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Laura is the vice president of content of Managed Healthcare Executive

 (MHE) and all its brands, including Formulary Watch

. She has been working on MHE since 2019 and has been with MHE's parent company, MJH Life Sciences

, since 2011. She has an MA in business and economic reporting from New York University.

Articles

Research at the annual meeting of the American Society of Hematology evaluated patient and caregiver perspectives on gene therapies for sickle cell disease, which offer great potential but have had slow uptake.

Patients Express Concerns Over Costs, Risks of Gene Therapies for Sickle Cell Disease

Researchers at Brigham and Women’s Hospital Harvard Medical School looked at clinical trials and compared these biologics to placebos to see how their treatments improve and manage severe asthma.

How Biologic Treatments Are Transforming Severe Asthma Management

Researchers have compiled a list of chemicals commonly found in plastics, including benzophenones, chlorinated paraffins and PFAS, known as “forever chemicals,” and they say there might be a connection to breast cancer. 

More Than 400 Plastic Chemicals Could Be Linked to Breast Cancer

Researchers are investigating the therapy as a treatment for B-cell malignancies, but they might also  investigate as a treatment for multiple sclerosis and lupus. 

Roche to Acquire CAR-T Cell Therapy Candidate for Possible Use for MS in Poseida Merger Deal

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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Jazz Pharmaceuticals announced the recent FDA accelerated approval of Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. This approval makes Ziihera the first and only dual HER2-targeted bispecific antibody treatment for this indication. An investor webcast will be held on Dec. 11 at 4:30 p.m. EST to discuss further details, according to a 

Potential Ziihera patients may have their cancer identified using the PATHWAY HER2 (4B5) test, 

 under an FDA label expansion. This test, approved on Nov. 25, is the first and only FDA-approved companion diagnostic for HER2-positive biliary tract cancer. 

Ziihera is produced in Chinese hamster ovary cells via recombinant DNA technology, official prescribing information 

. These cells are chosen because they can produce complex proteins similar to human cells. More than 70% of all recombinant antibodies have been produced from Chinese hamster ovaries since 2016, a 

Biliary tract cancer affects bile ducts within the gallbladder, liver and small intestine. The cancer becomes HER2-positive when the tumor cells overexpress the HER2 protein, which causes the tumors to grow rapidly. When it becomes metastatic, the five-year survival rate is less than 5%.

The recommended dose of Ziihera is 20 mg/kg given as an intravenous infusion every two weeks. It’s also recommended that patients be given acetaminophen, an antihistamine and a corticosteroid 30 to 60 minutes before treatment to avoid infusion-related reactions. Ziihera comes as a powder that must be reconstituted and diluted with sterile water before use.

This approval is based on the results of the phase 2b HERIZON-BTC-01 trial in which 52% of the 87 patients given Ziihera saw improvements. The median duration of response was 14.9 months, determined by independent central review. Results were published in 

Ziihera safety was demonstrated in the HERIZON-BTC-01 and ZWI-ZW25-101 trials, which enrolled 109 patients with biliary tract cancer and 124 patients with other cancers. The most common adverse reactions in HERIZON-BTC-01 were diarrhea (50%), abdominal pain (29%) and fatigue (24%).

"As a clinical investigator and medical oncologist focused on advancing the care of patients with biliary tract and liver cancers, I have experienced firsthand the significant unmet need for effective therapies for patients with these diseases," James Harding, M.D., associate attending, Gastrointestinal Oncology and Early Drug Development Services, at Memorial Sloan Kettering Cancer Center said in the news release. "[Ziihera] has demonstrated antitumor activity and is now a new option for patients with HER2-positive biliary tract cancer.”

A phase 3 HERIZON-BTC-302 trial investigating the effectiveness of Ziihera in combination with standard-of-care therapy is ongoing. Ziihera effectiveness is also being testing on metastatic breast cancer tumors and gastroesophageal adenocarcinomas.

The wholesale acquisition cost WAC for Ziihere is $7,110 for a two-pack of two 300 mg bottles, according to the investor call. Financial assistance is available through JazzCares and commercially insured patients can pay as little as

Produced in Chinese hamster ovary cells, Ziihera (zanidatamab-hrii) is the first HER2-targeted bispecific antibody treatment for patients with previously treated, unresectable or metastatic biliary tract cancer.

Formulary Watch

Clinical

FDA Approves Biliary Tract Cancer Antibody Treatment 

Private equity firms have been buying spree in U.S. healthcare, acquiring hundreds of hospitals and physician practices, especially specialty practices whose clinicians perform highly compensated procedures.

The firms and their advocate say the bolus of capital into healthcare delivery can result in increased efficiency and improved patient care and for struggling hospitals, a lifeline and the difference between shutting down and continuing to serve patients.

But in a presentation Thursday  at the AHIP annual meeting Las Vegas, Zirui Song, M.D., Ph.D., an associate professor of health care professor in the Department of Health Care Policy at Harvard Medical School, shared an impressive collection of his and other researchers’ findings that show the opposite: that after they have been acquired by private equity firms, hospitals and physician practices raise prices and have results suggestive of poorer quality care.

“In these evaluations over the past 5 to10 years, it hasn’t panned put,” Song said about the argument for private equity, “and if it were to pan out, the academic narrative around private would change.”

Song said he and other researchers who have published numerous research articles in 

and other top-tier journals have offered many opportunities to private equity firm to partner with academic to study the acquisitions and their consequences and publish the results in peer-reviewed journals.

“Not one has taken the offer. The offer still stands,” Song said.

Song said his research has shown hospitals cut emergency room and intensive care unit staffing and salaries after private equity acquisition and that mortality rates and transfers to other hospitals increase.

“I think staffing is really important,” Song said. “If we were creating widgets, then an assembly line with great efficiency, cutting out the redundancy may be the ideal business model in many industriesin the other 82% the U.S. economy could be much better for that type of thing.” But, Song added, “staffing cuts just may not be the right strategy in health care,” and he suggested that setting a floor of staffing ratios could be one way to deal with the consequences of private equity acquisition.

Song also touched on ideas for regulation and polices to curb the negative consequences of private equity that include affiliation rules that would tie acquired hospitals and physician practices legally and financially to the parent private equity firm. Other proposals Song mentioned include putting percentage limits on the debt that can be used to make acquisitions and increasing transparency by lowering the thresholds at which private equity deals would need to be reported.

In 2024, approximately 460 hospitals in the U.S. are owned by private equity firms, according to data that Song shared during the AHIP session. Proportionally, that is 8% of all private hospitals and 22% of the for-profit ones, his slide showed.

Private equity firms have targeted gastroenterology, ophthalmology, urology, dermatology and several types of specialty practice for acquisition, Song said, citing research from two studies.

Most of Song’s presentation consisted of a rapid-fire review of his and others’ research findings about private equity acquisition. Many of the studies were designed to compare hospitals and specialty groups economics and other outcomes before and after private acquisition and to compare the post-acquisition entities to a control group of similar entities that hadn’t been acquired. When the findings were published and the time periods covered varied. Here are some of the findings that Song shared:

Relative to a control group hospitals, those acquired by private equity firms increased net income by 27% and charges per day by 7%.

Hospital adverse events, such as pressure ulcers, falls and central line infections, increased in hospitals acquired by private equity firms relative to a control group of hospitals. The difference was 25% in a composite calculation of adverse events, 27% in falls and 38% in central line infections, despite 16% fewer central lines being placed in patients in hospitals acquired by private equity firms. The research findings also showed by surgical site infections doubled at the private equity-owned hospitals while they declined in the control hospitals.

The 30-day mortality rate was for COVID-19 patients was 2.3% higher among patients at hospitals owned by private equity firms during the first year of the COVID-19 pandemic relative to a set of control hospitals. Among non-COVID-19 patients, the 30-day mortality rate was 11% higher.

When physician practices are acquired by private equity firms, their charges increase by 20% and their prices by 11%.

Compared to hospital-owned gastroenterology practices, those owned by private equity firms increased prices by 28%, professional fees by 78% and patient volume by 23%.

Compared to control practices, retina practices owned by private equity firms increased Medicare spending by 22% and spending on expensive agents — Eylea (aflibercept) — by 22%.

Emergency room visits (11%), hospitalizations(9%), Medicare spending (4%) and mortality (10%) increased in private equity firm-owned nursing homes

Song emphasized that the research findings are averages that reflect a distribution that would include private equity firm-owned hospitals and specialty practices that were higher and lower than the average of whatever is being measured. In other words, some individual private equity firm-owned entities might be providing high value care (lower cost and high quality).

But overall, Song said the evidence he and his colleagues have generated suggests that private equity firm ownership has had negative consequences for U.S. healthcare. “At the end of the day, you can put money into a delivery system in good and bad ways. The evidence is leaning one way at the moment but it doesn’t have to be this way.”

Song noted that groups that represent physician interests “often are not super excited” about policies and regulations that might rein in private equity purchases. He said that posture may reflect the fact that private equity purchases are often attractive to older physicians who can get a high price for their practices and wind down their clinical practice as they head toward retirement. In contrast, for younger physicians, working for private equity firm-owned practice may mean working harder and for less money than they would for practices that have other kinds of owners.

Harvard researcher Zirui Song says research findings show that nospitals higher prices and lower quality.

Harm Not Help: Private Equity's Influence on U.S. Healthcare | AHIP 2024

MHE Week in Review – United Healthcare CEO Shot, Magic Mushroom Benefits and More

Each Sunday we feature a highlight reel of various articles posted on our website that week.

We’ll be back on Monday morning with more fresh content!

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

MHE Week in Review – United Healthcare CEO Shot, Millions May Benefit From Magic Mushrooms and More

Biocon Biologics Ltd. announced today the FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara (ustekinumab) biosimilar, for the treatment of patients with inflammatory bowel disease, plaque psoriasis and psoriatic arthritis, according to the details of a 

 no later than Feb. 22, 2025 in the United States.

 which are artificial proteins that are meant to stimulate the immune system, according to the National Cancer Institute.

Launch date is based on a licensing agreement between Biocon Biologics, Janssen Sciences Ireland and Johnson & Johnson. Although the patents for ustekinumab began expiring in 2023, licensing agreements prevent its biosimilars from being released in the United States until next year. 

Stelara was originally approved by the FDA in September 2009 for the treatment of adults with moderate to severe psoriasis.

In addition to Yesintek, the other Stelara biosimilars are:

Imuldosa (ustekinumab-srlf) approved in Oct. 2024

Otulfi (ustekinumab-aauz) approved in Sept. 2024

Pyzchiva (ustekinumab-ttwe) approved in June 2024

Selarsdi (ustekinumab-aekn) approved in April 2024

Wezlana (ustekinumab-auub) approved in Oct. 2023

Stelara, developed by Janssen, a Johnson & Johnson company, is a high-cost drug with a list price of $13,836 for one month’s supply. It generated $10.86 billion in revenue globally in 2023 compared with $6.4 billion the previous year. Stelara is available for $5 a dose for eligible patients through the savings program 

Stelara is one of the drugs soon to be discounted under the Inflation Reduction Act. Starting in 2026, Medicare members will be able to get a 30-day supply for 66% off list price, costing $4,695.

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

Sixth Stelara Biosimilar, Yesintek, Approved by FDA

UnitedHealthcare CEO Brian Thompson was shot and killed this morning in front of the New York Hilton Midtown in Manhattan by a masked man, according to news reports.

During a live press conference broadcasted by the 

 this morning, NYPD Chief of Detectives, Joseph Kenny, stated in a preliminary report a 911 call was made at 6:46 a.m. for a person shot in front of the hotel.

Thompson, 50, was identified as the victim of the targeted attack by the gunman who fled the scene and is still at large.

Police are currently unaware of the motive. 

Thompson was taken to Mount Sinai Hospital and was later pronounced dead.

Chief Kenny shared that the gunman, who appears to be a light-skinned male, arrived at the location of the shooting on foot roughly 5 minutes prior to Thompson's arrival. The gunman stood alongside the building as numerous pedestrian's passed.

Thompson, who was on his way to attend an annual investor conference in Manhattan today, was shot after 6:45 a.m. in a targeted attack, police officials say.

Julie A. Murphy, PharmD, BCPS, FASHP, FCCP

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