An overview of the significance of the Seema S. Sonnad Emerging Leader in Managed Care Research Award and why this year's recipient, Christopher M. Whaley, PhD, early career achievements in the field of managed care deserved recognition.

Recipient of the 2021 Seema S. Sonnad Emerging Leader in Managed Care Research Award

View news from the CHEST 2021 Annual Meeting, including session summaries, poster write-ups, and interviews with key opinion leaders

Coverage of CHEST 2021 Annual Meeting

If 2020 was dominated by the news of how COVID-19 spread across the globe, then 2021 has so far been focused on ending the pandemic through vaccine distribution.

A Timeline of COVID-19 Vaccine Developments in 2021

This AJMC® Profiles in Care provides an in-depth look into the results of the outcomes-based agreement between Boehringer Ingelheim and Highmark Inc.

AJMC® Profiles in Care Launches

Some policy reforms can help incentivize more use of value-based contracts, but overall an area that needs more work is value-based contracts with pharmaceutical companies, said Steven Peskin, MD, executive director, director of population health, Horizon Blue Cross Blue Shield of New Jersey.

What policy reforms are needed in order to successfully incentivize the use of value-based contracts?

There are policy reforms related to that recognition that self-referral and the so-called Stark amendment may not be in the best interest of or it has a negative impact on value-based arrangements. So, that that would certainly be one.

I would say another would be that with commercial payers oftentimes, at least to some extent taking some license or following or acknowledging the important role of the Centers for Medicare and Medicaid Services and Center for Medicare and Medicaid Innovation. So, the OCM [Oncology Care Model] as well intentioned as it was didn't end up working very well. And it just doesn't apply to cancer care other areas, as well. So that kind of thought leadership and framing at the federal level that allows some of the private payers, commercial payers like ours to work within a particular policy framework. So, there's a couple of things that come to mind,

How have value-based contracts with pharmaceutical companies progressed?

The number of value-based contracts that exist between pharmaceutical/life sciences companies, biopharmaceuticals, cell therapy, gene therapy, is really few and far between. And it really is an area that needs to evolve. It’s something that is sort of a societal expectation, the way in which we as a nation approach health care and percentage of the gross domestic product. So, it’s definitely a work in progress and it needs a lot of work.

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Dr Steven Peskin on Reforms Needed to Incentivize Value-Based Contracts

After the public health emergency is over, there will likely remain incentive to keep some administration of specialty therapies at home, in a less acute setting of care, said Lance Grady, market access practice director, Avalere Health.

What services will stay online for patients on specialty drugs in the post-pandemic world?

Well, I think under the commercial benefit, the ability to have a homebound administration is really critical. Do we see that homebound administration always be self-administered meaning by the patient, or will we see, you know, caregiver administration or home administration via IV [intravenous], but coordinated by say a specialty pharmacy? I think there is a real opportunity there for that to stick or remain.

Does that extend over into government books of business where those products are usually physician administered? I think that remains to be seen as to how that will continue to evolve or expand post the PHE [public health emergency]. But certainly, flexibility of choice and the beneficiary having that choice could line up with a plan of interest in more preferred or mandated step therapy of products that are self-administered versus those that are physician administered or those that might be administered in a hospital outpatient setting.

So, I think those incentives start to line up the patient might not want to ambulate, the plan may want to have that patient managed in a less acute setting of care. Does that lead to more self administer? Probably so. Does that lead to more pharmacy-coordinated physician or nurse administered in home? Probably so as well.

Lance Grady Discusses Continued At-Home Administration of Specialty Pharmaceuticals

® since 2019 after receiving his Bachelor's degree at Rutgers University–New Brunswick in journalism and economics.

As the number of pharmacy locations with specialty pharmacy accreditation more than tripled in the United States from 2015 to 2020, the financial and structural impact of specialty drugs on the health care system continues to expand.

Kicking off the first session at the Asembia 2021 Specialty Pharmacy Summit, “The Post-Pandemic Outlook for Specialty Pharmacy,” panelist Adam Fein, PhD, chief executive officer, Drug Channels Institute, noted that specialty drugs currently represent 40% of the entire pharmaceutical industry’s revenue, and this share will likely grow to 50% within the next 4 years.

When examining the more than 1200 locations today with specialty pharmacy accreditation, Fein said that a significant change has occurred in the composition of who is actually operating the pharmacy.

“The biggest share of specialty pharmacies is still independent specialty pharmacies, but the second biggest category is now health care providers. In 2015, 1 out of 10 specialty pharmacies was run by a hospital or a physician practice. Today, it's 4 out of 10. So, when you say specialty pharmacy, it’s not just the local retail pharmacy–now it’s a lot of the providers.”

With health care provider influence growing in specialty pharmacy, consolidation within the US health care system overall has created vertically integrated entities that comprise of the insurer, pharmacy-benefit manager (PBM), specialty pharmacy, and provider services.

In addressing the implications of this industry shift, more than three-quarters of specialty drug dispensing revenues in 2020 were shown to be with the specialty pharmacies owned by the PBMs, which are part of these vertically integrated, consolidated operations.

As PBMs seek to stratify both drugs and patients, specifically patients who take the more expensive and profitiable specialty drugs in their health plans, large health care organizations have also begun to examine how to control their health care costs.

Notably, 9 in 10 large hospitals now have their own in-house specialty pharmacy. Fein highlighted that these entities are beginning to use these pharmacies as the driver for their benefit plans, with three-quarters of large specialty pharmacies indicated as exclusive specialty pharmacies in the health plan’s network.

“They've learned from what the PBMs are doing to channel patients into their business. And in fact, the majority of the prescriptions filled by these specialty pharmacies are written by the prescribers who work at the health systems.”

Although Aetna and CVS or Cigna and Express Scripts may represent the main examples of vertical integration, Fein said this occurrence is not limited solely to the insurance companies, with many entities in the health care industry seeking to figure out how to consolidate power in the specialty drug industry.

“One of the ways this battle is playing out is in starting to address the medical benefit drugs–the buy-and-bill drugs…. Buy-and-bill has been just terrible for the payers because of the commercial market. The hospitals are taking the drugs that they're buying from the manufacturer and marking them up 2 to 3 times over every other channel–often, in many cases, multiples of the list price.”

For an average buy-and-bill drug in a hospital, the manufacturer gets about 20% of the revenue that the insurer pays and the rest gets absorbed due to both the markups and 340B, added Fein.


Focusing on the 340B drug pricing program, roughly half of all US pharmacies are now 340B contract pharmacies. In addition to hospitals and clinics who receive a majority of 340B funding, retail and mail pharmacies now receive a large share of these dollars as well, despite pharmacies not being covered entities.


“If you just look at a share of purchases by list prices, excluding all discounts and everything, 340B is more than 13% of all dollars in retail and mail pharmacy.”

Generating above average profits for pharmacies that are 4 to 5 times as much gross profit dollars per script as a normal commercial script, revenue growth from 340B prescriptions, driven primarily by specialty drugs, have led pharmacies to become PBM contracted pharmacies.

With 340B purchases dominating the market, growth in value of 340B products at list prices for mail pharmacies was shown to increase 56% per year from 2017 to 2020. Conversely, non-340B purchases grew by 9% yearly in this time frame, with retail pharmacies also exhibiting 22% growth in 340B purchases and 1% in non-340B products.

“[The presence of] 340B distorts channel economics in such a complex and subtle way that no one frankly understands what's really going on….There's a lot that's changing, and a lot of what was specialty pharmacy is going to start to look very different.”

Delving further into the trends and issues within US specialty pharmacy, panelist Doug Long, MBA, vice president, Industry Relations, IQVIA, noted the differences in specialty areas between mail, retail, and non-retail pharmacy.

“Looking at the top 10 specialty areas of retail, mail, and non-retail, retail is HIV, immunology, and oncology; mail is immunology, oncology, and multiple sclerosis; non-retail is oncology, immunology, and multiple sclerosis,” said Long.

Long discussed several trends that will impact each industry in the next few years, including the emergence of 6 biosimilars for adalimumab (Humira) and the expiration of other immunology drugs, the expiration of HIV generic drug patents, and increased demand for mental health drugs and pain medications during the pandemic.


“The generic market has had price deflation coming up on 5 years now–it represents the same dollar sales in the marketplace as it did 5 years ago….the biggest reason why we contain health care costs in the United States is generics, we need to see a lot more specialty generics and we need to see a vibrant biosimilar marketplace, which we're starting to see.” 

Articles

Panelists of the opening session at Asembia 2021 Specialty Pharmacy Summit in Las Vegas address emerging shifts in specialty pharmacy, its impact on the health care system, and future implications post-pandemic.

Unraveling the Growing Influence of Consolidation, 340B, and Industry in Specialty Pharmacy

 of risankizumab for the treatment of asthma found it did not meet its primary end point in the phase 2a trial and made symptoms worse twice as fast as the placebo group.

Risankizumab, a biologic, is sold under the name Skyrizi for the treatment of psoriasis. It inhibits interleukin-23 (IL-23), which is mediated by type 2 and type 17 cytokines, but it isn't known if targeting IL-23 for asthma improves disease control and reduces airway 

The international study recruited 214 patients into the trial; 105 patients were randomized to a risankizumab injection every 4 weeks over a 24-week period while 109 patients received a placebo.

Time-to-first asthma worsening was determined by deterioration from baseline on 2 or more consecutive days; deterioration was classified as a decrease of at least 30% in the morning peak expiratory flow or an increase from baseline of at least 50% in the number of puffs of rescue medication in a 24-hour period (equating to at least 4 additional puffs). 

Deterioration also included a severe asthma exacerbation or an increase of 0.75 or more points on the 5-item Asthma Control Questionnaire (ACQ-5).

Secondary end points were the annualized rate of asthma worsening; the annualized rate of severe exacerbations; the ACQ-5 score; and the forced expiratory volume in 1 second (FEV

Participants were treated with 90 mg of risankizumab or placebo, consistent with the efficacy trial for plaque psoriasis. 

Patients treated with risankizumab had an average time-to-first-worsening of 40 days compared with 86 days for the patients given a placebo (hazard ratio [HR], 1.46; 95% CI, 1.05-2.04; 

The rate ratio for annualized asthma worsening with risankizumab as compared with placebo was 1.49 (95% CI, 1.12-1.99), and the rate ratio for severe exacerbations was 1.13 (95% CI, 0.75-1.70).

No safety concerns were linked with risankizumab therapy.

In addition, the investigators studied gene signatures from immune cells in airway samples. The biologic attenuated the sputum interleukin-23 gene set and gene pathways associated with activation of cytotoxic T cells and natural killer cells and the Th17 transcription factor RORC and the Th1 transcription factor TBX21.  Risankizumab appears to have had a biologic effect on airway immunity, which may have contributed to the poor clinical outcome.

"Our findings therefore challenge the current understanding of the role that Th17- and interleukin-23–mediated pathways play in the pathogenesis of asthma," wrote the authors.

The study had a number of limitations, the researchers said. The sample-size calculation for the primary end point was based on a one-sided power calculation with a sample size that was powered for the secondary and exploratory end points. Other aspects of severe asthma, such as airway hyperresponsiveness, airway remodeling, airway microbiome, and autoimmunity, could not be explored. It is also possible that certain subgroups of patients with severe asthma, who were not enrolled in this trial, might have had better outcomes.

Brightling CE, Nair P, Cousin DJ, Louis R, Singh D. Risankizumab in severe asthma — a phase 2a, placebo-controlled trial.  

2021;385:1669-1679. doi:10.1056/NEJMoa2030880

Risankizumab, a biologic, is used for psoriasis, but whether it can improve asthma control has been unclear. 


Patients in Risankizumab Phase 2a Trial Saw Some Asthma Symptoms Increase

From a 4-decade evaluation of adults classified as being at a stable normal weight, considered to be at a stable overweight level, or having stable obesity, individuals who fell into the 2 latter categories had higher levels of cardiac troponin I, a biomarker known to indicate cardiac injury, including 

. Persons with long-standing obesity also had a greater chance of cardiac injury, even in the absence of symptoms, according to 

“Although obesity is associated with subclinical myocardial injury as quantified by concentrations of cardiac troponin T,” the authors wrote, “whether lifetime excess weight history is associated with increased concentrations of cardiac troponin I and how indices of abdominal adiposity and glycemic dysregulation affect these associations remain unclear.”

A high-sensitivity assay gauged cardiac troponin I levels among 9739 Trøndelag Health Study participants at their fourth study visit. For this study—the largest population-based cohort in Norway—the cohort was evaluated at an overall 4 participant visits: visit 1 took place between 1984 and 1986; visit 2, 1995 and 1997; visit 3, 2006 and 2008, and visit 4, 2017 and 2019. Body mass index (BMI) results from visits 1 and 4 were also compared. A majority of participants were women (59%), and the final median study age, as indicated at visit 4, was 68.7 (range, 52.6-101) years.

An overall 84.1% of the entire study cohort had detectable cardiac troponin I levels, with the median (interquartile range) measurement being 2.5 (1.5-4.5) ng/L. These levels were evaluated using nonfasting serum samples collected during the period of visit 4.

The greatest associated risk of adverse cardiac outcomes was seen among those classified into the stable obesity category, who had a 70% greater risk of elevated cardiac troponin I at visit 4 (odds ratio [OR], 1.70; 95% CI, 1.33-2.17). These individuals also more often had hypertension and 

. Participants in the stable overweight group also had an increased risk, albeit to a lesser degree at 27% (OR, 1.27; 95% CI, 1.09-1.47; 

In addition, compared with those who maintained a normal weight over the 40 years of the study, the stable obesity group had a 22% greater risk of higher concentrations of cardiac troponin I (95% CI, 14.1%-29.9%; 

< .001), despite the fewest study participants (9.9%) being classified into this group. Most of the entire study group (47.8%) was categorized as having a stable normal weight.

Findings were not influenced by dysregulated glucose metabolism or abdominal obesity, the authors highlighted. However, “BMI and body weight at study visit 4 exhibited comparable associations with subclinical myocardial injury, and more strongly so than body fat mass and visceral fat area,” they added.

In addition to heart failure and coronary artery disease, long-term obesity has been linked to greater risks for stroke, peripheral artery disease, and sudden cardiac death and has been shown to have independent associations with hypertension, diabetes, inﬂammation, and dyslipidemia. Meanwhile, previous research has shown a link between elevated cardiac troponin I and most cardiovascular conditions.

Together, obesity and having a high cardiac troponin I measure combine to especially increase the risk of heart failure.

“Our data support a direct detrimental effect of long-standing obesity on cardiovascular health,” the authors concluded.

Still, because of study limitations that include lack of a retrospective biomarker analysis, the cardiac troponin I assay used having low analytical precision, recall bias, lack of myocardial imaging, and most study participants being of European Caucasian ethnicity, the results may not be generalizable to a wider population. Additional study is needed.

Lyngbakken MN, de Lemos JA, Hveem K, Røsjø H, Omland Torbjørn. Lifetime obesity trends are associated with subclinical myocardial injury: the Trøndelag Health Study. 

Published online October 19, 2021. doi:10.1111/joim.13391

For 3 categories of evaluation, elevated cardiac troponin I levels most influenced the development of myocardial injury among persons at higher lifetime weight totals.

Obesity Shown to Adversely Influence Heart Health Prior to Symptom Onset

Investigators reported success with an investigational therapy for

 (CDI) as well as an improved understanding of health care outcomes for patients with CDI at the American College of Gastroenterology (ACG) 2021 meeting.

CDI causes severe diarrhea and colitis and is the most common health care–associated infection in the United States, affecting an estimated 462,100 individuals in 2017.

In a retrospective study of RBX2660, an investigational live microbiota-based biotherapeutic, investigators enrolled patients 18 years of age (mean 59.8) or older with recurrent CDI (rCDI).

Most (96.8%) had been previously treated with an antibiotic (vancomycin, 81.9%).

Because trial eligibility is narrowly defined, investigators exercised “enforcement discretion” under FDA 2013 guidance for the treatment of patients nonresponsive to standard therapies.

They defined treatment success as the absence of CDI recurrence for 8 weeks or less following RBX2660 dosing.

Investigators said that 8 weeks after initial treatment with RBX2660, absence of CDI recurrence was noted in 82.8% of patients (53/64) in the primary safety set (PSS), which included patients not previously exposed to RBX2660.

Further, 88.7% of patients (47/53) who responded had a sustained clinical response at 6 months.

Investigators reported that for PSS patients, a single dose of RBX2660 was as efficacious as 2 doses of the same drug (83.3% vs 82.5%, respectively).

Findings for treatment emergent adverse events (TEAEs) were consistent with previous studies of RBX2660. Overall TEAEs were experienced by 62.5% of PSS patients (n = 40); and TEAEs related to RBX2660 were reported for 17.2% (n = 11).

There were 126 TEAEs reported for 32 patients (71.1%) with gastrointestinal and nonspecific inflammation; and for patients with immune-mediated autoimmune disorders, the respective numbers were 76 and 25 (59.5%).

TEAEs related to RBX2660 numbered 22 among 6 patients (13.3%) with gastrointestinal and nonspecific inflammation, and 9 among 4 patients (9.5%) with immune- mediated disorders, respectively.

“RBX2660 demonstrated safety and efficacy under real-world conditions for reduction of rCDI in adult patients,” investigators concluded. They said patients with comorbidities had comparable safety outcomes to the broader patient population.

Common comorbidities included gastroesophageal reflux disease (47.9%), irritable bowel syndrome (17.0%), gastritis (11.7%), and constipation, 8.5%.

“These results reinforce the safety and efficacy profile illustrated in 5 prior prospective studies of RBX2660, contributing to the totality of evidence of RBX2660 throughout the clinical development program,” they said.

In the second study presented at ACG 2021, investigators compared health care outcomes in patients with primary CDI (pCDI) and rCDI, both with and without inflammatory bowel disease (IBD).

They noted that IBD is a common chronic disorder that includes Crohn disease (CD) and ulcerative colitis (US).

As many as 35% of patients with pCDI will experience a recurrence, and roughly 65% of patients who have an initial recurrence will have a subsequent recurrence. There is a higher likelihood of death with rCDI, and health care resource utilization is also higher, authors of the study wrote. “Compared with pCDI, rCDI results in direct health care costs totaling over $2.8 billion annually in the United States.”

IBD leaves patients prone to CDI, and investigators said they sought to better understand the burden of CDI for patients 65 years of age or older. Their retrospective analysis employed Medicare fee-for-service claims data from 2009 to 2017 for patients with 1 or more CDI episode.

Authors of the study identified a pCDI episode as 1 or more inpatient stay with a CDI diagnosis or 1 or more outpatient claim with CDI diagnosis plus CDI treatment.

Investigators said 497,489 patients were identified with CDI, and 7.2% or 36,059 had IBD, consisting of CD (27.3%) or UC (72.7%).

Mortality was higher among patients with CDI but without IBD than for those with IBD (CD 42.9% vs 34.7%; UC 42.9% vs 40.0%).

Among patients with IBD, mortality was higher for those with pCDI (CD 37.6% and UC 44.6%) vs those with rCDI (CD 28.7%, UC 31.1%, 

For patients with pCDI and rCDI, the mean time to death was 67.1 days and 122.1 days, respectively; and for those with UC, 51.3 days and 115.6 days, also respectively.

The authors concluded that patients with CDI and IBD had lower mortality rates but higher health care resource use costs than patients without IBD. This was because of longer survival for the former group.

They hypothesized that patients with IBD are likely identified more rapidly given their higher risk, but require more resources to stabilize their condition.

They recommended that clinicians consider aggressive early treatment for patients to prevent pCDI and recurrences. “Aggressive treatment diminishes the risk of poor outcomes among the elderly Medicare population and lower costs for the growing Medicare population.”

1. Feuerstadt P, Harvey A, Bancke L. RBX2660, an investigational live microbiota-based biotherapeutic, improves outcomes of 

infection in a real-world population: a retrospective study of use under enforcement discretion. Presented at ACG 2021, October 22-27. Poster 2217.

2. Feuerstadt P, Dahdal DN, Wong AC, et al. A real-world comparison of mortality, healthcare resource utilization, and cost among Medicare beneficiaries with 

 infection (CDI) with and without inflammatory bowel disease (IBD). Presented at ACG 2021, October 22-27. Poster 2611.

In studies presented at the American College of Gastroenterology 2021 meeting, success was reported for RBX2660, a treatment for clostridioides difficile infection (CDI). 

Investigators Elucidate Outcomes and Costs in CDI

 (PD) has risen about 63% in the United States over the past 2 decades, according to a study released Thursday.

Although the increase was regardless of age, sex, race/ethnicity, urban-rural classification, and geographic location, some groups were affected more than others—namely men and White individuals. In addition, city residents had higher death rates than rural ones.

, said it is the most comprehensive study to date on the issue,  that long-term trends were previously unknown, and that the findings are key to determining health care priorities, including financing and research.

In the United States, about 1 million individuals have PD, and nearly 60,000 new cases are diagnosed each year.

The investigators used data on 479,059 deaths due to PD from 1999 to 2019 from the National Vital Statistics System (

), a nationwide, population-based death registry. More than 99% of US deaths are recorded in the database, which is part of the CDC’s National Center for Health Statistics.

After adjusting for age, the researchers found that the number of people who died from the disease increased from 5.4 per 100,000 people in 1999 to 8.8 per 100,000 people in 2019. The average annual increase was 2.4%.

During that time, the number of deaths from PD more than doubled, from 14,593 to 35,311.

White individuals were more likely to die from PD than other racial and ethnic groups. In 2019, the death rate for White patients was 9.7 per 100,000, followed by Hispanic patients with PD at 6.5 per 100,000, and non-Hispanic Black patients at 4.7 per 100,000.

, one of the authors noted that previous studies have shown that compared with Whites, Black and Hispanic populations are less likely to see an outpatient neurologist, suggesting that Whites have a greater likelihood of receiving a diagnosis for the disease.

Last month, The Michael J. Fox Foundation for Parkinson’s Research (MJFF) 

 to reduce health disparities, including those related to socioeconomics or ethnicity.

We know that people are living longer and the general population is getting older, but that doesn’t fully explain the increase we saw in the death rate in people with Parkinson’s,” said study author Wei Bao, MD, PhD, who conducted the research at the University of Iowa in Iowa City.

The authors said one possible explanation for the sex difference in death rates between men and women is the protective effect of estrogen, which leads to higher dopamine levels in parts of the brain that control motor responses. In addition, men receive their diagnosis  earlier and die earlier, which would “offset other competing risk events in men.”

Globally, brain disorders ranked as the second-leading cause of deaths in 2016, and the number of deaths from neurological disorders rose 39% from 1990 to 2015, even as age-standardized rates of death decreased by 28%. PD had the largest increase of age-standardized rates of deaths among brain disease, rising 29% between 1990 and 2016, the authors said.

A limitation of the study is that only 1 underlying cause of death was recorded on each death certificate, so only people who were recorded as having died of PD were included. This may not accurately reflect prevalence if several co-existing diseases were present at the time of death, the authors said.

Rong S, Xu G, Liu B, et al. Trends in mortality from Parkinson disease in the United States, 1999 2019. 

. Published online October 27, 2021. doi:10.1212/WNL.0000000000012826

The authors said long-term trends in Parkinson disease were previously unknown and that the findings are important to determining national health care priorities.

Large Study Finds Parkinson Disease US Death Rate Soared 63% Over 20 Years

 since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey. 

Vitamin D deficiency (VDD) is prevalent in pancreas transplant candidates with 

 (T1D) and is associated with an increased prevalence of coronary disease, according to results of a cross-sectional study. Findings were published in 

Despite being an established method of treatment for certain patients with T1D, pancreas transplantation “is associated with a high risk of cardiovascular events, and cardiovascular complications are still the most common cause of death in this group of patients,” the researchers explained.

Patients with T1D are already at an increased of cardiovascular disease due to the adverse effects of hyperglycemia, while additional risk factors are thought to impact the prevalence of coronary artery disease (CAD) in this population.

Because individuals with T1D present with VDD more often than the general population, investigators sought to determine the prevalence of VDD among pancreas transplant candidates with T1D. They also assessed the relationship between vitamin D status and prevalence of CAD and between vitamin D and lipid profile.

Forty-eight patients were recruited from a medical center in Poland between August 2018 and September 2020. As part of the cross-sectional study, researchers collected demographic and medical data and all participants underwent a coronary angiography.

The mean (SD) participant age was 41.6 (8) years and 50% were male. The majority of patients (66.7%) were eligible for simultaneous pancreas/kidney transplantation and the rest for pancreas transplant alone.

“VDD was revealed in 48% of patients and CAD in 35% of patients. The mean concentration of vitamin D in the entire cohort was 21.3 (9.48) ng/mL,” the authors wrote.

The median (interquartile range) value of 25-hydroxyvitamin D (25(OH)D) in patients with CAD was significantly lower than in patients without CAD (18.5 11.6-21.5] vs 24.8 [18.4-31.8] ng/mL; 

There was a significant relationship between VDD and CAD (odds ratio [OR], 4.36; 95% CI, 1.22-5.64; 

A patient’s odds of having CAD while having a sufficient level of vitamin D was 4.36 times lower than if the patient had VDD

There was a significant relationship between VDD and hypertension (OR, 5.91; 95% CI, 1.12-31.20; 

 = .039) and hemodialysis (OR, 4.25; 95% CI, 1.25-14.5;

There was no significant correlation between 25(OH)D and lipid profile

Results indicate measurement of serum 25(OH)D levels plays a key role in the diagnosis and treatment of VDD in this group of patients, the researchers explained.

The fact that the majority of study participants used statins may explain the lack of a relationship between vitamin D levels and lipid profiles. They noted the association between VDD and increased incidence of CAD is thus likely not due to lipid effects.

The cross-sectional nature of the study and a single timepoint of assessment of vitamin D status used mark limitations.

Overall, “VDD may represent an additional, modifiable cardiovascular risk factor among pancreas transplant candidates with T1D. The measurement of 25(OH)D concentration should be considered in all type 1 diabetic patients eligible for pancreas transplantation,” the authors concluded.

More research is needed to confirm the existence of a cause-and-effect relationship between CAD and VDD, they added.

Buksińska-Lisik M, Kwasiborski PJ, Ryczek R, Lisik W, Mamcarz A. Vitamin d deficiency as a predictor of a high prevalence of coronary artery disease in pancreas transplant candidates with type 1 diabetes

 Published online August 11, 2021. doi:10.3389/fendo.2021.714728

Researchers in Poland examined the impact of vitamin D deficiency on patients with type 1 diabetes undergoing pancreas transplants.

Assessing the Relationship Between Vitamin D Deficiency, T1D, and Coronary Disease

 (CGP) in the management of advanced non–small cell lung cancer (NSCLC) was shown to assist in matching patients with targeted therapies and clinical trials with those matched to these therapies associated with improved survival outcomes. Findings were published in 

Despite the identification of several new targetable drivers in advanced NSCLC, the standard of care for these populations only includes genetic testing for 

 mutations. Notably, previous research shows use of the broader CGP profiling can better assess for emerging mutations, but research regarding its efficacy has not yet been determined.

“Patients carrying alterations other than 

 now have increased access to targeted drugs off label or through a clinical protocol,” said the study authors. “Therefore, a re-evaluation on the clinical implications of CGP in the current treatment landscape of advanced NSCLC is warranted.”

Seeking to further examine the clinical utility of CGP, they prospectively applied the approach to Chinese patients with advanced NSCLC registered in the Precision Medicine Project from October 2016 to October 2019 (N = 1564).

Efficacy of CGP in treatment selection was measured by the proportion of patients receiving a genomic profiling–directed, matched targeted therapy and the proportion of patients being enrolled into a biomarker-selected clinical trial directed by their profiling results.

Those provided with genotype-matched therapy were compared with those who were not matched for progression-free survival (PFS) and overall survival (OS).

In their findings, tumor genomic profiles were established in 1166 participants who underwent CGP:

Potentially actionable alterations were identified in 781 people (67.0%)

37.7% (n = 440) were matched to targeted therapy

29.9% (n = 244) were enrolled in genotype-matched trials

Compared with patients with a nonmatched therapy, those who were given genotype-matched therapies showed significant improvements in PFS (9.0 vs 4.9 months; 

After excluding patients with standard targeted therapies, genomic profiling led to a matched targeted therapy in 16.7% (n = 24) and a matched trial enrollment in 11.2% (n = 16) of patients. Contrary to that found in the overall cohort, no PFS (4.7 vs 4.6 months; 

 = .238) benefit was observed with the use of genotype-matched targeted therapies in these populations.

In concluding, researchers said that given the low likelihood of benefit from the investigational or off-label use of targeted therapies, applicability of genomic profiling results should be taken with caution in patients without standard-of-care drugs.

Zhao S, Zhang Z, Zhan J, et al. Utility of comprehensive genomic profiling in directing treatment and improving patient outcomes in advanced non-small cell lung cancer. 

. Published online October 1, 2021. doi:10.1186/s12916-021-02089-z

Use of comprehensive genomic profiling in patients with advanced non–small cell lung cancer (NSCLC) was linked with significant improvements in progression-free survival and overall survival.

Genomic Profiling Linked With Improved Patient Outcomes in Advanced NSCLC

Diagnostic testing in thyroid cancer is important in order to use biomarkers and quickly identify appropriate treatments for patients.

In this podcast, The American Journal of Managed Care's associate editorial director, Mary Caffrey, speaks with Michelle Afkhami, MD, from City of Hope, about best practices for oncology organizations to leverage molecular/genomic testing, the importance of identifying 

-positive patients early so they can receive targeted treatment, and more.

Listen above or through one of these podcast services:

Podcasts

Michelle Afkhami, MD, from City of Hope, discusses best practices for oncology organizations to leverage molecular/genomic testing, the importance of identifying RET-positive patients early so they can receive targeted treatment, and more.

Diagnostic Testing in Thyroid Cancer: An AJMC® Profiles in Care

FDA Panel Votes to Authorize Pfizer COVID-19 Vaccine for Children 5 to 11 Years

A FDA advisory panel voted in favor of authorizing the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years, 

. The Vaccines and Related Biological Products Advisory Committee voted Tuesday 17-0, with 1 abstention, that two 10-mcg doses of the Pfizer vaccine should be granted emergency use authorization for this age group. This news comes after the Moderna vaccine was found to be 

 in children aged 6 to 11 years. The FDA is not required to adhere to this vote, but the agency usually follows the committee’s guidance. The vaccine will need to be reviewed by the CDC’s Advisory Committee on Immunization Practices and approved by the CDC director before it becomes available.

Merck Grants Royalty-Free License for COVID-19 Pill to Developing Countries

Merck granted a royalty-free license for its COVID-19 pill, molnupiravir, allowing the drug to be manufactured and sold cheaply in 105 developing nations, 

 was made with the Medicines Patent Pool, a United Nations–backed nonprofit that works to make medical treatment and technologies globally accessible. Molnupiravir is a twice-daily antiviral pill developed by Merck that has been shown to reduce the risk of hospitalization and death caused by COVID-19, and it is 

, new US COVID-19 infections dropped nearly 60% since the Delta variant caused a spike in cases in September. During the week of October 25, the 7-day average of infections was about 69,000, whereas the week of September 13 had an average of 164,475. Some states still face high rates of infection, such as Montana, where 45 in 100,000 people are hospitalized for COVID-19. The data suggested that higher vaccination rates are linked to lower rates of hospitalizations and deaths.

An FDA advisory panel voted 17-0 in favor of the Pfizer COVID-19 vaccine for children aged 5 to 11 years; COVID-19 pill molnupiravir to be manufactured and sold in 105 developing nations; new US COVID-19 cases dropped nearly 60% in just over a month.

What We’re Reading: FDA Panel Supports Pfizer Vaccine in Children; Merck Grants COVID-19 Pill License; Infections Down by 60%

Laura is the editorial director of The American Journal of Managed Care

) and all its brands, including The American Journal of Accountable Care

, Evidence-Based Oncology™, and The Center for Biosimilars

's parent company, MJH Life Sciences™, since 2011. She has an MA in business and economic reporting from New York University.

The incidence of chronic liver disease is expected to sharply rise by 2030, making it important to understand the factors that influence patient outcomes.