Nicholas Saraceno, Editor

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In a climate where an estimated two out of three babies get respiratory syncytial virus (RSV) disease,

 Sanofi has started shipping Beyfortus (nirsevimab-alip) 50 mg and 100 mg injection doses in the United States to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to make sure that the most batches are available before the start of RSV season.

 The upcoming RSV season for the Northern Hemisphere—which runs November-March—is fast approaching.

Specifically, the objective for the US market is to have enough doses for not only every eligible baby born outside of the RSV season to have access to the show at his or her regular checkup, but even for those who are born during the season. According to Sanofi, the company’s vaccine is considered “the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.” The FDA had approved the drug in July 2023 given those age parameters.

"We're proud to offer Beyfortus doses to help protect every eligible baby in the US this RSV season,” said Thomas Grenier, head of vaccines, North America, Sanofi. This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the US Food and Drug Administration, and healthcare providers to make Beyfortus widely available. This upcoming season, we look forward to Beyfortus offering its demonstrated real-world protection to as many infants as possible."

AstraZeneca has been assisting Sanofi with the development and manufacturing process. In fact, following FDA’s approval, production of these doses on a new filling line are already underway, and the doses are prepared to be shipped out. There is also an additional filling line that is expected to provide doses for this 2024/2025 season.

In other Beyfortus news, an observational study (NCT06030505) in a real-world setting surrounding the drug determined that it reportedly decreases the risk of hospitalized (RSV)-associated bronchiolitis in infants younger than 12 months of age.

1. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-546.

2. Sanofi shipping BEYFORTUS in US to help protect babies against RSV disease; new manufacturing line approved by FDA. 

. September 16, 2024. Accessed September 16, 2024. 

https://www.news.sanofi.us/2024-09-16-Sanofi-shipping-BEYFORTUS-R-in-US-to-help-protect-babies-against-RSV-disease-new-manufacturing-line-approved-by-FDA

3. Assad Z., et al. Nirsevimab and Hospitalization for RSV Bronchiolitis. 

 2024;391:144-154. DOI: 10.1056/NEJMoa2314885. Vol. 391 No. 2.

4. Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (ENVIE). ClinicalTrials.gov. April 19, 2024. Accessed July 11, 2024. 

https://clinicaltrials.gov/study/NCT06030505

5. James D. Real–World Data Show Efficacy of Beyfortus Against Hospitalization for RSV-Associated Bronchiolitis. 

. July 11, 2024. Accessed September 16, 2024. 

Articles

The manufacturing line producing the company’s branded form of nirsevimab-alip has been approved by the FDA.

Sanofi Gears Up for RSV Season, Begins Shipping Beyfortus

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Statistics show that 116 million adults in the United States have hypertension, also known as high blood pressure. There are various modifiable risk factors for cardiovascular disease— smoking, diabetes, high cholesterol, obesity, physical inactivity, and poor nutrition to name a few—but hypertension is considered the top one.

Also, hypertension in middle-aged adults (those 35-50 years of age) is reportedly associated with “poor cardiovascular health in subsequent decades. ”.

 As a result, in a cross-sectional study published in 

 investigators sought to figure out and understand how hypertension differs by race and ethnicity across various levels of neighborhood socioeconomic position.

Between the Aug. 7, 2023, and June 1, 2024 timeframe, the investigators examined electronic health record (EHR) data of adults aged 35 to 50 years who lived in Cuyahoga County, OH, and had one or more primary care appointments within the Cleveland Clinic Health System or MetroHealth System in the year 2019. Geocoded EHR data were then linked to the area deprivation index (ADI), which is a neighborhood disadvantage measure, at the US Census Block Group level (such as by neighborhood).

The total sample size consisted of 56,387 adults (median [IQR] age, 43.1 [39.1-46.9] years; 59.8% female) spanning 1,157 neighborhoods. Overall, this included 3.4% Asian, 5.5% Hispanic, 31.1% Black, and 60.0% White patients being evaluated. The study authors observed a gradient of hypertension prevalence, consisting of the highest versus lowest ADI quintile neighborhoods having a higher hypertension rate (50.7% vs 25.5%) and a lower treatment rate (61.3% vs 64.5%).

Out of the 315 neighborhoods containing mostly Black (>75%) patient populations, 200 (63%) had a hypertension rate greater than 35% combined with a treatment rate of less than 70%; this means that 31 of 263 neighborhoods (11.8%) making up 5% or less Black patient populations met this same benchmark. When compared alongside a spatial model without covariates, inclusion of ADI and proportion of Black patients comprised 91% of variation in hypertension diagnosis prevalence among men, and 98% among women. Men therefore presented a greater prevalence of hypertension than women across race and ADI quintiles, but the association of ADI and hypertension risk was stronger in women. Sex prevalence differences were smallest between Black men and women, particularly in the highest ADI quintile (1689 [60.0%] and 2592 [56.0%], respectively).

However, it’s important to note that the study does present various limitations, including that the population is only limited to patients who actually engage with the healthcare system and utilize the primary care services. This means that the above hypertension estimates only represents the people who accessed care.

Given these results, the investigators concluded that, “The findings of this cross-sectional study suggest stark racial and neighborhood disparities in hypertension prevalence and antihypertensive treatment among adults in midlife, with a significant burden of undertreated hypertension in socioeconomically disadvantaged and racially segregated communities. Using spatial analysis techniques to identify neighborhoods in need, future research might investigate structural interventions to address place-based hypertension disparities.”

1. Blazel MM, Perzynski AT, Gunsalus PR, et al. Neighborhood-Level Disparities in Hypertension Prevalence and Treatment Among Middle-Aged Adults. 

2. Cardiovascular Disease Risk Factors. 

http://www.idph.state.il.us/heartstroke/cvd_rf.htm#:~:text=The%20more%20risk%20factors%20a,physical%20inactivity%20and%20poor%20nutrition

3. Liu EF﻿, Rubinsky AD﻿, Pacca L﻿, et al. Examining neighborhood socioeconomic status as a mediator of racial/ethnic disparities in hypertension control across two San Francisco health systems. 

A study aims to determine whether there are disparities in burden and treatment across neighborhoods, and if socioeconomic position, race, ethnicity have an impact.

Hypertension Prevalence and Treatment Among Middle-Aged Adults

digital solution trends

Pertaining to the implementation of digital solutions in the marketplace, what kinds of successes have you seen?

We've seen some great success with implementing these solutions in the marketplace. One example I can share is a manufacturer who decided up front to build a really robust roadmap. They decided to map out exactly what they were looking to achieve and how they were going to achieve it. They allowed for enough time, and they made sure that they had all the right financial investments in place. They had the right players and stakeholders involved, and that was really crucial as well. They brought industry experts to the table, and they made sure they had the right teams of operational expertise, IT expertise, business process expertise. They were able to bring everyone together, and they focused first on building their platform and their core infrastructure. They were really thoughtful around how they did that, and then from there, they were able to evolve their roadmap, and they've continued to build off of that solid foundation that they built, and they've continued to enhance and evolve that along the way. Ultimately, they have a package where it’s a solid foundation, they're able to meet patients and customers where they are, and their technology is really supporting the patient journey. So that's been really successful. 

Another thing that I've seen several manufacturers do that I am in favor of—and I think works really well—is the pilot approach. Traditionally, you see a manufacturer go through an RFP process, select a vendor, and then implement their solutions into their patient support program, but they're fully invested at that point. I think what works better are some of these manufacturers who have engaged in a pilot first, so they still go through that RFP process, but when they select their vendor, they develop a short-term pilot so that they can fully vet that solution on a smaller scale and in a narrower focus, and that enables them to gather some data to determine: are the outputs of what they expected? Are they getting accuracy results that they were told they were going to get? Are those solutions being utilized in the way they thought they were going to be utilized?

I've seen some manufacturers come out of that pilot with much lower accuracy rates than they were expecting. I've also seen some come out of the pilot phase with the same or higher accuracy results that they were expecting, but ultimately, they have the data that then they can decide, is this investment truly worth it, and are we going to get what we were expecting to get without having to fully invest? So that's been a really smart approach as well.

Heading into 2025, what trends in the space are you envisioning?

Digital solutions aren't going anywhere. I think you're going to hear about more manufacturers who are interested in implementing these solutions or expanding on what they already have in place today. I think we'll see more service providers pop up, new service providers we hadn't heard about before, and maybe new service offerings we hadn't heard of before. I just think there's going to continue to be an expansion in this space. Perhaps we'll hear of more well-rounded packages of solutions being offered, but the other thing I think we're going to hear a lot more about—and I'm excited to see where this conversation goes—is around AI. It’s the buzzword of late, so I think we're going to hear a lot more about AI and how that is integrated in some of these solutions. I'm curious to see where that conversation goes.

Videos

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, shares implementation success stories, and provides an outlook on future of the space. 

Digital Solution Trends Heading into 2025

Image Credit: Adobe Stock Images/ArtiOm.com

In the United States alone, kidney failure affects more than 800,000 individuals, most notably those who are considered low-income and minorities.

 Depending on the situation, treatment can require in-center dialysis sessions three times a week, at-home dialysis, or even kidney transplants.

Those with kidney failure can qualify for Medicare coverage via the program’s end-stage renal disease (ESRD) benefit, with coverage taking effect the fourth month of in-center hemodialysis treatment, or at the 90-day mark. As a result of the 21

 Century Cures Act, Medicare beneficiaries with ESRD were allowed to sign up for private Medicare Advantage (MA) plans for the first time, which become effective Jan 1, 2021.

It’s important to note that prior to the above date, Medicare beneficiaries with ESRD could only enroll in MA plans if they had developed incident kidney failure while enrolled in an MA plan, and if they were enrolled in traditional Medicare (TM).

Keeping all of this in mind, a cross-sectional study published in 

 sought to analyze changes in MA enrollment among Medicare beneficiaries with ESRD in the first two years of the Cures Act, and among those who became newly-enrolled MA in 2021, evaluate the proportion of beneficiaries who changed MA contracts, and the manners in which the contract characteristics changed.

This population-based time-trend study was conducted from January 2020 to December 2022, while the data analysis occurred from August 2023 to March 2024.

In total, there were 718, 252 unique Medicare beneficiaries with ESRD between the years 2020 and 2022. In 2022, there were 583, 203 beneficiaries with ESRD (mean [SD] age, 64.9 [14.1] years, 245,153 females (42.0%); 197, 988 Black [34.0%]; 47,912 Hispanic [8.2%]). The proportion of beneficiaries with ESRD who were enrolled in MA increased from 25.1% (118,601 out of 472 ,234 beneficiaries) in January 2020 to 43.1% (21, 896 of 491,611 beneficiaries) in December 2022.

The boost in MA enrollment was larger in the first year of the Cures Act (12.6 percentage points [pp]; 95% confidence interval, CI 12.3-12.8 pp) compared to the second year of the Act (5.7 pp; 95% CI, 5.5-5.9 pp). Changes between December 2020 and December 2022 ranged between 49.3% for Asian or Pacific Islander beneficiaries (difference = 13.0 pp; 95% CI, 12.2-13.8 pp) and 207.2% for American Indian or Alaska Native beneficiaries (difference = 17.0 pp; 95% CI, 15.3-18.7 pp). Changes were high among partial dual-eligible (difference = 35.5 pp; 95% CI, 34.9-36.1 pp; 134.7% increase) and fully dual-eligible beneficiaries (difference = 22.8 pp, 95% CI, 22.5-23.1 pp; 98.0% increase). Among the 53, 366 beneficiaries enrolled in MA in 2021, 37,439 (70.2%) continued with their contract, 11,730 (22.0%) switched contracts, and 4,197 (7.9%) switched to TM by 2022. When analyzed alongside the characteristics of MA enrollees with ESRD in 2021, those in 2022 were more likely to be in contracts with lower premiums and with a rating of 4.5 stars or higher.

And overall, the percentage of beneficiaries with ESRD that were enrolled in MA increased by 71.7% between the January 2020 and December 2022 timeframe, and the authors note that “few beneficiaries switched from MA to traditional Medicare.”

Overall, the investigators concluded that, “In this cross-sectional time-trend study, we found that among Medicare beneficiaries with ESRD benefits, MA enrollment continued to increase in the first two years of the Cures Act, albeit relatively smaller in magnitude compared with the first year. Black, Hispanic, and American Indian or Alaska Native beneficiaries and those with any dual Medicare-Medicaid coverage continued to enroll MA plans at substantially higher rates in the second year of the Cures Act, highlighting the need to monitor the equity of care for patients with kidney failure as they transition to managed care.”

1. United States Renal Data System. 2020 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health: National Institute of Diabetes and Digestive and Kidney Diseases. 2020. Accessed August 6, 2024. 

2. Patzer RE﻿, McClellan WM﻿. Influence of race, ethnicity and socioeconomic status on kidney disease. 

3. Nguyen KH﻿, Thorsness R﻿, Swaminathan S﻿, et al. Despite national declines in kidney failure incidence, disparities widened between low- and high-poverty US counties. 

4. Vart P﻿, Powe NR﻿, McCulloch CE﻿, et al; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. National trends in the prevalence of chronic kidney disease among racial/ethnic and socioeconomic status groups, 1988-2016. 

5. 21st Century Cures Act, HR 34, 114th Cong (2015). Pub L No. 114-255. Accessed August 6, 2024. 

https://www.congress.gov/bill/114th-congress/house-bill/34/text

6. Centers for Medicare & Medicaid Services. Medicare and Medicaid programs; contract year 2021 and 2022 policy and technical changes to the Medicare Advantage program, Medicare prescription drug benefit program, Medicaid program, Medicare cost plan program, and programs of all-inclusive care for the elderly. Federal Register. January 19, 2021. Accessed August 6, 2024. 

https://www.federalregister.gov/documents/2021/01/19/2021-00538/medicare-and-medicaid-programs-contract-year-2022-policy-and-technical-changes-to-the-medicare

7. Nguyen KH, Oh EG, Meyers DJ, et al. Medicare Advantage Enrollment Following the 21st Century Cures Act in Adults With End-Stage Renal Disease. 

A cross-sectional study investigates changes in Medicare Advantage enrollment among Medicare beneficiaries with end-stage renal disease in the first two years of the Act.