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Stephanie Graff, M.D., FACP, FASCO, director of breast oncology at the Lifespan Cancer Institute, explains the importance of the term “clinically meaningful” and shares some of the ways it can be defined. 

Differences in Defining “Clinically Meaningful” in Metastatic Breast Cancer Care

The twice yearly lenacapavir injection will be available in 120 countries with a series of regulatory filings beginning by the end of this year. 

Gilead to Distribute Lenacapavir in Top HIV Countries, Critics Unhappy 

Paul W. Noble, M.D., of Cedars-Sinai in Los Angeles, and Paul Frohna, M.D., Ph.D., of Endeavor BioMedicines, discussed the symptoms, epidemiology diagnosis and treatment of idiopathic pulmonary fibrosis (IPF) in a Managed Healthcare Executive K-Cast video series.

Exploring Key Unmet Needs in Idiopathic Pulmonary Fibrosis

Peter Wehrwein has been the lead editor of Managed Healthcare Executive since February 2020.

Luke Greenwalt, MBA, vice president and lead, IQVIA Market Access Center of Excellence, has joined the editorial advisory board of Managed Healthcare Executive.

A Conversation With Luke Greenwalt, MBA

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Alex Sommer is the vice president of state Government affairs at Avalon Healthcare Solutions.

Gold carding eliminates prior authorization  for top-performing labs and eases plan workflows while controlling spending and preventing abuse. 

Unlocking Efficiency: How A Lab Gold Card Program Can Transform Prior Authorization

Breast cancer death rates overall have dropped 44% since 1989, which equals about 517,900 averted deaths, the latest American Cancer Society Breast Cancer Facts and Figures 2024-2025 report 

. While death rates have dropped overall, in the last decade (2012 to 2021), breast cancer incidence has increased 1.4% yearly for women under the age of 50 versus women aged 50 and older (0.7%). Breast cancer is the second most common cancer in women in the United States, behind skin cancer.

Inequalities are especially prevalent in communities of color. Breast cancer death rates for American Indian and Alaska Native (AIAN) women have remained unchanged. Although AIAN women have a 10% lower breast cancer incidence rate than White women, they have a 6% higher mortality. Since the year 2000, only 51% of AIAN women aged 40 or older have had a mammogram in the past two years while 68% of White women have had a mammogram in the past two years, according to 

Asian American/Pacific Islander (AAPI) women of any age experienced an increased breast cancer diagnosis average of 2.5% per year in women ages 20–49 year's and 2.7% per year in women ages 50 and older, the fastest increase in breast cancer incidence. This is followed by the rates of Hispanic women, who saw a breast cancer increase of 2.4% and 1.6% per year, respectively.

Black women also continue to be disproportionately affected. They have a 38% higher breast cancer mortality rate than White women, as well as a lower survival rate for every cancer stage other than localized disease (58% vs. 68%).

“Women today are a lot less likely to die from breast cancer, but alarming disparities still remain, especially for Asian American, Pacific Islander, Native American and Black women,” said 

, M.D., CSO at the American Cancer Society, in a 

. “These gaps need to be rectified through systematic efforts to ensure access to high-quality screening and treatment for every woman.”

In May 2024, the ACS addressed ongoing inequalities surrounding Black women with breast cancer with the launch of the 

 . The study aims to enroll 100,000 Black women in the United States ages 25 to 55 who have not been diagnosed with cancer to better understand cancer risk and outcomes. Participants will be followed for at least 30 years.

Although many women are living longer after a breast cancer diagnosis, inequalities persist. 

Clinical

Breast Cancer Mortality Drops 44%, ACS Reports

 added to the evidence linking obesity with more severe atopic dermatitis (AD) symptoms but also suggested a new connection between the chronic skin condition and abnormal blood lipid levels.

, found that 47% of obese patients had severe AD, compared to 24% of nonobese patients. The obese AD patients also had elevated triglyceride and LDL-cholesterol levels compared with nonobese patients.

The interest about the association between atopic dermatitis (AD) and obesity is increasing, yet the possibility of abnormal lipid metabolism has never been investigated before, according to the authors. The findings suggest that patients with AD who are obese have a greater propensity to have abnormal lipid metabolism.

Led by Chang Ook Park, M.D., of Yonsei University College of Medicine in Seoul, Korea, the study examined 167 AD patients, including a subset of 36 who were obese. The obese group had a median Eczema Area and Severity Index (EASI) score of 20, nearly double the score of 11 that non-obese patients had. Obese AD patients also reported significantly higher itch intensity scores.

The lipid panel results showed obese AD patients had median triglyceride levels of 142 mg/dL, near the borderline 150 mg/dL 

 for healthy adults, compared to 76 mg/dL for the nonobese study participants. For LDL (“bad”) cholesterol levels, obese AD patients had a median of 118, versus 92 for the non-obese patients. An 

 is approximately 100 mg/dL, according to the Centers for Disease Control and Prevention. Both groups had similar, lower than ideal HDL (“good”) cholesterol levels.

The obese AD patients in the study also had a substantially higher level — more than four times — of immunoglobulin E (IgE), an antibody produced by the immune system that plays a 

 in allergic responses, including those seen in atopic dermatitis. In this study, higher levels of IgE in obese AD patients suggest a stronger allergic response, potentially indicating more severe disease and increased sensitivity to allergens.

“AD patients who are obese had higher serum total IgE levels and higher numbers of allergens sensitized, which may also contribute to the increased severity of symptoms,” wrote Park and colleagues. “Taken together, obesity is a factor that should not be overlooked and AD patients who are obese should be monitored for any possible abnormal lipid metabolism.”

Previous research has shown an association between atopic dermatitis and obesity. But these findings elaborate on that observation and point to a connection to abnormal lipid metabolism and elevated  "bad" LDL cholesterol levels.


Obese Patients Have ‘Significantly Higher’ Severe Atopic Dermatitis, Abnormal Lipid Profiles, Study Finds

Boehringer Ingelheim announced today that its nerandomilast, its novel treatment drug for idiopathic pulmonary fibrosis (IPF), meet its primary endpoint in a pivotal phase 3 trial.

In recent years, several promising treatments for IPF have faltered in late-stage trials, so the currently approved treatment drugs are limited to Ofev (nintedanib) and Esbriet (pirfenidone), both of which have problematic side effect profiles. Because of the dearth of new treatments in recent years, approval of a new drug would be an especially significant development for people IPF, their loved ones and the clinicians who take care of them.

“This is the first IPF phase-3 trial in a decade to meet its primary end point” Ioannis Sapountzis, head of global therapeutic areas at Boehringer Ingelheim, a German company, said in a news release. “Today’s announcement represents the next step in our long history in the research of this disease.”

Nerandomilast, an oral drug, is a preferential inhibitor of phosphodiesterase 4B, an enzyme that is believed to play a central role in inflammatory processes. It was given FDA breakthrough therapy designation in February 2022. Boehringer Ingelheim said in today’s news release that the positive results will mean that it will submit a new drug application for nerandomilast with the FDA and other countries’ drug regulators.

Participants in the FIBRONEER-IPF trial randomly assigned 1,177 people with IPF to one of three group: those who took a placebo and those who took either a 9 milligram or an 18 milligram dose of nerandomilast. The placebo and the nerandomilast doses were given twice a day as pills. The trial has been conducted in more than 30 countries.

Today’s new release provided limited information about the FIBRONEER-IPF results. Full efficacy and safety data from the trial will be presented in the first half of next year, according to the news release.

The company said that it will submit a new drug application for the IPF drug, called nerandomilast, based on the positive results.

Boehringer Ingelheim's IPF Drug Meets Primary End Point

 Cobenfy (xanomeline and trospium chloride), an oral medication to treat adults with schizophrenia.

Schizophrenia can cause psychotic symptoms including hallucinations (such as hearing voices), difficulty controlling one’s thoughts and being suspicious of others. It affects about 1% of Americans.

“For people living with schizophrenia, it's often difficult to find a treatment that works for them. Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition,” Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance, said in a 

Developed by Karuna Therapeutics, Cobenfy is a new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. Bristol Myers Squibb 

 Karuna in December 2023 for about $14 billion.

All other treatments for schizophrenia work by targeting dopamine receptors, Dr Robert McCutcheon, Wellcome Clinical Research Career Development Fellow, Department of Psychiatry, University of Oxford, said in a 

. “This is the first treatment that has a different target. We hope this may mean it can help people who don’t respond to standard treatments and maybe help the symptoms that aren’t helped by existing treatments.”

Cobenfy is expected to available in October 2024. Bristol Myers Squib has also launched the Cobenfy Cares program to assist patients with access.

Cobenfy will cost about $1,850 for a month’s supply or $22,500, according 

. This priced just above what the Institute for Clinical and Economic Review (ICER) indicated would be a cost-effective price. In a 

 issued in March 2024, ICER indicate the drug would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.

The FDA approval is based on data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials. In the phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms.

Cobenfy demonstrated a 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared with placebo at week five. Additionally, in EMERGENT-2, Cobenfy demonstrated a statistically significant improvement in illness measured by the Clinical Global Impression-Severity (CGI-S) score, a secondary endpoint in the trial.

The most common adverse reactions were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness and gastroesophageal reflux disease. Cobenfy does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.

KarXT — now with the brand name Cobenfy— is expected to be available in October with a list price of about $22,500 annually. The drug represents a new way to treat adults with schizophrenia.

Formulary Watch

FDA Approves the Oral Medication KarXT for Schizophrenia

Pain medicine is on the cusp of a transformative era driven by a convergence of innovative technologies and novel treatment strategies. An article from the 

, various emerging modalities, including virtual reality (VR), artificial intelligence (AI), wearable medical technology, and psychedelics, are reshaping how chronic pain is perceived and managed.

, M.D., Ph.D., from the Department of Anesthesiology and Pain Medicine at Harvard Medical School, and colleagues reviewed the potential impact of these advancements on pain management, patient outcomes, and physician education. 

“If we don’t start thinking outside of the traditional pain tool box, we will continue to hit the same obstacles with pain management," says Robinson. "All these new technologies offer us a new angle and modalities to treat the most costly condition known to the human race – chronic pain. 

 The integration of VR in pain management represents a pioneering shift away from traditional methods. By utilizing VR as a distraction tool, patients can experience a significant reduction in the perception of pain. The ability of VR to engage users in immersive environments not only diverts focus but also promotes mindfulness, facilitating a multifaceted approach to pain relief.

 The growth of wearable technology is equally noteworthy. Wearables can continuously monitor vital signs and physiological parameters, providing real-time data to inform treatment decisions. This data-driven approach enhances patient engagement and allows for tailored interventions that address individual experiences of pain, thus improving overall outcomes.

AI's role in pain medicine is pivotal. AI algorithms are poised to significantly enhance pain assessment and management by analyzing vast amounts of patient data. For instance, AI can customize VR experiences based on real-time patient feedback and physiological data. Moreover, AI's predictive capabilities enable healthcare providers to identify potential pain crises before they escalate, thereby improving preventive care and personalized treatment plans.

 Neuromodulation is another exciting frontier in pain management. By regulating nerve activity through electrical or pharmaceutical interventions, neuromodulation can effectively alleviate chronic pain. The integration of AI in this modality could lead to advancements in monitoring and adjusting treatment in real time, enhancing the efficacy of neuromodulatory approaches and ultimately optimizing patient outcomes.

 The renewed interest in psychedelics for pain management is a significant development. Research indicates that psychedelics, traditionally associated with psychiatric conditions, also hold promise for chronic pain relief. The potential of substances such as psilocybin to provide long-lasting relief from pain as well as the effects of conditions such as anxiety and depression opens new avenues for treatment. Furthermore, the discussion around psychedelics necessitates a cultural shift in how pain and mental health are approached in medical settings.

Despite these promising innovations, challenges remain. The reduction in opioid prescriptions following the opioid crisis has created an environment of hesitance among healthcare providers to prescribe pain medications, even when warranted. This trend may inadvertently limit patients' access to necessary pain relief.

Furthermore, while emerging technologies offer significant advantages, their integration into clinical practice requires careful consideration of ethical implications, patient privacy, and data security. Medical professionals must be adequately trained in using these technologies to ensure they are effectively integrated into patient care.

Training the next generation of pain management specialists becomes vital in this context. Education must evolve to include a comprehensive understanding of these new modalities, emphasizing hands-on experience with VR, wearables, AI, and psychedelics to equip future professionals with the necessary skills to leverage these technologies effectively in clinical practice.

The future of pain medicine is characterized by an unprecedented array of innovative treatments and technologies that promise to significantly enhance patient care. By integrating VR, AI, wearable tech, and psychedelics, the field can address the multifactorial nature of pain more holistically. However, the medical community must navigate the accompanying challenges while prioritizing education and ethical practice. 

As these technologies evolve, the potential for improved pain management and patient quality of life becomes an increasingly tangible reality.

The future of pain medicine is characterized by treatments and technologies — including virtual reality, AI, wearable tech and psychedelics — that promise to significantly enhance patient care. 

Insights into Emerging Technologies in Pain Medicine

After a delay, the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic approved in the United States to treat these patients.

“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” Jean Wright, M.D., CEO of The COPD Foundation, said in a 

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline. In the United States, approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation. COPD with type 2 inflammation leads to elevated blood eosinophil counts and can increase the exacerbation of the disease.

Developed by Sanofi and Regeneron Pharmaceuticals, Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways. These pathways are believed to drive the type 2 inflammation. The 

This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.

Alex Sommer

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