Category: Health

On average, nearly four million annual surgical procedures in the U.S. are completed on pediatric patients. Despite this growing figure, surgical innovation has focused heavily on technologies for treating adults — until now. With advancements on the horizon, new features of robotic-assisted surgery are being developed to address the unique obstacles of pediatric surgery.

In recent years, robotic platforms have been employed in pediatric patients; however, they used relatively large instruments. As we’ll explore below, smaller instrument sizes are now becoming more prevalent, and surgeons performing pediatric procedures may benefit significantly from the precision and dexterity of robotics platforms.

Advantages of smaller incision size

Beyond aesthetics, smaller incisions can shorten recovery time and cause less pain for the patient. As opposed to making one large abdominal incision, multiple smaller incisions can reduce both blood loss and recovery time. It is not only the size of the incision, but also the proportion compared to overall abdominal surface that impacts pain, tissue damage, and length of the hospital stay.

Incision size matters to all patients, but more specifically to pediatric patients. As children continue to grow, their incision scars grow with them and proportionally increase in size over time. We also must consider that pediatric patients have different pain thresholds than adults and may not tolerate the same pain medications. This places a premium on minimizing the initial incision with the smallest possible instruments in robotic procedures.

Today’s most robust robotic platforms offer 3mm and 5mm instrumentation, allowing for more increased dexterity and control. This enables surgeons to navigate delicate anatomical structures as well as access hard-to-reach areas.  Not only are these instruments less invasive, but they enable smaller incision sizes and improved patient outcomes.

Unique challenges and complexities of pediatric surgery

Incision size is not the only factor pediatric surgeons must consider. The anatomy of young patients can make surgery extremely challenging as surgeons have limited access to organs and a smaller working space.

As opposed to adult patients whose bodies are larger and fully developed, it is difficult to anticipate anatomical issues during a pediatric procedure. Children’s bodies are not simply smaller versions of adults, but are also more delicate. Their organs are developing and their tissue and blood vessels can be more fragile. These challenging cases may benefit from the increased precision offered by robotically-enabled laparoscopic approaches.

Surgeon benefits 

While many features of robotic-assisted surgery are aimed at improving patient outcomes, there are also various benefits for surgeons themselves. Meticulous pediatric procedures can be taxing, and long hours on their feet, strenuous movements, and repetitive actions can leave a surgeon exhausted. In fact, 68% of surgeons report experiencing generalized pain following procedures, with minimally invasive surgeons reporting the most amount of pain, fatigue, and numbness.

Many robotic platforms allow for the surgeon to be seated in an ergonomically comfortable position  throughout the procedure. This allows for a range of adjustments to customize the console setup according to the surgeon’s preferences. Additionally, some systems offer an open cockpit design, which enables easy access to the patient and clear communication between the surgeon and staff.  With a range of ergonomic options, robotic surgery can make strenuous procedures easier – and even extend the surgeon’s career.

Benefits of digital surgery

Surgeons need real-time information to make informed decisions, navigate challenging anatomy, and reduce variability. In addition to improving upon the basic mechanics of traditional surgery, the advanced features on a robotics platform can help surgeons provide a new standard of care. For example, eye tracking, a software feature available on newer platforms, follows a surgeon’s eye movements and repositions the surgical camera inside the patient. This provides the OR team with a stable and optimum view of the patient’s anatomy.

One of the most unique features in newer robotic platforms is haptic feedback, or physical sensation. Not only does it provide a more natural sensation of pressure when completing surgical tasks, but it allows the surgeon to feel when they are in contact with anatomy that can be potentially damaged or injured by instrument movements. Additional features available on some newer platforms include digital measurements and tagging – both of which provide visual instruction for enhanced communication and coordination of the surgical team.

From what we’ve seen, pediatric patients can clearly benefit from robotic-assisted surgery. With the many advantages of robotics, it is time for pediatric patients to garner the same attention and technology development that adult patients have benefitted from for decades.

Photo: FatCamera, Gett. Images

I’m too old to be a millennial. I’m too young to be a Gen X-er. Folks like me who were born in the late 1970s are better classified as the Oregon Trail Generation, named after the Apple II computer educational game many of us played in elementary school.

We grew up in the analog world of wall-mounted telephones, printed newspapers, nightly news shows, cassette tapes, and VCRs. We came of age as the internet took off, first through online bulletin boards, then chatrooms, and later AOL, Netscape, and Napster. We’ve lived our adult lives in the increasingly digital, hyper-connected world of smartphones, social media, news feeds, eCommerce, and streaming.

I’m also part of a generation of Oregon Trail doctors who graduated from medical school around “Y2K,” just as healthcare started slowly transitioning from analog to digital. As interns and residents, we carried mini-reference books like the Washington Manual and Sanford Guide. (A few of our tech-forward colleagues used Palm Pilots). We handwrote progress notes that we’d deposit in patients’ physical charts at the end of the day. We regularly trekked to the medical records department and repeatedly scribbled orders for insulin sliding scales and heparin drips.

Later, as newly minted attending physicians, we turned to online tools like UpToDate to review medical literature, dictated our notes using phone-based transcription services, used homegrown electronic health records (EHRs) to review patient records, and placed orders verbally or using paper slips. Our patients increasingly started showing up with information from their Google searches.

Soon, the “Meaningful Use” program pushed our practices to implement certified EHRs. Later, the Covid-19 pandemic temporarily forced us to provide care virtually. Today, artificial intelligence is promising to reshape further how we practice. In total, our experiences give us a unique perspective that blends analog old school and digital new school and points to several key lessons.

Digitization has both positive and negative effects.

Technological advances bring benefits along with unanticipated side effects. The digitization of healthcare is no exception.

For one, far more accessible information both empowers and overwhelms us. Clinical notes are now legible and easy to retrieve but bloated with unnecessary, often duplicative, and, at times, unintelligible content. We’ve traded cumbersome message slips and results printouts for overloaded digital In Boxes, much of it filled with junk and nonsense. We can conveniently access EHRs anywhere, anytime, but we struggle to disconnect from work. Though we can monitor our patients remotely, we fight to sort meaningful signals from noise. And by accessing online content and their own medical records, our patients have better access to information but sometimes still remain misinformed.

Digital technology has also brought us closer together and pushed us further apart. In the hospital, we spend far more time in workrooms glancing at computer screens than rounding at the bedside. We easily communicate with colleagues via rapid-fire text messages at the expense of in-person interactions that foster teamwork and build community. In clinics, obtrusive keyboards and screens sit between our patients and us. And though our patients can more easily reach us through portal messaging and video visits, we are more distracted and less present.

Digital tools also make us both more and less productive. We can quickly notify patients about their test results but strain to keep pace with a barrage of incoming patient messages. We easily prescribe medications electronically but must enter orders for tests that non-clinical staff used to place for us. We use eConsults to obtain specialists’ advice rapidly but suffer through endless clicks and alert fatigue. We spend up to half our days interacting with the EHR during and after hours.

Healthcare has digitized but has not yet digitally transformed.

In the early 1900s, manufacturers started replacing steam-powered motors with electric motors, otherwise leaving their factories unchanged. They did not realize returns on their investment until many years later, when they radically redesigned factories and workers into modular units with smaller production lines, taking advantage of the smaller electrical motors.

Similarly, while healthcare has digitized, few healthcare provider organizations have digitally transformed. Instead, we’ve digitized our old paper-based processes within EHRs without evolving systems needed to manage the digital exhaust. We continue to primarily provide care during intermittent, in-person visits rather than more continually over multiple asynchronous and synchronous channels. Stuck using new digital tools within the confines of old systems, we feel strained and increasingly burned out.

We must shape a better future.

For decades, many have hoped digital technology would solve healthcare’s most vexing challenges. So far, digital technology has not delivered its promise. Still, we should remember Amara’s Law: “We tend to overestimate the effect of a technology in the short run and underestimate the effect in the long run.”

Today, many hope artificial intelligence will be the key that unlocks the value of digitization. Perhaps it will, but the claim that better technology will necessarily improve healthcare is no longer credible.

Historian Melvin Kranzberg famously stated, “Technology is neither good nor bad; nor is it neutral.” In other words, it’s up to us to shape how we use it. New technologies can help us dream of better ways of doing things. But healthcare is complex, the stakes are high, and it is difficult to effect change.

Having lived in both analog and digital worlds, who better than us Oregon Trail doctors to help ensure digital health technologies best serve our workforce, patients, and communities?

A Takeda Pharmaceutical drug for an allergic condition affecting the esophagus is now approved, a regulatory decision that comes a little more than two years after the FDA initially turned down the pharma giant’s application. The regulatory decision gives Takeda the opportunity to offer patients a drug with different dosing than a blockbuster product that Sanofi markets for the condition.

The FDA approval announced Monday covers the treatment of pediatric and adult patients who have eosinophilic esophagitis, a condition in which eosinophils, a type of white blood cell, build up in the esophagus, causing inflammation and swallowing difficulty. Consequently, food often gets stuck in the esophagus, leading to emergency room visits.

Eosinophilic esophagitis has been treated with corticosteroids used off label. Takeda’s new drug, brand name Eohilia, is also a corticosteroid, a twice-daily oral suspension formulation of an old drug called budesonide. This anti-inflammatory drug reduces swelling in the airways, which led to initial approval of inhaled formulations of the molecule for the prevention of asthma attacks. The drug, which works by binding to glucocorticoid receptors, later found additional uses in other diseases. The exact way this mechanism treats eosinophilic esophagitis is not known, but inflammation is key part of the chronic condition’s progression.

Eohilia is one of the drugs that came to Takeda via the $62 billion acquisition of Shire in 2019. The Japanese pharma giant continued late-stage clinical development of the drug, then submitted a new drug application in eosinophilic esophagitis in 2020. The following year, the FDA turned down Takeda’s application. According to the company, the regulator recommended another clinical study. Rather than do that, Takeda opted to stop further development.

This past September, Takeda revealed that the FDA accepted the company’s resubmission for oral budesonide. Takeda did not conduct another clinical trial. Instead, the pharma giant said it reanalyzed the clinical trial data. Discussions with the FDA led to the resubmission of the drug as a treatment for short-term treatment of eosinophilic esophagitis.

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda, said in a prepared statement. “With Eohilia, patients and their physicians now have the first and only FDA-approved oral treatment option for [eosinophilic esophagitis] that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

The prescribing information recommends treatment with the drug for no longer than 12 weeks. The label includes warnings of a higher risk of developing infections, which is consistent with the risks for other corticosteroids. The prescribing information also cautions that treatment can lead to systemic effects such as too much or too little production of the adrenal hormone cortisol, another known complication of steroid drugs.

The first FDA-approved drug for eosinophilic esophagitis was Dupixent, an antibody drug from partners Sanofi and Regeneron Pharmaceuticals that has regulatory approvals for treating multiple autoimmune conditions. The 2022 approval of Dupixent in eosinophilic esophagitis covered the treatment of adults as well as children age 12 or older. Approval in this indication has since expanded to children as young as age 1. Dupixent is administered as a once-weekly injection. Unlike Eohilia, Dupixent’s prescribing information does not recommend limiting the duration of treatment, which could be a competitive advantage given that  eosinophilic esophagitis is a chronic condition.

Takeda had previously said it would record an impairment charge due to the discontinuation of its eosinophilic esophagitis drug, formerly known ats TAK-721. The company now says it is assessing the financial impacts of Eohilia’s FDA approval, including a reversal of the impairment loss for the fiscal year ending March 31, 2024. The company added that it does not anticipate this impact will be material.

Photo: Scott Eisen/Bloomberg, via Getty Images

The California Office of Healthcare Affordability’s (OHCA) cost and market impact review (CMIR) regulations were recently approved and will drastically change California’s healthcare regulatory system. Under the California Healthcare Transactions Law, healthcare entities are required to inform OHCA of “material change transactions” that are expected to close on or after April 1. The new law aims to provide oversight of healthcare consolidation.

Who is required to file with OHCA under these new regulations? That depends on three questions, according to Jordan Grushkin, who spoke on a webinar last week about the regulations and is the senior associate of the National Health Care Team and leader of firmwide OHCA initiatives at Sheppard Mullin. If the answer is “yes” to all of these questions, then an organization’s transaction falls under OHCA’s new regulations, according to Grushkin:

1. “Is your company a ‘healthcare entity?’”

The healthcare entities that are potentially included in the CMIR process fall into three buckets: providers, payers and fully integrated delivery systems. The provider category includes physician groups with at least 25 doctors, hospitals, outpatient clinics, clinical labs, imaging centers, restricted Knox-Keene plans, risk-bearing organizations and medical foundations. 

Payer organizations include fully licensed Knox-Keene plans, California Department of Insurance licensees, third-party administrators and pharmacy benefit managers. The payer category also includes “entities that act in California on behalf of a payer, and either govern or control the health care entity or are governed/controlled by the health care entity,” according to Grushkin’s presentation. 

Fully integrated delivery systems include a physician organization, a health facility or health system and a nonprofit healthcare service plan.

2. “Has a monetary or [health professional shortage area] threshold been met?”

Healthcare entities have to hit “one of three thresholds” in order to be subject to the review process under OHCA, Grushkin said. Healthcare entities applicable for the review process include those that have at least $25 million in California-derived annual revenue or with $25 million in California assets; those that have at least $10 million in California-derived annual revenue or with $10 million in California assets and are part of a transaction with a $25 million healthcare organization; those in a designated primary care health professional shortage area in California.

“Certainly the takeaway here is that all three thresholds should certainly be examined when determining whether or not your company is an applicable healthcare entity,” Grushkin said.

3. “Is there a ‘material change transaction?’”

There are eight transactions that would be considered a “material change transaction:”

• A deal valued at more than $25 million involving healthcare services.
• A party’s annual earnings increase by at least $10 million or 20%.
• Transferring more than 25% of a company’s assets.
• When a company’s ownership or control changes by at least 25%.
• When healthcare providers pair up with insurance companies in a way that raises their revenue by $10 million or 20% in California.
• Creating a new healthcare organization anticipated to make at least $25 million a year.
• A series of similar deals involving the same healthcare companies or related ones in the last 10 years.
• When a healthcare organization is acquired by another, and the buyer has done a similar deal with a similar organization in the last decade.

If the transaction applies to the regulations, then notice needs to be submitted to OHCA 90 days before the transaction closes, according to the webinar.

Photo: sdecoret, Getty Images

Cancer remains one of the most complex and devastating diseases, posing significant challenges to both patients and healthcare professionals. As we witness the emergence of more treatments, personalized medicine becomes crucial to tailoring therapies to each individual patient. However, the lack of effective cancer treatment-specific biomarkers presents a major roadblock in this pursuit.

While we have made significant progress in understanding the biology of cancer, there is a pressing need for biomarkers that can guide physicians in administering the correct treatment for each individual patient, and we seem to have reached a plateau in biomarker development. The approval of numerous drugs and modalities has only added to the confusion, necessitating novel approaches to tackle this issue.

In this context, artificial intelligence (AI) and machine learning (ML) have shown immense potential in revolutionizing cancer research and healthcare, offering new hope in the fight against cancer.

The significance of cancer-specific biomarkers

Biomarkers are the cornerstone of personalized medicine, offering valuable insights into the biological and medical characteristics of the patient or their disease. This enables healthcare providers to identify the most effective treatment strategy for each patient and distinguish patients who will respond favorably to a particular therapy from those who may not benefit from it.

While we have some effective biomarkers that help us understand cancer mechanisms, such as driver mutations in genomics, the lack of biomarkers for systemic treatments is a pressing challenge given that the majority of cancer patients are not eligible for targeted therapies. Biomarkers are indispensable for selecting the right patients and capturing the true potential of treatments. Without them, it becomes challenging to determine the optimal treatment for individual patients, leading to potentially suboptimal outcomes. However, the complexity of cancer biology demands comprehensive data analysis and pattern recognition, which traditional biomarker discovery methods struggle to achieve, hence the low success rate.

The growing role of AI and machine learning

AI and ML have proven transformative across various industries, and their potential in cancer research and healthcare is no exception. This approach is capable of processing vast amounts of complex data, detecting intricate patterns, and identifying novel biomarkers that may have otherwise gone unnoticed. This ability to generalize biomarkers and incorporate multiple features through a single AI marker is a game-changer, providing a comprehensive view of a patient’s cancer profile.

AI models require extensive data to achieve reliable results, which can be a challenge in the realm of cancer research. However, overcoming this hurdle can lead to groundbreaking discoveries and personalized treatment options for patients.

Traditional biomarker discovery methods often focus on single quantifiable traits, limiting their ability to capture the intricate complexities of cancer biology. With AI, the concept of a biomarker evolves beyond a single measure to a generalized pattern. This approach allows researchers to analyze thousands of features and integrate complex data points into a single, informative biomarker.

While AI holds great promise, ensuring the detection of real effects while avoiding false discoveries remains critical. Applying stringent methodologies and good machine learning practices, such as preventing overfitting and data leakage, is essential to maintain the accuracy and reliability of AI-driven biomarkers.

The significance of plasma proteomics

Plasma proteomics for biomarker discovery has had a vast impact on cancer research. By utilizing liquid biopsies, patients are offered a non-invasive and convenient way to gain valuable insights into their cancer biology through a simple blood test.

Plasma proteomics allows us to directly probe the immune system, which plays a crucial role in cancer progression and treatment response, especially in the era of immunotherapy, where the immune system is unleashed to fight the disease. By examining proteins in the blood, we can uncover intricate interactions between cancer cells and the immune system, unlocking potential treatment strategies. Proteins are the essential building blocks of cellular functions and signaling, and analyzing them provides comprehensive information about cancer biology, helping us create personalized treatment plans tailored to each patient’s unique biological profile.

The immune system is complex, with many cell types, proteins and cellular pathways involved. This makes it almost impossible to find one component that will tell us a story of resistance. By combining plasma proteomics with AI-powered analysis, we can explore thousands of proteins and identify patterns that traditional biomarkers might miss. This approach offers a more accurate and nuanced understanding of each patient’s cancer, leading to better treatment outcomes with minimal invasiveness.

Development stages and personalized medicine

In our quest to harness the potential of AI-driven biomarkers, the development stages play a crucial role in ensuring their clinical validity and utility. The emphasis on both these elements is paramount to bring personalized medicine to the forefront of cancer care.

Clinical validity relates to the objective assessment of the accuracy of the AI algorithm performance and can be achieved by subjecting the algorithm to a blinded validation process. By doing so, one can rigorously evaluate its performance. This approach ensures that the algorithm’s predictions are accurate and reliable, setting the foundation for its effective application in real-world scenarios. On the other hand, clinical utility delves into the practical impact of biomarkers on personalized medicine. This involves comparing different treatment modalities for the same sub-population, highlighting how the biomarker-driven approach can significantly influence treatment decisions.

Personalized medicine holds immense promise in improving patient outcomes. By leveraging AI algorithms to identify the most effective treatments for specific sub-populations, we can optimize therapeutic strategies for individual patients. This targeted approach enhances treatment efficacy by ensuring that patients receive the most appropriate therapies tailored to their specific needs.

Collaboration and future outlook

The success of AI-driven biomarker research requires collaborative efforts among researchers, healthcare providers, and technology experts. By sharing data and adopting a multiomics approach, we can gain comprehensive insights into cancer biology and develop more robust biomarkers. Looking at just one specific genomic signal or protein level is simply not enough.

The future prospects of AI in cancer-specific biomarkers are promising. As technology continues to advance, AI-driven biomarkers have the potential to revolutionize health and improve patient outcomes, particularly in cancer care. However, it is crucial to exercise caution and adhere to stringent practices to ensure the accuracy and reliability of these biomarkers.

By leveraging AI and machine learning, researchers can analyze complex data sets, identify novel biomarkers, and provide more effective and tailored treatment options for cancer patients. The collaborative efforts of researchers, healthcare providers, and technology experts will be instrumental in harnessing the full potential of AI and advancing cancer care to a new AI era. As we continue to explore the complex world of cancer biology, we must embrace the power of AI to unlock innovative solutions and improve patient outcomes.

As we continue to refine the craftsmanship of AI-driven biomarkers, we inch closer to a new age of cancer care. The ability to select the most effective therapies and spare patients from unnecessary treatments represents a significant advancement in oncology. With AI as our ally, we are transforming personalized medicine from a visionary concept into a practical reality that will benefit patients worldwide.

 

Photo: Eraxion, Getty Images http://www.gettyimages.com/license/94456546

If there’s one word that sums up the Medicare Advantage (MA) revolution over the past decade, it’s “consumerism.” The quest to put the patient in the center of their own care has influenced everything about the industry, from zero-premium plans and personalized benefit perks to the widespread use of connected devices, such as continuous glucose monitors (CGMs).

And MA plans aren’t the only ones trying to get in on the trend. Supersized retailers, like Apple, Target, CVS, Amazon, and Best Buy, are using their retail models to change what it means to purchase and engage with care. As these new players start to gain interest from consumers, the first instinct from healthcare stakeholders is to try becoming more like retail.

So far, however, the results have been somewhat disappointing. Ad hoc forays into healthcare from the retail side risk increasing fragmentation of the member journey. Meanwhile, MA plans that only offer hints of retail-style service and value might not be going far enough to secure member loyalty while meeting their quality and performance obligations, which are tightly tied to financial incentives available through the Star Ratings system.

An increasingly sharp regulatory focus on quality, combined with growing diligence in decision-making from consumers and the overall rising costs of care, is putting pressure on MA plans to find new solutions for delivering exceptional services at acceptable costs.

To meet the needs of members, the key to success for MA plans will be to up their game by focusing on the following:

1. Integrate comprehensive consumer data assets to hyper personalize benefits and overall experiences for members.
2. Tailor education and coaching to simplify chronic care management for members and improve long-term adherence; and
3. Create a one-stop shop for healthcare so members build trust and loyalty over time with their MA plan.

Integrating data-driven insights to personalize benefits and experiences

Big retail pioneered the art of collecting consumer data to target the right products to the right personas at high-impact points in the buying process. Even before web cookies allowed for extraordinarily precise online ad targeting, companies like CVS Health were using their loyalty cards to track in-store purchases and serve up coupons designed to match the individual’s buying habits.

Nearly every retailer now uses advanced customer analytics to guide their decision-making around marketing goods to their target audience. But MA plans are still in the early stages of learning how to craft meaningful healthcare consumer personas; generate real-time, consumer-level insights; and apply those insights to improve engagement and create positive member experiences.

These plans will need to refine their skills with a focus on aggregating multisource data, including claims, clinical records, pharmacy and lab data, social determinants of health (SDOH) data, and purchase activity, to understand member activities and get predictive about future needs.

Real-time analytics leveraged during the natural connection points between a member and their MA plan will be key to optimizing personalization — such as reaching out for a check-in when it’s time to reorder diabetes supplies to ensure there are no clinical, administrative, or socioeconomic barriers that need to be addressed.

Tailoring education and coaching to ensure understanding and adherence

When a customer walks into a Best Buy or an Apple Store, they’re not just greeted by a salesperson. They’re also funneled toward the Geek Squad and the Genius Bar, which are available even if the customer isn’t there to make a new purchase. These amped-up help desks let consumers sit down with an expert and learn how to navigate their devices on their own terms.

This is something that healthcare needs to adopt — and fast. Members now have more personal devices than ever, and they need to know how to use them in conjunction with clinical care to successfully manage their own health.

Personalized clinical coaching and education, with an eye toward meeting patients where they are in their health literacy journey, will be essential for ensuring value from connected devices and complementary chronic care management initiatives. MA plans should consider investing in programming and partners to provide onboarding education and ongoing coaching to ensure that members are getting the most out of their digital tools.

Transforming an MA plan into an all-in-one healthcare destination

Target is changing the big-box shopping experience by leaning into their identity as a self-care retreat for busy moms or a fun Saturday afternoon outing for the whole family. Co-locating with other retailers, such as Starbucks, Ulta Beauty, and CVS, means that shoppers can have an entire experience in the store, sipping their lattes while stocking up on essentials — and leaving with a cartful of things they did not know they needed when they walked in.

Medicare Advantage could consider becoming a similar one-stop shop for healthcare needs, especially as consumers continually express frustrations with fragmentation and phone tag.  Members should be able to come to their MA plan to easily find providers, compare prices on services, browse benefit options, and engage with partners providing complementary services, such as dental and vision care, chronic care management coaching, and SDOH-related resources.

When MA plans transform into centralized healthcare hubs that emphasize a holistic experience, they can proactively meet member needs; generate loyalty and consumer satisfaction that is reflected in the Star Ratings system; and create opportunities to collect more data that can then be reintegrated to offer increasingly precise member insights.

Adopting these consumer strategies from leading retailers can give MA plans an edge in an increasingly competitive market filled with new entities while improving quality, reducing cost, and improving member loyalty. By zeroing in on timely, personalized consumer insights, prioritizing person-centered education and coaching, and making it easy for members to engage with a full range of services on-demand, MA plans can deliver exceptional chronic disease management services while creating a consumer experience that exceeds expectations.

Picture: Ligorko, Getty Images

Gilead Sciences is acquiring biotech company CymaBay Therapeutics in a $4.3 billion deal that comes with a drug candidate currently under FDA review in a rare liver disease with few treatments.

According to deal terms announced Monday, Gilead will pay $32.50 cash for each share of CymaBay. That price is a 27% premium to CymaBay’s closing stock price on Friday. The acquisition marks a comeback for the company and its drug, which just a few years ago faced an uncertain future amid safety questions.

The main asset of CymaBay is seladelpar, a drug that the Newark, California-based company has developed for treating primary biliary cholangitis (PBC), a rare and progressive autoimmune condition that destroys the bile ducts of the liver. But this small molecule was at one time among the leading drug candidates for nonalcoholic steatohepatitis (NASH), a fatty liver disease that has no FDA-approved treatments.

In 2019, a safety signal led CymaBay to stop a mid-stage test of seladelpar in NASH as well as a recently started study in primary sclerosing cholangitis, another chronic liver disorder. The FDA subsequently placed a formal clinical hold on the drug. The hold also stalled the development of the drug in PBC. The FDA cleared the company to resume testing of the drug in 2020, but CymaBay elected to continue development only in PBC.

PBC is a chronic disorder that mainly affects women over the age of 40, impairing liver function. Common early symptoms include severe pruritus (itching) and fatigue. PBC can progress to cirrhosis and liver failure. The first-line drug treatment for PBC is ursodeoxycholic acid, or ursodiol, an old drug for dissolving gallstones that in 1996 won an additional approval as a treatment for PBC. The Intercept Pharmaceuticals drug Ocaliva was approved in 2016 as a second-line therapy for PBC.

CymaBay’s seladelpar is a small molecule designed to bind to and activate peroxisome proliferator activated receptor delta (PPAR delta), a receptor that regulates genes involved in the synthesis of bile acids, metabolism, inflammation, and fibrosis. In its placebo-controlled Phase 3 clinical trial, results showed treatment with the drug led to statistically significant normalization of enzymes indicative of liver disease as well as improvement in pruritus. Late last year, CymaBay submitted a new drug application seeking approval of seladelpar as a treatment for patients who are inadequate responders to or intolerant of ursodiol. CymaBay announced Monday that the FDA will evaluate the application under priority review, setting an Aug. 14 target date for a regulatory decision.

Gilead’s portfolio of liver disease drugs include the hepatitis B drugs Vemlidy and Viread as well as hepatitis C drug Harvoni. The Foster City, California-based drugmaker is also in the chase for NASH (now also called MASH, for metabolic associated steatohepatitis) with cilofexor and firsocostat, which are in Phase 2 testing as part of a combination treatment with Novo Nordisk’s semaglutide.

“Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement.

CymaBay licensed seladelpar from Johnson & Johnson in a 2006 deal. If it’s approved, J&J is in line to receive royalties from sales. The CymaBay pipeline also includes MBX-2982, a molecule in Phase 2a testing for treating hypoglycemia in patients with type 1 diabetes.

In a note sent to investors, William Blair analyst Andy Hsieh wrote that the CymaBay acquisition validates the clinical performance and commercial potential of seladelpar in PBC. He called the acquisition “poetic closure” for the company following the molecule’s previous clinical trial setbacks

“We commend management’s resilience and persistence that ultimately led to seladelpar demonstrating the best-in-class clinical profile in PBC, and we expect the drug to benefit thousands of patients living with PBC as soon as later this year,” Hsieh said.

Hsieh said the Gilead offer is fair and it is unlikely another bidder will emerge. The transaction requires the majority of CymaBay shareholders to tender their shares. The companies expect to close the transaction in the current quarter.

Photo: David Paul Morris/Bloomberg, via Getty Images

The decisions health insurance executives make reverberate across the healthcare industry. Reimbursement policies, billing practices, the decisions that govern which technologies to adopt affect members, physician practices, hospitals and health systems. The Biden administration has embraced several reforms to our health system including reducing the cost of drugs for chronic conditions such as Type 2 diabetes. But the administration also wants to improve prior authorization so it can be more efficient.

These are some of the topics that will be discussed in three panel discussions at the Payer Insights Program, hosted in partnership with MedCity News, held at the ViVE 2024 event on Sunday, February 25, from 1-3 PM PT in the Los Angeles Convention Center in Room 408A on the second level. Sessions will explore prior authorization and price transparency policy developments, interoperability and data sharing, the use of digital tools to advance equitable, accessible care plus, tech innovation, automation, AI and more.

In the runup to the Payer Insights program at ViVE 2024, we reached out to some of the speakers and sponsors for their insights on digital innovation in the payer space and they responded via email. 

Rajeev Ronanki, Lyric CEO, said he’s encouraged by the potential for AI to reduce fraud and waste and make healthcare more predictable for providers. Lyric is a sponsor of the Payer Insights Program.

“AI-driven innovation is showing strong promise in the areas of payment integrity and accuracy. We can expect to see improvement in the risk of fraud, waste, and abuse. We can expect to see reimbursement become faster and more predictable for providers,” Ronanki said. “Payers will unlock greater levels of value through increased savings and decreased administrative costs. Most importantly, patients stand to benefit through greater transparency, more predictability in care costs, fewer billing errors and greater level of communication with healthcare organizations. I see AI innovation in payments as a win-win—elevating experiences for healthcare stakeholders.”

Yet there are many challenges for digital health implementation that healthcare organizations have to contend with.

For Shawn Gremminger, CEO, National Alliance of Healthcare Purchaser Coalitions, the push for transparency in healthcare is easier to achieve on paper than in practice. 

“Some providers and plans, particularly hospitals and PBMs, continue to either refuse to provide or make it very difficult to access transparent information for the public and their clients,” said Shawn Gremminger, President and CEO, National Alliance of Healthcare Purchaser Coalitions. “The information that is available is so complex, dense and difficult to decipher that even sophisticated employers struggle to make the data digestible and actionable.”

Gremminger added that he also sees reason to be optimistic that health tech will make transparency more manageable and that greater access to data will lead to better purchasing decisions.  

“We are encouraged to see a growing number of vendors such as Turquoise Health that are helping make the data understandable and actionable for employers and even consumers. While this will take some time, the market is there for information that employers can use to make better purchasing decisions and to shield themselves from the kind of lawsuits recently leveled against Johnson & Johnson.”

Shruti Kothari, Director of Industry Initiatives, Blue Shield of California, emphasized the need for collaboration to ensure that health tech addresses structural barriers to care, as well as the need to improve collection of patient’s self-identified data.  

“Blue Shield of California recognizes that we must have strong collaboration across our industry to fully realize the opportunity digital tools provide to address structural barriers to care,” Kothari said. “Additionally, we need a way to ingest self-identified data such as language, race, ethnicity, gender, and sexual orientation so we can better meet patients’ individual health needs. California’s Data Exchange Framework (DxF) represents a great step forward in our ability to collect and share data. Having all eligible entities fully participate and comply with the DxF will be critical to realizing the full potential of statewide data-sharing in California.”

Ronanki added that achieving payment innovation in healthcare will require “replacing antiquated processes and technologies, driving greater efficiency, and facilitating greater trust between stakeholders. AI and blockchain will serve as key drivers for this long-overdue change and transformation.”

Here’s a preview of the agenda for the Payer Insights Program, which is included when you register for ViVE.

Click here to register!

Navigating the Prior Authorization Landscape

Prior authorization is complex and plays a crucial role in ensuring appropriate and cost-effective utilization of medical services. Explore challenges and opportunities for improved data sharing, workflow efficiency, quality measures, and decision-making for better patient care and outcomes. Hear practical strategies for adapting to recent and proposed regulatory changes designed to streamline the prior authorization process, enhance seamless data exchange, and promote interoperability.

Moderator: Katie Adams, Senior Reporter, MedCity News

Speakers:

• David Dobbs, Chief Data Officer, Hawaii Medical Services Administration
• Timothy Law, Chief Medical Officer and Vice President Integrative Care Delivery, Highmark Health
• Ginny Whitman, Senior Manager of Public Policy, Alliance of Community Health Plans

The Future of Payment Innovation

As the healthcare industry adapts to the Transparency in Coverage rule, there’s a growing focus on revolutionizing payment systems. Learn about the changing healthcare payment landscape including the latest compliance requirements for cost-sharing data disclosure and broader implications for payment accuracy, efficiency and innovation. Delve into how health plans are navigating these changes, addressing data sharing complexities, and leveraging AI to transform payment models.

Moderator: Marissa Plescia, Reporter, MedCity News

Speakers:

• Shawn Gremminger, CEO, National Alliance of Healthcare Purchaser Coalitions
• Tawfiq Bajjali, General Manager of Platform Solutions, Lyric

Transforming Healthcare with Digital Tools & AI

Innovative technologies are not only improving health outcomes but also enhancing patient satisfaction and engagement in health care. Hear about cutting-edge approaches, challenges, lessons learned and opportunities that arise when health plans leverage the power of digital transformation and AI to create a more patient-centric and effective healthcare ecosystem.

Moderator: Arundhati Parmar, Editor-in-Chief, MedCity News

Speakers:

• Shruti Kothari, Director of Industry Initiatives, Blue Shield of California

Keep posted on speaker updates for the Payer Insights Program by checking the agenda here.

Photo: HLTH