In 2019, Time magazine listed virtual reality (VR) as one of the 12 innovations that will change health care and medicine in the 2020s. With this projection, the probability that you will use VR sometime in your life is high! VR is currently being used in a variety of fields, including

• Mental health
• Pain management
• Rehabilitation
• Training and education

VR is not a fad, as studies are underway for its potential efficacy to treat Alzheimer’s disease, depression, addiction, and other illnesses. This new field of medicine collectively referred to as medical extended reality (MXR), encompasses VR and augmented reality (AR). There are many aspects in the VR landscape including safety, regulations, and value to name a few. Let’s dive in and explore some of the clinical uses of this emerging trend.

Pediatric Intervention
Children are often under-treated and under-recognized when it comes to managing pain, fear, and anxiety. Thus, VR is utilized in children’s hospitals, such as Stanford Children’s Health, to engage and distract children during painful procedures. At the Lucile Packard Children’s Hospital Stanford, VR is used in several ways to reduce pain and stress, including the use of AR goggles for patients in the pre-op so they can watch movies and play games prior to surgery, and the use of VR games in the intensive care unit (ICU).

Mental Health Treatment
With an estimated 52.9 million adults suffering from mental illness in 2020 according to the Substance Abuse and Mental Health Services Administration (SAMHSA), one of the biggest challenges today is the rising demand for mental health treatment and a shortage of available providers. As another tool to tackle mental health conditions, VR now contributes to the availability of additional resources.

The use of VR software simulates real-world settings that closely resemble the surroundings of daily life so that triggering stimuli such as anxiety, paranoia, fear, and cravings can be assessed and treated. Anxiety disorders are already being treated using virtual reality exposure therapy (VRET) as a potentially scalable tool. In addition to anxiety-like disorders, VR is being studied for several other disorders.

There is evidence that VRET reduces post-traumatic stress disorder (PTSD) symptoms, with sustained improvements at six and twelve months after treatment. Among children with autism spectrum disorder (ASD), a recent research initiative demonstrated that VR combined with cognitive behavioral therapy (CBT) improved specific phobias. For seniors who suffer from social isolation, Rendever has developed a VR platform designed to reduce depression and loneliness.

Chronic Pain Treatment
A Centers for Disease Control and Prevention (CDC) survey in 2019 found that 20.4% of US adults have experienced chronic pain. Persistent pain is linked to depression and anxiety and can become an overlapping symptom.

In a study conducted by Cedars Sinai, VR reduced hospitalized patients’ pain scores by 24% and was most effective for patients with severe pain. In November 2021, a prescription medical device (RelieVRx) was authorized by the US Food and Drug Administration (FDA) as the first at-home VR therapeutic as an adjunct to treat chronic lower back pain.

Virtual Rehabilitation
While the benefits of physical therapy have long been established, some patients who would benefit from PT do not have access to it. In recent years, VR rehabilitation has been gaining traction with a host of conditions from chronic pain, stroke, and Parkinson’s disease to multiple sclerosis, dementia, and cerebral palsy. VR-assisted rehab may offer advantages for patients such as improved patient engagement and motivation, poststroke functional recovery, and improved mobility in Parkinson’s patients.

Training and Education
It can be challenging for educators to meet learning objectives through standardized medical training, especially as healthcare systems evolve. VR training and education, allow personnel, students, and residents to learn in a controlled environment while minimizing risks to real patients. As a result, VR systems are increasingly used in hospitals to train residents, assist surgeons with surgical planning, and educate patients. In a UCLA study, participants using the Osso VR platform significantly improved their overall surgical performance compared to conventional training methods.

Health Inequities
The healthcare system continues to be affected by structural racism, affecting the well-being of all people, especially those who have historically been marginalized. The use of VR as a training tool is currently being explored for a better understanding of the cultural needs of patients, with the possibility of VR becoming a tool for increasing empathy and giving people a broader perspective when interacting with individuals of different racial and economic backgrounds.

With VR technology developing at record speed and its potential to transform healthcare, we are keeping VR on our radar. We encourage you to learn more about VR and the world of MXR by visiting our website to explore our latest white paper: Virtual Reality – An Emerging Paradigm in Healthcare

This is just the beginning!

Written by Noushin Izadifar Hart, MD

As the second leading cause of death among U.S. women, most of us know someone who has or have experienced breast cancer ourselves. One in eight of us will develop it in our lifetime, and every 13 minutes one of us dies from it. Understanding breast cancer and early screening can increase survival and help us all live happier, healthier lives, including men, who have a 1 in 833 lifetime risk.

What factors increase my breast cancer risk?

In women, the risk of breast cancer increases with age, with the average woman being diagnosed at age 63. Other contributing factors are:

• Personal and family history of breast cancer, including ductal cancer in situ

• Benign (non-cancerous) breast conditions, including lobular cancer in situ

• Radiation treatments to the chest before age 30

• Physical inactivity, alcohol use and obesity

• Inherited gene mutations

• Risk factors for men are similar, and also include liver disease, Klinefelter’s syndrome, estrogen treatment and testicular conditions.

What are the signs and symptoms of breast cancer?

Breast cancer is caused by a growth of abnormal cells in the breast, which should die but don’t. It is often found when a new lump or mass is discovered. Signs and symptoms of breast cancer include:

• Lump or mass in the breast area

• Persistent changes to the breast, including:

Skin thickening
Nipple abnormalities/discharge
Skin redness or swelling

While most early-stage breast cancer does not have symptoms, it is important to quickly identify any changes to your breasts.

How do I screen for breast cancer?

Monthly self-breast exams are one way you can detect any breast changes that may need to be reported to or discussed with your healthcare provider. Self-screening is easy to do and can be incorporated into a regular routine. Learn how here.

Yearly mammograms are another way to identify any abnormalities. These low-dose breast X-rays are used to set a baseline and determine if changes have occurred. From 1989 to 2019, mammograms decreased breast cancer death rates in the U.S. by 42%. The American Cancer Society recommends the following mammography screening guidelines for women:

• 40-44 years old—Option of yearly mammograms
• 45-54 years old—Yearly
• 55 years and older—Yearly or every other year, and continue with overall good health and a life expectancy of 10 or more years

If you have a higher risk of developing breast cancer, you should create a screening plan based on your family history and risk level with your doctor, regardless of your age. This may include adding magnetic resonance imaging as part of regular screening.

What advancements are being made in breast cancer screening?

The FDA recently approved, iSono Health wearable 3D breast ultrasound, an automated whole-breast ultrasound system and intuitive software for image acquisition and analysis. The 3D breast ultrasound unit can automatically scan and analyze your entire breast in under two minutes. This unique system does not require a trained sonographer (someone who uses imaging equipment and soundwaves to form images of parts of the body) and allows for 3D visualization of the breast tissue. Breast ultrasound is a useful supplement to mammography to improve breast cancer detection in women with dense breasts. This system has the potential to improve breast cancer screening worldwide, especially in countries with limited resources.

Currently, iSono Health is conducting prospective case studies to validate the deep learning software that aids clinicians in localization and classification of breast lesions. This up-and-coming technology made for point-of-care physicians should be monitored by healthcare professionals as it could potentially be performed during an in-office visit by a breast surgeon or gynecologist.

What treatment options are available if I am diagnosed with breast cancer?

The earlier a diagnosis is made, the greater the options for treatment. This is another reason why self-screening and yearly mammograms are so important. Healthcare providers review each case for individual factors that assist in selecting the best treatment plan for each patient. Treatment options include the following, or a combination of them.

• Surgery to remove breast cancer involves two main types:

Breast-conserving surgery, also known as a lumpectomy, quadrantectomy, partial mastectomy or segmental mastectomy, is used to remove the part of the breast containing the cancer. It depends on where and how large the tumor is, as well as other factors, how much breast is removed. Sometimes surrounding normal tissue may also be removed as a precaution.

Mastectomy involves removing the entire breast, including the breast tissue and sometimes adjacent tissues. Some individuals may have both breasts removed. This is called a double mastectomy.

• Chemotherapy is the use of drugs to target and destroy breast cancer cells. The drugs can be administered intravenously or taken orally in the form of a pill. Chemotherapy can help those with breast cancer live longer and have a better quality of life, including increasing the chances of a cure, decreasing the risk of breast cancer returning and alleviating symptoms. Depending on the type and dose of chemotherapy drugs given, and the length of treatment, chemo drugs may cause side effects. Some of the most common side effects include hair loss, nail changes, mouth sores, loss of appetite or weight changes, nausea and vomiting, diarrhea, fatigue and nerve damage.

• Radiation therapy is a localized treatment that destroys cancer cells with high-energy rays delivered directly to the cancer. Potential side effects include skin changes and feeling tired, which can be managed with skincare techniques and creams, and rest and hydration to aid in the body’s repair and recovery process. Three types of radiation therapy utilized to treat breast cancer are:

External beam radiation therapy uses a machine called a linear accelerator that produces a radiation beam administered to the cancerous region outside of the body. The machine has parts that shield the normal organs from exposure, and others that target and focus the beam on the treatment site. Depending on the breast cancer’s stage and other factors, 5-36 treatments could be prescribed and are usually given five days a week.

Brachytherapy, or radiation inside the body, usually consists of 1-10 treatments administered over a couple of days.

Intraoperative radiation therapy is a less common treatment type consisting of a dose of radiation delivered at the time of breast cancer surgery.

What are the survival rates for breast cancer?

Survival rates are directly correlated with the stage of the disease. While the five-year survival rates for localized breast cancer (i.e., no cancer has spread outside of the breast) and regional (i.e., cancer has spread to nearby structures or lymph nodes) are 99% and 89%, respectively, the survival rate drops dramatically to 29% for distant disease (i.e., cancer has traveled to the bones, liver, lungs, etc.). Therefore, early screening, detection and diagnosis are extremely important and greatly improve your chances of breast cancer survival.

This article was co-authored by Toby Shutters, CMD, R.T.(R)(T) and Carrie Carter, RT (T).

Resources:

• Breast Cancer Statistics | How Common Is Breast Cancer?
• Breast Cancer | Breast Cancer Information & Overview
• Cancer Facts & Figures 2022| American Cancer Society
• Chemotherapy for Breast Cancer | Breast Cancer Treatment
• Chemotherapy for breast cancer – Mayo Clinic
• Get Involved to Stop Breast Cancer – National Breast Cancer Coalition
• Radiation Therapy | Radiation Treatment for Cancer
• Stop the Clock! – National Breast Cancer Coalition (stopbreastcancer.org)
• Surgery for Breast Cancer | Breast Cancer Treatment
• What Is Breast Cancer? | American Cancer Society

November is National Diabetes Awareness Month. Perhaps you, a family member, or a friend has diabetes. By reading this article, you can share this information and/or use it yourself to help manage diabetes. The first step to effective management is a good understanding of the diabetes disease process. From there, you can build upon that foundation to know signs or symptoms, how to monitor, knowing when to call your provider before symptoms worsen, importance of provider follow up, and most importantly adhering to the non-pharmacological (diet and exercise) and pharmacological prescribed regimens. This article will focus on four key questions surrounding diabetes and diabetes management.

1) How does diabetes affect Americans?
In 2019, 37.3 million Americans, or 11.3% of the population, had diabetes. Nearly 1.9 million Americans have type 1 diabetes, including about 244,000 children and adolescents.1 1.4 million Americans are diagnosed with diabetes every year, making the U.S. #3 in countries with the highest rate of Diabetes.2

2) What are the different types of diabetes?

Type 1 Diabetes:
Type 1 diabetes is a disease that starts when the pancreas stops making enough of a hormone called insulin. Insulin helps the body use sugar from food as energy or store it for later use. If there isn’t any insulin, too much sugar stays in the blood. Over time, high blood sugar can harm many parts of the body. These include the eyes, heart, blood vessels, nerves, and kidneys.
Type 1 diabetes can occur at any age, but it usually starts in children or young adults. It’s a lifelong disease. But with treatment and a healthy lifestyle, people can live a long and healthy life.3

Gestational Diabetes:
Gestational diabetes is high blood sugar that first occurs during pregnancy. High blood sugar can cause problems for you and your baby. But with treatment, most women can control their blood sugar and have healthy babies. Blood sugar levels usually go back to normal after the baby is born.4

Prediabetes:
Prediabetes is a warning sign that you are at risk for getting type 2 diabetes. It means that your blood sugar is higher than it should be, but not high enough to be diabetes. Prediabetes is also called impaired glucose tolerance or impaired fasting glucose. Most people who get type 2 diabetes have prediabetes first.5

Type 2 Diabetes:
Type 2 diabetes is a condition in which you have too much sugar (glucose) in your blood. Glucose is a type of sugar produced in your body when carbohydrates and other foods are digested. It provides energy to cells throughout the body. Normally, blood sugar levels increase after you eat a meal. When blood sugar rises, cells in the pancreas release insulin, which causes the body to absorb sugar from the blood and lowers the blood sugar level to normal.When you have type 2 diabetes, sugar stays in the blood rather than entering the body’s cells to be used for energy. This results in high blood sugar. It happens when your body can’t use insulin the right way. Over time, high blood sugar can harm many parts of the body, such as your eyes, heart, blood vessels, nerves, and kidneys. It can also increase your risk for other health problems (complications).6

3) What are some potential complications associated with diabetes?
There is no cure for diabetes. Management of diabetes is important to prevent and/or delay long term complications (risk for getting other health problems). This is especially true if your blood sugar levels stay high. Over time, high blood sugar can damage many parts of your body. It can lead to a variety of problems, including problems with your:

Eyes: High blood sugar levels may cause temporary blurred vision. Blurry vision, floaters, or flashes of light may be a sign of diabetic retinopathy, which can lead to severe vision loss. Having diabetes also puts you at risk for cataracts and glaucoma.
Heart and blood vessels: High blood sugar damages the lining of blood vessels. This is called hardening of the arteries, or atherosclerosis. It can lead to stroke, heart attack, peripheral arterial disease, or heart failure. Erection problems can be an early warning sign of blood vessel disease and may mean a higher risk of heart disease.

Nerves: High blood sugar levels can damage nerves throughout your body. This damage is called diabetic neuropathy. There are different types of neuropathy. They may be caused by damage to nerves that sense things like pain or touch or that control things like your heartbeat, digestion, or blood pressure. Nerve damage can be painful, especially in the feet.
Feet and skin: You may have less feeling in your feet. This means that you can injure your feet and not know it. Common infections from blisters, ingrown toenails, small cuts, or other problems can quickly become more serious when you have diabetes.

Kidneys: High blood sugar can damage tiny blood vessels in your kidneys that help filter waste from your blood. This kidney damage is called diabetic kidney disease (sometimes called diabetic nephropathy). You may not have any symptoms until the damage is severe. Then you may notice swelling in your feet or legs or all over your body.

Infections related to diabetes: High blood sugar from diabetes can affect the body’s immune system. The immune system is the body’s natural defense system that helps fight infections.
People with high blood sugar from diabetes can be more severely affected by common infections, such as influenza and pneumonia. They also are more likely to be infected with unusual organisms, such as Gram-negative bacteria or fungi.7

4) What can you or someone you know do to help prevent and/or manage diabetes?

Prevention – You can help prevent or delay complications by keeping your blood sugar in a target range. You also need regular medical checkups to look for early signs of complications. If complications are treated early, the damage may be stopped, slowed, or reversed. 7

Management of diabetes –
• Follow up with your physician. Your physician will monitor lab values (hemoglobin A1C) (defined below), kidney function tests, and others as needed/warranted] on a routine basis. Eye and foot exams are also recommended to be performed every year.
• Stay up to date with recommended vaccinations.
• Keep up on latest education, treatments for diabetes. Diabetic educators are available to assist and educate with diabetes. The ADA (American Diabetic Association) is a great resource.
• Monitor your blood sugar based on your physician’s treatment plan.
• Understand the signs and/or symptoms of low and/or high blood sugar.
• Diet, nutrition, exercise – follow your physician’s suggestions. Coaches, Dieticians, Care managers, and/or Diabetic educators are available to assist, check with your health plan for benefit coverage.
• Take your medications/insulin as prescribed by your physician.
• Utilize your smart phone application(s) that help with managing Diabetes.
• Joining a support Group (online and/or in person sessions) may be beneficial in connecting with others that are affected by Diabetes.

• List of Sources:
  1) American Diabetes Association. Website url: https://diabetes.org/about-us/statistics/about-diabetes. Accessed 10/19/22
  2) Medical News Today. Website url: https://www.medicalnewstoday.com/articles/diabetes-rates-by-country#type-2. Accessed 10/23/22
  3) Healthwise: Website url link: Type 1 Diabetes (healthwise.net). Accessed 10/19/22
  4) Healthwise: Website url link: Gestational Diabetes (healthwise.net). Accessed 10/19/22
  5) Healthwise: Website url link: Prediabetes (healthwise.net). Accessed 10/19/22
  6) Healthwise: Website url link: Type 2 Diabetes (healthwise.net). Accessed 10/19/22
  7) Healthwise: Website url link: Diabetes Complications (healthwise.net). Accessed 10/19/22
  List of additional Resources:
  1) https://www.heart.org/en/health-topics/diabetes/diabetes-tools–resources
  2) https://professional.diabetes.org/search/site?f%5B0%5D=im_field_dbp_ct%3A32&retain-filters=1

Influenza (flu) season can be unpredictable. In the United States (US), flu activity typically begins in October and peaks between December and February, but activity can even continue into May. Australia recently finished their winter where they experienced the most severe flu season in five years, and the season started earlier than usual. Although flu forecasting is not perfect, the Southern Hemisphere serves as a barometer for what might happen in the Northern Hemisphere. In the US, flu activity is elevated across the country.

COVID-19, which is still circulating, is generally mild for children. During the pandemic flu was virtually non-existent. This can be partly attributed to mitigation measures such as handwashing, masking, distancing, as well as remote school, work, and limited travel. The flu hiatus also translates into less pre-existing immunity to influenza due to lack of exposure – from natural infection or vaccines – particularly notable in younger children who may have never been exposed to flu. Further, there is currently a surge in pediatric respiratory syncytial virus (RSV) cases and hospitalizations. Children and the elderly are among the populations at higher risk of influenza complications. With pre-pandemic activities resuming and school back in-person, flu is making a comeback this season.

According to the Center for Disease Control and Prevention (CDC)’s FluView (a weekly US influenza surveillance report), influenza-like illness (ILI) activity is elevated across the country. The CDC’s interactive map offers a visual picture of outpatient ILI activity in the US and links out to state-level information. Additional data such as hospitalization and mortality surveillance are also captured on the CDC’s site.

The best protection against the flu is prevention. The CDC recommends an annual flu vaccine for everyone ages ≥6 months old with rare exceptions. The ideal time for the flu shot is in September or October, and it can be offered throughout the season, as long as flu viruses are circulating. It takes about two weeks after vaccination to develop protection against the flu. New this year, all available flu vaccines in the US are quadrivalent, meaning they contain two influenza A and two influenza B virus antigens, thus designed to protect against four flu viruses. The dominant strain is currently influenza A (H3N2), which is especially tough on the elderly. Also new this year, is a preferential recommendation from the CDC Advisory Committee on Immunization Practices (ACIP) for high-dose, adjuvanted, or recombinant vaccine over other flu vaccines for adults ≥65 years old.

To find a flu vaccine provider, visit vaccines.gov. The flu and COVID-19 vaccines can be given at the same time. Prescription flu antiviral medications to treat flu are currently available. Remember, good hygiene and self care are critical in fighting the flu and a number of other viruses, so wash hands, cover your cough, rest, and stay home when sick.
As the flu continues to unfold this winter, prevention, awareness, and health literacy are key to being prepared.

Disclaimer: The content in this blog 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.

Millions of people are affected by mental health conditions each year. Unfortunately, more than half of them either delay seeking treatment or do not get help at all due to the associated stigma. Stigma causes people to feel ashamed, be concerned about being treated differently, or fear the loss of their livelihood due to something that is out of their control.

Mental health stigma is among the factors contributing to Black, Indigenous and People of Color (BIPOC) being less likely than White people to receive treatment.[1] In 2020, 5.7% of Asian Americans, 9.4% of Black people or African Americans, and 10.7% of Hispanic or Latinx people received mental health services, compared to 21% of White people.[2]

What you can do

With compassion and support, people can recover and lead happier, healthier lives. Treatment is available and recovery is possible. But overcoming stigma is a critical first step in the process.

The National Alliance on Mental Illness (NAMI) offers some suggestions about what we can do as individuals to help reduce the stigma of mental illness:

1. Talk openly about mental health—and discuss it no differently than physical health.
2. Show compassion for those with mental health challenges.
3. Be conscious of language—remind people that words matter.
4. Educate yourself and others—respond to misperceptions or negative comments by sharing facts and experiences.
5. Encourage equality between physical and mental illness—draw comparisons to how they would treat someone with cancer or diabetes.
6. Be honest about treatment—normalize mental health treatment, just like other healthcare treatment.
7. Let the media know when they are presenting stories of mental illness in a stigmatizing way.

Additional mental health support and resources for BIPOC

On July 20 Magellan Healthcare hosted a webinar, “Navigating mental healthcare: Unique challenges faced by the BIPOC community,” for BIPOC Mental Health Awareness Month. Watch a recording of the webinar as we explore different roles in behavioral healthcare and overcoming stigma to help BIPOC feel more knowledgeable and comfortable about reaching out for help: https://www.magellanhealthcare.com/event/navigating-mental-healthcare/.

Visit Magellanhealthcare.com/BIPOC-MH for more information and resources covering racism, stigma and more for BIPOC mental health.

[1] “Mental Health Disparities: Diverse Populations” American Psychiatric Association

[2] 2020 SAMHSA National Survey of Drug Use and Health (NSDUH) Adult Mental Health Tables

Magellan Healthcare is a proud supporter of BIPOC Mental Health Awareness Month in July. BIPOC is an acronym for Black, Indigenous and People of Color that aims to empower groups formerly identified as “minority” or “marginalized.”

In this post, we’ll discuss BIPOC mental health and barriers to care. You can learn more by watching a recording of our webinar, “Navigating mental healthcare: Unique challenges faced by the BIPOC community,” here.

Prevalence of mental health conditions among BIPOC communities

BIPOC face unique stressors that increase mental health vulnerability. Racism and discrimination are consistently found to be associated with poorer mental health.[1]

The Substance Abuse and Mental Health Services Administration (SAMHSA) reports the prevalence of mental health conditions among BIPOC:[2]

BIPOC adults (prevalence of any mental health condition)

• 32% Two or more races
• 19% American Indian and Alaska Native
• 18% Hispanic or Latinx
• 17% Black or African American
• 17% Native Hawaiian and Other Pacific Islanders
• 14% Asian American

BIPOC youth (prevalence of depression)

• 21% Two or more races
• 17% Hispanic or Latinx
• 15% Asian American
• 12% American Indian and Alaska Native
• 11% Black or African American
• (data not available) Native Hawaiian and Other Pacific Islanders

Barriers for BIPOC in accessing mental healthcare

BIPOC are less likely to receive treatment for mental health or substance use conditions.[2] In 2020, 5.7% of Asian Americans, 9.4% of Black people or African Americans, and 10.7% of Hispanic or Latinx people received mental health services, compared to 21% of White people.[2]

Research indicates, compared with people who are White, people in BIPOC communities are:[3]

• Less likely to have access to mental health services
• Less likely to seek out treatment
• More likely to receive low or poor quality of care
• More likely to end services early

Several factors contribute to BIPOC being less likely to receive treatment for mental health or substance use conditions, including a lack of insurance or underinsurance, mental illness stigma, a lack of diversity and cultural competence among mental healthcare providers, language barriers and distrust in the healthcare system.[4]

Increasing awareness of the issues people of color and those in marginalized communities face helps reduce stigma so those with mental health concerns can get the help they need to thrive in their lives.

On July 20 Magellan Healthcare hosted a webinar, “Navigating mental healthcare: Unique challenges faced by the BIPOC community,” for BIPOC Mental Health Awareness Month. Watch a recording of the webinar as we explore different roles in behavioral healthcare and overcoming stigma to help BIPOC feel more knowledgeable and comfortable about reaching out for help: https://www.magellanhealthcare.com/event/navigating-mental-healthcare/.

[1] “Racism as a Determinant of Health: A Systematic Review and Meta-Analysis”, “Self-Reported Experiences of Discrimination and Health: Scientific Advances, Ongoing Controversies, and Emerging Issues”, “Discrimination and Subsequent Mental Health, Substance Use, and Well-being in Young Adults”

[2] SAMHSA 2020 National Survey of Drug Use and Health Adult and Youth Mental Health Tables

[3] Counseling Today, “The historical roots of racial disparities in the mental health system”

[4] American Psychiatric Association, “Mental Health Disparities: Diverse Populations”

What a year it’s been for relapsed refractory multiple myeloma (RRMM)!!  The year has already ushered in an FDA approval of a second CAR-T therapy, Carvykti™ (ciltacabtagene autoleucel, cilta-cel), in February!  Last year we saw the approval of the first RRMM CAR-T therapy, Abecma® (idecabtagene vicleucel, ide-cel). Both are approved as a single dose after at least 4 lines of therapy, with many patients enrolled in each pivotal trial having received a median of 6 or more lines of therapy.

The FDA approval and NCCN 2A recommendation for both drugs is for patients who failed prior treatment with an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. In the ide-cel trial, 92% of patients had received prior autologous stem cell transplant while in the cita-cel trial, 90% of patients had received prior autologous stem cell transplant and, of note, 8% had received a prior allogeneic stem cell transplant. Unfortunately, RRMM has no known cure for heavily pre-treated patients. That being said,  B-cell maturation agent-directed CAR-T cell therapies reported high response rates (ide-cel:  72% ORR [28% sCR; 25% VGPR]; cilta-cel: 97.9% ORR [78.4% sCR; 16.5% VGPR]) which were durable (median DOR: ide-cel 11 months; cilta-cel 21.8 months).

MM is largely a disease of the elderly with a median age of diagnosis being 69 years. In 2018, an estimated 149,956 Americans were living with MM.  The rate of new multiple myeloma cases is trending up, with an estimated 34,920 new cases diagnosed in 2021 (1.8% of all new cancer cases) and a projected 2,410 deaths.  Even though relative 5-year survival has increased over time, it has been 55.6% from 2011-2017.

Concerns around the monetary cost of CAR-T therapy continue.  Even though CAR-T therapy demonstrates high response rates and carry the hope of a sustained, durable response, how long will response last? What treatment(s) will follow?

CAR-T therapy is a single dose, with a significant high monetary cost. The medication wholesale acquisition price for ide-cel and cilta-cel is $419,500 and $465,000 respectively. In addition, the time to product availability and rate of manufacturer product failure remains a concern (ide-cel median availability of 33 days with a 1.5% failure rate; cilta-cel median availability of 32 days with an 18% failure rate). Another hurdle is the shortage of the lentiviral vectors used to deliver ide-cel. However, the manufacturer is working to increase production.  For cilta-cel, the manufacturer plans to make vectors in-house in order to meet longer-term demand.

A forecasted cost impact model is demonstrated below. With more than 8 CAR-T drugs in the pipeline for multiple myeloma, more for hematologic cancers, and the possible expansion from hematologic to solid tumor treatment, more contemplation is sure to follow.

References:

1. Martin T, Usman SZ, Berdeja JG, et al. Updated Results from CARTITUDE-1: Phase 1b/2Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma. ASH update 12 December 2021. https://ash.confex.com/ash/2021/webprogram/Paper146060.html. Accessed April 12, 2022.
2. Berdeja JB, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324 doi: 10.1016/S0140-6736(21)00933-8.
3. Carvykti [package insert]. Horsham, PA; Janssen; March 2022
4. Abecma [package insert]. Summit, NJ; Celgene; March 2021.
5. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med 2021;384:705-16. DOI: 10.1056 /NEJMoa2024850.
6. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Myeloma. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed April 12, 2022.
7. Kanas, G, Clark O, Keeven, K et al. Population-level Projections for Multiple Myeloma Patients by Line of Therapy in the USA. Poster No. 653 | Presented at the 62nd American Society of Hematology Annual Meeting and Exposition (Virtual Format) | December 5–8, 2020. https://d201nm4szfwn7c.cloudfront.net/5f95dbd7-245e-4e65-9f36-1a99e28e5bba/5b3ee4c1-c770-4504-9d91-08c64ae7bcc6/5b3ee4c1-c770-4504-9d91-08c64ae7bcc6_viewable_rendition__v.pdf?medcommid=REF–ALL-003261. Accessed 4-12-22.
8. Liu A. Johnson & Johnson, Legend’s CAR-T Carvykti enters myeloma ring with FDA nod. Fierce Pharma. Johnson & Johnson, Legend’s CAR-T Carvykti enters myeloma ring with FDA nod | Fierce Pharma. Accessed April 14, 2022
9. Osterweil N. Novel CAR T Therapy for Solid Tumors: ‘Exciting Advance’. 2022. https://www.medscape.com/viewarticle/972297. Accessed 4-19-22.

Magellan Federal honors military caregiving children through a commitment to Hidden Helpers Coalition

Military Appreciation Month is celebrated in May and is a special month for those in and out of uniform. Throughout the month we celebrate Memorial Day (May 30), Military Spouse Appreciation Day (May 6), and Armed Forces Day (May 21). But did you know that it is also Month of the Military Caregiver?

Month of the Military Caregiver

The Month of the Military honors more than five million self-identified caregivers in the United States. By observing Military Caregivers, we can raise awareness and support for both wounded warriors and the people who care for them. Many of those caregivers are children, who have largely been unrecognized and unsupported—until now.

Honoring Military Caregiving Children

There are 2.3 million children of injured, ill, and wounded service members and veterans who play a crucial role in caring for their loved ones.

Magellan Federal has joined the Elizabeth Dole Foundation’s Hidden Helpers Coalition, a group of more than 60 organizations committed to recognizing the service of military caregiving kids and enhancing support services available to them. As a Coalition member, we have pledged to engage our nation’s health care providers to create a new national model of support for caregiver children within medical institutions to ensure that the physicians, nurses, and mental health and allied health professionals better understand and address the unique challenges military children face at every stage of their development.

Through the work of targeted sub-committees, the goal of the Hidden Helpers Coalition is to create a comprehensive framework of best practices, impactful tools, and action steps focused on supporting the overall well-being and long-term positive outcomes of Hidden Helpers and their families. Through this holistic approach, the coalition will develop baseline best practices for the ecological systems that impact Hidden Helpers.

This commitment reinforces what we do here every day at Magellan Federal — supporting the behavioral health of military service members, veterans, civil servants, and their families — and is just one example of how we give back to the military community beyond our everyday work.

If you or your organization is interested in supporting military caregivers, I encourage you to stand with us to make a difference by reading more at Hiddenheros.org