1

Minority Mental Health Awareness

Magellan Health Insights: Dr. Ghani, thank you for chatting with us today. Why do you think it’s important to be aware of minority mental health?

 Dr. Shareh Ghani: Many psychological conditions have a connection to the individual’s perception of themselves. How comfortable do we feel in our environment? How well do we fit into what is seen as the norm? It’s human nature to want to fit in. Being a minority myself as an immigrant to the U.S. from Pakistan, I can see that there is extra pressure when you may be uncertain about fitting in or what is expected.

Seeking treatment for mental health unfortunately carries a degree of stigma for everyone and minorities are much less likely to seek or receive treatment for mental health conditions. For those who don’t speak the primary language or do not speak fluently, it can be even more difficult to seek these services and treatment. In addition, there may not be bilingual providers available or covered in the network, if the patient has insurance coverage – which is less likely for minority members. We are starting to see improvements, but for immigrants and members of other minority groups, it can be even more difficult to ask for help.

 

Magellan Health Insights: Why wouldn’t a minority member seek out care for mental health?

 Dr. Shareh Ghani: There are many reasons. Fundamentally, these members are often challenged by the complications of poverty and social determinants of health (SDOH). Language, i.e. communication and or comprehension, can be a barrier. Beyond language, it may not be culturally acceptable to ask for help. It may seem embarrassing. Which leads us to stigma. The person’s community at large, the clinicians and physicians providing care, and even the patients themselves may see it as stigma. People openly discuss their diabetes but not their depression.

 In addition, these patients are less likely to be routinely screened. They also may not be able to specify that their symptoms are symptoms of a behavioral health condition. In the U.S., patients come to me and say they think they may be depressed. In India, my patients would describe physical symptoms – like gastrointestinal problems. This means they may go through a battery of tests to eliminate physical diseases before behavioral health is addressed.

 

Magellan Health Insights: How can providers best support minority mental health?

Dr. Shareh Ghani: Paying extra attention and being aware of the cultural needs of every individual is key. In order to come up with a successful treatment plan, providers need to be knowledgeable about cultural factors. And they need to ask about what their patients preferences are related to care. Unless and until we talk to each person about their comfort level working with a provider of a particular gender, someone from their own culture or sexual orientation, or even age group, we can’t provide the best treatment. We, as patients, are most likely to speak openly when we feel comfortable. Being able to speak openly with a therapist or provider will make it more likely that the member will be accurately diagnosed and that treatment will be more successful.

Providing culturally competent care is critical – all care must be culturally competent care. What does that mean? We must be able to provide care to patients with diverse values, beliefs and behaviors and meet patients’ social, cultural and linguistic needs. We must acknowledge the importance of culture, recognize the potential impact of cultural differences, and adapt services to meet culturally unique needs. By taking training and educating ourselves on cultural competence we can reduce the racial and ethnic disparities in healthcare and give all of our members the best care. 

Magellan Health Insights: We couldn’t agree more! Thank you, Dr. Ghani!

Read more about Minority Mental Health Here




Automating Prior Authorization at the Point of Care

For healthcare providers, prior authorization (PA) via fax or telephone is the second most costly medical administrative function. On average, medical staff spend two business days per week on PA. Automating PA while maintaining clinical excellence is essential for better care delivery. With a focus on leveraging digital solutions and fostering data-enabled decisions, Magellan Healthcare is building more provider-friendly approaches to improve care.

Recently Magellan announced a collaboration with Stanson Health, Premier, Inc.’s clinical decision support (CDS) technology division, to deploy DecisionPoint, an industry-leading automated PA solution. Powered by Premier’s CDS technology, DecisionPoint is available at the point of care and supports true automation within the electronic health record (EHR) and the physician workflow, making the PA process easier and more efficient for providers, patients and health plans.

DecisionPoint is built with Magellan Healthcare’s Advanced Imaging Management program clinical guidelines and Premier’s award-winning technology platform. Magellan maintains one of the industry’s most comprehensive evidence-based sets of clinical guidelines. Our clinicians develop our criteria through an extensive process of innovation and refinement. We base these guidelines on the analysis of public, peer-reviewed articles; health plan medical policies; the Centers for Medicare & Medicaid Services (CMS) policies; specialty physician reviews, professional society guideline statements; and other rigorous reviews of scientific documents. We continually monitor peer-reviewed literature, professional society guideline statements, and CMS-covered criteria to update our guidelines regularly, no less than annually. Initially, DecisionPoint will include our suite of the 20 highest-volume advanced imaging studies that make up 85% of all requests.

Working directly in the EHR, DecisionPoint guides provider decisions in real time in response to key workflow events, such as ordering an advanced imaging study. Integrating within the EHR improves efficiency while ensuring safety and quality and reducing undesirable variation in care.

Rules-based programming leverages EHR data, locating all relevant patient clinical information and citing appropriate Magellan clinical guidelines. Requests that satisfy the clinical guidelines are automatically approved and posted in the EHR, and approval IDs are automatically loaded to the record. With a confirmed authorization determination, the member leaves the appointment with a clear plan of action.

P317rev5_MHC_EnhancedCDSToolProcessGraphic

Hawai‘i Pacific Health (HPH), one of the largest healthcare providers in Hawai‘i, is leading the way in automating prior authorization by piloting DecisionPoint to help ensure their patients receive real-time, evidence-based decisions at the point of care whenever possible. Administered through HPH’s Accountable Care Organization (ACO) with over 800 physician members, the pilot leverages Magellan’s clinical guidelines and our full panel of clinical experts. We expect DecisionPoint to be available to additional providers in the fourth quarter of 2019 and include additional specialties and tests in the future.

The healthcare industry is in the midst of a significant paradigm shift as it transitions from a fee-for service model to value-based care. As a technology-augmented service backed by the support of providers, DecisionPoint is designed to minimize the industry’s challenges by fully integrating with EHRs at the point of care to enable faster PA and help deliver on the triple aim—improved quality, reduced cost and improved patient/provider experience.

To learn more about DecisionPoint, click here to go to our website, or email ProviderSolutions@MagellanHealth.com.

 




One Suicide is Too Many

One suicide is too many. Yet more than 47,000 Americans die each year as a result of suicide. Because suicide is the 10th leading cause of death in our nation, we at Magellan Health believe it is nothing short of a public health crisis. Thankfully many experts and organizations agree.

Recently, Magellan had the privilege to host a suicide prevention conference in Boise, Idaho. The free conference brought almost 200 local and national leaders together to exchange ideas, share successes and discuss solutions around the challenges we face together in addressing this crisis in our communities. Suicide is a topic that’s difficult, but we must talk about it and deal with it by creating an environment for genuine caring for one another. To have the greatest impact possible, this should start by encouraging those who are struggling to ask for help, and we need to remind one another to watch for signs and signals with our family, friends and colleagues.

The suicide crisis is particularly impacting the state of Idaho. In 2017, Idaho’s suicide rate was 22.9 per 100,000 residents. The state’s suicide rate is 58 percent higher than the national rate and reflects a 44 percent increase over the past 10 years.

During the conference, Dr. Michael F. Hogan, principal, Hogan Health Solutions, LLC, gave one of three keynote addresses. He spoke about opportunities to prevent suicide in all healthcare settings. As I shared in my remarks at the conference, I wholeheartedly agree with his perspective. From the examination room to the boardroom, healthcare leaders and executives play a critical role in helping solve this crisis. We must lead the charge—drawing in other key stakeholders like providers, lawmakers, teachers and family members to support efforts to make this crisis visible, reduce stigma and drive solutions.

One important place to start is by ensuring people understand the signs of suicide. First, we must increase education and awareness and promote community and statewide educational programs. We should focus on an audacious goal, a path to zero suicides, to drive the sense of urgency needed to get community-wide buy-in. In addition, we should invest in suicide training for family members and peers of those with a mental health diagnosis. Such training fosters early detection and, in the case of peer support, provides a common frame of reference, making individuals more likely to engage.

Second, we must work to break the stigma around mental health issues — and normalize the need for care. As Dr. Thomas Joiner, The Robert O. Lawton Distinguished Professor of Psychology at Florida State University, said during his keynote address, “Reach out and tell someone when you see that someone is desperate. These person to person connections as we look out for each other can have such a significant impact in reducing suicides. It is important to keep in mind that all of us hold an important role in caring for one another.” Creating opportunities for open dialogue in the community, like the workshops during our Boise conference, helps shine a light on the problem and engages more people in helping others before it’s too late.

Finally, improved access to care and early screening will go a long way toward reducing the risk of suicide. Ensuring people of all economic status and backgrounds have access to behavioral healthcare is key. However, finding specialists who are skilled in suicidology isn’t easy. One study in Maricopa County, Ariz., determined that only 30 percent of behavioral health professionals in the county believed they had the necessary skills and support to treat at-risk patients. We need increased funding for suicide training among all medical professions.

As many as 38 percent of people making a suicide attempt did so within a week of a healthcare visit. Our healthcare system must look for ways to support early detection by making depression screenings part of every primary care visit. To help identify patients with mental health conditions, Magellan Healthcare has developed SmartScreenerSM. SmartScreener is a digital application that contains standard screening tools used by behavioral health professionals like counselors, psychologists and psychiatrists. While the patient waits to be seen by the physician, he/she completes the screener. Answers are confidential and only shared with the physician, who will discuss the patient’s results during the appointment and can help with next steps.

This routine screening is making a difference in identifying patients with behavioral health concerns. In a six-month primary care SmartScreener implementation, approximately half of the patients screened positive for a behavioral health concern. About 38 percent were deemed appropriate to be referred to digital cognitive behavioral therapy (DCBT). Fifty-four percent of these appropriate patients then enrolled in DCBT, getting help for which they may otherwise never have been referred.

The path to zero suicides requires that healthcare leaders—and the nation as a whole—treat suicide as a public health crisis and that we normalize discussions about mental health, suicide and treatment. I hope everyone who attended our Boise conference left as inspired about the urgency of this issue as I did. Let’s all commit to strategies that involve our communities in suicide prevention and draw upon multiple resources for continuing education and improved access to treatment.

 

 For more information about suicide prevention, read our other blog articles here.




Is Prior Authorization in need of an Upgrade?

Prior authorization (PA) goes by many names—preauthorization, preapproval, advance notification, precertification and preadmission, to name a few. All these terms refer to the utilization management (UM) process used by many U.S. health insurance companies to ensure patients receive the right services, equipment and prescriptions at the right time and place. PA requires healthcare providers to request and obtain approval before rendering certain services, equipment or prescriptions in order to receive insurance reimbursement for those services. Not everything requires PA. Typically, authorization is needed for more complex services such as hospital admissions, diagnostic tests, medical equipment and complex prescription medications.

The PA process is intended to act as a safety and cost-saving measure. It can lower costs to the patient, prevent unnecessary or invasive procedures, and reduce the use of unnecessary tests that may expose patients to potentially harmful radiation and/or undue stress. For example, up to half of advanced imaging procedures ordered fail to provide information that improves patients’ welfare.[i] In addition, despite studies demonstrating overuse, rates of advanced imaging procedures continue to rise—increasing costs and exposing consumers to excessive radiation.  Despite its benefits, the prior authorization process needs an upgrade.

According to the 2018 CAQH Index , manual prior authorizations (via fax or telephone) are the second most-costly medical administrative transaction, costing providers $6.61 per submission. Providers estimate their staff members spend up to 30 minutes completing one manual prior authorization. While manual prior authorization is a much-debated topic due to the time and cost it requires, many parties support standardizing and simplifying the process.

Technology can significantly  decrease the need for expensive manual processes.  According to the 2018 CAQH Index, the medical industry could save $417 million annually by transitioning to electronic prior authorizations, which includes $278 million in annual savings for providers and $139 million for health plans.

While many health plans offer web portals to process prior authorizations, this approach requires providers to use different online systems for each health plan. Instead, digital solutions should include automation within the electronic health record (EHR) and the physician’s workflow. Automation is essential to reducing inefficiencies for providers and health plans and enabling authorizations at the point of care while maintaining clinical integrity.

The goal is to make the right decision for each patient—quickly and easily so patients get the care they truly need. Automating prior authorizations will benefit everyone involved.

 

 

[i]Beachy, D. (2014, September 8). Defensive medicine driving up wasteful imaging. Retrieved from https://www.healthimaging.com/topics/healthcare-economics-policy/defensive-medicine-driving-wasteful-imaging.




21st Century Measles Outbreak

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 “21st 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.




Minority Mental Health Awareness Month Q&A

As we observe National Minority Mental Health Awareness Month, we sat down with Dr. Rakel Beall-Wilkins, a former Magellan Healthcare medical director.

 Magellan Health Insights: Dr. Beall-Wilkins, thank you for speaking with us today. Of course, everyone’s mental health is critical, but why is it important to pay particular attention to the mental health of Black, Indigenous and People of Color (BIPOC)?

Dr. Rakel Beall-Wilkins: We know that mental health conditions can be successfully treated. However, BIPOC are significantly less likely to receive treatment for mental health conditions, including substance use. And it’s reaching crisis levels, especially among our young people. For example, suicide is now the third leading cause of death among African American males who are 15-24 years old.

Magellan Health Insights: What are the barriers to BIPOC receiving high quality mental health treatment?

Dr. Rakel Beall-Wilkins: BIPOC are less likely to seek treatment, both for their physical and mental health. However, when they do reach out for assistance, they are less likely to receive consistent, high-quality treatment.

There are many contributing factors to these barriers. The high costs of care can be a deterrent. Most BIPOC in the U.S. (with the exception of Asians) have higher than average rates of poverty. BIPOC are more likely to lack insurance coverage, and may only seek emergency care, which costs more and is less effective than sustained treatment. Medications or diagnostic procedures may be viewed as too expensive. Or reliable transportation for follow-up care may not be available.

There are also what are called the social determinants of health (SDoH). These include factors such as consistent transportation, the availability of healthy food, safe and affordable housing, access to education, public safety and working conditions. BIPOC are more frequently negatively impacted by the SDoH. For example, these members are more likely to be homeless or move frequently, which interferes with maintaining consistent treatment. They may lack adequate nutrition and are at greater risk for having associated medical conditions like hypertension or diabetes.

Further, the stigma around mental health conditions, while improving, is still a deterrent to seeking treatment—for everyone. Some cultures may see it as taboo to request help or be seen as someone who needs help.

When BIPOC patients do seek treatment, there may be no one available who speaks their language. In some clinical settings I’ve been in, it could take a week to arrange for an interpreter or a therapist who was proficient in the patient’s language. They may not have a primary care physician (PCP) to help with screening for mental health conditions or provide follow-up care. In addition, the community clinics where BIPOC are more likely to receive care may be understaffed, overcrowded and have long wait times. Understaffing may lead to inadequate screening or even misdiagnosis. And, frankly, the clinic also may not be in a place where the member feels safe traveling so, they may hesitate to go in the first place or return for continued treatment.

Magellan Health Insights: How can everyone, including healthcare professionals, best support minority mental health?

Dr. Rakel Beall-Wilkins: Everyone can help eliminate stigma. Be open to talking and hearing about mental health conditions, and make it clear that you know that having a mental health condition is nothing to be ashamed of. When someone you care about is going through a difficult time, encourage them to get help, and learn ways you can support someone who coping with a mental health challenge.

As healthcare providers, we personally can help by:

  • Ensuring we are taking into account each person’s wishes when referring them to other providers: We should ask every patient whether they prefer to see someone of a specific race, ethnicity, gender or sexual orientation.
  • Educating ourselves to be more culturally competent and making cultural training a priority for our staff.
  • Expanding our workforces with staff from various backgrounds, sexual orientations, cultures and with varied linguistic skills particularly for the unique cultures that are most prevalent in the community.
  • Screening for psychiatric conditions during routine visits. Many patients will report physical symptoms instead of talking about the underlying mental health concerns. PCPs and others see many cases of mild or moderate depression during routine care, and screening every patient can help prevent costly emergency visits and admissions. Self-screening tools can also help.

Beyond what we can personally do to educate and equip ourselves and our staff, I believe that the best solutions come from an integrated, collaborative approach. Everyone can help eliminate the disparities. If we work with leaders in the community, for example in churches and schools, we can raise awareness of mental health conditions, destigmatize treatment seeking, help address the social determinants, and improve the lives of everyone in our communities.




Going Beyond Traditional Benefits: Healthcare Systems Begin to Address Social Determinants of Health

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.




Stuck between a Rock and an Empty Insulin Vial

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?