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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

Artificial intelligence is quickly becoming a valuable tool in the U.S. healthcare industry. Experts say a thoughtful approach can head off ethical problems and optimize efficiency.

How AI is Changing Healthcare

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

Breast Cancer Mortality Drops 44%, ACS Reports

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According to research-backed statistics, telepsychiatry improves the behavioral health outlook for today’s veterans.

Veteran Access to Mental Health Expands Under Telepsychiatry 

 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

Clinical

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 

 of Dupixent is $3,803.20 per carton. For commercial patients, Sanofi offers a $0 copay card with an annual limit of $13,000. The company also offers patient assistance for those who qualify.

This is the sixth indication for Dupixent and the only biologic therapy for COPD. Dupixent is also approved to treat eosinophilic esophagitis, moderate-to-severe atopic dermatitis, moderate-to-severe asthma, chronic rhinosinusitis with nasal polyposis and the rare skin disease prurigo nodularis.

The approval in COPD was based on two phase 3 trials evaluating the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation. The primary endpoint was met in both trials, showing Dupixent reduced annualized moderate or severe acute COPD exacerbations by 30% in one trial and 34% in the second trial, compared with placebo. In both trials, Dupixent improved lung function compared with placebo, with improvements sustained at 52 weeks.

The most common adverse events in the two trials were more frequently seen in patients on Dupixent compared with placebo and include viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache, and gastritis.

Dupixent is also being studied to treat patients with bullous pemphigoid (BP), chronic and relapsing disease, is characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning.

 from the pivotal ADEPT study that showed improvements at 36 weeks in disease remission and symptoms in patients with bullous pemphigoid.

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

FDA Approves Dupixent for Patients with COPD

Effective Care Delivery for TRD

 You mentioned guidelines. Dr Ares-Romero, can you talk about evidence-based guidelines that you use or that are commonly used in the approach to prescription for people with TRD [treatment-resistant depression]?

 Having evidence guidelines is the most challenging part. When you look at the literature, there’s no consensus. It goes back to the definition, despite the fact that this has been around for over 40 years. Refractory depression was the name that was used before, and now it’s treatment-resistant depression. It’s been around for a long time, but we still don’t have the practice guidelines for what we should do and what the best treatment is for the patient.

In my practice, I want to make sure I collaborate with and engage my patient and have communication about where they’ve been and what their journey has been up to the point when they come and sit in front of my desk for the first time. What are their goals for treatment? How can we work together to get the best treatment for them within guidelines? It’s about engaging the patient and making sure this is going to work for the patient and that the treatment will improve their outcomes. That’s what I follow.

Of course, I do the whole optimization and all that good stuff. But once they’ve been there, most of the time they’ve seen 4 providers, maybe 1 family practitioner, and have been to the ED [emergency department] 3 times, and now they’re seeing me. What other alternatives can we try? A lot of times, they’re like, “I’m tired of this. I don’t want to take any more medication. Why do I have to keep going through this?” Or, “I’m hopeless and helpless, and I don’t know what’s going to come next.” It’s about engaging the patient, seeing where they are, and finding how we can best help them. Sometimes it’s with alternative treatments.

 That makes a lot of sense. To layer on top of all of this, the lack of clear consensus guidelines, some of the difficulty in identifying patients with TRD, the lack of options for all patients with TRD that are guaranteed to be effective outside that level of precision. We can then layer on top something you alluded to earlier, Dr Nordberg, when you started talking about social determinants of health and the extra complexity that adds. Can you say a bit more about that?

 I’m happy to. One challenge, with mental health in general but captured in treatment-resistant depression, is that a lot of these challenges are multimodal, meaning that the developing, supporting, and maintaining factors come from a variety of places, some of which we don’t measure, or some of which we’ve only just started to measure.

With regard to social determinants, the broad takeaway is some people are depressed because their lives are depressing and they’re not getting enough sleep, they’re not safe, or they’re constantly under threat. Maybe they have food insecurity, financial insecurity, or housing insecurity. These are some of the key social determinants that can contribute to people being depressed, because they feel defeated by life. They’ve given up hope of a better future, and all they’re doing is surviving day in and day out. Without a thorough assessment of social determinants, you can’t understand that someone’s depression may be largely maintained by the fact that their life is terrible. Therefore, you’re throwing a bunch of interventions at something that ultimately doesn’t matter if they end up back on the street.

Part of the challenge in delivering more precision interventions is understanding what you’re trying to intervene with first. At Reliant Medical Group, we’ve started collecting data about social determinants. For example, if I’m presented with a patient who has been depressed for a long time and is also homeless, we’re probably not going to throw an alternative intervention at them until we can address the homelessness. Because if you can’t create a stable environment in which to recover and benefit from something like ECT [electroconvulsive therapy], the patient isn’t going to be able to sustain their benefit anyway.

Measuring for social determinants is a perfect example of that multimodal assessment that’s required if you’re going to get a robust enough picture. It ties back to what Dr Rosenzweig was saying, which is that a critical part of intervening successfully is having a good diagnostic frame for what’s going on for this patient. What’s primary and dominant? What’s the node that we need to hit first, second, and third to have a shot at addressing these complex and often deeply entrenched problems?

If you’re not using data and assessing your patients using patient-reported outcomes, leveraging the health record to the extent that you have it, and leveraging claims and other sources of information, in many respects, you’re just increasing the chances that you’re going to make the wrong choice. Often from the payer perspective, it may seem like in the clinical world we’re just throwing 1 thing after another at a patient willy-nilly. To get away from that, we need more of a robust data collection process and a robust treatment framing and intervention design system so that we’re being very deliberate about how we target patients. All that comes back to collecting the right data.

 If I can add 1 piece as well. There are 3 areas that commonly get overlooked or underassessed. One is trauma and its role in this, particularly adverse childhood events. The second is substance. More worrying is alcohol, because it’s very hard to detect the direct effect of alcohol, but also because it interferes with the medication at the pharmacokinetic level. The third is under-recognition of medical comorbidities that impact the rate of response. Chronic pain is a vastly underestimated factor that contributes to the lack of treatment responsiveness in this population.

Sam, in your setting in primary care, you have a better shot at this, but the problem is that a lot of psychiatrists don’t operate in those integrated settings. They don’t look or understand. The studies show that 10% to 15% of psychiatric patients have a medical condition that’s causing their presentation. It’s being attentive to those factors. If someone isn’t responding, the first step is to say, “What am I missing?” vs “What can I add?” It’s that shift in mindset that’s very important in helping this population.

 If I may add 1 more thing about this, there’s so much potential relevant information that you can’t do this via a chart review. It’s hard to put the expectation on any 1 person to figure out that full picture. This is a place where data, data visualization, and helping the critical key components of the data rise to the surface are untapped resources that we need to be leveraging a great deal more to help reduce the amount of noise and focus on the critical important signal that tells us what kind of a patient this person is and that can spread that information across multiple providers.

Drs Samuel Nordberg, Patricia Ares-Romero, and Martin Rosenzweig share considerations for effective care delivery for patients with TRD.

Video Series

Approaching Patient Identification for Alternative Therapies for TRD

 Dr Nordberg, thinking about your health system as an integrated primary care system, you’re often having patients transition from primary management by primary care to specialty care with psychiatrists. How do you identify the patients in need of alternative therapies for TRD [treatment-resistant depression] outside of their oral medications?

 There are a variety of different hallmark markers that tend to help them rise to the surface in an integrated primary care environment. One of them Dr Rosenzweig referenced in talking about bogging things down. One of the things that often happens is you may be making a number of referrals and treatment recommendations for patients with TRD, and they just keep coming right back into the primary care system over and over again because those treatments are failing them. They’re maybe not even engaging in those treatments because they don’t have the wherewithal to do so.

One of the things we see is churn. We thought we had a disposition and a treatment plan for that patient, and then they’re right back with us or right back into the emergency department [ED]. Other key indicators are use of crisis services or family outreaching for support and help because they’re at their wit’s end. With TRD, you often see patients who lack the motivation and wherewithal to advocate on their own behalf. You may also see it on behalf of the patient from family members or friends. One of the things that we see is a lot of churn, a lot of noise, and a lot of phone calls and conversations. We see a lot of frustration on the part of the primary care physician who’s trying to coordinate all of this work but meeting with real difficulty. That’s 1 indicator that we see that you can track in the health record and develop algorithms to surface patients where there are enough things like ED visits and phone calls. We do that at Reliant Medical Group.

At Reliant, we have the advantage of having consulting psychiatrists who support primary care physicians [PCPs] in prescribing new medications, changing dosage, etc. One of the things we also have is we get eyes on those patients, where this is maybe the third, fourth, or fifth medication change. At that point, we’ll pull them in with us and do a complete robust differential diagnosis and try to get to the root cause of what’s going on. That gives us an opportunity to take and triage those patients into another level of care.

The last thing that we also use is patient-reported outcomes. We’re using the PHQ-9 [Patient Health Questionnaire-9] for depression, but shortly we’ll be boosting that with a bunch of other more computer-adaptive measures that will hopefully allow us to get at a bit more of the nuance and complexity that’s going to allow us to picture that better. You can use data over time. You alluded earlier to the complexity around differentiating between 1 episode vs multiple strings of chained-together episodes. Those longitudinal data can also be very helpful in surfacing that information.

Those are some of the key ways that we start to identify treatment-resistant depression. You can also do a claims lookback, which can sometimes be helpful but suffers from the fact that our claims are lagged by 3 or 4 months. The better indicators are much more real-time and exist either in the health record or in the real face valid treatment experience that our PCPs are having with their patients.

 You take a very comprehensive approach, and you also measure outcomes. Good for you. As you know, many don’t. It sounds like within Reliant, many of your patients get a level of care that isn’t necessarily the standard across the mental healthcare landscape.

 We’ll talk about whether they actually get that care in a little bit, but we have a better opportunity to identify them.

Dr. Samuel Nordberg discusses methods for identifying patients in need of an alternative therapy for TRD at the health system level.

Geoffrey Boyce

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