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The path to appropriate biosimilar management

Magellan Rx has been a market leader in developing forward-thinking solutions to combat rising specialty spend on the medical benefit for nearly 20 years. With a passion for solving complex pharmacy challenges, such as biosimilar management, we roll up our sleeves and tackle what is truly driving trend while ensuring a high quality of care for the members we serve.

Building on the success of our industry-first medical pharmacy program, including management of medical benefit oncology drug spend, we began to focus on advancing biosimilar utilization in 2015. Our goal was to empower health plan customers with education and strategies that turned biosimilar availability into cost savings while maintaining clinical quality. From the high-cost autoimmune category to oncology and beyond, our philosophy to biosimilar management involves three key components:

  • Proactive Management: Assessing and developing clinical protocols while educating and communicating with network providers
  • Medical Pharmacy Execution: Leveraging Magellan Rx’s innovative medical management expertise by incorporating biosimilars into key utilization management programs such as medical prior authorization and provider reimbursement/fee schedule management
  • Expert Opinion: Continuously working to gain insights from our advisory board of specialists and Expert Clinical Network of key opinion leaders

But first, what is a biosimilar?

According to the U.S. Food and Drug Administration (FDA), a biosimilar is a drug type that is highly similar to an FDA-approved biologic, or reference product, with regards to its purity, molecular structure, and bioactivity. The biosimilar approval pathway starts with an application submission that includes analytical studies, animal studies, and at least one clinical study. A biosimilar is approved by the FDA after evaluation and testing to show it is as safe and effective as its reference product.

As of April 2021, there are now 29 FDA-approved biosimilar products across three different categories—20 have been launched to date, and 18 are oncology or oncology support.

To learn more about the biosimilar landscape, watch this MRx Events webisode.

Magellan Rx’s approach

In 2015, ahead of the first biosimilar approval in the U.S., our work began with a committee of experts to review the biosimilar landscape and potential impacts for payers. By 2016, we had established our first biosimilar-over-reference policy on the medical benefit, and in 2017 additional clients opted into the strategy with more growth in biosimilar savings.

The program was expanded in 2018 to include infliximab—the biosimilar for Remicade, a top spend drug used to treat autoimmune conditions such as rheumatoid arthritis and inflammatory bowel disease—by leveraging a comprehensive utilization management solution. As part of this initiative, our team of highly-trained pharmacists worked with physician offices and hospitals to ensure appropriate utilization for each patient’s unique situation.

Also in 2018, we established an Oncology Biosimilar Workgroup to prepare for future launches in this high-spend category (in fact, oncology and oncology support accounts for more than 40% of total medical pharmacy spend across the Commercial, Medicare, and Medicaid lines of business1). We aimed to educate health plan customers, members, and providers through individualized strategies that consider clinical, financial, and regulatory factors. The oncology biosimilar program was launched in 2019 as oncology biosimilars hit the market, with early adopter implementation that resulted in maintaining or expanding member access to clinically-effective treatments while delivering significant drug spend savings.

To learn more about oncology biosimilars, watch this MRx Events webisode.

Due to the success of the infliximab program and proactive approach to the launch of oncology biosimilars, we experienced a rapid expansion in 2020 as clients, representing millions of lives, began to adopt these innovative solutions. Oncology biosimilar utilization surged, and the (measured by the number of prior authorizations approved for the first two therapies with biosimilars compared to the reference brands) for early adopters. We also showcased results in research presented at the 2020 AMCP Annual and AMCP NEXUS industry events.

So far in 2021, biosimilar uptake continues to increase. Our team of experts previewed results from the oncology biosimilar program at the 2021 AMCP Annual event and spoke to The Center for Biosimilars on strategies that payers are using to promote biosimilar adoption.

Looking ahead, Magellan Rx remains committed to the biosimilar-first strategy and will continue to expand the program to include additional categories and available biosimilar agents as they are approved by the FDA. For more on payer management concerns related to biosimilars, read page 24 of the latest Magellan Rx Management Trend Report.  For up-to-date pipeline news, check out the MRx Pipeline Report. Have questions or want to implement a solution to meet the needs of your unique population? Connect with us today!

To learn more about Magellan Rx’s work, click here. 

  1. Magellan Rx Management Medical Pharmacy Trend Report™, © 2021.



A pandemic’s impact on children’s mental health

By: Linda Y. Evans and Greg Dicharry

Before the COVID-19 pandemic started wreaking havoc on various aspects of our “normal” lives, including our mental health, 1 in 6 children aged 2-8 years in the United States was diagnosed with a mental, behavioral or developmental disorder.[1] While these children have endured the impacts of drastic changes over the past year, so too have others who did not previously have a mental health diagnosis; some children have been newly diagnosed with a mental health condition as a result of COVID-19. When considering how to nurture the mental health of our children during a pandemic, we must understand their pre-pandemic mental state and monitor how they are coping.

Children diagnosed with a mental health condition before COVID-19

For children who experienced mental health challenges before COVID-19, the pandemic may have imposed new complications. In many cases, before COVID-19, families practiced a routine in their daily lives, which helped everyone manage their feelings and behaviors. When routines changed – kids were no longer going to school, adults were working from home, or not at all, and in-person interactions with friends, extended family, and even doctors were cut off – that familiarity and rhythm, and the associated therapeutic effects, were lost. Another part of the pre-pandemic routine for many children with a mental health diagnosis was the special help received by trained teachers and therapists in schools. While this support could be a vital lifeline, it was completely cut off for the kids who depended on it. Other treatment options, through primary care and other outpatient settings, also dwindled due to office closures caused by COVID-19. As a result, an increasing number of children were seen for mental health-related care in emergency departments (EDs). From mid-March to October 2020, the Centers for Disease Control and Prevention reported an increase in the proportion of mental health-related ED visits among children aged 5-11 years (24%) and 12-17 years (31%) compared with the same period in 2019.[2]

Serious mental health impacts for children as a result of COVID-19

Children and youth who started off 2020 without a mental health diagnosis may not have ended the year in the same way, as newly developed depression and other mental health conditions were caused by the pandemic. A CDC report on mental health, substance use, and suicidal ideation during the COVID-19 pandemic shows that while 11% of adults seriously contemplated suicide in June 2020, the same was disproportionately reported by young people aged 18 to 24 (26%).[3] The serious effects on younger children include delays in social and emotional development, as their brains are forming amidst irregular human activity. In some cases, when parents weren’t adjusting or handling the increased stress and uncertainty well, maltreatment in the form of child neglect or abuse has resulted.

Negative mental health consequences of COVID-19 for all children

Because of COVID-19, all children are coping with unprecedented change and loss. Children feel the family stress of economic hardships, health concerns, social isolation, exhaustion, bereavement, and worsening mental health and substance use. And children have stressors of their own. When healthy outlets, like school, sports, and social engagements, are lost, that energy may become more negative and unproductive. The impacts of missed once-in-a-lifetime childhood events, like birthdays, graduations, and family vacations, may not even be fully realized until later in life. Children and youth may also experience their own anxiety and stress about what the future looks like.

The state of mental healthcare for children

There have always been barriers for children to access mental healthcare. Among them are stigma, availability, misinformation, and lack of information. While these factors impact access to care for adults, as well, they may be more pronounced for children. Parents are afraid or do not want to accept that their child is affected by a mental illness. There is a shortage of child and adolescent psychiatrists and therapists trained to work with children in our country. In addition, many parents and caregivers are misinformed about child psychiatric services that are meant to improve a child’s mental state, and not necessarily their behavior, although the latter may be a secondary effect.

With the pandemic, parents may be so preoccupied that they cannot see potential conditions in their children. The advent of a pandemic has stretched an already thin system of specialized mental healthcare for children at a time when it may be needed the most. And misinformation continues to plague our news sources and social media.

Where to go from here

There are many things that parents and caregivers can do to support and nurture their child’s mental health. We encourage you to learn more in a recording of the webinar, “How are your kids doing?” where I was joined by Greg Dicharry, CPRP, youth empowerment director, to share knowledge and our years of experience working with children to improve mental health and wellness and answer audience questions.


[1] https://www.cdc.gov/childrensmentalhealth/data.html

[2] https://www.cdc.gov/mmwr/volumes/69/wr/mm6945a3.htm

[3] https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm




Navigating Autism

About 1 in 54 children in the U.S. has been diagnosed with autism spectrum disorder (ASD), according to estimates from the CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network.[1] Getting an ASD diagnosis is a life-changing event for families that can trigger feelings of panic, fear and distress. You may be uncertain or confused about what to do next and how to navigate your new reality. Here are tips to help you and ensure your child lives their best life.

Do your homework—Learn everything you can about ASD and how it may affect your child throughout their life, including the laws and rights that you and your child have under the Individuals with Disabilities Education Act. The knowledge you gain will help you be an effective advocate for your child.

Become a voice for your child—As a parent, you are your child’s first, strongest and lifelong advocate. No one knows your child better than you do. You are the best qualified person to shape your child’s situation in the most caring way and speak out when it comes to their well-being and ensuring that they have the supports they need to flourish.

Seek help—The autism community is full of parents and professionals willing to help others in their ASD journeys. Allowing others to help can lighten your load, help you become a better advocate and protector for your child, and make the sometimes difficult journey more enjoyable. Seek out support groups, teachers, therapists, social workers and others for help.

Give help when you can—If you can, helping other parents on their ASD journeys can help you to put things in perspective, feel more positive about your own circumstances and create a sense of belonging. Helping others has shown to lower levels of stress and anxiety, which improves overall well-being.

Express yourself—As human beings, we need connection. Sharing your feelings with someone you trust, such as your partner or spouse, parents and/or siblings, can be liberating and go a long way in deepening your relationships, and improving your physical and mental well-being, making you a better person, parent and family member.

Make self-care a priority—Spending most of your time caregiving can quickly lead to burnout. Proper hydration, a healthy diet and sufficient sleep can help you cope best with daily challenges. Finding time for activities that are fun and fulfilling, such as going to the gym, going for walks and meeting friends, can help you recharge and be the best parent you can be.

Find the right providers—While it is important that your child’s providers use evidence-based practices and keep abreast of treatment options, it is also important that they are culturally aware and respect your ideas and traditions. Each cultural group has its own customs, thoughts and taboos regarding physical and mental health care. Find a doctor who not only speaks your language, but is also sensitive to your cultural, religious and personal beliefs.

Foster healthy eating habits—Children with ASD often experience issues such as insomnia, eczema, constipation, diarrhea, behavioral outbursts and more. If your child has any of these issues, you might want to see if it is a reaction to foods that are not good for their system or if their intestines are out of balance. Healthy eating habits can make a big difference in the lives of children with ASD.

Nurture your child’s strengths—Children improve faster when they work on strengths. Focusing on your child’s strengths, not weaknesses, puts them on the path to their personal best, allows them to develop and excel in things they’re good at, and can greatly improve their self-esteem and well-being. It can also foster a better parent-child relationship.

Magellan Healthcare is committed to improving all lives affected by autism. Visit our Autism Awareness website here for free resources that increase awareness, celebrate differences and support inclusion.

Read more Autism content from Magellan Health Insights

 

[1] https://www.appliedbehavioranalysisedu.org/top-10-awesome-things-about-being-on-the-autism-spectrum/




The Future of Care for Oncology Patients

The Role of Precision Medicine in Oncology Care

The approach to cancer treatment has been transformed dramatically over the last decade. The use of medications to treat cancer is shifting from a “one size fits all” approach to more personalized therapies. The individual patient’s specific tumor characteristics may now drive the selection of the best treatment option. Identification of these tumor characteristics is often accomplished through genomic testing. Because clinical data regarding genomic testing is being published at an unprecedented pace, both providers and payers may struggle to keep up and need access to a shared, unbiased decision-support technology to ensure patients are receiving optimal treatment options.

How can you accurately approve tests and treatments while at the same time streamlining the prior authorization processes?  Here are four ways:

  1. Follow evidence-based standards – there are many different lab companies who offer genomic testing as well as variations in the testing products offered by many labs. Clinical decision support for genomic testing assures that that each molecular test ordered meets clinical, evidence-supported standards and also ensures the use of cost-efficient testing. When physicians utilize this clinical decision support to order genomic testing, it streamlines and optimizes prior authorization and reimbursement arrangements with health plans
  2. Enable transparency – provide a real-time window into the precision medicine decision-making process. Currently, it is difficult to ensure that all patients who could benefit genomic testing are receiving appropriate testing. When health plans have access to real-time genomic testing results, quality initiatives can be designed to track appropriate care interventions.
  3. Take a patient-centered approach – ensure patients get the most appropriate tests from preferred labs at the right time in their treatment journey. Patients are understandably anxious awaiting test results and a system that streamlines workflow for practices and expedites the delivery of test results ensures appropriate, quality care for patients when time matters most.
  4. Promote collaboration – ensuring scalable, appropriate use of precision medicine for cancer means working collaboratively with oncologists and molecular testing labs. Cancer care is often fragmented and solutions are needed that align all stakeholders while keeping the patient at the center of the solution. Providing clinical decision support for genomic testing as well as corresponding drug selection allows for all parties to work quickly and efficiently in order to maximize coordinated, quality cancer care.

To learn more about Magellan Rx Management’s approach to precision medicine in collaboration with Trapelo Health, click here.




A comprehensive approach to medical pharmacy savings: one plan’s real-word example

As a market leader and disruptor in specialty drug management, Magellan Rx Management has been delivering targeted and innovative solutions for over 16 years to help health plans reduce specialty drug costs on the medical benefit while maintaining a high quality of care for their members. Our suite of solutions can help plans develop customizable, flexible programs to meet some of their toughest challenges.

Why medical pharmacy management matters

With specialty drug costs accounting for nearly half of total drug spend, health plans continue to look for better ways to manage those rising costs while staying ahead of ever-changing market dynamics (like emerging therapies for rare and orphan diseases and new-to-market biosimilars). Specialty drugs administered by healthcare professionals (typically in a provider’s office, hospital outpatient facility, or through home infusion) are paid under the medical benefit—or what we like to call “medical pharmacy”—and remain a leading driver of rising costs. In fact, according to our research, the latest five-year per-member-per-month (PMPM) trend for medical pharmacy spend was 65% in Commercial, 40% in Medicare, and 78% in Medicaid.

A real-life customized solution

One of our health plan customers with a mix of Commercial, Medicare & Medicaid lives was beginning to see significant utilization in specialty medications. They turned to Magellan Rx’s clinical and pharmacy trend experts, who analyzed trend drivers, recommended a multi-pronged approach to management based on their unique data, and collaborated with the plan to implement several programs to maximize effectiveness and meet plan goals including innovative strategies such as a drug wastage solution.

So, what are the results?

Our health plan partner realized a cost reduction in just one year by implementing a suite of solutions alongside our team of medical pharmacy experts—resulting in a nine percent decrease in medical drug spend! Based on this particular’s plan size and benefit design, each solution contributed demonstrably to overall savings.

Results-Table-02

Individual program implementation is dependent on plan size and other factors. These flexible solutions can also operate outside of the traditional payer-PBM relationship. Now, you can plug in to the extensive clinical expertise and experience at Magellan Rx by delegating specialty and medical drug management services while retaining a separate pharmacy benefit manager.

Are you looking for a customizable, flexible solution to combat rising specialty spend? Connect with us today!




How are our kids doing?

For our kids, disruptions caused by the COVID-19 pandemic are likely more than just that – temporary inconveniences, varying in severity, until life goes back to “normal.” Besides missing out on once-in-a-lifetime events, like graduations, birthdays and other milestones – at least in a way they would traditionally be observed – regular human interactions, part of social and emotional development, have changed. While adults may be experiencing a serious blip on the radar, children may be experiencing an interruption in brain development and/or lack the ability to fully cope in this unchartered territory.

In this post, we will contemplate these issues and draw on knowledge from Magellan Healthcare’s recently updated clinical monograph, Understanding and Meeting the Needs of Children and Adolescents at High Risk, which highlights evidence-based prevention and treatment approaches for problematic behaviors and various types of behavioral health challenges in children and adolescents.

As we think about the significance of childhood development, the following points from Magellan’s monograph provide insights:

A growing body of scientific information has confirmed the importance of the first five years of life, when the ongoing construction of brain architecture impacts youth social and emotional development, the ability to learn new behavior and skills, and how the youth evolves into adolescence.

Advances in neuroscience have contributed new understanding of adolescent development. During adolescence, the brain experiences a period of major development comparable to that of early childhood.

With much changing in our kids’ lives and environment – virtual schooling, modified in-person play arrangements with friends and reduced time with extended family – the responsibility falls on parents and caregivers, as it always does, to ensure their child’s wellbeing and adjustment. Magellan’s monograph offers the following to ponder:

While genes determine when specific brain circuits are formed, experiences actually shape their formation and are fueled by a self-initiated, inborn drive toward competence. This phenomenon depends on appropriate sensory input and stable, responsive relationships whereby adults respond to a child’s natural reaching out for interaction.

However, when parents are under unprecedented stress and often just trying to make ends meet, attending to their child’s increasing needs can understandably be overwhelming. In addition to the role of parent and full-time employee, many adults have taken on the additional roles of teacher, daycare worker and entertainer, to name a few. In some cases, however, a parent’s struggles may lead to neglect of their children. Magellan’s monograph highlights the following of child neglect:

While child abuse is more widely acknowledged and publicized, child neglect is, in fact, the most common type of child maltreatment, which frequently goes underreported. Expanding on the earlier discussion of impaired brain development, it is now understood that lack of stimulation and necessary care early in life may cause children to remain in a state of “hyperarousal” (i.e., constantly anticipating threats and/or experiencing dissociation) rather than a normal state of attentive calm. This phenomenon leads to a decreased ability to benefit from social, emotional and cognitive experiences and results in other psychosocial consequences. Together with insecure attachments, this state of hyperarousal can significantly affect normal growth and development.

Many parents are also managing their own mental health conditions and substance use disorder during the pandemic, which adds to the impact of what children and adolescents are experiencing themselves. The monograph outlines the risks for children of these parents:

There are many serious risks to children and adolescents who have a parent or both parents with mental illness. The American Academy of Child and Adolescent Psychiatry (AACAP) calls attention to the strong genetic predisposition in children for inheriting bipolar disorder, an anxiety disorder, attention deficit-hyperactivity disorder (ADHD), schizophrenia, alcoholism or other SUD, or depression. Recent studies have also demonstrated delayed brain development in young children of depressed mothers. Further, the AACAP notes the additional stress that mental illness places on a marriage and parenting abilities of the couple, and the risks that stem from an inconsistent, unpredictable family environment that can contribute to psychiatric illness and developmental delays in children.

It’s also appropriate to consider the older children and young adults who may lack the ability to cope with increased stress and instability. Magellan’s monograph calls attention to recent research:

A CDC report on mental health, substance use and suicidal ideation during the COVID-19 pandemic shows that while 11% of adults seriously contemplated suicide in June 2020, the same was disproportionately reported by young people aged 18 to 24 (26%).

During these difficult times, we’re all doing the best we can. And we know that brighter days are on the horizon. Until then, and always, as we’re helping ourselves and our children through, let’s remember that “information is power,” as they say. To that effect, we encourage you to learn more in our full children’s clinical monograph here.




Autism Spectrum Disorder – Celebrating 6 unique qualities

Every April, we recognize National Autism Awareness Month, which focuses on spreading awareness, improving understanding and promoting acceptance of autism spectrum disorder (ASD). Most of us are aware of the challenges families impacted by ASD may face throughout their lives. Research studies, media reports, social media and events help us keep up to date. But do we really think about the many amazing positive qualities people with ASD possess?

Traits that make people with Autism Spectrum Disorder awesome people, friends and coworkers

  • Creative—People on the spectrum look at the world differently and process information in a unique way, making them independent and creative thinkers who can visualize solutions to problems that others may not see.
  • Detail-oriented—People on the spectrum are highly attuned to detail. Little things that most of us might overlook, such as spelling or punctuation, stand out to individuals on the spectrum. They take note of specific details such as colors and names and remember directions.
  • Honest—Many people with ASD are often black-and-white thinkers, so it makes no sense to them to lie. They are not afraid to tell us what they really think, but they tell the truth quite openly and accurately reflect their feelings, whether positive or negative.
  • Non-judgmental—Because of their black-and-white thinking, people with ASD rarely compare others to any set of standards or expectations. Therefore, they are more likely to accept differences, see us as we are and not expect us to change.
  • Passionate—Many people with ASD have a wide range of interests and are extremely impassioned about the things, ideas and people in their lives. They pursue interests with 100% of their energy and research obsessively until they have a deep understanding of the subject. They spend the time, energy and imagination needed to really master their interests and stick with things through difficulties and frustration.
  • Reliable—People with ASD appreciate routines. Once a routine or rule is set, you can rely on them to follow it precisely. If it is on the calendar, you can be sure they will be there and arrive on time.

Keeping an eye on the positive characteristics of people with ASD is key to promoting wider acceptance. Help your family, friends and others learn why they are amazing and special by sharing this blog post.

To learn more about Magellan Healthcare’s work with Autism Spectrum Disorder, click here. 

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2020 FDA Approvals: A Year in Review

In January 2021, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2020. This report provides a summary of a number of approvals and highlights the novel therapies approved in 2020, continuing the generally upward trend in approval volume seen over the past decade, despite the impact of coronavirus disease 2019 (COVID-19). Compared to 2018 and 2019, in which CDER approved 59 and 48 new drugs, respectively, 53 novel agents were approved in 2020. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or biosimilar approvals. Once again, the number of approvals exceeded the average of 41 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

Trend Alert figure 1_0221-01Despite the ongoing pandemic the FDA continued their strategic initiatives to expedite the safe review of treatments in 2020. With the unprecedented challenges incurred in 2020, the FDA acknowledged that maintaining their commitment to bringing forth innovative therapies was difficult. Remarkably, the numbers reported by the FDA do not include the several emergency use authorizations (EUAs) issued by the FDA for COVID-19.

Last year, all 53 novel drug approvals again met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2020, 40% were considered first-in-class, and 58% were approved for rare diseases (Orphan Drugs), the latter of which increased from 44% in 2019. Priority Review was granted to 57% of novel drugs, 23% received Accelerated Approval, 42% were designated as Breakthrough Therapy (up from 27% in 2019), and 32% garnered Fast Track designation. Overall, 68% of all drug approvals in 2020 used expedited development and review methods. In addition, 92% were approved in the first review cycle, and 75% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2020 is illustrated in Figure 2, with agents within the oncology spectrum representing over one-third of 2020’s novel approvals.

Trend Alert pie chart_0221-01

The notable 2020 approvals encompassed new advances for the treatment of infectious diseases, including a new medication class for the treatment of human immunodeficiency virus-1 (HIV-1). Garnering perhaps the most attention, the FDA also approved the first medication for hospitalized patients with COVID-19. Unique infectious diseases in the US also received attention, with a new drug for malaria, two new options for the Ebola virus, and a new treatment for Chagas disease approved in 2020. In the neurology arena, there were multiple approvals of agents for more common conditions, such as migraine or Parkinson’s disease. Moreover, there were significant advances for rare neurological conditions, including the first oral agent for spinal muscular atrophy and new treatments for rare seizure disorders. In addition, two immunological agents were approved for the treatment of neuromyelitis optica spectrum disorder. Additional treatment options emerged for several autoimmune conditions in 2020 as well. Not surprisingly, numerous advances were made within the oncology umbrella, including both novel approvals and new or expanded indications for several existing agents. With over half of the novel approvals being classified as Orphan Drugs, in 2020, the FDA has fortified their dedication to providing innovative and often targeted treatment options for all individuals.