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

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

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

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

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

Biologic Drugs for Autoimmune Disorders (BDAIDs)

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

Oncology & Oncology Support

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

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

Payer feedback on current bio-similar strategies

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

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

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

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

Learn more about our total specialty drug solutions.

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

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

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

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

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

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

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

Edith Calamia, DO, MPH, CMD, was a teenager when she saw the impact that lack of access to clean water, food insecurities, and unreliable access to care could have on vulnerable populations.

As a young woman Dr. Calamia traveled to the Philippines during summer vacations. There, she would assist her brother, a dentist, in small dental clinics in towns outside Manila. In the Philippines, where eight out of 10 people face dental health issues, millions of people have never seen a dentist due to absence of transportation and limited education. Without proper care, dental decay can lead to chronic disease, premature births, low birth weight, and more.

“As a young person growing up in the ‘70s, I remember thinking that sections of extreme poverty like those I had seen in the Philippines and also in Africa would no longer exist by the time I was in my 30s or 40s,” she says. “I thought we would solve those issues. Now, as the mother of a small child, I’m very passionate about addressing social determinants of health in the United States and abroad so that our children don’t have to find solutions to these problems in their 30s and 40s.”

Dr. Calamia, who joined Magellan Complete Care as chief medical officer in December 2019, sat down to discuss the role of healthcare organizations in addressing social determinants of health (SDOH)—the conditions in which people live, learn, work, and play that can affect health risks and outcomes—and ways that organizations can strengthen their approach.

Magellan: Could you tell us what sparked your passion for caring for vulnerable populations?

Dr. Calamia: My dad was a pilot for Pan American, and from an early age, my three siblings and I traveled internationally, including to Africa, the Philippines, and other countries. We became very cognizant of the impact that social determinants of health—from socio-economic factors to an individual’s physical environment—have on vulnerable populations, from the ability to access basic healthcare services to the ways in which barriers to basic necessities affect health and health outcomes. These experiences prompted each of my siblings and I to enter the medical field.

Early in my healthcare career I did work in Miami and was inspired to go into public health. I completed a fellowship in geriatrics, which enabled me to go into the homes of the seniors I was treating, which underscored for me the difference in health and health outcomes that can be achieved when individuals have reliable access to basic necessities as well as skilled care.

Magellan: What are some of the lessons you learned early in your career about ways to leverage federally funded programs to improve outcomes for the most vulnerable populations?

Dr. Calamia: When I was in private practice, my organization treated people who were on Medicare and Medicaid as well as those who were uninsured, but it was very difficult to support the care of these populations, financially. So, I got together with a group of providers on Staten Island [New York] to open a federally qualified health center (FQHC). This was a journey: It required us to form a community board to guide us through this process. I served as chief medical officer for the FQHC, and I worked with people who had been in the FQHC space for years and years. Through this experience, I learned how to be a good fiscal steward of the federal dollars we received by thinking about our programs strategically, with an eye toward which initiatives would make the biggest difference in members’ health. We concentrated on providing services for the most vulnerable mothers and infants in our community—for example, mothers who smoked or showed signs of substance use disorder; babies with low birth weights or whose first days or weeks were spent in the NICU. We were able to start the FQHC, and open two more centers. I’m really proud of that work.

Later, I joined a managed care company (MCO) and began to view social determinants of health initiatives from that organization’s point of view—which in some instances is a steward of both state and federal dollars.  Here, I began to look at the types of relationships that were necessary to ensure value. For example, how do MCOs find centers of excellence—the organizations that really move the needle on quality and value—to send their members? How do they make sure the programs these organizations provide meet the needs of their members and improve health outcomes?

As a result, we developed a partnership with Camden Coalition to determine how a very intense care management model could keep members out of the emergency department and keep them healthy. At that time, the managed care space incorporated more of a disease management model that wasn’t a face-to-face, in-home visit, hands-on model of care. After running a pilot program, we partnered with Camden Coalition to develop, test, and scale new models of care for members with complex health, behavioral, and social needs.

Magellan: What are some of the biggest challenges healthcare organizations face in addressing social determinants of health?

Dr. Calamia: I think we’ve been challenged as organizations to really measure the effectiveness of our interventions around the social determinants of health. We know that addressing social determinants of health is the right thing to do, and anecdotally, we have many stories about the ways in which addressing social determinants of health can change individual members’ lives. We need to aggregate, on a national level, the data we have and dig deep into the information we can glean from that—exploring where we can build relationships on a local level to change a few lives at a time and then using the lessons learned to scale our approach on a national level for specific populations.

Gaining access to this data may be a challenge for providers’ organizations as well because of limited resources and bandwidth. That’s why it’s so important that MCOs lean in and help them with the data piece—aggregating the data and providing the insight that can help providers dig deeper at the point of care.

When we think about social determinants of health, we have to look at the long game when it comes to understanding the results of our efforts. It’s also critical that we examine the potential for technology and digital apps, in combination with personalized care management, to help meet the needs of our most vulnerable populations in a holistic way. In doing so, we can more effectively help members live healthy, vibrant lives.

Magellan: How are SDOH coming into play during the COVID-19 pandemic?

Dr. Calamia: In so many ways. People are stuck in their homes. If they live in a crowded apartment building, it’s hard for them to distance themselves from others. Home may not be a safe place for victims of domestic violence. In certain urban areas, it’s already hard to get fresh food; with the pandemic limiting distribution, people are eating more processed foods. People who rely on home care services and home-delivered meals aren’t getting the services and sustenance they need. We’re seeing problems with meal distribution and have ordered restaurant take-out meals to ensure our members are fed. The health conditions many people have as a result of SDOH make them more likely to get very sick from the virus. That’s why it’s becoming more important than ever to address these issues.

 Magellan: What attracted you to Magellan?

Dr. Calamia: One of the biggest barriers I’ve seen in my career is helping patients and members determine where they are in their health journey and understanding their mental health needs. Magellan has a rich history of understanding mental health as a key social determinant of health. Frankly, the behavioral health community really understands social determinants of health. They have explored issues such as: Where do members live? Do they have food insecurities? Have they experienced childhood trauma that makes them more comfortable receiving care in an emergency department versus an office? Things of that nature. I believe there’s a chance to create something at Magellan that is really unique, leveraging Magellan’s behavioral health and pharmacy expertise as well as its depth of experience in working with MCOs to make a deep impact on social determinants of health.

We’re going to change the way in which people can access their healthcare, and we’re going to change the way that people feel about their MCO as a partner.

Edith Calamia, D.O., M.P.H., C.M.D., is national chief medical officer for Magellan Complete Care (MCC). Dr. Calamia joined Magellan in March 2020 and oversees all clinical programs within MCC. She also leads the development and delivery of health plan-specific clinical programs targeted to complex populations such as those needing Long-Term Services and Supports, those who are dually eligible for Medicaid and Medicare, people with Serious Mental Illness, and recipients of Temporary Assistance for Needy Families (TANF) and Children’s Health Insurance Program (CHIP) benefits.

There’s no denying that for many of us, our pets hold a special place in our hearts. They’re our loyal companions, can make a bad day better, and love us just the way we are. The First Week of May is National Pet Week. In honor of this, we wanted to take a moment to celebrate some truly amazing animals that have a profound effect on the lives of their owners: service dogs.

Humans and dogs have had a special bond since the early days of our history. So, it’s no wonder we looked to them as a potential resource for people with disabilities who need some extra assistance. Whether it’s retrieving things for their owner, helping them get dressed, acting as their eyes, or alerting their owner of an oncoming seizure or drop in blood sugar, service dogs perform the necessary tasks that make their owners’ lives easier and give them more independence.

In 1929, we were introduced to the first official service dogs in this country – then called seeing eye dogs – who helped people who were blind navigate their surroundings. By the 1960s, people realized that service dogs had the potential to take on other tasks beyond guiding their owners around. By the 1970s, we had created a more formalized set of guidelines and methods for what service dogs could be used for and how to properly train them. In 1990, the Americans with Disabilities Act (ADA) defined a service dog as “any guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.” Service dogs also became protected under the ADA, giving people with disabilities the right to take their service dog with them wherever they go.

Getting a service dog ready to serve their owner takes serious work. According to Aaron Backer, Executive Director of the Wisconsin Academy for Graduate Service Dogs (WAGS), it takes their dogs around two years of intensive training before they can go home with their owner. WAGS dogs begin their training at 8 weeks old so that all they know is how to be a service dog. During the first two years, the puppies are trained by and live with volunteer trainers, who work closely with WAGS staff to ensure the animals have what it takes to be a service dog. The WAGS dogs will not only need to learn 50 to 60 commands, but also to prove that they are capable of being on-call at all times.

“You need a dog that wants to work,” says Aaron. “If you want them to work, you expect them to jump up and say ‘Yep, I’m ready to go!’ It doesn’t mean the dog should be doing something every second of every day. It means when you ask the dog to do something, they’re going to jump up and do it. That’s the kind of dog that enjoys being a service dog.”

               Aaron & Ian

After the puppies have completed their training with the volunteers, the new owners work with the WAGS Program and Training Director to match them with the right service dog. Owners then train with their dogs at the WAGS office in Madison, WI, over the course of several weekly visits before the dog is finally ready to be taken to its new home.

WAGS primarily provides dogs to people with physical disabilities, and they work exclusively with Golden Retrievers and Labrador Retrievers. These larger breeds tend to have a friendly temperament and are motivated to work, making them a particularly good fit for people with physical disabilities and limited mobility. Kinsley Tarr of Appleton, WI, was paired up with Teal, a Golden Lab who was trained by WAGS, in 2016. Teal helps Kinsley, who uses a power wheelchair, by giving Kinsley her paper and pens, helping her put on her jacket, closing doors for her, and carrying her wallet, among other tasks. The two have formed a deep bond, and Teal has become one of Kinsley’s best friends.

“Teal is very smart and fun to be with. Playful and energetic,” says Kinsley. “She’s always a lot of fun.”

Teal isn’t Kinsley’s first service dog. When Kinsley was in high school, she was paired with Hawk, and then after he retired, Kinsley had Shelby until she retired, too. All three of Kinsley’s dogs were trained at WAGS. Kinsley, who is enrolled in the TMG IRIS Consultant Agency, was able to use her IRIS funds to purchase Teal. IRIS (Include, Respect, I Self-Direct) is a Wisconsin long-term care Medicaid waiver option that allows people with disabilities and those who are aging to self-direct their long-term care supports and services.

                             Kinsley & Teal

Kinsley’s mom, Jane Tarr, says that having Teal and the other service dogs has led to a richer life for Kinsley. Not only does Kinsley have more independence since she doesn’t have to rely as much on caregivers, but having Teal has opened up Kinsley’s world.

“Before Kinsley got her first service dog, we found she was struggling with friendship. Having a service dog, it brings people to her and gave Kinsley her own presence in her social environment in school, and it helped her in the community,” says Jane. “The service dog helped Kinsley expand her outlet for communication with friends and family and people she doesn’t know.”

Taking service dogs out in public so that people with disabilities have more opportunities to be involved in their community is an important benefit of having a service dog.  Organizations like WAGS have a deep understanding of all the things that go into creating and maintaining a good service dog – knowing what breed will best fit the person’s needs, having professional trainers to help the volunteers train the puppies, and being available to the owners to help with any issues that may come up with the service dog down the road.

Emotional support animals are different than service dogs. Many people find great comfort and joy in their pets, which is wonderful and why we have pets in the first place. However, there is no certification needed to deem that a dog is an emotional support animal. There are ways, however, to tell if a dog is a properly trained service dog or is simply a pet, says Aaron. When service dogs are working, they will be perfectly behaved. Also, most service dogs will be wearing a vest with text indicating that people shouldn’t try to pet or distract them.

Kinsley’s mom Jane knows that properly trained service dogs do more than simply help people with disabilities go about their day-to-day lives. These dogs show the world that with a little extra help from their canine companions, people with disabilities can live more independent lives. They also give their owners the opportunity  to talk to curious strangers about what work their service dog does for them, and why it’s so important for people with disabilities to continue having the right to use their service dogs wherever they go.

“A service dog can be an ambassador for people with disabilities,” says Jane.

For those lucky enough to have a service dog, they find themselves richly rewarded. It’s no small undertaking to commit to having a service dog, and Jane says she’s so proud of all the hard work that Kinsley has put into training and caring for Teal. Kinsley, in turn, is grateful that Teal is there to help her whenever she needs, and that she’ll always be by Kinsley’s side. Kinsley and Teal have a deep, unconditional love for one another and an unbreakable bond.

“I think Kinsley and Teal are mirrors to each other,” says Jane. “They both have an internal spirit of happiness and they make each other fulfilled.”

Perhaps, though, Kinsley best sums up this special relationship:

“A person with a service dog has a heart that’s full!”

Article submitted by TMG Wisconsin 

Fear and anxiety about a disease can be overwhelming and cause strong emotions in adults and children. The Social Distancing concept, which is intended to reduce disease transmission and currently being practiced by communities at large, can be very isolating and lead to increase in stress levels. How you respond to the outbreak can depend on your background, the things that make you different from other people, and the community you live in.

People who might have more difficulty responding effectively to the stress of a crisis include:

• Those who have mental health conditions including problems with substance use
• Children and teens

If you, or someone you care about, are feeling overwhelmed with emotions like sadness, depression, or anxiety, and feel like you want to harm yourself or others please call 911.

In general, health impacts from stress during an infectious disease outbreak can include:

• Fear and worry about your own health and the health of your loved ones
• Changes in sleep or eating patterns
• Difficulty sleeping or concentrating
• Worsening of chronic health problems
• Increased use of alcohol, tobacco, or other drugs

People with physical and mental health conditions should continue with their treatment and be aware of new or worsening symptoms. Make sure you continue to take your medications as prescribed and contact your healthcare provider if you find you are starting to feel worse.

Taking care of yourself, your friends, and your family can help you cope with stress. You can do this remotely through phone or video.

Things you can do to support yourself

• Take breaks from watching, reading, or listening to news stories, including social media.
• Take care of your body. Take deep breaths, stretch, or meditate. Try to eat healthy, well-balanced meals, exercise regularly, get plenty of sleep, and avoid alcohol and drugs.
• Make time to unwind. Try to do some other activities you enjoy.
• Connect with others over phone or video. Talk with people you trust about your concerns and how you are feeling.

Look out for these common signs of distress:

• Feelings of numbness, disbelief, anxiety or fear.
• Changes in appetite, energy, and activity levels.
• Difficulty concentrating.
• Difficulty sleeping or nightmares and upsetting thoughts and images.
• Physical reactions, such as headaches, body pains, stomach problems, and skin rashes.
• Worsening of chronic health problems.
• Anger or short-temper.
• Increased use of alcohol, tobacco, or other drugs.

Reduce stress in yourself and others

1. Take breaks from watching, reading, or listening to news stories, including social media.
2. Take care of your body. Take deep breaths, stretch, or meditate. Try to eat healthy, well-balanced meals, exercise regularly, get plenty of sleep, and avoid alcohol and drugs.
3. Make time to unwind. Try to do some other activities you enjoy.
4. Connect with others over phone or video. Talk with people you trust about your concerns and how you are feeling.
5. Use trusted sources for information such as the U.S. Centers for Disease Control & Prevention (CDC), The World Health Organization and state health department websites and encourage others to do the same.

For Parents

Not all children and teens respond to stress in the same way. Some common changes to watch for include

• Excessive crying or irritation in younger children
• Returning to behaviors they have outgrown (for example, toileting accidents or bedwetting)
• Excessive worry or sadness
• Unhealthy eating or sleeping habits
• Irritability and “acting out” behaviors in teens
• Difficulty with attention and concentration
• Avoidance of activities enjoyed in the past
• Unexplained headaches or body pain
• Use of alcohol, tobacco, or other drugs

There are many things you can do to support your child, including:

• Take time to talk with your child or teen about the COVID-19 outbreak. Answer questions and share factual information about COVID-19 from the aforementioned trusted sources in a way that your child or teen can understand.
• Reassure your child or teen it is ok if they feel upset. Share with them how you deal with your own stress so that they can learn how to cope from you.
• Limit your family’s exposure to news coverage of the event, including social media. Children may misinterpret what they hear and can be frightened about something they do not understand.
• Try to keep up with regular routines. If schools are closed, create a schedule for learning activities and relaxing or fun activities.
• Be a role model.  Take breaks, get plenty of sleep, exercise, and eat well. Connect with your friends and family members over the phone or through video.

Call your healthcare provider if stress gets in the way of your daily activities for several days in a row.

To learn more about what Magellan Healthcare is doing to support clients during the COVID-19 pandemic, visit MagellanHealthcare.com/COVID-19.

To learn more about Magellan Health’s corporate response to the COVID-19 pandemic and to view Magellan’s available resources click here: https://www.magellanhealth.com/news/covid-19/

While our everyday lives are becoming faster and more digital is your medical life doing the same? Do you miss filling your prescription because you forgot to call it in? Do you receive texts from pharmacists checking in on your current health conditions? Do you have a health coach a text away to help with your health goals?

Did you know that the average opt-in rate for receiving text messages is less than 2%? With MRx Connect we have seen more than 33% opt in. In addition, 98% of those who have opted in read the text message.

MRx Connect is an engaging digital communication service that helps prevent gaps in care and enhance awareness by sending proactive texts, emails, and chats. By receiving real-time information, people can make better healthcare decisions. MRx Connect messaging can be done in many ways and has shown many great results:

1. Refill Reminders: Receive a text when your prescription is getting low so that you know when to call in a new fill.
2. Flu Shot Reminder: Know when the best time is to receive your flu shot before it is too late in the season.
3. Re-enrollment Reminders: Be aware of when your enrollment is coming up, so you don’t have any gaps in care.
4. Health Coaching: Communicate with a professional health coach, pharmacist, or tech on your current health in real-time and on your own time.

Results:

• 35% engagement rate and improved refill rates for refill reminder for chronic conditions
• 23% of members received flu shots after receiving text message

Digital communication in healthcare allows you to be more aware and adherent to your care. You are never alone in your health journey and by being a click away from receiving answers or direction you are leading an even healthier, more vibrant life.

Making smoother transitions from work to home and vice versa can help you enjoy all aspects of your life more. While bringing work issues home seems to be the most common problem, some simple strategies can help ease the transition in either direction.

Use goodbye rituals
Whether it’s saying goodbye to your family members and pets, or playing a quick game with your kids, it helps to use a consistent pattern for your farewells. A dependable kiss and a phrase of affection can steer everyone toward having a good day.

Glance at your planner
To prepare for the day’s activities, take a quick look at whatever type of planner you use. This can trigger some creative ideas and strategies for the day. Each evening, check what is on the schedule or needed for the next day.

Try to cut down on the daily rush
When driving, ease up on the gas pedal. Try to leave a few minutes earlier so that you’re not weaving in traffic or tailgating slower drivers. If you are working from home, try preparing the night before your work day. If you’re going to be on your computer, tidy your home office, and pre-program your coffee maker or tea kettle.

From work to home
Leave work issues at work. If you’ve had a bad day, whether it be in your home office or at work itself, the last thing you want to do is bring those issues and feelings home with you. For everyone’s benefit, mentally remove yourself from work before coming home or logging off for the day.

Start fresh at home
Familiar end of work day rituals can help clear your head and refresh you. Do something simple like changing clothes or washing your face. Or, stand out on the back porch for a moment to breathe. Put on your favorite soothing music or do your favorite exercise. Sweep out the garage. Experiment and find out what works best for you.

Enjoy a little down time
Don’t rush right into preparing a meal if you can help it. Grab at least a few moments of relaxation with your partner, children and/ or pets first.

Make a clean break
At home for the evening, avoid work-related email and messaging if possible. If you can’t fully avoid it, limit it to just a set time, away from the family space.

For additional information, visit MagellanHealth/MYMH

This document is for your information only. It is not meant to give medical advice. It should not be used to replace a visit with a provider. Magellan Health does not endorse other resources that may be mentioned here.

In January 2020, 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 2019. This report provides a summary of a number of approvals and highlights the “game-changers” approved in 2019, solidifying the upward trend in approval volume initially seen in 2017. Compared to 2017 and 2018, in which CDER approved 46 and 59 new drugs, respectively, 48 novel agents were approved in 2019. 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 the 10 biosimilar approvals. This far exceeds the average of 38 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

In 2019, the FDA continued its strategic initiatives, with additional approvals of biosimilars and generics (both first-time agents and those off-patent with limited competition), as well as a focus on the expedited approval process, particularly for rare diseases and agents supported by positive patient-reported outcomes. Notably, the FDA hosted a public meeting in April 2019 to receive input on how to tackle barriers associated with the development of treatments for rare diseases, and held another meeting to celebrate “Rare Disease Day” in February 2020. Moreover, this trend is likely to continue, with the FDA releasing several guidances on gene therapy. The new pathway for insulin approval under biologic license applications planned for March 2020 and the launch of internet-based repositories or apps to improve access to information for both providers and patients (e.g., CURE ID in 2019, antiretrovirals in 2020) also highlight strategic initiatives of the FDA.

Last year, all 48 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2019, 42% were considered first-in-class, and 44% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 58% of novel drugs, 19% received Accelerated Approval (more than doubling the rate of 7% last year), 27% were designated as Breakthrough Therapy, and 35% garnered Fast Track designation. Overall, 60% of all drug approvals in 2019 used expedited development and review methods. In addition, 90% were approved in the first review cycle, and 69% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2019 is illustrated in Figure 2, with approvals once again dominated by drugs in the expansive oncology spectrum.

Some of the notable 2019 approvals included new advances for the treatment of cystic fibrosis (CF), with the first triple combination therapy and expanded indications of existing CF therapy available to younger patients, and the first new medications in several years for sickle cell disease. Additionally, several approvals targeted rare conditions, such as erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, tenosynovial giant cell tumor, Duchenne muscular dystrophy, and systemic sclerosis-associated interstitial lung disease. Beyond treatments for rare disease and cancer, the FDA also approved agents for more common disorders, including multiple sclerosis, novel treatments for depression, migraine and cluster headaches, epilepsy, several autoimmune conditions, age expansions for diabetes therapy, and a drug-sparing regimen and new prophylaxis option for human immunodeficiency virus-1 (HIV-1). Although down slightly from 2018, the large number of approvals from 2019 represent a continued trend by the FDA to expedite and increase the quantity of annual approvals.