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Patients and Physicians Go Online to Pressure Insurers on Prior Authorization Denial of Claims, Something Genetic Testing Labs Regularly Encounter

In a handful of cases, health insurers reversed denials after physicians or patients posted complaints on social media

Prior authorization requirements by health insurers have long been a thorn in the side of medical laboratories, as well as physicians. But now, doctors and patients are employing a new tactic against the practice—turning to social media to shame payers into reversing denials, according to KFF Health News (formerly Kaiser Health News).

Genetic testing lab companies are quite familiar with prior authorization problems. They see a significant number of their genetic test requests fail to obtain a prior authorization. Thus, if the lab performs the test, the payer will likely not reimburse, leaving the lab to bill the patient for 100% of the test price, commonly $1,000 to $5,000. Then, an irate patient typically calls the doctor to complain about the huge out-of-pocket cost.

One patient highlighted in the KFF story was Sally Nix of Statesville, North Carolina. Her doctor prescribed intravenous immunoglobulin infusions to treat a combination of autoimmune diseases. But Nix’s insurer, Blue Cross Blue Shield of Illinois (BCBSIL), denied payment for the therapy, which amounted to $13,000 every four weeks, KFF Health News reported. So, she complained about the denial on Facebook and Instagram.

“There are times when you simply must call out wrongdoings,” she wrote in an Instagram post, according to the outlet. “This is one of those times.”

In response, an “escalation specialist” from BCBSIL contacted her but was unable to help. Then, after KFF Health News reached out, Nix discovered on her own that $36,000 in outstanding claims were marked “paid.”

“No one from the company had contacted her to explain why or what had changed,” KFF reported. “[Nix] also said she was informed by her hospital that the insurer will no longer require her to obtain prior authorization before her infusions, which she restarted in July.”

“I think we’re on the precipice of really improving the environment for prior authorization,” said Todd Askew, Senior Vice President, Advocacy, for the American Medical Association, in an AMA Advocacy Update. If this was to happen, it would be welcome news for clinical laboratories and anatomic pathology groups. (Photo copyright: Nashville Medical News.)

Physicians Also Take to Social Media to Complain about Denials

Some physicians have taken similar actions, KFF Health News reported. One was gastroenterologist Shehzad A. Saeed, MD, of Dayton Children’s Hospital in Ohio. Saeed posted a photo of a patient’s skin rash on Twitter in March after Anthem denied treatment for symptoms of Crohn’s disease. “Unacceptable and shameful!” he tweeted.

Two weeks later, he reported that the treatment was approved soon after the tweet. “When did Twitter become the preferred pathway for drug approval?” he wrote.

Eunice Stallman, MD, a psychiatrist from Boise, Idaho, complained on X (formerly Twitter) about Blue Cross of Idaho’s prior authorization denial of a brain cancer treatment for her nine-month-old daughter. “This is my daughter that you tried to deny care for,” she posted. “When a team of expert [doctors] recommend a treatment, your PharmD reviewers don’t get to deny her life-saving care for your profits.”

However, in this case, she posted her account after Blue Cross Idaho reversed the denial. She said she did this in part to prevent the payer from denying coverage for the drug in the future. “The power of the social media has been huge,” she told KFF Health News. The story noted that she joined X for the first time so she could share her story.

Affordable Care Act Loophole?

“We’re not going to get rid of prior authorization. Nobody is saying we should get rid of it entirely, but it needs to be right sized, it needs to be simplified, it needs to be less friction between the patient and accessing their benefits. And I think we’re on really good track to make some significant improvements in government programs, as well as in the private sector,” said Todd Askew, Senior Vice President, Advocacy, for the American Medical Association, in an AMA Advocacy Update.

However, KFF Health News reported that Kaye Pestaina, JD, a Kaiser Family Foundation VP and Co-Director of the group’s Program on Patient and Consumer Protections, noted that some “patient advocates and health policy experts” have questioned whether payers’ use of prior authorization denials may be a way to get around the Affordable Care Act’s prohibition against denial of coverage for preexisting conditions.

“They take in premiums and don’t pay claims,” family physician and healthcare consultant Linda Peeno, MD, told KFF Health News. “That’s how they make money. They just delay and delay and delay until you die. And you’re absolutely helpless as a patient.” Peeno was a medical reviewer for Humana in the 1980s and then became a whistleblower.

The issue became top-of-mind for genetic testing labs in 2017, when Anthem (now Elevance) and UnitedHealthcare established programs in which physicians needed prior authorization before the insurers would agree to pay for genetic tests.

Dark Daily’s sister publication The Dark Report covered this in “Two Largest Payers Start Lab Test Pre-Authorization.” We noted then that it was reasonable to assume that other health insurers would follow suit and institute their own programs to manage how physicians utilize genetic tests.

At least one large payer has made a move to reduce prior authorization in some cases. Effective Sept. 1, UnitedHealthcare began a phased approach to remove prior authorization requirements for hundreds of procedures, including more than 200 genetic tests under some commercial insurance plans.

However, a source close to the payer industry noted to Dark Daily that UnitedHealthcare has balked at paying hundreds of millions’ worth of genetic claims going back 24 months. The source indicated that genetic test labs are engaging attorneys to push their claims forward with the payer.

Is Complaining on Social Media an Effective Tactic?

A story in Harvard Business Review cited research suggesting that companies should avoid responding publicly to customer complaints on social media. Though public engagement may appear to be a good idea, “when companies responded publicly to negative tweets, researchers found that those companies experienced a drop in stock price and a reduction in brand image,” the authors wrote.

However, the 2023 “National Customer Rage Survey,” conducted by Customer Care Measurement and Consulting and Arizona State University, found that nearly two-thirds of people who complained on social media received a response. And “many patients and doctors believe venting online is an effective strategy, though it remains unclear how often this tactic works in reversing prior authorization denials,” KFF Health News reported.

Federal Government and States Step In

KFF Health News reported that the federal government is proposing reforms that would require some health plans “to provide more transparency about denials and to speed up their response times.” The changes, which would take effect in 2026, would apply to Medicaid, Medicare Advantage, and federal Health Insurance Marketplace plans, “but not employer-sponsored health plans.”

KFF also noted that some insurers are voluntarily revising prior authorization rules. And the American Medical Association reported in March that 30 states, including Arkansas, California, New Jersey, North Carolina, and Washington, are considering their own legislation to reform the practice. Some are modeled on legislation drafted by the AMA.

Though the states and the federal government are proposing regulations to address prior authorization complaints, reform will likely take time. Given Harvard Business Review’s suggestion to resist replying to negative customer complaints in social media, clinical labs—indeed, all healthcare providers—should carefully consider the full consequences of going to social media to describe issues they are having with health insurers.

—Stephen Beale

Related Information:

Doctors and Patients Try to Shame Insurers Online to Reverse Prior Authorization Denials

Delays Related to Prior Authorization in Inflammatory Bowel Disease

Why You Shouldn’t Engage with Customer Complaints on Twitter

Feds Move to Rein In Prior Authorization, a System That Harms and Frustrates Patients

“Damaged Care” Premiere Features HMO Whistleblower

Major Insurers to Ease Prior Authorizations Ahead of Federal Crackdown

How Labs Can Improve Their Relationships with Payers for Genomic Test Reimbursement

Payers Request More Claims Documentation

CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups

Proposal comes as patient advocacy group reports poor compliance by hospitals with the federal price transparency regulation; AHA pushes back

Recent data compiled by Patient Rights Advocate, a non-profit group dedicated to nationwide healthcare transparency, appears to indicate that as many as two thirds of US hospitals continue to ignore hospital transparency rules established by Congress in 2021, according to an op-ed published in the Washington Examiner.

This may be why the Biden Administration has now proposed new amendments aimed at strengthening those requirements. According to KFF Health News (formerly Kaiser Health News), this new proposal “aims to further standardize the required data, increase its usefulness for consumers, and boost enforcement.”

However, “the goal of exact price tags in every situation is likely to remain elusive,” KFF Health News noted.

“Noncompliant hospitals are preventing patients and payers from shopping around for high-value care—and inflating healthcare costs in the process,” wrote Sally C. Pipes, President and CEO of Pacific Research Institute, in her Washington Examiner column.

Pathologists who were near the top of a Health Care Cost Institute (HCCI) list of medical specialties that most often billed out of network may be affected by CMS’ proposed new amendments to the transparency rule.

“The nonprofit group Patient Rights Advocate just published its fifth report exploring how hospitals are complying with federal price transparency requirements. About two-thirds are still flouting the rules. That’s unacceptable,” wrote Sally Pipes (above), President and CEO of Pacific Research Institute, in an op-ed she penned for the Washington Examiner. Federal law also requires clinical laboratories to post their prices for testing. (Photo copyright: The Heartland Institute.)

Hospitals, Clinical Laboratories Required to Post Chargemaster Prices

The proposed amendments were part of a larger proposed rule published in the July 31, 2023, Federal Register by the Centers for Medicare and Medicaid Services (CMS).

Dark Daily has long been reporting on the federal government’s efforts to mandate Hospital Price Transparency (HPT). Beginning Jan. 1, 2019, hospitals have been required to post pricing information on their websites, as Dark Daily reported in “New CMS Final Rule Makes Clinical Laboratory Test/Procedure Pricing Listed on Hospital Chargemasters Available to Public.”

That rule required hospitals to disclose chargemaster prices, essentially the “list prices” for hospital procedures.

But a year later, as we reported in “Hospital Associations and Healthcare Groups Battle HHS Efforts to Expand Pricing Transparency Rules to Include Negotiated Rates with Payers,” the CMS passed a final rule that required disclosure of prices negotiated with payers.

That rule also required hospitals to provide a list of charges for at least 300 “shoppable services,” including at least 14 laboratory and pathology tests.

“We’re closer to that, but we’re not there,” Gerard Anderson, PhD, a professor at the Johns Hopkins Bloomberg School of Public Health, told KFF. The goal may be the kind of pricing transparency that consumers are accustomed to when purchasing goods and services, but healthcare, he said, poses unique challenges.

“Each patient is unique and uses a slightly different bundle of services,” Anderson added. “You might be in the operating room for 30 minutes, or it might be 45. You might need this lab test and not that one.”

The KFF Health News story noted that health insurers have been subject to even stricter regulations, “with more prescriptive details and tougher penalties for noncompliance,” since 2022. CMS’ latest proposed amendments would bring requirements for hospitals that are more in line with those that apply to payers, KFF reported.

As described in the Federal Register, the proposed rule aims to:

  • Improve standardization of machine-readable file (MRF) formats and data elements.
  • Require hospitals to include a new data element known as the “consumer-friendly expected allowed charges,” KFF Health News noted.
  • Require hospitals to “affirm the accuracy and completeness of their standard charge information displayed in the MRF.”
  • Require hospitals to place a link to pricing information in the footers of their web pages.

The rule also includes provisions for enhanced enforcement of pricing transparency requirements. Under one proposal, CMS would publicly identify hospitals that are not in compliance.

Jeffrey Leibach, MBA, a healthcare finance strategist and Partner with the consulting firm Guidehouse, told KFF Health News that the new rules will make it easier for third-party data firms to create online price comparison tools. “And, ultimately, consumers who want to shop will then find this data more easily,” he said.

The proposal comes on the heels of a July report from Patient Rights Advocate (PRA) indicating that only 36% of US hospitals were in full compliance with the current transparency requirements. The report was based on an analysis of 2,000 hospital websites. However, that was an improvement over earlier reports. In February, the group reported that 24.5% were fully compliant, compared with 16% in August 2022.

Most hospitals in the report posted negotiated prices, but in many cases, “their pricing data was missing or significantly incomplete,” PRA contended. A total of 69 hospitals “did not post a usable standard charges file,” the report stated.

PRA Uses Humor to Highlight Discrepancies, AHA Pushes Back

According to KFF Health News, PRA is running a satirical ad campaign in which retailers adopt the “hospital pricing method,” listing estimates on store shelves instead of actual prices.

“When they ask for a price, we give them an estimate,” says one retail manager in the video ad. “Then we bill them whatever we want.”

This new video pokes fun at the lack of price transparency in healthcare. The American Hospital Association took issue with the clip’s tone.

“People need price certainty,” PRA founder and Chairman Cynthia Fisher, MBA, told KFF Health News. “Estimates are a way of gaming the people who pay for healthcare.”

However, executives from the American Hospital Association (AHA) pushed back on the video ad and PRA’s claims about HPT compliance. AHA contends that hospitals were flagged as being noncompliant if they left spaces blank or used formulas, both of which are permitted under the current rules.

“Very few health services are so straightforward where you can expect no variation in the course of care, which could then result in a different cost than the original assessment,” AHA Group Vice President for public policy Molly Smith, MS, told KFF. “Organizations are doing the best they can to provide the closest estimate. If something changes in the course of your care, that estimate might adjust.”

As for the July PRA report, in a July 25 AHA press release, Smith stated, “Patient Rights Advocate has put out a report that blatantly misconstrues, ignores, and mischaracterizes hospitals’ compliance with federal price transparency regulations.”

CMS, she said, “has found that as of last year 70% of hospitals had complied with both federal requirements and over 80% had complied with at least one. Due to the ongoing efforts of the hospital field, these numbers are surely higher today. Third party analyses have agreed that hospitals have made tremendous progress.”

But then what is motivating the government’s new amendments to the price transparency rule? Regardless, clinical laboratories and pathology groups should continue to monitor progress of these new amendments to the federal hospital transparency rule.

—Stephen Beale

Related Information:

Hospitals Are Still Neglecting Transparency Rules

Proposed Rule Would Make Hospital Prices Even More Transparent

CMS Proposes Updates to the Hospital Price Transparency Rule

A Progress Check on Hospital Price Transparency

Price Transparency: A Boon For Patients, a Bust for Hospitals?

Just More than a Third of Hospitals Are Complying with Price Transparency Rules

Scientists and Medical Professionals Face Huge Fees, Court Costs after Speaking at Certain COVID-19 Webinars

Little-known Polish company relied on suspect arbitration court to demand thousands of euros from conference speakers

Clinical laboratory and pathology professionals may want to heed the phrase “caveat emptor” (“let the buyer beware”) if invited to speak at events organized by little-known entities. That appears to be the lesson from a rather bizarre story coming out of Poland involving scholars from multiple countries who agreed to speak during a series of online COVID-19 webinars and who were later billed thousands of euros for their participation.

In “Costly Invite? Scientists Hit with Massive Bills after Speaking at COVID-19 ‘Webinars,’Science magazine reported that in 2020 and 2021, dozens of researchers were invited by a Polish company called Villa Europa to speak in a series of online conferences about modeling of COVID-19.

But months after the event, the organizer demanded payment for the researchers’ participation, and in some cases, turned to a Polish arbitration court to enforce the demand. But in a curious twist, the legitimacy of that court has itself been called into question.

“I was interested in the topic, and I agreed to participate,” Björn Johansson, MD, told Science. “I thought it was going to be an ordinary academic seminar. It was an easy decision for me.” Johansson, a physician and researcher at the Karolinska Institute in Sweden, has since “come to regret that decision,” the publication reported.

Villa Europa is now seeking €80,000 ($86,912 in current US dollars) from Johansson, including legal costs and interest, after turning to a Swedish court. Others have received demands for €13,000 to €25,000 ($14,123 to $27,156) in fees, late payment penalties, and court costs, Science reported.

Researchers Axel Brandenburg, PhD (left), and Björn Johansson, MD (right), are two of the 32 scholars from six countries who are now being billed thousands of euros for their participation in the Villa Europa COVID-19 modeling webinars. Pathology and clinical laboratory leaders who receive similar invitations may want to thoroughly read the contracts before agreeing to participate. (Photo copyright: Axel Brandenburg, Björn Johansson.)

How Did It All Happen?

According to Science, the ordeal began when an individual named Matteo Ferensby invited the scientists to speak at the webinars. His email signature indicated an affiliation with the University of Warsaw, but the university “has no employee by that name, according to the institution’s press office,” Science reported, adding that “there is no track record of scientific publications from a Matteo Ferensby.”

By one speaker’s count, the company produced at least 11 webinars between April 2020 and June 2021. “The speakers themselves—about 10 people in each session—were the only audience, but participants were told the recordings would be published open access afterward,” Science reported.

Ferensby did not disclose that speakers would be charged conference fees. In fact, one speaker was told explicitly that no fees would be requested, Science noted.

However, the speakers were later asked to sign a license agreement that would allow the organizer to publish the recordings. It included a clause on the last page stating that they would have to pay fees of €790 and €2785 (US$859 and $3,029) related to publication.

The financial amounts were written in words rather than numbers with no highlighting, according to Science, which reviewed some of the contracts.

“Many of the speakers, already busy studying COVID-19 and under pressure from the transition to remote teaching, did not notice these clauses,” Science reported. Said one speaker: “The contract was unreadable [but] I eventually sent it.”

Questionable Arbitration

Some of the webinar participants told Science that they later received altered versions of the contracts with “an additional page where the fees are made explicit, and [with] modified clauses, one of them stating that disputes can be settled by a Polish arbitration court.”

That court, identified as Pan-Europejski-Sąd-Arbitrażowy (Pan European Arbitration Court or PESA), apparently does not exist. Agnieszka Durlik, JD, Director General of The Arbitration Court at the Polish Chamber of Commerce, told Science that she had never heard of PESA, and it that appears Villa Europa set up the PESA website.

“In my opinion this is fraud,” Durlik said. Nevertheless, Villa Europa used alleged rulings by PESA to go after some of the speakers in their own local courts.

“For the researchers now under pressure from the courts, ignoring the demands is not an option,” Science reported. “They have all submitted court filings supporting their case.”

The speakers claim that “the demands are illegitimate and that they were deceived about what they were signing in the contracts,” Science noted. One speaker, Axel Brandenburg, PhD, of the Nordic Institute for Theoretical Physics (NORDITA), is awaiting a ruling in September, Science reported.

Warnings against Predatory Conferences

The story comes amid increasing concerns about so-called “predatory conferences,” in which scientists are invited under false pretenses to participate in what appear to be legitimate meetings.

“Would-be attendees should expect missing plenary speakers, multiple fields of research smashed together in a Frankenstein program, and an absence of the important academic rigor that fuels the conferences that scientists know and love,” wrote senior science writer Ruairi J. Mackenzie in Technology Networks. “The companies organizing these events are motivated by profit above all else.”

Mackenzie offered several tips to help both speakers and attendees spot fake conferences:

  • Examine the promotional materials. “Whether you are studying an unprompted email or a conference webpage, look for shoddy writing quality or outlandish layouts.”
  • Check with your colleagues. “The dominant conferences in your field are probably in that position because they have proved time and time again that they can deliver a valuable experience for attendees.”
  • Look at other conferences from the same producer. If a company produces a high volume of conferences on a wide range of topics, that can be a sign that the quality will be shoddy, he suggested.
  • Look at the contact information. A legitimate conference should have ties to an established society or conference organizer. Get the address, and then look at that location in Google Street View to see if it’s the kind of building where you’d expect a legitimate company to be located.

The experience of these 32 scientific and medical scholars demonstrates that there is always a new twist in how honest citizens can be defrauded. For that reason, clinical laboratory managers and pathologists should be wary when approached by unknown organizations with speaking invitations, particularly in Europe.

—Stephen Beale

Related Information:

Costly Invite? Scientists Hit with Massive Bills after Speaking at COVID-19 ‘Webinars.’

The Ultimate Guide to Avoiding Predatory Conferences

The Alarming Rise of Predatory Conferences

The Ethics Blog: Predatory Conferences

Arbitrarily Applied: Another COVID-19 Scam, This Time On Scientists

Health Officials and Clinical Labs Gear Up to Deal with Another ‘Tripledemic’

In preparing to deal with outbreaks of three different respiratory viruses, measures include newly approved vaccines for RSV and reformulated COVID-19 shots

Clinical laboratories are the frontline of testing for respiratory infections, and as such, were heavily involved in last winter’s so-called “tripledemic” of Influenza, SARS-CoV-2, and respiratory syncytial virus (RSV). According to a Kaiser Family Foundation (KFF) survey, 38% of US households were affected. Now, federal health officials are taking steps to prevent a repeat tripledemic season, which includes new vaccines for RSV as well as reformulated COVID-19 vaccines.

Dark Daily covered this tripledemic in “Early Appearance of RSV Cases, Combined with Influenza and COVID-19, Raises Concern about Possibility of a Tripledemic During This Flu Season.” We noted how in 2022 the federal Centers for Disease Control and Prevention (CDC) had issued a Health Alert Network (HAN) advisory stating, “Co-circulation of respiratory syncytial virus, influenza viruses, SARS-CoV-2, and others could place stress on healthcare systems this fall and winter.” This was especially true of clinical laboratories that were struggling to keep pace with demand for COVID-19 testing.

The big breakthrough this year is the federal Food and Drug Administration’s (FDA) first-ever approval of RSV vaccines in the US. On May 3, the FDA approved GSK’s Arexvy for use in adults 60 years or older. Then, on May 31, the agency approved Pfizer’s Abrysvo for use in the same age group.

“Older adults, in particular those with underlying health conditions such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), in an FDA statement announcing approval of the GSK vaccine. “[The] approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

A GSK press release notes that a clinical trial is underway to evaluate the vaccine for adults aged 50 to 59.

“The number of elders who die of viral infection every winter in our intensive care units, and also sometimes in the summer, is large—it’s in the tens of thousands of individuals,” pediatrician Ofer Levy MD, PhD (above), an advisor to the FDA, told The New York Times. “Each of these vaccines is a huge win.” Clinical laboratories will be looking for these new vaccines to help protect their customers from tripledemic infections. (Photo copyright: Harvard.)

New Targets for COVID-19 Vaccines

Meanwhile, following a June 15 meeting of the FDA’S Vaccines and Related Biological Products Advisory Committee (VRBPAC) the agency announced that it is advising drugmakers to develop COVID-19 vaccines targeting the XBB 1.5 subvariant of the Omicron SARS-CoV-2 variant.

As of early June, XBB lineages accounted for more than 95% of the SARS-CoV-2 variants circulating in the US, noted a recommendation from the VRBPAC committee. The recommendation also noted that the XBB 1.16 and 2.3 variants are on the rise as XBB 1.5 is declining, but “the protein sequences of XBB.1.5, XBB.1.16, and XBB.2.3 spike protein appear similar, with few amino acid differences. Available evidence suggests little to no further immune evasion from these new substitutions in the XBB.1.16 spike protein compared to XBB.1.5.”

The committee recommended a monovalent vaccine composition in contrast to the current bivalent vaccines, which have separate components targeting the original coronavirus strain and the Omicron variant.

Experts Differ on How Best to Administer New Vaccines

One question is whether the three vaccines—COVID-19, RSV, Influenza—should be given in a single visit or spread out. FDA advisor and pediatrician Ofer Levy MD, PhD, told The New York Times that bundling the shots could result in higher rates of immunization. “Plus, you want to get these shots in arms before the viral respiratory season in the winter,” he said. Levy is Director of the Precision Vaccines Program at Boston Children’s Hospital and Professor of Pediatrics at Harvard Medical School.

However, advisors to the federal Centers for Disease Control and Prevention (CDC) have warned that administering the flu and RSV vaccines at the same time could make both less effective. “I would say, when possible, it might be good to spread them out,” Camille Kotton, MD, Clinical Director of Transplant and Immunocompromised Host Infectious Diseases in the Infectious Diseases Division at Massachusetts General Hospital, told The New York Times. “I remain clinically concerned, especially where influenza vaccine doesn’t engender as much protection as we might like,” she said.

Looking Back at Last Winter

Just how bad was the last triple outbreak? In the KFF survey, 38% of respondents said their households were affected by at least one of the three diseases in the previous month:

  • 27% reported someone in their household having the flu,
  • 15% reported COVID-19,
  • 10% reported RSV, a KFF press release notes.

“News about the three viruses also made some people more likely to take preventive measures such as:

  • Wearing a mask in public (31%),
  • Avoiding large gatherings (26%),
  • Traveling less (20%),
  • Avoiding eating indoors at restaurants (18%).” 

Additionally, people with compromised immune systems were more likely to take precautions, as were Black and Hispanic adults, KFF reported.

Clinical laboratories will soon have new vaccines to combat another potential tripledemic. Whether people will line up to receive them is another matter.

—Stephen Beale

Related Information:

Pfizer and BioNTech Submit Applications to US FDA for Omicron XBB.1.5-adapted Monovalent COVID-19 Vaccine

Nearly Four in Ten Say Their Households Were Sick with COVID-19, the Flu, or RSV Recently Even as Most People Say They Aren’t Too Worried About Getting Seriously Ill

KFF COVID-19 Vaccine Monitor: January 2023

‘Tripledemic’ Infected Nearly 40% of Households, Survey Finds

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023

US FDA Approves GSK’s Arexvy, the World’s First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Recommendation for the 2023-2024 Formula of COVID-19 Vaccines in the US

Federal Officials Hatch a Three-Pronged Defense against Another ‘Tripledemic’

FDA Advisory Committee Recommends a Monovalent COVID Booster

Preparing for the Next ‘Tripledemic’

Early Appearance of RSV Cases, Combined with Influenza and COVID-19, Raises Concern about Possibility of a Tripledemic During This Flu Season

Precision Medicine May Have a New Lung Cancer Treatment That Can Be Staged with an EGFR Test as a Companion Diagnostic

There’s evidence that a cancer drug can cut deaths from lung cancer by as much as 50% when pathology testing indicates the patient has the EGFR mutation

Results from a decade-long clinical trial indicate that lung cancer patients with the epidermal growth factor receptor (EGFR) mutation have significantly better survival rates when treated with the drug osimertinib. This is a positive step forward for precision medicine and will give clinical laboratories an opportunity to deliver more value to physicians and patients.

The study known as ADAURA was led by scientists at Yale University and funded by British pharmaceutical/biotechnology company AstraZeneca. The researchers recently found that taking the cancer drug osimertinib (brand name Tagrisso) reduces by half the number of deaths among patients who had undergone surgery for EGFR–mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), according to NBC News.

Lung cancer has been one of the toughest types of cancers to diagnose early. When finally diagnosed, many patients do not have a good prognosis. Thus, the results of this multi-national study—and the connection involving patients with the EGFR gene—is a welcome development that promises better outcomes for cancer patients.

At the same time, this increases the value of EGFR as a biomarker for clinical laboratories and pathology groups that offer EGFR testing. It could become a companion diagnostic test—part of a clinical guideline for diagnosing lung cancer—that helps identify appropriate anti-cancer drugs for specific patients.

The researchers published their findings in the New England Journal of Medicine (NEJM) titled, “Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC.” They also presented the results of their study at the American Society for Clinical Oncology (ASCO) conference.

“Adjuvant osimertinib is currently the only EGFR tyrosine kinase inhibitor to translate a statistically significant and practice-changing disease-free survival benefit into a significant [overall survival] benefit in a phase 3 trial, supporting osimertinib as the standard of care for patients in this setting,” said Roy Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center, who led the Yale study, at the 2023 ASCO Annual Meeting, according to an ASCO news release. (Photo copyright: Yale School of Medicine.)

Identifying Best Candidates for Specific Cancer Drugs

The results of the Yale-led study of the cancer drug osimertinib suggest that testing for a mutation in the EGFR gene could become part of the standard-of-care for NSCLC. Researchers found that NSCLC patients with the mutation showed improved survival rates and reduced risk of recurrence when taking the drug following surgery. EGFR tests could thus become companion diagnostics to determine whether patients are good candidates for the drug.

“We have been using one-size-fits-all adjuvant chemotherapy for every patient with lung cancer despite a decade of advances in targeted treatments for select groups of patients that result in dramatically better outcomes,” Nathan Pennell, MD, PhD, Vice Chair of Clinical Research and Director, Lung Cancer Medical Oncology Program Cleveland Clinic Taussig Cancer Institute, told the ASCO Post.

Pennell, who was not involved in the Yale research, described the finding as “a first for the lung cancer field,” and said adjuvant osimertinib “should be the new standard of care” for patients with EGFR-mutated NSCLC.

‘Practice-changing’ Cancer Drug

The study was led by Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Assistant Dean for Translational Research at Yale School of Medicine. Herbst is the principal investigator for the ADAURA global multi-site clinical trial which enrolled 682 patients with stage IB-IIIA NSCLC, in an effort to determine the efficacy of the cancer drug osimertinib, a pill taken once a day, which, according to NBC News, has fewer major side effects than chemotherapy.

The FDA approved the drug in 2015 for patients with advanced lung cancer. In 2020, the agency approved its use at earlier stages of the disease.

The ADAURA study included patients from 26 countries across Europe, North America, South America, and the Asia-Pacific region. About half of the patients took the pill each day for three years following surgery. The other half received a placebo.

According to a Yale news release, the researchers reported that 88% of patients treated with the drug were still alive five years later, compared with 78% of patients who received the placebo.

Earlier research demonstrated that the drug prevented recurrence of tumors and kept the disease from spreading to other organs, NBC News reported. “However, what we are seeing now is that patients will also live longer,” said oncologist Charu Aggarwal, MD, MPH, of the University of Pennsylvania’s Perelman School of Medicine, who was not involved in the study.

Herbst described the drug as “practice-changing” in the Yale news story.

An EGFR ‘Off Switch’

Non-small cell lung cancer is the most common form of lung cancer, The Guardian reported, adding that the EGFR mutation “is found in about a quarter of global lung cancer cases, and accounts for as many as 40% of cases in Asia. An EGFR mutation is more common in women than men and in people who have never smoked or have been light smokers.”

The mutation can cause cells to “excessively divide and multiply, which may cause cancer,” NBC News explained. Herbst described osimertinib as an “off” switch for the mutation.

“I think we’re curing some patients,” he said at the ASCO annual meeting, NBC News reported. “We’re really showing progress in lung cancer like never before,” he noted, adding that the results were “about twice as good as we expected.

“Overall survival has historically been considered the gold standard efficacy endpoint for randomized adjuvant clinical trials. The results of the ADAURA trial will broaden treatment access for patients with EGFR-mutated NSCLC,” Herbst told ASCO Post. “Together with the practice-changing disease-free survival data from our primary analysis, the overall survival benefit instills confidence that adjuvant osimertinib is the standard of care for patients with resected EGFR-mutated stage IB to IIIA NSCLC.”

Side effects of the pill include skin rashes and mild diarrhea, but in general the drug is “quite well tolerated,” Herbst said.

Impact on Labs

In Herbst’s view, the results of the Yale study demonstrate that patients diagnosed with lung cancer should be tested for the EGFR mutation, which is not always the case, The Guardian reported. “This further reinforces the need to identify these patients with available biomarkers at the time of diagnosis and before treatment begins,” he said.

Aggarwal agreed, telling NBC News that data from the study could be a “call to action” for more EGFR screening.

In light of the results, clinical laboratories and anatomic pathology groups should expect that EGFR screening may soon become a companion diagnostic test as part of a precision medicine clinical guideline for early diagnosing of lung cancer.

—Stephen Beale

Related Information:

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

Study Shows Osimertinib Improves Survival Following Surgery for Non-Small Cell Lung Cancer

Lung Cancer Deaths Cut in Half with AstraZeneca Pill, Large Trial Finds

Adjuvant Osimertinib Improves Survival in Patients with Resected EGFR-Mutated NSCLC

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumor Resection With or Without Adjuvant Chemotherapy. (ADAURA)

ADAURA Trial Results Provide New Hope for Patients with Early-Stage Non-Small Cell Lung Cancer

Updated Results from the ADAURA Trial: Continued Disease-Free Survival Benefit with Adjuvant Osimertinib vs Placebo in EGFR-Mutated Stage IB–IIIA NSCLC

Final ADAURA OS Analysis Reinforces Adjuvant Osimertinib as a Standard of Care for Patients with Stage IB to IIIA EGFR-Mutated Non–Small Cell Lung Cancer

NIH: Stage IIIA Non-Small Cell Lung Cancer

Lung Cancer Pill Cuts Risk of Death by Half, Says ‘Thrilling’ Study

Tagrisso Demonstrated Strong Overall Survival Benefit in the ADAURA Phase III Trial for Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer