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.

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.

October is Breast Cancer Awareness Month, which focuses on increasing awareness and highlighting the importance of early detection. Although there has been a significant increase in awareness over the years, there is still a great deal of information about the disease that can cause some confusion.

Here is a look at three common myths about breast cancer and the truth behind them.

Myth: Finding a lump in your breast means you have breast cancer.
The Truth:  Only a small percentage of breast lumps turn out to be cancer. If you find a lump in your breast or notice changes in tissue, it is very important that you see a physician for a clinical breast exam or imaging.

Take charge of your health. Perform routine breast self-exams, establish ongoing communication with your doctor, get an annual clinical breast exam, and schedule your regular screening mammograms.

Myth: Men do not get breast cancer; it affects women only.
The Truth:  Quite the contrary. Annually, approximately 2,190 men¹ will be diagnosed with breast cancer, and 410 will die each year. While this percentage is small, men should also periodically do a breast self-exam while in the shower and report changes to their physicians.

Breast cancer in men is usually found as a hard lump underneath the nipple and areola. Men carry a higher mortality than women do, primarily because awareness among men is less. Men are less likely to assume a lump is breast cancer, which can cause a delay in seeking treatment.

Myth: You are not likely to develop breast cancer if you do not have a family history of breast cancer.
The Truth:  Women who have a family history of breast cancer are in a higher risk group. However, most women who have breast cancer have no family history. Statistically, only about 10% of individuals¹ diagnosed with breast cancer have a family history of this disease.

• A first-degree relative with breast cancer: If you have a mother, daughter, or sister who developed breast cancer below the age of 50, you should consider regular diagnostic breast imaging starting ten years before the age of your relative’s diagnosis.
• A second-degree relative with breast cancer: If you have had a grandmother or aunt who was diagnosed with breast cancer, your risk increases slightly. It is not at the same risk as those with a first-degree relative with breast cancer.
• Multiple generations diagnosed with breast cancer: If there are several family members diagnosed under age 50, the probability increases that there is a breast cancer gene contributing to the cause of this familial history.

When breast cancer is detected early, in the localized stage, the 5-year survival rate is 98%.³

Knowledge is power, it is vital to learn the facts about the disease. The more you learn about this disease, the better equipped you will be to make decisions about annual exams, screenings, risk reduction, and treatment options. Work with your provider to better understand your risk, and the steps you can take to be in charge of your breast health.

1. https://seer.cancer.gov/statfacts/html/breast.html
2. https://www.cancer.gov/about-cancer/causes-prevention/risk/myths/antiperspirants-fact-sheet
3. https://www.nationalbreastcancer.org/breast-cancer-stage-0-and-stage-1

October is American Pharmacists Month and an excellent opportunity for us to celebrate all of our Magellan Rx pharmacy heroes that help our members live healthy, vibrant lives! To kick off American Pharmacists Month, we wanted to shine a spotlight on our two pharmacy residents. We will be taking you behind the scenes to find out what got them interested in pharmacy and what they love most about their residency program.

Magellan Rx: Why did you decide you wanted to become a pharmacist?

Shyra Bias, PharmD: I decided at a young age that I wanted to be the drug expert in my family after witnessing a family member suffer from the complications of extremely uncontrolled latent autoimmune diabetes in adults (LADA). My desire to help my family led to a passion to improve many patients’ lives by ensuring that they can receive the medications they need at a cost they can afford.

Alaka’i Montalbo, PharmD: Growing up, I played a lot of sports and was always in the gym. As an athlete, you learn about sports supplements and how they can help you. In high school, I loved diving into the science of supplements. I later learned in life that the “science” of supplements was not backed by clinical data. After having my dreams crushed, I was working in the hospital and one of the nurses asked me if I had ever considered being a pharmacist? She knew I enjoyed talking about supplements and learning how different medications worked in the body. After researching what pharmacists do, I realized this was exactly what I wanted to do, and I have not looked back since.

Magellan Rx: What advice would you give to someone who wants to become a pharmacist?

Shyra Bias, PharmD: Keep your eye on the prize! The road to PharmD is not an easy one, but if you are truly passionate about the profession, you will get through it. Also, pharmacy is a very small world, so be intentional about making connections because you never know who may be able to change the trajectory of your career.

Alaka’i Montalbo, PharmD: Find joy in your journey. While pharmacy school is a long journey, it will fly by in the grand scheme of life. Don’t give up and never stop believing that you can do it. Don’t fall into the trap of saying to yourself I’m not ready yet. Right now, start making connections with pharmacists and current pharmacy students.

Magellan Rx: What different career paths can you do as a PharmD?

Shyra Bias, PharmD: There are many options for Pharmacists; many do not come to mind immediately when someone thinks of the traditional roles of a pharmacist. Some of the first paths that come to my mind include industry pharmacy, nuclear pharmacy, managed care pharmacy, and clinical pharmacy (hospital setting) to name a few.

Alaka’i Montalbo, PharmD: During pharmacy school, I had the opportunity to go to local high schools and talk about the profession of pharmacy. There are so many different careers Pharmacists can choose and every route is unique. There are traditional roles like retail, hospital pharmacy, and then some non-traditional roles are academia, nuclear (chemotherapy) pharmacy, FDA pharmacists, and Indian health services.

Magellan Rx: What made you choose managed care pharmacy?

Shyra Bias, PharmD: I chose managed care because I really enjoy the population health aspect of the industry. It gives me a true feeling of gratitude to change millions of lives with “the click of a button.”

Alaka’i Montalbo, PharmD: Managed care is the perfect balance between using clinical data and real-world efficacy to help patients manage their disease states. One of my favorite quotes about pharmacy is from Everett Koop, “Drugs don’t work in patients who don’t take them.” I would add to this quote, also with patients who can’t afford them. Managed care is that perfect bridge between both worlds of pharmacy, and I feel like I am making a huge difference every day, not just for one patient but for entire populations.

Magellan Rx: How do you like your residency at Magellan Rx?

Shyra Bias, PharmD: I am grateful beyond words to have been matched with Magellan Rx. The company culture makes me feel extremely welcomed, and the variety of experiences that we are exposed to through our rotations will allow us to succeed no matter where I end up in the managed care industry.

Alaka’i Montalbo, PharmD: Being Native Hawaiian, Ohana (family) means everything to me, and family means no one gets left behind or forgotten. Magellan Rx is one big Ohana and every day, I get to stand on the shoulders of giants. I feel so blessed to be a part of this company and everyone in this residency program is always willing to stop what they are doing, take time out of their busy schedules to help me grow! I cannot express my gratitude enough and I look forward to paying it forward in my career.

Don’t forget to follow us on LinkedIn and Twitter where we will be featuring different pharmacists and pharmacy techs throughout October. #MRxAmericanPharmacistMonth

By Caroline Bohn, R.N., Senior Care Manager, Magellan Behavioral Health of Pennsylvania

Millions of Americans suffer with chronic pain issues, every day of their lives. Conditions such as migraines, back injuries, fibromyalgia, or neuropathy, for example, can cause serious, ongoing pain. Ongoing chronic pain can be a debilitating problem for those suffering with it. Dealing with a chronic pain issue can lead to additional problems, such as a loss of pleasure in life, inability to work, poor sleep or depression. People often seek treatment for chronic pain, to be able to live a better life.

We live in a fast-paced world where we can access just about anything, 24 hours a day, 7 days a week. We can shop and order things on the internet at any time of the day or night, or even go to stores that are open 24/7. No longer must we wait for someone to get home and check an answering machine to receive our messages because we can reach out to others in an instant via cell phones, email, texting, and instant messaging. Going to the movie theatre or buying a DVD in the store are almost obsolete. The limitless availability of television and internet streaming services allow us to watch our favorite shows and movies at any time. The ability to get so many needs met instantly, leads us to expect this type of immediate fix for everything in our lives, including medical issues.

It is understandable that people desire immediate relief from pain, and there are many ways in which pain can be treated successfully and alleviated. One option, which people often choose, is the use of prescription pain medication. But the natural desire to relieve pain immediately can cause people to opt for taking pain medication before trying less invasive alternatives. There are many options for treating chronic pain without prescription medication. For example, interventions such as physical or occupational therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture, biofeedback, or cold laser therapy. Wearing supportive braces or orthotics can be helpful with eliminating pressure on inflamed areas. Yoga, weight loss, and therapeutic massage can aide in reducing muscle and joint pain. Mind-body techniques are also effective methods to address pain, such as meditation, mindfulness, progressive muscle relaxation, and deep breathing exercises. To clarify, the use of prescription pain medication is not an inappropriate choice, but it is wise to explore other options as well. Pain itself, is not a disease. Pain is a symptom or signal used to alert us that something is going wrong within the body. Use of medications to eliminate the pain signal, is not helping fix the problem that is causing the pain. The first step to solving a pain issue is to identify and address what is causing the pain so you do not have to experience pain in the first place. There are situations where it is not possible to eliminate the source of the pain completely, but in cases like these, there could be treatments available to lessen the severity of the pain, so it is manageable with less medication or without the use of medication at all.

Regular use of prescription medication to alleviate pain could cause other issues to arise, even when a medication is appropriately prescribed by a physician and taken according to the physician’s orders. Unfortunately, it is possible for your body to become dependent on certain types of prescription pain medication. Dependence on pain medication is evident when an individual experiences symptoms of withdrawal when taking less of the medication or stopping it altogether. If a person feels they must continue taking pain medication to avoid experiencing withdrawal when not taking it, this could indicate that their body has become dependent on it. If this occurs, a consultation with your physician to discuss next steps is essential.

There are different classes, or types, of pain medications which can be prescribed by your physician. One of these types, called opioids, has a greater risk for dependence than other types of prescription pain medication. If your body becomes dependent on opioid pain medication, it can be difficult to stop taking it. Opioid pain medications have a higher risk for causing withdrawal symptoms when discontinued than other types of pain medication. People could experience nausea, vomiting, sweating, feeling excessively hot or cold, or muscle aches throughout their body, when taking less of or stopping the opioid pain medication. If this were to happen, alerting your physician is crucial. Your physician can assist you with safely discontinuing an opioid pain medication, so you do not have any withdrawal symptoms. If you do not feel comfortable telling your physician you may be dependent on opioid pain medication, there are other ways to seek help. If you have access to the internet, you can visit the SAMHSA website (https://www.samhsa.gov/find-treatment) to get education and information about seeking help with opioid pain medication dependence. If you do not have access to the internet, SAMHSA offer a toll-free helpline as well (SAMHSA’s National Helpline: 1-800-662-HELP (4357).

There is nothing wrong with seeking help when your health is at stake. Reaching out to a trusted family member or friend, to ask for their help, is also a great way to start on the road to your recovery. Above all, it is important to remember that maintaining your physical health and well-being, is crucial to living your best life.

Behavioral health is an important indicator of a society’s overall wellbeing, as it interacts closely with physical health. Unfortunately, most individuals do not receive the behavioral health treatment they need. Fear of treatment, shame, and embarrassment keep many from seeking care. More than one-third of Americans live in areas lacking mental health professionals.[1] Fifty percent of individuals who receive a behavioral health referral do not follow through or have only one visit.[2] Collaborative care addresses these problems by providing physical and behavioral health care in the primary care setting.

What is collaborative care?

Collaborative care is a specific type of integrated care developed at the University of Washington’s AIM Center that treats common mental health conditions, such as depression and anxiety, that require systematic follow-up due to their persistence. Based on principles of effective treatment of chronic illness, collaborative care focuses on defined patient populations tracked in a registry, measurement-based practices, and treatment to target. Trained primary care providers and embedded behavioral health professionals provide evidence-based medication or psychosocial treatments, supported by regular psychiatric case consultation and treatment adjustment for patients who do not improve as expected.[3]

Principles of collaborative care

Developed in consultation with a group of national experts in integrated behavioral health care in 2011 with the support of the John A. Hartford Foundation, The Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality, and California Healthcare Foundation, five core principles define collaborative care and should inform every aspect of implementation to ensure effective collaborative care is practiced.[4]

• Patient-centered team care—Primary care and behavioral health providers effectively work together using shared care plans that include patient goals. Being able to receive both physical and mental health care in a familiar location provides patients with comfort and reduces duplication of assessments. Increased patient engagement often leads to a better health care experience and improved patient outcomes.
• Population-based care—Care teams share a specific group of patients that are included in a registry. The registry is used to track patients and ensure that no one falls through the cracks. Patients who do not show improvement are outreached, and behavioral health specialists offer caseload-focused consultation.
• Measurement-based treatment to target—Each patient’s treatment plan includes personal goals and clinical outcomes that are measured using evidence-based tools, such as the Generalized Anxiety Disorder scale on a routine basis. If patients do not improve as expected, treatments are adjusted until clinical goals are met.
• Evidence-based care—Patients receive treatments with sound research evidence to support their efficacy in the treatment of the target condition, including various evidence-based psychotherapies that have proven effective in primary care, such as problem-solving treatment, behavioral activation, and cognitive behavioral therapy, and medicines.
• Accountable care—Providers are responsible for and receive reimbursement for the quality of care and clinical outcomes, not just the volume of care provided.

Collaborative care has been proven to double the effectiveness of depression care, improve physical function, and reduce health care costs. Magellan Healthcare’s evidence-based Collaborative Care Management product, enabled by NeuroFlow, provides care management and psychiatric consults for primary care patients and augments physical health providers’ staff with Magellan staff to facilitate integrated physical and behavioral healthcare. Learn more here.

[1] https://usafacts.org/articles/over-one-third-of-americans-live-in-areas-lacking-mental-health-professionals/

[2] https://aims.uw.edu/collaborative-care

[3] https://aims.uw.edu/collaborative-care

[4] https://aims.uw.edu/collaborative-care