NPC Weighs in on PBM Inquiry; Radiologist Receives Award; OneOncology Creates Disease Groups

In Reversal, FTC Launches Inquiry Into PBM Industry

The Federal Trade Commission (FTC) on June 7 moved to investigate how merging health plans with specialty pharmacy providers has affected drug prices and the ability of doctors to prescribe the treatments they think are best for patients.

The commissioners’ 5-0 vote reverses a decision earlier this year to not take up an investigation, which disappointed physicians and patient advocates. They say that determinations made by pharmacy benefit managers (PBMs), the so-called “middlemen” in health care, have had undue influence on medical decisions since a string of mergers starting around 2017. Putting health plans and pharmacies under one roof creates incentives for the plans to steer patients to their own pharmacies and make formulary decisions based on profitability, not patient needs, according to critics.

The move came after 24,000 comments were turned in by the May 24 deadline, according to the FTC statement.

As part of its inquiry, the FTC will demand that the 6 largest PBMs submit records and answer questions regarding their business practices. FTC’s compulsory orders will go to CVS Caremark; Express Scripts, Inc; OptumRx, Inc; Humana Inc; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. The orders are permitted under Section 6(b) of the FTC Act, which allows the agency to conduct studies without a specific law enforcement purpose. The companies have 90 days from the date they receive the order to respond.

“Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the US prescription drug system,” FTC Chair Lina M. Khan, JD, said in a statement. ”This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors, and patients.”

PBMs, created more than 50 years ago to negotiate prescription prices and fees with drug manufacturers and develop formularies, have more recently become brokers with the power to make or break a drug’s ability to secure a position in the market. As a result, manufacturers have high list prices for drugs but pay rebates back to the PBM; ostensibly these payments are used to lower overall premiums for those in the health plan. But for patients who are charged a percentage of a drug’s list price as a cost share—or for those without insurance—the rebate system saddles the sickest patients with the highest costs. Some have described this as “the sick subsidizing the well.”

John M. O’Brien, PharmD, MPH, a former senior advisor at HHS who is the president and CEO of the National Pharmaceutical Council, said in an interview with Evidence-Based Oncology™ (EBO) that the questions in the FTC’s order suggest that the commissioners “had a really good sense of what they wanted to ask—and that there was a desire to do something.”

It’s hard to know what happened between the prior vote and this one, which came shortly after the end of the comment period, O’Brien said. But he is heartened that the order is written with an eye toward creating more fairness for consumers—it’s evident that the FTC is hearing from the public on this issue.

“Clearly, something was behind the commissioners’ decision to move quickly,” O’Brien said.

Kathy Oubre, MS, who is CEO of Pontchartrain Cancer Center and among the most active members of the Community Oncology Alliance on this topic, hailed the FTC’s move in an email to EBO. She noted how PBM behavior has harmed the biosimilars market, since oncology practices are sometimes forced to use higher-priced brand name products instead of lower-priced biosimilars.

“Lack of PBM transparency and their monopolistic behaviors—through vertical integration—have resulted in increased prescription drug costs and decreased patient affordability and access,” wrote Oubre, an EBO board member. “We have seen this directly undermine the long-term sustainability of the biosimilar market since many PBMs have implemented utilization management strategies [that] incentivize higher and higher rebates given by pharmaceutical manufacturers for formulary placement.”

Mergers that have combined health plans with pharmacies have further strengthened PBMs’ clout. Some PBMs now bar oncology practices from dispensing drugs within practices—a system known as “white bagging.” Some force patients to use a particular pharmacy, even if it requires more travel. And independent pharmacies that are not affiliated with health plans have complained of abuses, such as:

• being charged new fees or asked to repay funds, a practice known as “clawbacks”;
• facing questionable audits;
• facing a lack of transparency in how their reimbursements are calculated;
• the increased use of prior authorizations and related restrictions; and
• being forced to use a limited specialty drug list: Even when doctors try to use lower-priced drugs, their efforts are sometimes rejected.

O’Brien noted that it’s hard to predict how the PBMs will respond. Some may choose to make changes voluntarily, since they are aware that whatever information is submitted to FTC will undoubtedly find its way to investigative arms of Congress.

“If I’m an innovative PBM CEO, I may want to decide that my business is going to do something different,” O’Brien posited, because that might allow companies to craft their own solutions instead of allowing the government to dictate how they will run their operations.

In short, O’Brien concluded, “I might want to think about a different mousetrap.”

Reference

FTC launches inquiry into prescription drug middlemen industry. News release. Federal Trade Commission; June 7, 2022. Accessed June 8, 2022. https://bit.ly/3uDbHle


Claudia Henschke, MD, PhD, of Icahn School of Medicine, Receives Alton Ochsner Award

Ochsner Health, headquartered in New Orleans, Louisiana, announced July 8 that the recipient of the 37th Annual Alton Ochsner Award Relating Smoking and Disease is Claudia Henschke, MD, PhD, the director of the Early Lung and Cardiac Action Program (ELCAP) and professor of radiology at the Icahn School of Medicine at Mount Sinai, New York, New York.

The award is named after Alton Ochsner, MD, who cofounded Ochsner Health in New Orleans and published the first paper linking smoking and health in 1939. The award recognizes scientists who have made major contributions to understanding the relationship between smoking and disease and who have advanced the development of major prevention and treatment modalities.

“It is an honor to receive this award for my work in lung cancer screening,” Henschke said in a statement. “The ability to be able to detect early lung cancer by screening and change it from an essentially incurable disease to one with a high cure rate, saving countless lives, is a culmination of 30 years of work.”

Henschke pioneered the use of CT screening for lung cancer, the leading cause of cancer death worldwide.

“I have had the rewarding experience of first introducing low-dose CT screening in 1992 when almost nobody really believed it would work, and then partnering with a global community of researchers,” she said, referring to the International ELCAP (I-ELCAP). “This has allowed screening to achieve mainstream acceptance.”

From its beginnings in 2001, Henschke’s I-ELCAP research consortium grew to include 80 national and international sites focused on developing the most effective diagnostic protocol. Ongoing updates incorporated imaging advances and improved the diagnosis of lung cancer at ever earlier and more curable stages.

This research triggered randomized controlled trials in the United States and 5 other countries that have validated mortality reductions, which led to a US Preventive Services Task Force recommendation for screening and, in turn, health coverage for screening from public and private insurers, both in the United States and abroad.

“At Ochsner, we support pioneers who explore complex health care issues and develop innovative treatments relating to smoking cessation and disease prevention, because we know collaboration is a critical component of research and disease prevention,” said Leonardo Seoane, MD, chief academic officer of Ochsner Health. “We commend Dr Henschke’s dedication and passion [for] this important topic.”

Reference
Dr. Claudia Henschke, professor of radiology at the Icahn School of Medicine, receives the 37th annual Alton Ochsner Award. News release. Ochsner Health; July 8, 2022. Accessed July 11, 2022. https://bit.ly/3IvyWDR


CLINICAL PATHWAYS
To Support Pathways, OneOncology Creates Disease Groups

As use of clinical pathways becomes more common in cancer care, a leading national platform for independent community practices is building the infrastructure to develop and maintain them.

OneOncology, based in Nashville, Tennessee, today announced formation of 5 disease groups, which will offer subspecialty expertise and create education opportunities for the network’s 700 providers, who work in 181 care sites and a variety of settings.

“With science evolving at such an incredibly rapid pace, every physician cannot become an expert across all settings, but all our patients deserve and expect expert advice,” Davey Daniel, MD, chief medical officer for OneOncology, said in a statement. “We’ve developed OneOncology Disease Groups to account for subspecialization across our platform. By tapping into the expertise of leaders across our practices, the disease groups equip every provider on our platform with the latest scientific information to help them provide the best care possible for their patients.”

Each disease group guides and approves OneOncology clinical pathways to reflect evidenced-based national guidelines, which are updated often as new trial results are published or presented at major scientific meetings. For a physician using the OneOncology platform, the pathways serve as a foundation to providers as they address the specific features of each patient’s cancer.

According to the statement, OneOncology has already developed disease-specific pathways for many common cancer types, such as non-small cell lung cancer, renal cell cancer, and prostate cancer. Once the pathway is developed, each disease group will continuously oversee updates as new therapies are developed and standards of care change. Pathways can then be utilized through clinical decision support tools and software.

In addition, the disease groups provide guidance in multiple areas:

• They offer direction on clinical trials to OneR, the in-house research arm of OneOncology.
• They provide the Pharmacy & Therapeutics Committee expertise on newly approved therapies.
• They oversee medical education topics and deliver strategic direction regarding innovative care models.

Disease groups and chairs are: for lung cancer, Melissa Johnson, MD, Tennessee Oncology; for breast cancer, Gregory Vidal, MD, PhD, West Cancer Center & Research Institute; for genitourinary cancers, Jahan Aghalar, MD, New York Cancer & Blood Specialists; for gastrointestinal cancers, Henry Xiong, MD, PhD, The Center for Cancer and Blood Disorders; and for hematologic malignancies: Jonathan Abbas, MD, Tennessee Oncology.

“Each disease group chair is a well-regarded expert in their subspecialization, and all are leaders who other physicians turn to when they have a confounding clinical case and need advice,” Jeff Patton, MD, CEO, OneOncology, said in the statement. “Each of these physicians also has a propensity for leadership and zest for inspiring other physicians. I know each will be an incredible partner willing to share their expertise with physicians throughout our platform.”

Reference
Hoffman E. OneOncology establishes disease groups and appoints chairs. News release. OneOncology. July 19, 2022. Accessed July 19, 2022. https://www.oneoncology.com/blog/oneoncology-establishes-disease-groups-and-appoints-chairs