Precision medicine is the concept of tailoring disease treatment and prevention to account for differences in genetic, environmental, or even lifestyle factors specific to groups of people.¹ Precision medicine takes genetic and biochemical information unique to a group of patients and uses that information to develop more specific and streamlined medications or treatments. The goal is to ensure that each medication or treatment is best suited to treat the individual, resulting in decreased side effects and increased effectiveness.²

Precision vs Personalized Medicine

Although the terms precision medicine and personalized medicine are used interchangeably, there can be nuanced differences. The National Research Council (NRC) issued a statement saying that the term “personalized medicine” can refer to a treatment that may be completely individualized to a specific patient, which is not the true definition of precision medicine.³ The difference here is that precision medicine seeks to create treatments that are applicable to groups of individuals who meet certain characteristics. This is different from “personalized medicine,” which implies individualized treatments available for every unique patient.

Current Landscape

In 2015, the Precision Medicine Initiative (PMI) was launched, with $215 million dollars invested into precision medicine research.⁴ A new program was created—All of Us Research Program—which had the goal of recruiting 1 million Americans and creating a nationwide database for research.⁵ Other examples of precision medicine initiatives include the Geisinger Health System’s National Precision Health Initiative, the Partnership for Accelerating Cancer Therapies (PACT), and Cancer Moonshot.¹ There has been particular success in the field of cancer, with new medications developed for a specific cancer types with certain genetic characteristics. With increased funding, decreased costs to sequence DNA and analyze genetic information, and improved data analytics, many believe precision medicine to be the future of healthcare delivery.

1. Bresnick, Jennifer. 2018. “What Are Precision Medicine and Personalized Medicine?” HealthITAnalytics. HealthITAnalytics. January 11, 2018. https://healthitanalytics.com/features/what-are-precision-medicine-and-personalized-medicine.
2. Genetics Home Reference. n.d. “What Is the Difference between Precision Medicine and Personalized Medicine? What about Pharmacogenomics?” Genetics Home Reference. Accessed October 11, 2019. https://ghr.nlm.nih.gov/primer/precisionmedicine/precisionvspersonalized
3. Council, National Research, Committee on a. Framework For Development a. New Taxonomy of Disease, and Others. 2010. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. National Academies Press.
4. “FACT SHEET: President Obama’s Precision Medicine Initiative.” 2015. Whitehouse.gov. January 30, 2015. https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative.
5. “Program Overview – All of Us | National Institutes of Health.” n.d. Accessed October 11, 2019. https://allofus.nih.gov/about/all-us-research-program-overview.

Primary care providers can be responsible for everything from first line dermatology to behavioral health to musculoskeletal injuries. In a world of rapidly changing technologies, and in which new therapies can cure or alter diseases that only a few years ago would have never been thought possible, the basics still matter. As a clinician, I’ve practiced internal medicine and psychiatry, and still have the opportunity to work with a FQHC in building integrated care. Those experiences and my national view of utilization and prescribing patterns highlight the need for provider support to care for persons with mental health conditions, including opioid use and abuse.

It is often challenging to translate new medical knowledge to the clinic setting. How does a provider care for the individual on a potentially lethal combination of opioids, benzodiazepines, and muscle relaxants? Or, how does one address the young child who has been placed on a combination of psychotropic medications.

In our current health system, primary care providers are in the best place to begin patient care journey or change the course of an already established treatment plan. An effective solution for supporting providers in delivering high quality care is in the form of provider support, especially through programs that involve data analytics, followed by one on one academic detailing. PBMs are in a unique position, having the ability to assist providers in working with patients on complex behavioral health or opioid regimens. PBMs have access to data that allows for identifying outlier member and provider behavior and finding patients who are at risk for adverse outcomes. While PBMs don’t have access to prescription drug monitoring programs, they can see what prescriptions are filled, where there is overlap, and where there are multiple providers interacting with a patient.

Magellan Rx developed the Live Vibrantly: Whole Health program to address those outlier providers and members, with the goal of achieving higher quality care. This program uses evidence-based algorithms to find members who may be at risk for adverse outcomes, and targets prescribers who may be over-prescribing. We become the provider’s go-to source for translating the evidence to the bedside through assistance with difficult issues, such as withdrawing an individual from high dose opioids. Through taking an approach to support providers in delivering high quality care, we’ve been able to truly partner in leading our members to leading more healthy vibrant lives.

In 1989, one survey of the general public found that more than half of respondents believed lack of discipline was a possible cause of mental illness. The survey found that, at that time, Americans were more likely to receive information about mental illness from mass media than from medical providers or psychologists. Thirty years later, with the availability of information on the internet, the public should theoretically have a more accurate and balanced perspective of mental illness. But is the public obtaining their information from science-based sources? While there is still much to learn about mental illness, scientists have identified several factors that can play a role in mental health, including genetics, environmental exposure, altered brain chemistry, significant stress, and comorbid medical conditions. With the availability of misinformation on the internet and on social media websites in particular, are we really any better educated on mental health than we were 30 years ago?

The National Institute of Mental Health (NIMH) reports that approximately 1 in 5 adults experiences mental illness annually, with approximately 1 in 25 experiencing mental illness that substantially interferes with or limits 1 or more major life activities. Based on data from the 2018 National Survey on Drug Use and Health, approximately 19% have an anxiety disorder, 2.8% live with bipolar disorder, and fewer than 1% have schizophrenia in the United States (US) adult population. In addition, 7.2% of adults have experienced at least 1 major depressive episode in the last year. Unfortunately, only about 43.3% of adults with a mental health condition received mental health services within the past year, and of those with a serious mental illness, only 64.1% received mental health services within the past year. Even the indirect costs of mental health have a significant impact. Serious mental illnesses have been estimated to cost over $193.2 billion in lost earnings per year in the US, and mental illness has been predicted to cost the global economy $16 trillion by 2030.

Much has changed in the treatment of mental illnesses in the past 30 years. Key treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and newer serotonin-norepinephrine reuptake inhibitors (SNRIs), have mitigated some of the limitations of earlier antidepressants (e.g., drug-food interactions or select adverse effects). Even in the past year, novel approvals for treatment-resistant depression (TRD) and postpartum depression (PPD) have emerged. For those with schizophrenia, the availability of newer generation antipsychotics has significantly altered care as well. Although testing for genetic alterations to better identify the best medication choice for a patient is in its relative infancy, the role of pharmacogenomics is rapidly expanding, too. These advances offer promise for individuals with mental illness, but no medication is without risks, and a discussion with a licensed medical provider is essential to establish an appropriate treatment regimen. In addition to medications, the role of nonpharmacologic treatment has expanded in the past 30 years as well, with additional treatment modalities beyond the advancements in psychotherapy alone (e.g., modern cognitive behavioral therapy, interpersonal therapy). A more holistic approach, incorporating lifestyle changes (e.g., diet, exercise) and non-traditional medicine (e.g., meditation, acupuncture), is also gaining in popularity; however, it is critical to understand that herbal or “natural” treatments can have adverse or toxic effects and drug interactions. These should only be used in consultation with a healthcare provider.

Mental illness can contribute to the risks for suicide. Unfortunately, the Centers for Disease Control and Prevention (CDC) reports that suicide rates have increased by approximately 30% from 1999 to 2016. Notably, suicide is rarely caused by a single factor, and the National Alliance on Mental Illness (NAMI) reports that approximately 54% of those who die by suicide do not have a diagnosed mental health condition. Regardless, this leaves a significant portion of patients with known mental health conditions where intervention may have been helpful. Moreover, NAMI also reports that approximately 90% of those who die by suicide show symptoms of a mental health condition. The CDC includes several warning signs on their website and offers advice to several groups ranging from laypersons to the government to healthcare providers. One component the CDC emphasizes to healthcare systems is the need for affordable and effective mental and physical healthcare where people live. In addition, the Zero Suicide Institute provides a framework for continuous quality improvement in health and behavioral healthcare systems aiming to prevent suicide.

Of late, the public seems particularly concerned with the risk of violence in those with a mental illness. A 2006 survey found that 32% and 60% of Americans thought people with depression and schizophrenia, respectively, were likely to act violently toward someone else; however, research has demonstrated that there are several factors that contribute to violence, and that when accounting for these additional factors, the presence of a mental illness is only a modest contributor (at best) to violence. According to the 2018 National Survey on Drug Use and Health, approximately 19.4% of those over 12 years of age have used an illicit drug in the past year and 3% had at least 1 illicit drug use disorder. Additionally, 3.7% of adults reported dual diagnosis (both any mental illness and substance use disorder). Studies of patients with substance abuse or dual diagnosis have found higher correlations with violence compared to mental illness alone. Most importantly, adequate treatment has demonstrated improved outcomes.

With the discussion of mental health in the press and the plethora of inaccurate information on mental health online, it is difficult for the public to develop a truthful foundation on mental illness. While public access to information and scientific discovery have advanced in the past 30 years, the most critical component for the proper diagnosis, effective treatment, and safety of those with mental illness remains consultation with a healthcare provider and/or team.

If you or someone you know may be at risk for suicide, contact the free and confidential Suicide Prevention Lifeline at 1-800-273-TALK (8255). It is available to anyone 24 hours a day, 7 days a week.

More than 400 nationally-recognized payers, physicians, and industry insiders came together to share thoughts and insights on the ever-evolving specialty drug landscape at the 16^th annual 2019 Magellan Rx Management Specialty Summit hosted August 26-28 in New York City.

As the specialty drug trend continues to rise (especially on the medical benefit) and the pipeline continues to expand, focusing on management strategies and solutions is key. With biosimilars flooding the market and capturing the headlines, and looming policy updates creating uncertainty, this year’s event was a platform to tackle these critical topics and the future of our industry.

“We’re honored to be the forum that brings people together to share insights, engage in thoughtful debate, so that we can all walk away with actionable solutions to effectively manage this growing specialty drug trend.” –Steve Cutts, senior vice president & general manager, specialty, Magellan Rx Management

Highlights from this year’s program include:

• Dr. Peter Bach of the Memorial Sloan Kettering Cancer Center reviewed the latest developments for better oncology management and Dr. Rafael Fonseca, a Mayo Clinic Distinguished Investigator, examined applications for a more personalized approach to treatment for complex specialty conditions.
• Magellan Rx chief medical officer Dr. Caroline Carney was joined by Sarah K. Emond, executive vice president and chief operating officer of the Institute for Clinical and Economic Review (ICER), in a fireside chat about ICER’s approach to health policy and excellence in the U.S.
• Mostafa Kamal, CEO of Magellan Rx, led a panel of forward-thinking innovators who are disrupting the status quo by providing tech-based solutions to improve healthcare delivery and outcomes: Raj Agarwal, chief executive officer at Medocity; Adam Hanina, chief executive officer at AiCure; and Richard Waithe, president of VUCA Health.
• Several panel discussions highlighted next-level management strategies around medical pharmacy solutions as well as emerging therapies like CAR-T and other gene therapies to treat rare and orphan diseases, and featured a diverse group of speakers including executives from national and regional payers, pharmaceutical manufacturers, and physicians:
  • Martin Burruano, RPh, Vice President, Pharmacy Services, Independent Health
  • Mona Chitre, PharmD, CGP, Chief Pharmacy Officer & Vice President Clinical Analytics, Strategy & Innovation, Excellus BlueCross BlueShield
  • Kim Dornbrook-Lavender, PharmD, BCPS, Director, Clinical Pharmacy, Medica
  • Pat Gill, RPh, Director of Pharmacy Programs, Horizon BCBCS of NJ
  • Doug Long, Vice President, Industry Relations, IQVIA
  • Joseph Nolan, General Manager – US, AveXis, Inc.
  • Helio Pedro, MD, Clinical Geneticist, Hackensack Meridian Health
  • Carly Rodriguez, PharmD, Pharmacy Director, Clinical Innovation, Moda Health
  • Natalie Tate, PharmD, MBA, BCPS, Vice President, Pharmacy Management, BlueCross BlueShield Tennessee
• Industry experts Claire Wulf Winiarek, Beth Hebert-Silvia (VP & Practice Lead, Health Plans at Pharmaceutical Strategies Group) and Michael McCaughan (founding member of Prevision Policy LLC) shared their insights on the current policy landscape.
• TV personality and author Janice Dean graced the audience with her very own patient story—after receiving a Multiple Sclerosis diagnosis in 2005, she underwent treatment and found hope and a passion for sharing her story to encourage others who are living with MS to live their best lives as well.
• Keynote speaker Keller Rinaudo shared his incredible story of perseverance that led to the launch of a revolutionary healthcare startup, Zipline, that is rapidly changing the face of medicine in remote parts of the world—and future expansion for U.S. disruption.

As pioneers in specialty pharmacy management since 2005, Magellan Rx has been leading the conversation around better management strategies that not only provide cost savings for payers but positively impact patient health outcomes. Each year, we develop the Specialty Summit agenda with those values in mind. Mark your calendars and join us next year in NYC on August 24-26, 2020 as we host another event that will ignite inspiration and innovation across the industry.

Nearly 2 decades after measles was declared “eliminated” in the United States (US), we find ourselves in the midst of an unprecedented measles outbreak in the modern era of vaccination. As of July 25, 2019, a total of 1,164 active cases of measles have been confirmed in 30 states. As one of the most contagious human diseases, measles can lead to serious health complications such as pneumonia, encephalitis, and even death. Given its highly contagious nature, the measles resurgence has public health officials on high alert.

Once relegated to the history archives thanks to a widely effective immunization program, measles is an acute respiratory illness spread through coughing or sneezing. The virus can linger for up to 2 hours after an infected person leaves an area. Symptoms typically begin 1 to 2 weeks after a person becomes infected. High fever, cough, runny nose, and red/watery eyes are followed after a few days by the hallmark red rash. Patients are considered contagious from 4 days before and after the rash appears. It is so contagious that following exposure, about 90% of unprotected individuals will develop measles.

According to the Centers for Disease Control and Prevention (CDC), the measles outbreak has proliferated due to factors including international travel and unvaccinated individuals. Unfortunately, measles is common in many parts of the world, and Europe is experiencing an ongoing spike, which is contributing to the measles surge in the US. In late April 2019, the CDC reported that, of the 44 “imported measles” cases that came into the US this year, 34 cases were in primarily unvaccinated US residents traveling abroad. The majority of imported measles cases in the US have been from popular travel spots such as the Philippines, Ukraine, Israel, Thailand, Vietnam, and Germany. In June 2019, the CDC issued a Level 1 Global Measles Outbreak Notice, alerting US travelers to the current situation and reminding them to check their immunizations before traveling internationally. Regardless of destination, the CDC recommends visiting their “destinations” site to view valuable traveler’s health updates to safely plan for travel.

Insufficient measles vaccination coverage, the other culprit in this outbreak, has also been fueling US circulation of the disease. The majority of measles cases in the US have been among unvaccinated individuals. CDC statistics show that there are pockets of unvaccinated close-knit communities in certain US jurisdictions, such as in parts of New York, experiencing an outbreak. Measles spreads quickly through these populations, making it difficult to limit transmission. Personal and religious beliefs, complacency, and unproven risks thought to be associated with vaccines, are among the reasons behind vaccine hesitancy and avoidance, leading to undervaccination in vulnerable communities. Moreover, unfounded concerns regarding vaccines and autism, which have been refuted by scientific evidence, have also led to skepticism in select groups.

In the pre-vaccine era, an estimated 3 to 4 million people in the US contracted measles each year, resulting in significant deaths and hospitalizations. In modern times, a vaccine is the strongest weapon to combat measles. For best protection, 2 doses of the measles, mumps, and rubella (MMR) vaccine are recommended and are approximately 97% effective at preventing measles; 1 dose is roughly 93% effective. The MMR vaccine is part of routine childhood immunizations. Measles vaccine recommendations for all age groups, as well as for international travelers, are available on the CDC website.

The CDC deems a disease “eliminated” after 12 continuous months of no active transmissions. If the current outbreak, which started in New York in October 2018, is not contained by October 2019, the US risks losing its measles elimination status. Whether traveling abroad or enjoying a summer staycation, individuals and communities should guard against the measles virus. The best protection against the “21^st century measles outbreak” is immunization. Armed with awareness, education, and appropriate vaccinations, this preventable disease can once again be banished to the history books.

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

Two patients, both 73-year-old males with newly diagnosed congestive heart failure, are seen by the same provider and prescribed the same therapeutic regimen. Despite the similarities, the 2 patients experienced drastically different therapeutic outcomes. These divergent outcomes were not attributable to the clinical care they received but instead to non-clinical factors surrounding each patient’s circumstances. These non-clinical factors are also referred to as social determinants of health (SDOH). According to the Centers for Disease Control and Prevention (CDC) website, SDOH are conditions in the places where people live, learn, work, and play that affect a wide range of health risks and outcomes. Some key SDOH that may influence clinical outcomes include housing insecurity, food insecurity, lack of transportation, and lack of family or other social support.

It is widely known that social and economic factors have significant impacts on health outcomes of both individuals and communities. At a population level, it has been estimated that clinical care accounts for only 20% of a community’s health outcomes while the remaining 80% is related to a combination of health behaviors (e.g., diet and exercise), the physical environment (e.g., housing security), and socioeconomic factors (e.g., education and social support). Despite this insight, addressing SDOH has traditionally been the purview of government and charitable organizations rather than healthcare providers. However, with the shift toward value-based reimbursement and increased accountability for the costs and health status of patients, there is an incentive for health plans and providers to further consider the social and economic barriers that contribute to poor health outcomes. Models are being developed that link healthcare systems, providers, and community resources in an integrated fashion to address SDOH. These models are evolving from systems that rely on acute episodes of care to a coordinated system focused on prevention and care management.

As the largest payer for healthcare in the United States, Medicare has also recently begun to make accommodations in order to address SDOH in the privately administered Medicare Advantage (MA) program. MA is a capitated system placing health plans that administer MA benefits at risk for the cost of caring for each beneficiary. MA plans are permitted to offer supplemental benefits beyond traditional Medicare offerings as long as those benefits are “primarily health-related.” Historically, the most common supplemental benefits offered by MA plans have been services not traditionally covered by medical insurance such as vision exams, hearing tests, and preventative dental services.

The Centers for Medicare & Medicaid Services (CMS) have recently begun to implement regulatory changes allowing MA plans more flexibility with regard to these supplemental benefits. First, the definition of “primarily health-related” has been expanded. Examples of this expanded interpretation include providing in-home support for activities of daily living (ADLs) or installation of grab bars in the bathroom in order to prevent injuries and reduce avoidable emergency room utilization. In addition, supplemental benefits that may reduce exacerbations of existing illnesses, such as installing air conditioning units or providing carpet shampooing for patients with asthma, may be considered. Beginning in 2020, MA plans may offer chronically ill patients additional benefits that directly impact SDOH, such as expanded meal delivery options to address food insecurity and transportation for non-medical needs like grocery shopping. In announcing the expanded options for MA plans, CMS Administrator Seema Verma said the changes “give plans the ability to be innovative” and the changes permit “benefits and services that address SDOH for people with chronic disease.”

The shifts occurring in healthcare delivery, including the expansion of accountable care organizations (ACOs), the rise of capitated reimbursements, and penalties associated with hospital readmissions, incentivize healthcare systems to become increasingly focused on holistic care for beneficiaries. By addressing individual and population SDOH, healthcare systems, providers, and community support can be integrated to improve health outcomes and reduce unnecessary healthcare utilization.

While there may be some debate as to who deserves credit for originally developing insulin in the 1920s, there is no doubt that its serendipitous discovery had a life-saving impact. In an attempt to provide affordable treatment to the public, the researchers opted to sell the patent for insulin to the University of Toronto for $1. The researchers later collaborated with a pharmaceutical company to develop insulin due to limited ability of the university to develop it on its own. Once made primarily from animal sources in limited selection, several insulin options are now available, and each product differs slightly in manufacturing and design to better mimic the lacking endogenous insulin in patients with diabetes. Today, insulin is marketed primarily by three manufacturers, and counterintuitive to its length of time on the market as a primary treatment, insulin costs continue to increase. One assessment reported that annual spending per person with type 1 diabetes nearly doubled between 2012 and 2016, and the reported cost of one specific brand of insulin increased by 668% from 2001 to 2015. There are several purported reasons for the high costs of insulin, even resulting in lawsuits and a push for legislative involvement.

The high cost of insulin is a hurdle for many patients and the entire healthcare system, especially considering a reported 1.2 million Americans have type 1 diabetes and a portion of the nearly 30 million Americans with type 2 diabetes are insulin-dependent. So, what happens when a medication necessary for life continues to increase in price? Patients may resort to acquiring insulin from less expensive resources outside of the United States (US). In addition, some patients will continue to use insulin vials beyond their stable use (i.e., beyond 28 days once opened) or share insulin pens. Patients may ration their insulin for their own use or sell the remaining insulin to others, as the temptation for potential income may be too enticing for those with limited financial means. One study reported that the rise in costs has resulted in nearly 25% of patients not taking insulin as directed. Lack of blood glucose control resulting from these measures could be life-threatening.

Taking insulin access to another level, one project aims to develop a protocol for insulin production that would circumvent intellectual property concerns, enabling manufacturers to produce more affordable insulin. Theoretically, an open protocol for manufacturing of insulin could result in community biolab production or somewhat “home-brewed” insulin, but there would still be several costly regulatory hurdles for each product. Even if crowdfunding could support these “biohacked” insulin barriers, would the resulting product be the best treatment for all patients? Would it still result in a high-cost product?

Historically, the US Food and Drug Administration (FDA) has regulated insulins as small molecule drugs; thus, the few generics available are actually branded competitors and considered “follow-on” insulins. The FDA has announced insulins will be transitioned from the small molecule pathway to the biologics pathway effective in March 2020 as part of their Biosimilars Action Plan. According to acting FDA Commissioner, Dr. Ned Sharpless, after this transition, the FDA will be able to license biosimilar and interchangeable insulin products that may be substituted at the pharmacy, potentially leading to increased access and lower costs for patients.

While the idea for “generic” (cheaper) insulin is becoming more of a reality, what will patients do in the meantime for a disease state in which the treatment is not optional? Will interchangeable biosimilar insulin finally be the solution for reversing the constant upward trajectory of insulin prices?

For many patients, receiving an organ transplant may feel like the end of a painful, stressful journey. In fact, the transplant serves as the starting point of a new chapter of life which will require lifelong management. There are many factors that can impact an individual’s health after an organ transplant. Leading a healthy, vibrant life requires commitment from patients, caregivers, and providers.

The main goal of any post-transplant treatment is to prevent organ rejection by the body. To help reduce the risk, there are a variety of treatments available. These drugs, often called immunosuppressants or anti-rejection medications, help the body to shield the newly-transplanted organ from the body’s immune system. In doing so, these drugs help to minimize the risk of transplant rejection.

It is very important that these medications are taken consistently every day as prescribed. It is also crucial to not skip or miss doses. Coordination with the transplant team is a must before making any changes to these medications or how they are taken. Even though some of these medications may be associated with side effects, they can be managed. It is crucial to tell a healthcare provider about any side effects experienced.

Possible side effects from transplant medications include:

• High blood pressure
• Weight gain
• New-onset diabetes
• High cholesterol
• Increased risk of bone disease
• Kidney disease
• Increased risk of infection

Advances in post-transplant treatments have made it possible for patients to live healthy, vibrant lives. That said, patient management programs may be very valuable to patients whose ability to take their medications as prescribed has a direct impact on the long-term success of their transplant.