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Peter Wehrwein has been the lead editor of Managed Healthcare Executive since February 2020.

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We spoke recently with Craig Burton, MBA, executive director of the Biosimilars Council, a trade and lobbying group for the biosimilars industry.

Health of the Biosimilars Industry, Getting Rid of Clinical Trials, PBMs As Obstacles and Other Biosimilar Topics | Q&A With Craig Burton, MBA

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Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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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

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 

MDS occurs when some of the cells in the bone marrow become abnormal and crowd out healthy cells, leading to amenia. MDS is uncommon before age 50; t is most commonly diagnosed in people in their 70s. According to the 

, the number of people diagnosed is not known, but some estimates have placed it about 10,000 people diagnosed in the United States.

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

Stem cell transplantation is considered the only curative treatment for patients with AML or MDS. Before receiving donor stem cells, patients receive a conditioning regimen designed to destroy existing bone marrow cells. These regimens typically consist of high-dose radiation or chemotherapy treatment and, due to associated toxicities, are often reserved for younger patients without comorbidities. 

Reduced-intensity conditioning regimens have been developed for use in older patients or those who are otherwise ineligible for the more aggressive treatment. However, these reduced-dose treatments have been associated with higher rates of disease recurrence after transplantation.

A pivotal phase 3 trial compared treosulfan with fludarabine to the conventional reduced-intensity regimen busulfan with fludarabine as a stem cell transplant preparative treatment. The study included 570 patients with AML or MDS who were considered ineligible for high-intensity regimens due to age (between 50 and 70 years) or the presence of comorbidities.

Results showed that more participants receiving treosulfan with fludarabine had event-free survival three years after treatment compared with patients who received the conventional regimen (60% versus 50%). Three-year overall survival rates were also higher in the treosulfan group versus the busulfan group (67% versus 53%). The most common adverse effects included musculoskeletal pain, fever, stomatitis, nausea, vomiting, edema, and infection.

Medexus plans to release Grafapex in the U.S. market during the first half of 2025. The treatment has the potential to generate over $100 million in annual revenue within five years of launching, according to Richard Labelle, chief operating officer at Medexus. The product’s Orphan Drug designation confers up to seven years of marketing exclusivity.

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

Grafapex Approved for Reduced-Intensity Stem Cell Transplants in AML and MDS Patients

The Center for International Blood and Marrow Transplant Research (CIBMTR) named the Blood and Marrow Transplant Program in the Division of Hematology and Cellular Therapy at Cedars-Sinai Cancer in Los Angeles among the top transplant programs in the U.S. This is the fifth consecutive year Cedars-Sinai has earned this distinction.

CIBMTR is a nationally funded research collaboration between the Medical College of Wisconsin and the National Marrow Donor Program. The center collects and analyzes data from over 300 transplant centers throughout the world to determine patient outcomes after bone marrow transplantation or cell therapy.

Cedars-Sinai was one of 12 among 172 adult transplant centers in the U.S. with a one-year patient post-transplant survival rate above the expected outcome. In 2024, the survival rate for Cedars-Sinai was 90% versus the expected rate of 68% to 83%.

Ronald Paquette, M.D., clinical director of the Stem Cell and Bone Marrow Transplant program at Cedars-Sinai, attributes these outcomes to a series of changes implemented over the past several years at the transplant center. A significant change Paquette highlights is the addition of cyclophosphamide as routine post-transplant therapy for each patient to help prevent graft-versus-host disease. This modification alone resulted in a 20% improvement in one-year survival rates, according to Paquette.

Another change the center has made has involved adjustments to pre-transplantation conditioning regimens designed to ablate the patient’s cancerous bone marrow cells to make room for the transplanted stem cells. Some of these regimens are prone to toxicities, but Cedar-Sinai’s transplant team has discovered that using conditioning regimens more compatible with cyclophosphamide reduces the risk for excessive toxicities.

“There are many possible combinations, and we initially tried to match the conditioning therapy to each patient’s specific disease scenario,” Paquette said in a 

. “What we have learned by carefully tracking patient outcomes is that it is more important to choose a regimen that pairs well with the posttransplant cyclophosphamide,” he added.

Lastly, the center has migrated toward using more half-matched donors, also called haploidentical donors, instead of fully-matched donors. Transplantations involving half-matched donors now make up 85% of the center’s transplants. Half-matched donors are typically close family members, such as parents, children, or siblings. Less commonly, nieces, nephews, and grandchildren may be half-matched donors.

The average age for transplant patients at Cedars-Sinai is between 68 and 70 years. Half-matched donors for these older patients might be half their age. Paquette notes that patients receiving transplants from younger donors have considerably better outcomes than those matched with older donors.

He said the center continues to refine its process, and they are working to develop options for offering transplants to a broader range of patients. They also want to better understand the interaction between stem cells and host bone marrow and the effects of intestinal bacteria on the transplant process.

“Our current process is producing great outcomes, and through strategic steps we are continuing to refine it,” Paquette said. “Through all of these efforts, we hope to learn things that will help us further improve therapies in the future.”

Brian Drozdowicz

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