied behavior analysis (ABA), or a group that received only ABA as a control.

• Children engaged with Mightier at a high rate. On average, Mightier families played for 30.4 minutes above the 30 minutes per week recommended to see clinical change.
• Clinical symptoms improved. Eighty percent of children with ASD who used Mightier showed an improvement on primary symptoms, compared to only 50% in the control group.
• Children showed twice as much decrease in aggressive behaviors. Adding Mightier to ABA resulted in a reduction in aggressive behavior in children with autism by twice as much compared to ABA alone.
• Families reported a less stressful and more supportive environment. Families using Mightier showed 50% improvement in family stress, 114% improvement in parent confidence, and 114% improvement in access to resources relative to control.

Visit  Magellanhealthcare.com/kids-emotions-mightier/ to learn more about the pilot and how Mightier helps children build self-regulation skills and supports caregivers in building emotionally healthy homes.

Among those who experience a mental health illness, more than half do not receive treatment.[1] The 2019 National Survey on Drug Use and Health reveals no treatment was received by:

• 90% of the 20.4 million individuals aged 12+ who have a substance use disorder (SUD)
• 55% of the 51.5 million individuals aged 18+ who have any mental illness (AMI)
• 35% of the 13.1 million individuals aged 18+ who have a serious mental illness
• 90% of the 9.5 million individuals aged 18+ who have a co-occurring SUD and AMI
• 57% of the 3.8 million individuals aged 12-17 who have had a major depressive episode

In fact, what we’ve seen in our data is that 60% of patients who are admitted to inpatient care were first seen in a primary care setting within 6-12 months of the admission and the mental health condition was either missed or not addressed.

Through effective screening for mental health conditions on your own or through a physician or mental health professional, it is possible to identify problem areas and get help, so you can live a happier and healthier life.

Mental health self-screening tools

Magellan Healthcare provides links to reputable, free self-assessments of behavioral/mental health, substance use and more.* Once you complete an assessment, be sure to review your results and any recommendations with your doctor.

• Addiction(CAGE-AID)
• Alcohol consumption (AUDIT-10)
• Anxiety (GAD-7)
• Bipolar disorder
• Child depression (CES-DC)
• Child trauma (CTS)
• Depression (PHQ-8)
• Drug abuse (DAST-10)
• Eating disorder (SWED)
• Insomnia (ISI-7)
• Obsessive compulsive disorder (OCD) (Y-BOCS)
• Pain (PEG-3)
• Parent mental health
• Postpartum depression
• Post traumatic stress disorder (PTSD) (PC-PTSD)
• Psychosis (PQ-B)
• Youth mental health

*Note these are links to outside websites that are not monitored by or affiliated with Magellan Healthcare. If your screening results indicate you are at high risk, call 911 or go to the emergency room immediately.

We encourage you to watch a recording of our webinar, “Depression is more than just a rough patch,” and find additional resources addressing depression at MagellanHealthcare.com/Mental-Health.

[1] https://www.samhsa.gov/data/sites/default/files/reports/rpt29392/Assistant-Secretary-nsduh2019_presentation/Assistant-Secretary-nsduh2019_presentation.pdf