This issue includes the annual Emerging Health Leaders feature where we've spotlighted 13 young healthcare executives and innovators shaping the future of American healthcare.

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Vice president of business growth at Lightbeam Health Solutions in Irving, Texas

It’s nearly unanimous: 98% of healthcare executives believe population health management is important for their organizations’ future success, according to the 

 released in August. A combined 93% of respondents rated it between moderately and critically important.

These population health care models are often tied to some type of value-based care (VBC) payment, which rewards positive health outcomes and cost control. When asked about VBC, the same surveyed executives expressed concern about the possibility of financial loss when patient outcomes are linked to such payments. Only 31% of respondents reported they were at least very prepared to accept financial risk for managing patient populations.

Much of the concern over population health management may stem from the sheer number of patients attributed to an accountable care or some other type of population health management program. ACOs and health systems can suffer significant financial losses in risk-bearing VBC payment models when such care is not delivered strategically and efficiently. Certainly, every patient deserves the highest-quality care, but only a small segment requires the resource-intensive care outreach and management that can drive up costs and drive down VBC financial performance.

Risk stratification is the key to an efficient population health management program. ACOs and health systems understand their highest-risk patients are often their most expensive and the most challenging to manage. This is also true on a national level. A RAND study published in 2017 found that although only 12% of U.S. adults have five or more chronic conditions, they account for 

. Similarly, according to data from the Partnership to Fight Chronic Disease, the average annual healthcare cost for an American with no chronic conditions is $6,000. For people with five or more chronic conditions, the annual cost per person soars to $45,000.

Multiple chronic conditions do not only affect the frail, elderly population, either. The RAND study found that although patients, age 65 and older are most likely to have multiple chronic conditions, approximately half of the patients in their mid-40s to mid-60s also fall into that category.

Identifying and devoting care management resources to the highest-risk, highest-need patients is a well-established best practice for ACOs and health systems. The key to efficiency and success under VBC models, however, is a more strategic approach to risk stratification. The strategy involves targeting nonelderly patients highlighted in the RAND study between the fifth and 20th percentile of risk. These “rising-risk patients” likely have conditions, such as diabetes or hypertension, but overall are healthy. However, if left unmonitored, one in five of these rising-risk patients will escalate into the high-risk bucket annually. Given rampant nursing shortages, a lower-touch, automated approach with rising-risk patients eases burden on care managers while helping to increase adherence to care plans across a broader swath of patients. In this way, proactive intervention can be taken only against patients who need it, helping to avoid costly emergency department visits and hospitalizations.

As the manufacturing industry learned many decades ago, efficiency boils down to eliminating unnecessary steps and automating processes wherever possible. While patients are not cars or refrigerators, healthcare organizations that want to succeed in population health management and value-based care can still learn from these business principles.

In population health, for example, data management represents a major opportunity to automate processes based on identifying and highlighting patterns within said data. Collecting, analyzing, and sharing data across disparate sources, including multiple electronic health record systems, claims, public disease registries, and elsewhere, can be time-consuming and unproductive. Moreover, care managers using this data are often nurse-level clinicians who are increasingly receiving larger salaries due to the major labor shortage across the industry. Any minute spent on repetitive processes that can be avoided with automation is a minute they are not managing patients. Wasting this time is costly for the health system and does not support scaling optimal patient outcomes.

Fortunately, after starting from nearly ground zero at the dawn of the Internet era, the healthcare industry has made some strides in eliminating data silos and the manual effort historically associated with health data management. Building on this progress, efficient population health management today requires the right tools in terms of both back-end infrastructure (databases and analytics platforms) and “last mile” solutions, such as remote patient monitoring and apps for patient engagement, clinical coordination, and Hierarchical Condition Category (HCC) coding.

By using data and engagement capabilities (including texts, emails, and automated phone calls) to monitor and gather information from these rising-risk patients, providers can gauge whether a chronic condition is trending in the wrong direction and intervene before the patient becomes high-risk and high-cost. That’s effective and efficient population health management in action.

When dedicated physicians, nurses, and other clinicians waste time and effort, healthcare organizations are also squandering opportunities to deliver high-quality patient care and improve financial performance more broadly across their at-risk patient populations. Since there is a finite supply of healthcare with an ever-increasing demand, ACOs and health systems need to adopt automated, efficient population health management strategies to help them extend their reach well beyond their highest-risk patients.

Implementing technology to handle the time-consuming data management tasks empowers care managers and other clinicians to practice at the top of their licenses and productively deliver cost-effective preventive care that improves patient experience and results in optimal outcomes.

is the vice president of business development at 

Articles

The key to efficiency under value-based care models is a strategic approach to risk stratification.

Successful Population Health Management Hinges on Efficiency

Additional COVID-19 vaccine boosters receive EUA; positive results for Pfizer booster.

 an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine booster dose for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to the virus.

The agency also authorized a single booster dose of the Moderna’s COVID-19 vaccine for people who have completed a primary vaccination with other authorized or approved COVID-19 vaccines.

 for Johnson & Johnson’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine, and for eligible individuals who received a different authorized or approved COVID-19 vaccine.

The J&J booster will be the same formulation and dosage as the primary shot.

 an efficacy rate of 95.6% for their COVID-19 vaccine booster. The phase 3 randomized, controlled study encompassed more than 10,000 individuals 16 years and older.

FDA approves novel therapy for macular degeneration.

 Genentech’s Susvimo (ranibizumab) for the treatment of patients with wet, age-related macular degeneration (AMD). Susvimo is a refillable ocular implant that delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.

Susvimo was generally well-tolerated, but the implant was associated with a three-fold higher rate of infections than monthly intravitreal injections of ranibizumab. In clinical trials, 2% of patients with an implant experienced at least one episode of endophthalmitis.

Many of these events were associated with conjunctival retractions or erosions. Conjunctival retraction is an opening or gaping in the layer (conjunctiva) that covers the white part of the eye, which may cause the implant to be exposed. Conjunctival erosion is an area that becomes missing in the conjunctiva. Both of these events may require surgery.

In clinical trials, the most common adverse events were conjunctival hemorrhage, conjunctival hyperemia, iritis and eye pain.

FDA approves Dupixent for children with asthma.

 Dupixent (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent is the only biologic to improve lung function in children 6 to 11 years old.

 Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. It is the first nasal spray approved for this indication.

The therapy, developed by Oyster Point, is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease.

Tyrvaya is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease. Nasal delivery may allow some patients who have difficulty independently administering topical eye drops.

Tyrvaya will be available in November 2021 in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril.

FDA approves Biktarvy for young children with HIV.

 a new low-dose tablet dosage form of Gilead’s Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg) for pediatric patients living with HIV-1 infection.

The approval is based on data from a cohort of patients in a phase 2/3 study, which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing between 14 kg and 25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase.

Nearly 3 million children worldwide under the age of 19 are living with HIV. An estimated 120,000 children and adolescents died from AIDS-related causes in 2020. About 72% of these deaths occurred among children under 10 years old.

FDA approves ZIMHI to treat opioid overdose.

 ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection. It was developed by Adamis Pharmaceuticals.

ZIMHI received approval through the 505(b)(2) approval pathway, which allows review of FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. In this case, Adamis’ application relied, in part, on the FDA’s finding of safety and effectiveness for Narcan injection to support approval.

 Dr. Reddy’s abbreviated new drug application for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and given a tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is a therapeutic equivalent generic version of Celgene’s Revlimid, which is an oral cancer drug that is used for the treatment of multiple myeloma.

With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg.

In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug. Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the United States beginning on a date sometime after March 2022.

Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the United States without volume restrictions beginning on Jan. 31, 2026.

FDA issues complete response letter for Tyvaso DPI.

 for United Therapeutics’ new drug application for Tyvaso DPI (treprostinil), for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

The regulatory agency noted a deficiency related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.

Tyvaso DPI is a drug-device combination therapy comprised of a dry powder inhalation formulation of treprostinil. It was developed through a collaboration with MannKind, which developed the inhalation technology that is also used in MannKind's Afrezza (insulin human) inhalation powder product.

A nebulized formulation of Tyvaso is already available to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Company officials expect the DPI version to be available by the summer of 2022.

In COVID-19 news, the FDA issues EUA for both Moderna’s and J&J’s COVID-19 booster. In new drug approvals, there is a novel therapy for macular degeneration, new therapies for eye disease and opioid overdose, as well as new therapies for asthma and HIV in children.

FDA Updates for Week of October 18, 2021

Healthcare disparities, biosimilars, and digital therapeutics were among the topics featured at the education sessions of the AMCP Nexus 2021 meeting this week in Denver.

Academy of Managed Care Pharmacy (AMCP) officials said 1,914 people attended the in-person meeting at the Gaylord Rockies Resort and Convention, the first meeting that AMCP has held since AMCP Nexus 2019 meeting in the fall of 2019.

AMCP required attendees to be vaccinated against COVID-19 but also had separate protocol that involved verifying a negative COVID-19 test 72 hours prior the meeting. All attendees were also offered free onsite COVID-19 testing. The meeting had a requirement that people wear masks for indoor activities but from casual observation a large percentage of those in attendance were not wearing masks.

The meeting’s app listed 52 exhibitor and the exhibition hall was teeming with people during the meeting, which started on Monday and ended Thursday. The featured keynote speaker on Tuesday as 

, an inspirational speaker and spoken word artist.

“I had envisioned this meeting as a ‘managed care pharmacy reunion,’ but I didn’t anticipate the electricity that permeated every session and networking experience,” said Susan Cantrell, RPh, CAE, the CEO of AMCP. “It’s a catalyst for the work AMCP is undertaking through our new strategic priorities — optimize value and access, address health disparities, and smart membership growth — to get patients the medications they need at a cost they can afford.”

In addition to the broad themes of the education session, the meeting included 

 on research into nuts-and-bolts issues in managed care and manage care pharmacy, such as the economic burden of migraine, the demographics of people who take antiobesity medications and screening for hepatitis C at federally qualified health centers after the start of a pharmacist-led management program of the direct acting antivirals.

The meeting started on Monday with a panel discussion on best practices in addressing healthcare disparities and three other education sessions focused on disparities. Three of the education sessions focused on biosimilars and three others, on digital therapeutics.

In the Monday panel discussion, Aimee Loucks, Pharm.D., BCPS, manager, specialty pharmacy programs and formulary, Kaiser Permanente Washington, described a program to identify whether health plan practices, such as prior authorization and utilization management edits, might inadvertently contribute to healthcare disparities. 

In a session on Tuesday, Sharon K. Jhawar, Pharm.D., MBA, BCGP, chief pharmacy officer of the SCAN Health Plan, a Medicare Advantage in Southern California, and Timshel Tarbet, MBA, BSP, CCP, vice president of excellence and diversity, described the health plan’s effort to reduce racial disparities in medication adherence. They both emphasized that dealing with disparities is a process that is not accomplished quickly or perfectly in the first attempts. 

“It is a journey — we are learning so much through this process” said Jhawar.

Jeffrey Casberg, vice president, clinical pharmacy, for 

, a drug management and market access company, was one of the speakers on biosimilars. “I think the theme is that it seems like the tide is turning, market share is picking up, adoption is picking up,” he said in an interview with 

In the Tuesday afternoon session on prescription digital therapeutics, the panelists were enthusiastic about the data collection inherent to digital therapies. Patrick Gleason, Pharm.D., BCPS, FCCP, FAMCP, assistant vice president, health outcomes, at Prime Therapeutics, said data from digital therapies will make it easier for payers to administer value-based contracts for those therapies. 

“The payer can audit if they are concerned about that the information that is being provided back and fulfillment of the terms of the contract,” Gleason said. “But it is a lot less of burden on the payer in value-based contract as result of the way the data is being collected.”

Disparities, biosimilars and digital therapeutics were among the featured topics at the meeting in Denver that had 1,900 attendees.



AMCP Nexus 2021: A Wrap-Up

Videos

Michael Palantoni, vice president of platform services at Athenahealth, is one of the emerging health leaders featured in the October 2021 issue of Managed Healthcare Executive. In this video he talks about the career achievement that has given him the greatest satisfaction and who has had the greatest influence in his life, which are his parents, sister and aunt and uncle.

Michael Palantoni Says Building a Platform Business out of Athenahealth Considering Challenges to Innovate in Healthcare Has Been Rewarding 

Michael Palantoni, vice president of platform services at Athenahealth in Watertown, Massachusetts

I grew up outside of New York City and graduated from Johns Hopkins University with a concentration in systems engineering. Prior to my current role at Athenahealth, I was a management consultant at Deloitte Consulting, where I specialized in healthcare and technology.

Some of my formative leadership experiences at Athenahealth have been leading our patient engagement teams and running the Athenahealth Marketplace (app store) business. These have been great opportunities to learn from consumer-focused executives and to have front-row seats to the explosive growth of the health-tech ecosystem over the past five years.

At Deloitte, I worked on the firm’s response to the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which involved building models for how meaningful use requirements and funding would impact the industry. This was my introduction into healthcare technology strategy.

Who has had the greatest influence on your life?

On a personal level, definitely my wife. We’ve been together since we were 19, and she has been my consultant for virtually every major decision of my adult life. She’s incredibly mission driven and really grounds me. From a pure career perspective, I was fortunate to work with a unique group of senior people at Deloitte who showed me what could be possible with technology in healthcare at an early career stage. That influenced me to consider how I could best use technology in the healthcare space.

Why did you pursue a career in healthcare?

My mom battled and ultimately passed away from cancer and its complications during the four years I was in high school. During those years, I struggled to find an outlet for processing this and ended up channeling it into my education at college, my career and my purpose.

I became very focused on healthcare and medicine. I shadowed staff in various medical areas at a hospital and worked on a project to evaluate provider-to-provider communication in a new hospitalist program. I believe they gave me this project as an internal experiment. Ultimately, I discovered I really enjoyed this type of “systems thinking” work as an outlet for both my purpose and strengths.

Which career accomplishment has given you the greatest satisfaction?

I built a platform services business that enables others to innovate in healthcare quickly and effectively. This involved starting with a business plan, selling it to initial customers and then leading the product team to grow its capabilities. Seeing it launch as a mainstream part of our business has been an incredible journey.

I can’t think of anything more rewarding than enabling others’ innovation in healthcare delivery and patient experiences.

What has your organization’s role been in the rollout of COVID-19 vaccines?

Over the past year, Athenahealth has built a significant number of COVID-19 vaccine workflows in real time to help provider organizations create and administer vaccine delivery programs.

What would be the best way to reduce healthcare inequities in the U.S.?

I don’t think there’s a single best way. If you look at the challenges the healthcare industry is facing in addressing inequalities and access to care, they are multifactorial. There must be a layered approach that looks at everything from social determinants of health to local healthcare access levels to addressing clinical biases.

Name a book or article that everyone in healthcare should read.

“The Square and the Tower: Networks and Power, From the Freemasons to Facebook”by Niall Ferguson is a great primer on network theory and strategies. A key insight in the book is how people and organizations that are connected to more things are generally more resilient and influential in times of change. For example, a supply chain with only one supplier is more likely to be very brittle and might create risks for that company during a crisis like COVID-19. In healthcare, there are many implications for how providers build referral networks and how their design impacts access, quality and costs for patients.

Michael Palantoni is one of 13 up-and-coming health leaders featured in this annual Managed Healthcare Executive series.



Emerging Health Leaders: Michael Palantoni of Athenahealth

Brenden O'Hara, clinical pharmacist of Blue Cross Blue Shield of North Carolina, discusses innovations in diabetes management and what’s to come in 2022 at AMCP Nexus 2021.

AMCP Nexus 2021: Brenden O'Hara of BCBS of NC Talks Innovations in Diabetes Management and What’s to Come in the Next Year

Juday, director of specialty product development at CVS Health, shares how CBT’s for insomnia can save payers and can yield cost savings with or without a digital component.

AMCP Nexus 2021: Theresa Juday of CVS Health Shares How CBT’s For Insomnia Can Save Payers Money

Jeffrey Casberg, M.S., RPh, was a speaker at one of the three sessions devoted to biosimilars at the AMCP Nexus 2021 meeting in Denver, and he is not alone in believing that biosimilars are gathering momentum.

“I think the theme is that it seems like the tide is turning, market share is picking up, adoption is picking up,” said Casberg, who is vice president, clinical pharmacy, for 

, a drug management and market access company, in an interview with 

Casberg said he expects less push back from physicians as they prescribe biosimilars and their patients don’t report adverse reactions. And like many in the pharma industry he has an eye on 2023 when biosimilars to Humira (adalimumab) are expected to come on the market.

“I think over next 24 months, including the launch of the Humira biosimilars, will be the turning point,” he said.

Much has been made of interchangeability of biosimilars — whether the biosimilar can be substituted for the brand-name reference product at the pharmacy without the prescriber getting involved. Casberg said interchangeability will be a major factor in the insulin market because insulin tends to be dispensed at regular pharmacies. The FDA approved the 

, Semglee (insulin glargine-yfgn) in July. The reference brand-name product is Lantus (insulin glargine). But Casberg said interchangeability may not matter as much for the biosimilars dispensed through specialty pharmacies.

“Specialty pharmacies tend to have a lot of patient-provider contact anyways so they are going to be calling the physician for approvals whereas at the pharmacy things are done more rapidly and the pharmacist can take advantage of that interchangeability designation.

State-level pharmacy laws may affect interchangeability. The distribution of Semglee started this week, Casberg said, so the legal status of interchangeability will start to get tested.

Physicians are more likely to be comfortable with starting a patient on a biosimilar rather than switching them from a reference brand-name drug to a biosimilar. But Casberg said he expects some payers to start requiring “conversion” to a biosimilar. “Once they do, that is going to be a turning point,” he said.

In his presentation on Wednesday, Casberg shared data that showed the drop in the average sales price of the reference brand-name since the first biosimilar was approved, the number of biosimilars, and the market share of the biosimilars and the reference product. In some cases — notably, Remicade (infliximab) — the biosimilars haven’t cut into the reference product’s market share. Even so, the biosimilars seem to have had exerted some downward pressure on the price of Remicade. Casberg says price pressure without significant market share isn’t tenable over the long term.

“If biosimilars don’t end up being adopted eventually, manufacturers won’t make the products and we won’t see ASP (average sales price) decreases. We need biosimilars adoption to make this work.”

Consultant Jeffrey Casberg says biosimilars are coming on strong and that interchangeability may not be much for the products dispensed through specialty pharmacies because specialty pharmacies are often in frequent touch with physicians.

AMCP Nexus 2021: Biosimilars Are Gathering Momentum — and Interchangeability May Not Matter for Many of Them

Page and Taddei-Allen of WellDyne discuss precision medicine and its implications for pharmacy management at this year's AMCP Nexus Conference

AMCP Nexus 2021: WellDyne's Nick Page, Pharm.D., Chief Pharmacy Officer, and Patty Taddei-Allen, Pharm.D., MBA, BCACP, BCGP, Discuss Precision Medicine and its Implications for Pharmacy Management