Take a look at our latest issue featuring eight healthcare executives and their careers.

Managed Healthcare Executive July Issue

Highly anticipated data on Gilead’s novel twice yearly HIV treatment have been announced, suggesting that the therapy is effective in heavily pretreated patients who have stopped responding to other treatments. Early data from a second trial is also indicating that the treatment may yield benefits for patients who have not yet received treatment for HIV.

Presented at the International AIDS Society Conference in July, the results for lenacapavir have implications for the multidrug-resistant patients. The 

 from the Phase 2/3 CAPELLA study showed that lenacapavir was able to suppress HIV in those patients with 81% of the 36 patients having an undetectable level of HIV six months after receiving the treatment.

“Despite the advances in treating HIV infection, there remains an unmet need for treatment options for people who struggle with multi-drug resistance,” said Jean-Michel Molina, M.D., professor of infectious diseases and head of the infectious diseases department at the Saint-Louis and Lariboisière Hospitals, in a prepared statement. “The CAPELLA results are exciting as they demonstrate that an undetectable viral load is achievable in a patient population that has typically had challenges with viral suppression over the course of their journey living with HIV.”

Lenacapavir is currently being evaluated by the FDA for approval in these patients, with the CAPELLA trial forming the basis of Gilead’s application. If approved, it will become the first approved HIV treatment that can be administered just twice a year. Once-daily pills have been the main form of HIV treatment. So far, just one extended-release, injectable treatment for HIV has been approved, ViiV Healthcare’s Cabenuva, a combination of cabotegravir and rilpivirine, which is injected once a month.

These newly released findings for lenacapavir, which were presented by Molina, are likely to strengthen Gilead’s application and perhaps usher in a new era of HIV. Lenacapavir is designed to interrupt various phases of the HIV replication. Many of the current HIV treatment inhibit just one phase of viral replication.

Upon enrollment in the CAPELLA trial, patients continued taking treatment they stopped responding to and were randomized to receive either oral lenacapavir or placebo for 14 days. Following those two weeks, patients entered the maintenance part of the study, receiving subcutaneous injections of lenacapavir every six months for a year in addition to an optimized background regimen.

The findings from these 36 patients showed that the treatment was also generally well tolerated among the patients, with no patients discontinuing treatment because of adverse events and no reported serious adverse events related to the treatment. The most common adverse events were mild injection-site reactions.

Data from a different phase 2 trial called CALIBRATE trial suggests that lenacapavir may also be eventually become a treatment option for patients with HIV who have yet to be treated, a much larger group than the patients who have stopped responding to the current batch of treatment. Results from CALIBRATE, which were also presented the International AIDS Society Conference, showed that a combination of lenacapavir, given orally and subcutaneously, and the oral emtricitabine-tenofovir alafenamide combination (which Gilead is selling as Descovy) resulted in 94% of the 157 patients achieving viral suppression by 28 weeks.

The CALIBRATE trial results also show that lenacapavir is well tolerated.

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The favorable results could mean a new treatment option for patients with HIV whose disease has not responded to other treatments. They may also be another step toward HIV treatment that doesn’t depend on daily pills.





Gilead Reports Positive Results for Lenacapavir, Semiannual HIV Treatment

Climbing the Career Ladder: 10th in a series of 10 profiles of healthcare executives and their careers.

Growing up in Lake Success on Long Island, New York, Adam Sabloff had pinned his dreams to career in the film industry. He spent summers interning at various production agencies in Los Angeles, and after graduating from Emory University in Atlanta, he worked in the mailroom of an agency. “I loved the creativity and people in the industry,” Sabloff, “but I was quickly disillusioned by the spotlight.I wanted to tell stories and I wanted to create, but I didn’t want the fanfare.”

The real estate industry beckoned as the film industry’s appeal faded and faltered. Sabloff’s first job was in Manhattan with the Newmark Group, a large commercial real estate company. Sabloff says there’s more overlap between real estate and film than one might imagine: “There is a tremendous amount of collaboration that takes place between architects, interior designers, trade unions, marketing firms and brands. When it’s over, you have something that was far greater than the sum of the parts.” But his career veered off in an unexpected direction after one of his clients asked him to check out a waterfront property in New Orleans. Sabloff purchased a 75,000-square foot warehouse next to it “on a whim.” To cover the cost, the warehouse was rented out for events and live music. That business evolved into TwiRoPa, a huge entertainment complex with multiple stages and dance floors.

Then, in August 2005, total disaster. And another curve in the career path.

“We had just been named one of the top 10 venues in the country and were in the process of putting a restaurant on the second floor when Hurricane Katrina hit,” says Sabloff. The fledging entertainment center was irreparably damaged by the category five hurricane and Sabloff’s apartment, condemned. He says he lost everything and wound up living with his grandmother in Fort Lauderdale, Florida, while trying to figure out his next move. 

“At the time," he says, "I thought this was the lowest point of my life."

But Sabloff says he became closer to his grandmother — “one of the smartest and most magnetic people I have ever known" — and got an experiential, hard-knocks lesson about the down-then-up dynamics success. “It’s not about getting knocked down. Everyone gets knocked down,” he says. “It’s about getting back up again.”

At this point in his life, for Sabloff, “getting back up again” meant jumping back into real estate. He joined a New York City-based company called Midtown Equities and while with Midtown, Sabloff worked on a Ritz-Carlton Residences project in Baltimore. That undertaking and others opened up his eyes to the healthcare needs of older people and to “next generation care delivery that would make the home an organic extension of the healthcare continuum.” Then a late-stage cancer diagnosis and loss of a close family member hit hard and revealed to Sabloff the gaping shortcomings of American healthcare: extravagant costs, enormous resources in medical personnel and service, bad outcomes.

“If all of our incentives were aligned, why did we all lose?” says Sabloff. “Early detection and treatment would have saved a life, freed up resources, and saved the insurance company money.I vowed to be a part of the change to make healthcare proactive.”

Sabloff founded VirtualHealth in 2012, which markets Helios, a does-it-all care management platform designed to reduce unnecessary ER visits and avoidable hospitalizations, manage chronic conditions, administer community resources for social determinants of health, and align with care with national quality strategies and standards. The company, which is based in New York City, has about 150 employees. Two years ago, it closed Series B financing, bringing the total amount raised by the company to more than $25 million.

As terrible as the COVID-19 pandemic has been, Sabloff says it has pulled back the curtain on American healthcare and shown that it needs to be more proactive. Now is also time, in his opinion, to build on the advantages of digital health that the pandemic spotlighted. Sabloff unapologetically plugs his company’s platform: “Tools like telehealth, transportation coordination, connected devices, wellness apps and wearables, all of which have been part of Helios from its inception, have become exponentially more important. We are on the dawn of a healthcare revolution that was badly needed and long overdue.”

Sabloff says industry veterans were skeptical about his and VirtualHealth’s ambitions: They thought it was too much change too quickly and that legacy products were the better way to go.

He has kept his father’s watchwords in mind. “He would always remind me that ‘if you don’t quit, you’ll win.’ Nothing is more important than perseverance.” Customer service and happy employees also keys to running a business says the product of Lake Success: “In my opinion, there are really only two things that matter — happy clients and happy employees. If you have both you are guaranteed success.”

Sablofff's advice to others is to stay focused, believed in your mission and brace yourself for rejection if you’re trying to break new ground: “Many forget how badly panned the iPad was upon release.”

Adam Sabloff, CEO and founder of VirtualHealth, says his father’s watchwords, “if you don’t quit, you’ll win,” have inspired and motivated him throughout a varied career that has had ups and downs.





Adam Sabloff, VirtualHealth: "If You Don’t Quit, You’ll Win"

FDA approves first interchangeable biosimilar

Developed by Mylan Pharmaceuticals, now Viatris, in partnership with Biocon Biologics, Semglee (insulin glargine-yfgn) is interchangeable with its reference product, Sanofi’s Lantus (insulin glargine), a long-acting insulin analog used to improve the control of blood sugar levels in people with diabetes. Semglee is the 

product approved in the United States. The interchangeable designation means a pharmacy can use Semglee to fill a prescription for insulin glargine, although state-level pharmacy laws apply and may put some limitations on the substitution.

Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. It is not recommended for treating diabetic ketoacidosis. In a 

, Viatris officials said commercial preparations for launch are under way.

, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy before surgery and then continued as a single agent after surgery. The approval is based on the phase 3 KEYNOTE-522 trial, which found that Keytruda resulted in a 37% reduction in the risk of disease progression, a local/distant recurrence, a second primary cancer, or death from any cause.

Additionally, the FDA converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 to a full approval based on confirmatory data from KEYNOTE-522. This approval was originally granted in November 2020 based on results from the phase 3 KEYNOTE-355 trial.

 was first approved as a treatment for melanoma in 2014. It is now approved as a treatment for over a dozen different types of cancers.

FDA approves expanded label for Shingrix in new patient population

 the FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) to prevent shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by disease or therapy. Shingrix, which is administered intramuscularly in two doses, was initially approved in 2017 for the prevention of shingles in adults 50 years of age or older.

GSK’s Nucala approved for new indication

 Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. This is the first anti-IL-5 approved for this indication in the United States.

Nucala is approved for three other eosinophilic-driven diseases. It's first indication was as a treatment for patients with severe eosinophilic asthma aged six years and older. It was also first approved biologic therapy for adults with eosinophilic granulomatosis with polyangiitis (EGPA) and the first approved biologic for patients aged 12 years and older with hypereosinophilic syndrome.

IV form of Uptravi receives approval for PAH

 FDA approval for its IV formulation of Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension. The new IV formulation is approved for adult patients who are temporarily unable to take oral therapy. The approval is based on a prospective, multicenter, open-label crossover phase 3 study designed to assess the safety, tolerability, and pharmacokinetics of temporarily switching between the tablet and the IV formulations. Uptravi tablets were approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for pulmonary arterial hypertension.

Sol-Gel Technologies, an Israeli company, has 

 that the FDA has approved its first product, Twyneo,  for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. The therapy uses Sol-Gel’s patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients to provide a favorable efficacy and safety profile. Sol-Gel has partnered with Galderma, a Swiss company,  to commercialize Twyneo TWYNEO in the United States.

 that the FDA has approved a label expansion of Botox (botulinum toxin) to include eight new muscles for the treatment of upper limb spasticity in adults. These include muscles of the elbow and forearm as well as intrinsic hand muscles and thumb muscles.

Botox was first approved by the FDA in 1989 for two rare eye muscle disorders,  

. Today Botox is FDA-approved for 12 therapeutic indications, including chronic migraine, overactive bladder, incontinence due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, adult and pediatric spasticity, severe underarm sweating, and pediatric detrusor overactivity associated with a neurologic condition.

Olumiant now has EUA as monotherapy for COVID-19

 the emergency use authorization (EUA) for Eli Lilly’s Olumiant (baricitinib) so that it can be now used alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The change in the EUA is based on the phase 3 COV-BARRIER 

, which found that although Olumiant reduced the risk of mortality above the recommended standard of care, without additional safety risks, although it did not meet the primary endpoint based on stages of disease progression, 

The initial EUA was based on data from the adaptive COVID-19 Treatment Trial (ACTT-2), a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Olumiant in combination with Veklury (remdesivir) versus placebo with in hospitalized patients with or without oxygen requirements.

Olumiant has full FDA approval as a treatment for  rheumatoid arthritis in adults.

FDA expands EUA for Regeneron's COVID-19 cocktail

 the emergency use authorization (EUA) for Regeneron's  COVID-19 antibody cocktail, Regen-COV (casirivimab and imdevimab). The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, or who are at high risk of exposure occurring in an institutional setting.

Under the EUA for post-exposure prophylaxis, Regen-COV can be administered by subcutaneous injection or intravenous infusion. The initial 1,200-mg dose can be followed by repeat dosing of 600 mg once every four weeks.

Ardelyx receives Complete Response Letter for kidney disease therapy

Ardelyx has received a complete response letter (CRL) from the FDA for its application for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. A complete response letter from the FDA lists the shortcomings the agency's reviewers found in an application for approval. Regulators noted that data submitted show the treatment effect is small and of unclear clinical significance.

Additionally, the FDA noted that for the application to be approved, Ardelyx needs to conduct an additional well-controlled trial demonstrating clinical relevance on its effect on serum phosphorus. There were no safety, clinical pharmacology/biopharmaceutics, CMC or nonclinical issues identified in the CRL.

Approval of the first interchangeable biosimilar; new indications for Keytruda, Botox, and Nucala; Shingrix label's expanded to a new patient population; and Ardelyx’s Complete Response Letter round out this week's FDA news.


FDA Updates: An Interchangeable Biosimilar for Insulin Leads the Week

Certain types of common antibiotic, antidepressant, anti-nausea and anti-platelet drugs are associated with an increased risk of cardiac arrhythmia and sudden death in older patients, according to a study of Medicare claims data compiled by researchers from the National Library of Medicine (NLM) and FDB (First Databank, Inc.).

The study, “Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study,” was published in the journal 

, which targets research involving the use of real-world data to evaluate health outcomes and inform healthcare decision-making, with a particular focus on healthcare-related big data.

Researchers found 14 of the 17 drugs studied were associated with a higher risk of adverse or fatal outcomes in elderly patients based on analysis of claims data from 1.2 million de-identified Medicare beneficiaries over 5 million patient-years of follow-up.

“Our study shows that there is a definite safety issue with these drugs when prescribed to higher-risk patients such as the elderly, who will likely also require closer monitoring if alternative safer therapies cannot be prescribed,” said Joan Kapusnik-Uner, PharmD, FCSHP, FASHP, vice president of clinical content for FDB. “These findings, based on a deep dive of a large cohort using Medicare claims data, conclude that medication decision support systems that leverage patient-specific risk factors and contextual clinical information could help clinicians identify patients that require therapy switches or closer monitoring to prevent adverse events and save lives.”

Researchers limited their study to non-cardiac drugs with a known risk of QT-prolongation and torsades des pointes (TdP), a type of tachycardia that can lead to cardiac arrest. It was found that although QT prolongation can be measured physiologically, it's an unreliable predictor of the likelihood of evolving into a serious ventricular arrhythmia. This means outcome studies including the measure of sudden death based on large clinical data sets are especially important to assess the risk of drug-induced arrhythmia.

Two types of drug therapies were studied. 

The short-term use drugs studied included: three fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, and moxifloxacin, analyzed individually); three macrolide antibiotics (azithromycin, clarithromycin, and erythromycin, analyzed individually); one antifungal (fluconazole); and one anti-emetic (ondansetron). Nine chronic usage drugs (also known as maintenance drugs) were also analyzed: two selective serotonin reuptake inhibitor (SSRI) antidepressants (citalopram and escitalopram); three antipsychotics (haloperidol, thioridazine, and chlorpromazine); two anti-platelet agents (cilostazol and anagrelide); one anti-rheumatic drug (hydroxychloroquine); and one anti-Alzheimer's disease drug (donepezil).

Of the short-term drugs, researchers found the antibiotics levofloxacin increased the risk of cardiac arrhythmia or sudden death by 51% compared to the amoxicillin control, while erythromycin had an increased risk of 63%. The anti-nausea drug ondansetron increased the risk of a cardiac adverse event by 205%, while the antifungal fluconazole increased the risk by 123%.

Drugs taken for chronic conditions also seemed to result in dangerous QT prolongation among older patients, according to the study. Current patients prescribed the antipsychotics showed an increased risk of arrhythmia or sudden death of 118% compared to patients who never received the drug. Similarly, for both of the anti-platelet drugs, current users had an increased risk of 156%, while hydroxychloroquine showed an increased risk of 68% when comparing patient controls. Current users of both SSRI antidepressants studied showed increased risks, except if the patient had been taking the medication for more than a year, which appeared to help mitigate the risk.

“What was notable for us is that these are common, everyday drugs that are widely prescribed and administered in both inpatient and outpatient settings,” Dr. Kapusnik-Uner said. “The results indicate that prescribers may want to reconsider therapies for their higher risk, older patients if they currently include these drugs, especially if they have relevant cardiac comorbidities or electrolyte disturbances. Regardless, considering this is one of the largest studies of its kind, we hope it leads to further study of meaningful changes in patient prescribing that incorporates more clinically relevant evidence combined with patient-specific QT prolongation risk factor information.”

Hospitals and health systems are deploying new medication decision support tools that can help them identify potential medication risks described in this QT prolongation research. FDB Targeted Medication Warnings leverage patient-specific information within the electronic health record to identify patients who have higher risk, so that the resulting clinical guidance is more selective, actionable and presented at the most appropriate time, such as in the prescribing workflow.

This is achieved by pre-screening or considering relevant patient information first—such as patient lab values, clinical risk scores, and others—with the most up-to-date FDB drug knowledge before generating alerts. This approach targets alerts and guidance in a selective and more meaningful way that is also integrated into clinical workflows.

Study finds antibiotics, antidepressants, anti-platelets and other drugs contribute to adverse events and mortality.

Common Drugs Associated with Increased Risk for Cardiac Disease, Sudden Death in Elderly Patients

Below is a brief Q&A of the interview with Gottesman, which has been edited for clarity.

 Most of our readers and listeners are familiar with a stop loss insurance. So first, could you explain the difference between medical reinsurance and stop loss? And then secondly, is reinsurance completely different from stop loss? Or is it a broader category that includes stop loss?

 Essentially, they are similar in concept. So what you're doing is protecting an underlying risk taker from catastrophic financial exposure to a particular claim. So, whoever the risk taker is, in the case of employer stop loss, ESL, which we're most familiar with, it's almost always an employer group who's self insuring their health plan. So it's just for one employer group. It really goes back to how comfortable they are with their balance sheet, what type of Stop Loss Coverage they're willing to access at what deductible level; so it's almost always specific to just a single employer. That employer group is being administered by a third party claim payer of some sort. It could be it could be a number of entities that are administering the claim. So in the case of medical reinsurance, it's broadly based into three different categories. Broadly, based in sense that an HMO is one risk-taking entity we would reinsure. 

The second broad category is a physician group or provider group. Also, that segment is typically referred to as provider access. Thirdly, there's a category called medical access. Medical access is simply an underlying risk insurance company of some sort that's limiting, or wants to limit their own exposure to something they wouldn't have written. It could be, for example, a stop loss carrier, or someone like a stop loss carrier putting risk into captive. And then they're asking us to reinsure that captive at a certain level. So those are the three broad base categories of HMO provider and medical access. 

 What are the key determinants for the coverage need for medical reinsurance?

: Key determinants are almost always "What's the financial risk tolerance for the underlying entity?" "What can they tolerate based on the size of their balance sheet and what does their CFO think is adequate coverage for the risk they're assuming?" So it's interesting to see the differences and HMO, for example, can manage their own risks quite well, because they're actually performing the services themselves when they're in network and within their own facilities. 

So you may see an HMO saying, "Hey, we can take coverage on our entire patient population, when it's in network, or within our system have a certain high retention or high deductible." And if it does leak out to a specialty facility of some kind, then we'd be less comfortable with that and we'd structure our risk accordingly. Same is true for provider groups. Providers sometimes take risk on a very specific basis from these managed care organizations that they are receiving patients from. So they may want to, and in a lot of cases, these are things people don't see. But there's something called a doper, which is simply a deal for delegation of financial responsibility.

The construct of a of a provider risk contract can get quite detailed. It may be just on inpatient services, it might be on a specific type of care. It might be for a specific patient class, it could be Medicare, it could be Medicaid, or it generally could be on a commercial population, which in those categories, commercial population patients are much more subjected to large dollar swings because there is the underlying Medicare fee schedule. 

Podcasts

In this special episode of Tuning In to the C-Suite podcast, MHE Associate Editor Briana Contreras met with HM Insurance Group Sales Director Adam Gottesman to discuss the ongoing and critical need for reinsurance in healthcare.


The Importance of Reinsurance, Per Adam Gottesman of HM Insurance Group

Climbing the Career Ladder: Ninth of 10 profiles of healthcare executives and their careers.

Gurpreet “Sunny” Singh’s career has been a series of stepping stones – always improving from one entrepreneurial start-up to the next, eventually leading to the successful founding of the now leading global health IT company, Edifecs. Throughout his business ventures and education at the Indian Institute of Technology in his native country of India, Singh approached every opportunity to learn as a new attempt at innovation. With a knack for learning and creativity, Singh took his entrepreneurial spirit to the United States with only $200 in his pocket to attend Montana State University on a full-ride scholarship for industrial engineering.

It was during his time as a student at Montana State where his work ethic and unrelenting drive to succeed took root. Singh accepted as many jobs as he could to send money back home – from tutoring student-athletes, to packing and moving hay bales, and even fishing in Alaska during the summer. When it was time to begin his career in technology and innovation, he joined Expeditors International and then Microsoft, where he started narrowing in on a goal: to make electronic data more accessible, shareable, and optimized, and as a result more powerful.

 in 1996 out of the garage of his home outside of Seattle. The company provides integrated solutions for data exchange, analysis, and insights. Today, it has more than 350 healthcare customers, serving more than 215 million people.

Not all 25 years of Edifecs’ role in healthcare have been smooth sailing The company lost a big deal, IRS notices began coming in, and it had to suspend salaries. The stress of this period was all-consuming, Singh says, but it also drove him turn things around and put Edifecs back on a path to success.

“I figured out how to hustle, to stretch a dollar, to find innovative solutions, to work hard and not accept no for an answer,” Singh sayss. “While these early trials were difficult, they ultimately strengthened the company and led us on a path of tremendous growth and resilience and a valuation of over $1.5 billion in 2020.”

Singh recently transitioned from being CEO to chairing the company’s board. He continues to serve the organization by ensuring Edifecs is on the path to produce leading health IT solutions.

When he’s not serving as chairman, Singh also leads innovative well-being initiatives for the state of Punjab by way of his next entrepreneurial venture, 

Singh said his previous experiences from early childhood in both India and Ghana, through school, and into the first years of his career shaped the leader that he is today. He noted there are a few principles that have been consistent throughout his career. First, would be the people.

“My early experiences gave me an appreciation for what it takes to make a company run successfully,” he says. “Edifecs would not be the outstanding company it is today without our world-class team of associates. They’ve helped build this company and continuously contribute to our growth and success.” 

Second, is the importance and value of workplace wellness: “In order for your team to perform well, you need to ensure they are healthy and happy.”

“Third, you can do “good” while doing “well.” “While I’ve had the opportunity to build Edifecs into a global health IT player, our team has also been focused on giving back to our community and being strong stewards of the planet,” Singh says. “We believe wellness extends beyond the healthcare industry to the planet we all share. Since founding the company, we’ve embraced a green approach to our operations and made conservation a pillar of our culture.”
For those who may sit on full commitment toward their passions or growing their entrepreneurial ventures, Singh recommends following the advice his father passed down to himself.

“My father always encouraged me to pursue my passions and to dream big,” he said. “He also raised me to be generous and compassionate – to honor the human spirit. This is something that I’ve carried with me for my entire life, and it’s shaped the work that I do.”

He said this philosophy stretches from his time at Montana State in the 1980s, directly to his work today in India to improve the lives of billions through innovative wellbeing initiatives with RoundGlass.

Gurpreet “Sunny” Singh, chairman of the board at Edifecs, said he follows a philosophy in life that stretches from his time at Montana State University in the 1980s, directly to his work today, at Edifecs, and in India to improve the lives of billions through innovative wellbeing initiatives with RoundGlass. “My father always encouraged me to pursue my passions and to dream big. He also raised me to be generous and compassionate – to honor the human spirit. This is something that I’ve carried with me for my entire life, and it’s shaped the work that I do.”

Gurpreet “Sunny” Singh, Edifecs: Difficult Roads Lead to Wonderful Destinations

Vice president of client strategy, Welltock

 showed that as a result — under an optimistic scenario — hospitals could face a $53 billion total revenue loss in 2021 because of the pandemic. While the world has begun to reopen, health systems must take action to close gaps in preventive care, annual screenings and elective surgeries. 

Encouraging patients to return to care sooner will not only ensure better outcomes but also ease the healthcare system back to normal. Given the magnitude of postponed care, this will hopefully quell a sudden wave of hospitalizations for newly diagnosed conditions that could overwhelm hospitals that may be facing another COVID-19 surge.

Here are three ways that health systems can optimize their outreach to improve patient outcomes and begin the journey of revenue recovery:

1. Count on the tried and true: Multichannel communications

Multi-channel communications reinforce critical messaging by maximizing reach and frequency. Analyst firm Gartner reported that “integrating four or more digital channels will outperform single- or dual-channel campaigns by 300%.” Simply put, the more an individual is contacted the more likely they are to engage. Using multiple channels increases the likelihood of motivating people to take action.

Engagement channels include text, automated voice, email and direct mail. Each of these has a different appeal for different patients, ranging from the tangibility of a direct mailer to the shelf life of a searchable email. Multi-channel outreach can be applied for a range of uses like an automated voice call to improve COVID-19 vaccine education, a postcard reminder to schedule an annual physical or text messages for preappointment guidelines. Hospitals can see significant results by employing each of these channels. The key, though,  is using data to know which channel resonates best for each patient.

2. Address crucial gaps for relevant populations

With millions of Americans postponing care, every specialty has experienced revenue loss. For health systems to kickstart their revenue recovery, it’s wise to focus on seasonal and age-based services, such as annual health screenings, vaccinations and well-baby visits because these kinds  of services are most likely to bring patients into the office. Focusing on familiar care services such as these first will help organizations maximize their engagement efforts and reach their target audiences without exhausting outreach funds. To further optimize their results, hospitals must identify the customer personas and tailor outreach efforts around their particular needs and motivations.

Additional data points derived from a combination of consumer data, predictive analytics, and social determinants of health insights can identify which patients may be more likely to seek out preventive care, are at-risk for a certain condition or are least likely to opt into elective services. While COVID-19 has reinvigorated the way the world views health and well-being, health systems should still ensure their outreach is personalized to the audiences they want to engage.

Data and insights can also predict what type of message and channel people will be most receptive to. By consistently engaging with patients over their preferred channel, the higher the likelihood that the patient will engage with the outreach and act.

Health risk assessments (HRAs) can be beneficial to gauge patients’ health needs and priorities. These questionnaires engage patients and aggregate data that are designed to be useful for personalized recommendations. Since the data collected come directly from a patient, health systems can see a significant increase in the success of targeting efforts for initiatives like annual appointment scheduling. HRAs can be promoted to a patient base with predicted data modeling that identifies those who are most likely to fill it out, thus bolstering the database’s ROI and information quality. Given that not everyone is comfortable returning to in-person visits in the clinical setting right now, these are a valuable intermediary to connect with patients and learn about their health concerns directly and in safe manner. 

The way that hospitals marketed themselves before the pandemic is not going to work now. Patient needs and expectations have changed. The hospitals and health systems that embrace more of a high-tech and high-touch world will be successful today and into the future, especially when it comes to closing critical care gaps. Patients want to hear from them, and traditional strategies aren’t going to cut it. 

By using data to identify patients most likely to close a care gap and then using multiple channels for more touchpoints, new leaders will emerge that drive patient engagement and improve health outcomes all while growing the bottom line — a win-win for everyone involved.

is vice president of client strategy for Welltok.

Hospitals can't go back to their old ways. They need high-tech, high-touch strategies to engage patients.

Closing Gaps in Care: Improving Patient Outcomes and Revenue Recovery

In what may usher in a new era of competition on price among insulin products, FDA has approved the first interchangeable biosimilar insulin product.

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product, Sanofi’s Lantus (insulin glargine), according to the FDA approval yesterday. Being interchangeble means that Semglee doesn’t need to be explicitly prescribed and can be substituted for Lantus by a pharmacist who is filling the prescription.\

The FDA has approved 29 biosimilars but Semglee is the first that wasapproved as being interchangeable with its brand-name reference product.

The FDA approved Semglee last year and it has been on the market since but interchangeable designation is likely to increase its use and is intended to stir up vigorous price competition between Semglee and Lantus.

Theinterchangeabilityapproval was announced yesterday in a press release by the FDA. Biocon Biologics developed Semglee and Biocon’s distribution partner is Viatris, a company that is the result of a merger between Mylan and Upjohn.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D., in the 

The approval “furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock added.

Biosimilars in the U.S. typically have launched with initial list prices that are 15% to 35% lower than the list prices of the reference products, FDA said.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, M.S., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber, FDA explained. The substitution may occur at the pharmacy — “pharmacy-level substitution”—much like generic small-molecule drugs are now substituted for brand-name drugs, although there is state-to-state variability because state-level pharmacy laws apply to interchangeability. In most states, patients will need to be told they are getting an interchangeable biosimilar and pharmacists will not be allowed to make the switch if the prescribing physician have expressly indicated they are prescribing the reference product (in this case, Lantus).

The approval of Semglee as an interchangeable biosimilar to Lantus is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between them.

Research has shown that Semgleecan be expected to produce the same clinical result as Lantus in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee and Lantus (insulin glargine) is not greater than the risk of using Lantus without such switching, the FDA said.B

 for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.

An FDA First: Semglee Is Approved As An Interchangeable Biosimilar

As we come to a stabilizing stage in the pandemic, there is a refocus back to the quest for value-based care. Who will be the next generation access decision makers (NADMs) that will successfully take the triple aim premise of value-based care, couple them with the lessons learned from the pandemic, scale these up, and sustain success over time to make a palpable difference in the US healthcare system?

As it turns out there are a lot of players taking aim and the target is a person’s first key point of contact with health services and the key point of entry to the entire health system - the primary care gateway. It also plays a significant role in shaping and determining a consumer’s overall access to various services and resources within the health ecosystem.

Emerging from the pandemic there are now many payers, health systems, and new entrants looking to become the NADMs to transform this gateway entry and shape the entire patient journey. NADMs are increasingly focusing on health and well-being while impacting access to downstream services and therapy utilization that is being driven by two Nextgen Models.

As consumers increasingly turn to virtual care for their healthcare needs due to the pandemic, companies such as Teladoc, MDLIVE, Amwell and many others, are addressing consumer’s short and long-term health issues including wellness and prevention care, chronic conditions such as diabetes, mental healthcare, dermatology, and other health conditions remotely. The use of virtual services has skyrocketed in the last year and has provided these Nextgen Virtual Care Delivery Models with incredible opportunities to gain a solid footing in delivering healthcare differently and quality care anywhere.

Nextgen Hybrid Care Access and Delivery Models

In addition to these primarily virtual care access models, other entities such as Amazon, CVS Health, Cigna’s Evernorth, Oak Street Health, Optum, Oscar Health, Walmart and many others are redefining the entry level of care leveraging virtual and in-person care delivery models – the hybrid model for patient optionality and convenience. While redefining the entry level of care and primary care, they are also creating new integrated healthcare ecosystems focusing on wellness and lifestyle changes, social influencers of health, chronic and population health, mental and behavioral health, streamlined pharmacy benefits as well as other services, where, when, and how the consumer wants it. 

These NADMs are seeking to redefine and optimize the patient experience, leveraging patient convenience and connectiveness while pursuing affordable and cost value care. As these organizations seek to leverage this hybrid model to change how consumers access care from the onset of a need or issue to addressing acute or chronic care conditions, to influencing the services and therapies patients utilize across their healthcare journey, they look to impact healthcare utilization and costs across the care continuum.

As the scaling of NADMs virtual care and hybrid models continue, they will increasingly become a first point of contact and gateway into the healthcare system for health services. The ecosystem, however, is extremely complex thus the strategies being put in place within these models, accelerated by new technologies, are helping to advance key focus areas NADMs are tackling to further establish themselves as next generation healthcare access providers and decision makers in the evolving healthcare landscape.

It is extremely critical, therefore, that traditional healthcare systems and practices pay attention to these gateway-to-health strategies, catalyzed in part by the pandemic and NADMs entrants to the game. They will need to transform their current organization and/or partner with these entities to leverage evolving health innovations and practices with their own experience to further accelerate the shift towards value-based care.

Drug manufactures and device companies with also need to work closely with these increasingly influential entities as they continue to raise the bar on value demonstration of resources including therapies, services, and digital devices against their costs.

So, as we head into the next generation of care and NADMs continue to grow and scale, gain influence and experience (especially the non-traditional healthcare entities), their impact on downstream access to specialty services, drug costs, and therapy utilization could be significant. Their aim is to deliver care differently and their goal is to go beyond the triple aim to the quadruple aim where patient and population outcomes will be optimized, the patient experience enhanced, the total cost of care reduced, while at the same time create an environment where the work life of clinicians and staff is supported so that they can deliver high quality affordable and patient-centered care to all.

Authors are Elizabeth Oyekan, PharmD, FCSHP, CPHQ, and Dominic Galante, MD, Chief Medical Officer, Precision for Value.

As we come to a stabilizing stage in the pandemic, there is a refocus back to the quest for value-based care. Who will be the next generation access decision makers that will successfully take the triple aim premise of value-based care, couple them with the lessons learned from the pandemic, scale these up, and sustain success over time to make a palpable difference in the U.S. healthcare system?









NextGen Access Decision Makers Influencing Impact on Services and Therapies Across the Healthcare Ecosystem

Source: Vizient Summer 2021 Pharmacy Market Outlook

Hospitals, health systems and other nonacute providers will spend 3.1% more on drugs next year, with oncology drugs accounting for roughly quarter of the expense, according to a 

Vizient, historically a group purchasing organization for hospitals that now bills itself as healthcare performance improvement company, based the result on analysis of its members’ purchasing pharmaceutical data. The company, which is headquartered in Irving, Texas, also surveyed members about 

The report, titled the Summer 2021 Pharmacy Market Outlook, discusses the effect of the COVID-19 pandemic on drug expenditures and usage. Between April 2020 and March 2021, the hospitals and healthcare providers in Vizient’s drug purchasing database spent more money purchasing remdesivir, the antiviral sold under the brand name drug Veklury, than any other drug besides Humira (adalimumab), the immunosuppressive drug used to treat a variety of autoimmune diseases, and Keytruda (pembrolizumab), the leading drug among the new generation of cancer drugs that work by harnessing the immune system.

Vizient analyst also had access to a clinical database that included 436 hospitals to track the usage of COVID-19 medications. As the report notes, use of 

, a low-cost corticosteroid with anti-inflammatory effects, shot up in July 2020 after the report in June that it was effective in reducing mortality from COVID-19. Vizient’s data shows that by November, about 70% of hospitalized COVID-19 patients were treated with dexamethasone. The Vizient data also show steep climb in the use of remdesivir starting in May, the month that the FDA issued an emergency use authorization for the drug.

The Vizient identifies specialty drug as a major factor hospital and other provider organization spending, with spending expected to increase by 4.68%. FDA approval of increasing number of drugs for rare diseases and Humira price hikes prior to 2023 when biosimilars to Humira are scheduled to come on the market are the main reasons for the upward trend, said the press release about the report.

The report sounded an optimistic note about insulin and biosimilar competition. Early last year, insulins were reclassified in such a way as to open them up to biosimilar competition, Vizient noted. The report also mentions the possibility that 

, a spin-off company from Pfizer, is seeking FDA approval for versions of insulin glargine and insulin aspart that would be 

How ‘White Bagging’ Affects Patients, Physicians and 340B Funding

The Vizient report covers a wide range of topics from overall spending patterns to white bagging to FDA’s accelerated approval pathway and the use of surrogate markers.

Cancer drugs are the big-ticket class (24.3% of the spend) followed by drugs to followed by infectious disease products (12.77%) and the disease-modifying antirheumatic drugs, or DMARDs (11.4%). Vizient says the therapeutic class with the highest estimated price change next year is DMARDs because of anticipated Humira and Enbrel (etanercept) price hikes.

Inpatient volumes at hospitals will rebound but not quite return to prepandemic levels, Vizient predicts. The company says inpatient volume is expected to decrease by 1% over the next decade, partly because of the push to changing the side of care to lower-cost outpatient facilities.

Vizient said “premixed drug formulations” of drugs that used to be combined (“compounded’) in-house is a “notable trend.” The report gave Myxredin, an insulin product, as an example of premixed drug that is far more expensive ($420.20 vs. $14) than the version that could be created in hospitals and other facilities. “While patient safety is paramount and ready-to-use/ready-to-administer formulations may offer a safety advantage (e.g. reduction in compounding errors), it is also paramount for the industry to strike a balance between charging a premium for safety and innovation and taxing providers with a price increase.”

The report applauds biosimilars and generics coming on the market. Vizient mentioned that four generic versions of intravenous acetaminophen have come on the market starting late last year, giving the brand-name version, 

, some competition. But the report also noted the Humira biosimilars won’t be on the market for another two years and that biosimilars to Humira will perhaps be most impactful given the price of the drug and how commonly it is prescribed.

The report includes criticism of white bagging — the provision of a medication directly from a pharmacy to a patient. Specialty pharmacies and payers say white bagging is safe and saves money because it eliminates the “buy and bill” markup providers charge when they take possession of the medication and administer it. But Vizient says white-bagging as disrupts patient care and winds up adding cost, not saving money. Today’s report includes results from a survey Vizient conducted from March 24, 2021, to April 16, 2021, that had 268 respondents. According to the report, 83% of the respondents said they had an experienced a white-bagged drug not arriving in time for administration and 68%, a white-bagged medication that was the wrong drug or the wrong dose.