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More research on clinical meaningfulness is on the way, according to Stephanie Graff, M.D., FACP, FASCO.

Quantitative Studies Next Step to Understand Clinical Meaningfulness in Metastatic Breast Cancer Care

Early trial data of two virally suppressed, breast-feeding women with HIV shows that there may be less of a risk of HIV transmission during breastfeeding than previously believed. 

No HIV RNA Detected in Breast Milk of HIV-Positive Women, Preliminary Study Shows

Jill Zouzoulas, M.D., of  Tryon Medical Partners in Charlotte, North Carolina, and Jennifer Seminerio, M.D., of University of Southern Florida Health in Tampa, Florida, discussed the biologics and the pros and cons of the intravenous and subcutaneous delivery methods in Managed Healthcare Executive’s K-Cast video series.

Key Patient Considerations for Use of Intravenous and Subcutaneous Therapies

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

MHE Week in Review – UnitedHealthcare Adds Deductibles, Breast Cancer Mortality Drops and More

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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The healthcare system is facing an onslaught of patients with new and worsening conditions due the COVID-19 pandemic, but it is nowhere near ready to accommodate them. 



The Urgent Case for Proactive Behavioral Healthcare 

Are we as a society really getting the most value for our healthcare dollars? That was the question that Sanjula Jain wanted to answer. As senior vice president of market strategy and chief research officer at Trilliant Health, Jain wanted to look at the macroeconomic trends to assess whether consumers and payers are getting value from the dollars spent for healthcare in America.

What Jain and her colleagues found and documented in their recent 

 is that increasing utilization of healthcare services and the increasing amounts of money spent haven’t increased health, quality of life or life expectancy.

“There's a lot of indications that outcomes are getting worse,” Jain said in an interview. “We’re spending more money. Mortality is up. We’re not seeing a lot of compliance to value-based programs. Providers are having to spend millions of dollars just to do quality reporting, and what do we have to show for it?”

National health expenditures increased from $2.8 trillion in 2012 to $4.5 trillion in 2022. But there has been relatively little change in demand or utilization for healthcare services. In fact, according to the many macroeconomic measures that Trilliant Health assessed, the money spent on U.S. healthcare doesn’t appear to be leading to healthier Americans. Consider:

The health status of Americans is deteriorating. Data suggest that the number of Americans with chronic conditions will increase from 137.3 million in 2020 to 221.1 million in 2050.

Although the overall cancer incidence rate is decreasing, the incidence of melanomas, uterine and pancreatic cancers is growing since 1999. The breast cancer incidence rate has remained stable since 1999.

Cancers among people younger than 45 years of age are growing, especially breast, colon, kidney and uterine cancers, which are up since 2018.

Although life expectancy has increased over the last century, healthy life expectancy remained relatively flat from 2000 to 2019, with a decline in 2021 during the COVID-19 pandemic. Life expectancy in the United States is almost four years lower than in countries such as Australia, Canada, France, Japan, Sweden and Switzerland.

U.S. infant and maternal mortality rates also above those of other countries. Mortality from chronic liver disease for those between the ages of 18 to 44 years is growing.

Additionally, Trilliant Health’s data suggests that healthcare utilization patterns indicate further declines:

Healthcare spending is projected to grow to $7.7 trillion by 2032.

Primary care volume was down in 2022 and 2023 after a 2021 increase. Demand for behavioral health increased during the same time among a shortage of providers. Demand for behavioral health continues to trend higher.

Americans have higher rates of obesity and diabetes and more behavioral health conditions than ever before. Healthcare for children increased from 2022 to 2023 in the areas of eye, ear, nervous system and respiratory.

The value of technology innovation is uncertain: telehealth’s value is limited, patients remain uncomfortable with the use of AI in healthcare, biosimilar market share is low

After a decline, uninsured rates are predicted to reach 8.9% by 2034, with affordability being the top reason.

Value-based care, however, is not the same as getting value for money, Jain said. “Value-based care doesn’t move the needle on spending,” she said. “Value-based payments reallocate payments within the existing pool, which is different from value for money, which is about finding a way to shrink the pool. Value for money is focused on shrinking costs versus how to slice and dice an allocated amount among different physicians and providers.”

Stakeholders have defined value differently. Many of have focused on “outcomes” or “cost-effectiveness.”

Jain said outcomes measures and cost-effectiveness have their place, but these measures are focused on specific interventions or programs. “In healthcare, we’ve had tunnel vision,” she said. “Everybody’s focused on their individual initiatives and providing that in a way that is effective. But how does that fit in the broader system? What’s the impact downstream on what the patient does, what it costs and how does it fit into the broader system? At the health economy level, when you roll up the impact of all of these various things, the net value isn’t there.”

Jain said she hopes the larger view of healthcare will lead to changes that truly assess value in healthcare. Transparency initiatives, she said, are a positive step forward in enabling that assessment.

“Employer are frustrated right now because they’re not seeing the ROI for the amount of money they’re putting into their health benefit plans,” she said. “Now that prices are beginning to be exposed, there’s a lot of opportunities to steer employees to the higher-value providers.”

Although Jain and her colleagues said that all healthcare stakeholders can deliver more value for money, it is employers who are best positioned to demand that value.

Employers have been passive, but that is unlikely to continue as employers now face lawsuits for noncompliance with the Consolidated Appropriations Act of 2021, which amended the Employee Retirement Income Security Act (ERISA) to require greater transparency around prescription drug and healthcare spending.

These changes to ERISA have led to lawsuits for breach of fiduciary duty. Earlier this year, for example, a 

 was filed against Johnson & Johnson for mismanaging prescription drug benefits. The suit alleges that this has led to higher premiums, higher deductibles, and higher coinsurance and copays.

The lawsuit claims that J&J’s PBM Express Scripts has shown a pattern of unreasonable mark ups on prescription drugs. “No prudent fiduciary would agree to make its plan, and beneficiaries pay a price that is two-hundred-and-fifty times higher than the price available to any individual who just walks into a pharmacy and pays out-of-pocket,” the suit said.

 was filed against Wells Fargo for breaching its fiduciary duty for the mismanagement of prescription drug benefits, which also used Express Scripts as its PBM.

“Employers are starting to see that their middlemen, the brokers, have been steering them astray,” Jain said. “What’s different now is employers have fiduciary duty to be fiscally responsible about these dollars now. And now that information if becoming available, they can’t sit back.”

Sanjula Jain of Trilliant Health talks about how employers are best positioned to demand value for money from the U.S. healthcare system.

Formulary Watch

Clinical

Report Finds the Money Spent on Healthcare Doesn’t Provide Value

Medicaid work requirements would compel adults to work as a condition for coverage from a state’s Medicaid program. Usually, some provisions allow people to go to school, get job training, or volunteer as alternatives to holding a job. Republicans generally support Medicaid work requirements, and Trump granted waivers to 13 states to implement them. Democrats generally oppose them, and the Biden administration moved to reverse those waivers. Proponents of work requirements say work or going to school is associated with better health, that able-bodied adults should participate in the economy and that requirements help states hold the line on Medicaid spending. Critics say that many people covered by Medicaid work already and that the requirements will add needless red tape, creating another barrier to accessing healthcare that can help people stay healthy, which enables them to work or go to school.

We want to know what you’re thinking! Every Monday morning at 8:30 a.m. E.T. the editors of 

 are posing a question to our readers about a timely issue in U.S. healthcare. We collect your answers until 11 a.m. E.T. on Friday.

MHE Question of the Week: Do You Favor Medicaid Work Requirements?

President Joe Biden and other Democrats celebrated the 14th anniversary of President Barack Obama signing the Affordable Care Act (ACA) into law on Saturday with a flurry of online posts and images. “14 years later, the Affordable Care Act is still a very big deal,” Biden posted on X, a coy reference to his profane, 

 of the same expression at the bill’s signing. Although Biden is running behind Donald Trump in many polls, Biden and the Democrats believe that ACA will be a political asset this fall and could turn the election in their favor. KFF polling shows the law is viewed favorably overall, although approximately two-thirds (67%) of Republicans view it unfavorably and 39% say they want it repealed. Trump has focused on immigration and Biden’s age at his rallies, but in a Truth Social post late last year he said that “the cost of Obamacare is out of control” and that he was seriously looking at alternatives.

The 14th anniversary of the Affordable Care Act was this past Saturday. 

MHE Question of the Week: Will the ACA Help Biden and the Democrats?

Change Healthcare, a revenue cycle and healthcare analytics company now part of UnitedHealth Group’s Optum division, was cyberattacked on Feb. 21, according to a Securities and Exchange Commission (SEC) filing by UnitedHealth. To contain the attack, Change Healthcare’s information systems were disconnected. UnitedHealth said in the SEC filing that a “suspected nation-state associated cyber security threat actor” had been identified but hasn’t released any information on the perpetrator since. The outage has affected pharmacies throughout the country, including those at some military medical facilities. The American Hospital Association 

 that all healthcare organizations disrupted or “potentially exposed by this incident” consider disconnection from Optum. Numerous status updates on the situation on an Optum website, including one this morning at 8:04 a.m. EST, have said, "we have a high level of confidence that Optum, UnitedHealthcare and UnitedHealth Group systems have not been affected by this issue.”

It is a dangerous sign of the vulnerability of healthcare information systems.

The damage was limited, and it shows the strength of the defenses against cyberattacks.

UnitedHealth Group needs to do a better job of defending itself against cyberattacks.

Healthcare companies need to move faster to strengthen their cybersecurity defenses to keep such outages from happening in the future.

Cyberattacks are common and need to be dealt with, but we shouldn’t get panicky about them.

Share your view about the Change Healthcare cyberattack.

MHE Question of the Week: Your Opinion of the Change Healthcare Cyberattack

Chronic viral infections from diseases such as herpes simplex virus (HSV), human papillomavirus (HPV) and cytomegalovirus (CMV) can have a serious impact on those with immune systems already compromised by HIV, according to a session held today at the International AIDS Conference in Munich, Germany. The session featured three speakers who discussed each of these diseases.

The first presentation was about CMV immune activation, by Lena Royston, M.D., Ph.D., from the Division of Infectious Diseases at the University Hospital of Geneva. CMV is in the herpes family and is extremely common. It is not considered a sexually transmitted infection. Most people will contract CMV in their lives but will only be symptomatic if they a have compromised immune system from another infection such as HIV.In advanced stages of HIV infection,CMV can lead to nausea, headaches, fever, confusion and even blindness, Royston said. CMV is currently in about 

 of the world's population, according to the National Library of Medicine.

“People living with HIV have the highest prevalence of the global CMV population,” Royston said.“We think that there might be some kind of synergy between the two viruses on immune activation and immunosenescence.” Immunosenescence refers to age-related changes in the immune system. As someone ages, their immune system typically weakens.

The main way CMV is treated is through antiviral drugs, which have a high rate of toxicity, leading to further complications.

The second discussion was about HPV, a viral infection, presented by Nelly Mugo, from the University of Washington in Kenya. An estimated 5% of all cancers are caused by HPV. About 85% of those cancers are cervical cancer, Mugo said. A 2023 study published in the 

 found that HPV exists in about 36.9% of HIV-positive individuals.

“In the HPV world, especially related cervical cancer, we know a lot, but we implement really poorly,” Mongo said. “We have very high recurrence amongst women living with HIV.”

“The road looks clear because we know what the pathogen is and what to do about it, we're unable to deliver so the outcome is still a distance away from us.”

The third presentation was about HSV by Anna Wald, M.D., a professor of epidemiology, medicine, and laboratory medicine at the University of Washington. She is also the director of the University of Washington Virology Research Clinic. The disease is characterized by painful blisters and ulcers and is often spread by sexual contact. People with HIV are 

 more likely to contract HSV because the open sores provide a pathway for the virus to travel from partner to partner during sex. There are currently no biomedical interventions for HSV prevention that are extremely effective. It is not curable, but it can be managed with daily antiviral medication.

“I think there's a huge need for an accurate test,” Wald said. “People both with HIV and without HIV want to know their HSV status. We can't really control a disease unless we have reliable diagnostics.”

Wald recommends that HSV tests be available at home like COVID-19 tests,continuing condom usage and not having sex while lesions are present since this is how it is transmitted.

An overview of the complex relationships between herpes simplex virus, human papillomavirus, cytomegalovirus and HIV. 

Chronic Viral Infections Common in Those with HIV | AIDS 2024 

It’s been seven years since the FDA approved the first gene therapy to treat an inherited disorder. Luxturna (voretigene neparvovec) was developed by scientists from the University of Pennsylvania and Children’s Hospital of Philadelphia and is still the only gene therapy approved for hereditary blindness despite considerable attention paid to a range of related conditions.

Now, other researchers from the same Center for Hereditary Retinal Degenerations at Penn’s Perelman School of Medicine reported positive  results from a phase 1/2 trial of a gene therapy for another of these diseases. At the same time, scientists at the Karolinska Institutet in Sweden reported encouraging results from their gene therapy trial for a different condition causing hereditary blindness.

Both conditions are rare, begin in childhood, and have no current treatments — glasses don’t help. Both open-label trials (participants knew they were receiving the gene therapy) were primarily for safety and dosing. But efficacy end points found significant improvement, mainly in night vision.

Penn trial for patients with Leber congenital amaurosis 1 (LCA1)

LCA1, which is caused by mutations in the GUCY2D gene, affects an estimated 100,000 people globally, causing them to lose much of their sight in early childhood. It is one of more than 20 variants of Leber congenital amaurosis — Luxturna treats another — all of which cause either early onset or congenital blindness. They typically are diseases of dysfunction as opposed to degeneration, which accounts for most congenital retinal diseases. 

So rather than seeking to slow progression, which is hard to measure, the Penn researchers wanted to see if they could “turn on” the affected cells, which might restore vision quickly. But most participants in their trial had blindness in one eye for decades, and it was unclear what impact time might have had on the cells.

The experimental gene therapy, ATSN-101, developed by Atsena Therapeutics of Durham, North Carolina, was injected via three incisions near the iris. Researchers tested three dosage levels on three adult cohorts of three patients each, then gave the high dosage to one adult and one pediatric cohort, also three apiece, allowing analysis of 12 patients who received the high dosage. As it turned out, only the high dosage produced significant results.

People with normal vision can see in a wide range of lighting conditions, from bright sunny days to nights lit only by stars. LCA1 diminishes that range. The gene therapy improved vision mainly in dim light, but the improvement was substantial.

The Phase I/II trials for rare forms of hereditary blindness further confirmed the potential for gene therapy treatments of congenital diseases of the retina.

David Ramirez, MD

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