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Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D, spoke with Managed Healthcare Executive, talks about the possible impacts of the NIH’s cuts to indirect research funding.

Cuts to Indirect Research Costs To Impact Type 1 Diabetes

CVS Health Names Ed DeVaney President of CVS Caremark

Here’s what you missed this week on Managed Healthcare Executive.

MHE Week in Review – RFK MAHA Commission, CVS Transformation Journey and More

Inhalon plans to begin a human challenge for their inhaled antibody therapy study in 2026.

Inhaled Antibody Therapy for RSV Moving Forward

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Consider these five opportunities to help curb one of the biggest public health issues of the year.

Five ways health executives can impact the opioid crisis

Consider these tactics that analyze and address medical errors at a system level.

Four ways to reduce dangerous medical errors at your hospital

Although doctors prescribe pharmaceuticals for various ailments, they also understand that drugs are only one way to improve a patient’s health. Another is food. The “food is medicine” movement is not new, but it is gaining prominence. The idea is to bolster treatment by providing nutritious foods and medically tailored meals to address diet-related illnesses (diabetes, heart disease and some cancers) and supporting those with conditions such as cancer and kidney disease.

The food is medicine concept is wide-ranging, from specifically made, medically tailored meals to produce prescriptions to nutrition security programs such as the Supplemental Nutrition Assistance Program. One problem for payers — whether government programs, private insurers or philanthropies — is ensuring that the program provides nutritious and appropriate foods. What’s missing from this equation is standards.

Studies have shown that medically tailored meals can improve health metrics. A recent study by the

 investigated health outcomes of medically tailored meals. It found that 62% of clients with hypertension significantly improved their blood pressure and those with diabetes improved their hemoglobin A1c levels when receiving these meals for at least two months, indicating that their diseases may be better managed through proper nutrition. Also, 88% of those with obesity decreased their body mass index or ensured it remained stable. In 

, researchers estimated that in Pennsylvania, increasing access for at-risk patients could save $4,370 per patient annually in health costs.

Another study showed that providing medically tailored meals for those with diet-sensitive conditions and activity limitations could save $13.6 billion in national healthcare costs, averting 1.67 million hospitalizations annually.

Drugs approved by the FDA undergo rigorous testing. “People go to the pharmacy and don’t question [quality] because it’s approved,” Sue Daugherty, R.D.N., L.D.N., CEO of MANNA, an organization providing these meals to people with serious illnesses, says. “With medically tailored meals, anyone can say they’re doing it and there’s no regulation on what that means.” There has been some controversy, however. Some medically tailored meals have been marketed as “dietitian approved,” including meals marked as “heart healthy” or “renal friendly,” that contain high levels of saturated fat, sodium and additives.

Gaining accreditation can assure payers and patients that the food includes nutritious components in the right quantities. “There has to be some type of regulation showing you’re getting what you were prescribed,” says Daugherty. MANNA was 

 by the Food Is Medicine Coalition last month. The coalition is a nonprofit national collective of agencies providing medically tailored meals. The accreditation is rigorous, Daugherty says. During the accreditation process, meals are tested; for a renal diet, the testing measures how much phosphorous, potassium and sodium are in a meal, for example. Also, patients and the program must have access to dietitians.

MANNA has been providing patients with medically tailored meals since 2005. In 2023, they served meals to patients with 85 different illnesses. Diabetes is the disease required for most people entering the program. “Our research shows that we have [the] most impact on superutilizers — the 5% who cost the healthcare system 50% of the [healthcare] cost,” she says. These patients have complex needs. She is seeing an increase in patients with high-risk pregnancies or heart diseases receiving meals for whom low-sodium diets are recommended.

Standardizing how to identify a person’s social risk factors and using validated screening tools are important to appropriately refer patients to community-based providers, Denise Diaz Payán, Ph.D., M.P.P., an associate professor at the University of California Irvine Joe C. Wen School of Population & Public Health, says. “People are using all kinds of screening tools at their convenience,” she says. “You’ll hear feedback from facilities that they don’t have time, they don’t have a person to do the screening.”

Medically tailored meals are an appealing idea, but there is little regulation or standardization.

Clinical

A Key Ingredient to ‘Food is Medicine’: Standardization

The Cigna Group released their revenue report for 2024 which showcased their 27% revenue jump to $247.1 billion — with Evernorth much to credit.

Evernorth, which includes pharmacy benefit services such as Express Scripts, contributed to the increase that clocked in at $195.3 billion in 2023.

David M. Cordani, chairman and CEO of The Cigna Group, highlighted Evernorth’s contributions during a conference call discussing the results.

“Evernorth continues to drive strong results in line with our expectations, primarily driven by our specialty and care services segment,” Cordani said.

The numbers highlight this statement, with pharmacy benefit services reaching $111.8 billion in adjusted revenue, a 46% jump from $76.8 billion in 2023.

Cigna's 27% Revenue Increase in 2024 and the Outlook on 2025

In addition, specialty and care services recorded $90.3 billion in adjusted revenue, marking an 18% increase from the previous year.

Evernorth's growth pattern has remained consistent, establishing itself as the backbone of Cigna’s financial performance.

As Cordani noted, Evernorth's leadership in biosimilars plays a crucial role in addressing major healthcare challenges.

For instance, the company introduced the Humira interchangeable biosimilar last summer, offering eligible patients access at $0 cost. 

By the end of 2024, nearly 50% of eligible Humira prescriptions were filled with biosimilars, and Evernorth is now extending this benefit to the interchangeable Stelera biosimilar.

Over the next five years, Cordani said approximately $100 billion in specialty drug spend in the U.S. will be subject to biosimilar and generic competition, positioning Evernorth to lead the way in delivering significant savings.

He also emphasized the growing need for affordable prescription drugs, especially with the rising use of GLP-1 medications, which have become a major driver of drug spending trends.

While these medications are relatively inexpensive to produce, U.S. patients are paying several times more than those in other countries, even with full pass-through rebates.

By advancing biosimilars and working to reduce drug costs, Evernorth remains committed to ensuring that patients can access medications at fair prices while maintaining long-term sustainability in the healthcare system.

Eric Palmer, president and CEO of Evernorth Health Services, highlighted in a 

, the organization's continued innovation in response to market demands.

"We know that healthcare and prescription drugs need to be more affordable, and coverage needs to be more transparent and less complex," he said.

To further enhance affordability, Evernorth has recently introduced several initiatives focused on cost transparency and patient protections.

These protections ensure that patients benefit directly from the savings Express Scripts negotiates.

For example, patients will no longer pay the high list prices for medications, and those in high-deductible plans will receive the lower prices negotiated by Express Scripts, even during the deductible phase when costs can be highest.

Beyond price protections, Evernorth is increasing transparency by offering personalized reports to patients, detailing their prescription drug costs, negotiated savings and plan-paid amounts.

Plan sponsors will also receive detailed, annual reports that provide greater visibility into pharmacy claims and costs than what is typically offered.

These efforts are part of Evernorth's larger strategy to make healthcare more affordable and transparent for all involved.

Adam Kautzner, president of Evernorth Care Management and Express Scripts, stressed that these initiatives are designed to ensure there are no surprises at the pharmacy counter.

A key factor in Evernorth’s innovation is the data-driven EncircleRx program, which expanded to cover about 8 million lives in 2024, Cordani added.

The program helps plan sponsors reduce costs and improve outcomes, with its Cardiodiabesity solution offering predictability in managing obesity, diabetes, and cardiovascular disease.

It also provides lifestyle support and tools to help patients on GLP-1 medications sustain long-term improvements.

Cordani expressed the importance of these solutions, especially given the rising costs of GLP-1 medications in the U.S.

"Despite these medications being relatively cheap to produce, Americans are paying prices that are multiples higher compared to other countries," he said. "This is not acceptable, nor sustainable."

Formulary Watch

Evernorth Drives Cigna's Strong Revenue Growth and Focuses on Biosimilars and Drug Affordability

Merck has stopped a study of Winrevair (sotatercept-csrk) early because of positive results seen an interim analysis of a separate trial.

Merck officials made the decision to stop the HYPERION study prior to its scheduled completion. The phase 3 HYPERION study evaluating recently diagnosed adults with pulmonary arterial hypertension (PAH) was stopped because an interim analysis of the ZENITH trial and a review of the totality of data from Winrevair the clinical program to date that showed positive efficacy results, Merck officials said in a 

Winrevair is currently approved in the United States and 38 countries to treat pulmonary arterial hypertension and to reduce the risk of clinical worsening events. In preclinical models, Winrevai induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. The FDA approved Winrevair in March 2024, and it has a 

Pulmonary arterial hypertension is a rare, progressive and life-threatening disease in which blood vessels in the lungs narrow, causing strain on the heart. About 40,000 people in the United States are living with PAH. The five-year mortality rate is about 43%.

“PAH is a progressive and debilitating disease with a high incidence of morbidity and mortality, and we look forward to continuing to evaluate these patients and any potential impact to the treatment landscape as a result of these data,” Vallerie McLaughlin, M.D., said in the news release. She is the Kim A Eagle M.D. Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program at the University of Michigan in Ann Arbor.

The phase 3 HYPERION study was evaluating Winrevair compared with placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension. The study enrolled about 300 patients, and the primary composite outcome measure is time to clinical worsening, as measured by first confirmed morbidity or mortality event. Secondary outcome measures include improvement of six-minute walk distance and improvement and maintenance or achievement of N-terminal pro-B-type natriuretic peptide. Company officials said in the release that findings from the HYPERION study will be available later this year and presented at a future medical congress.

Related: Winrevair Advanced PAH Trial Stopped Early Due to ‘Overwhelming’ Efficacy

The ZENITH study was evaluating Winrevair in advance patients when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours. The study enrolled 172 participants. ZENITH was also stopped early because it had shown a statistically significant and clinically meaningful reduction in morbidity and mortality risk compared with placebo.

Participants in the HYPERION trial will have the opportunity to be part of the open-label, long-term extension study, SOTERIA, which is evaluating the long-term safety, tolerability and efficacy of Winrevair when added to background therapy to treat patients with PAH.

The HYPERION study was evaluating Winrevair in recently diagnosed adults with pulmonary arterial hypertension.

Another Trial of Winrevair Stopped Early Due to Positive Efficacy

Exploring Nintedanib and Pirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis

Video content above is prompted by the following:

How do nintedanib and pirfenidone differ in their mechanisms of action and efficacy in treating IPF?

An expert discusses how nintedanib and pirfenidone differ in their mechanisms of action and efficacy in treating idiopathic pulmonary fibrosis (IPF).

Video Series

The Role of Corticosteroids in Managing Pulmonary Fibrosis

What is the current understanding of the role of corticosteroids in managing pulmonary fibrosis, and how has this evolved in recent years?

Are there specific patient populations for whom steroids remain a viable treatment option?

An expert discusses the current understanding of corticosteroids in managing pulmonary fibrosis and how it has evolved in recent years, and identifies specific patient populations for whom steroids may remain a viable treatment option.

Canadian company Medexus Pharmaceuticals recently announced the FDA approval of Grafapex (treosulfan) as part of a conditioning regimen for allogeneic hematopoietic stem cell transplantation. 

The chemotherapy drug was approved for use in combination with fludarabine in adults and children one year and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

AML is a rare blood cancer that begins in the bone marrow. In 2025, about 22,000 people in the United States will be diagnosed with AML and about 11,000 Americans will die from the disease, according to the 

Treosulfan (Grafapex) was approved in Canada in June 2021 for the same use and is marketed under the brand name Trecondyv.

Kenneth Maxik, MBA, MBB, FACHE

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