The American Cough Conference was held June 11-12. Coverage from the meeting, which brought together health care professionals involved in the research and management of patients with cough, is now available.

Coverage of the American Cough Conference

The SLEEP Meeting was held June 10-13. Coverage includes session summaries and interviews with key opinion leaders in sleep and circadian science.

Coverage of the SLEEP Meeting

Coverage from the EHA2021 Virtual Congress, including session summaries, poster write-ups, and interviews with key opinion leaders is now available

Coverage of EHA 2021

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

We interview experts on investigational treatments such as liso-cel, and ask how to bring them to community practice.

Spotlight on CAR T-Cell Therapy

The American Journal of Accountable Care® features research and commentary on new payment models.

New Members for AJAC Board

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

We need to move into a space now thinking about implementation science, said Stephanie Lovinsky-Desir, MD, MS, a pediatric pulmonologist at Columbia University Medical Center and incoming director of that program.

What are some potential solutions to address social determinants of health in respiratory health? 

That's a big question. What are the solutions? I think, on the one hand, identifying the problem is really important. I think a lot of the research to date has been focused on describing the problem. But we really need to move into a space now, thinking about implementation science and how do we implement interventions that will have meaningful and lasting change. That comes on the individual level. What are some strategies to mitigate individual-level exposure to pollutants and other social stressors that may contribute toward disease? But also thinking in a broader political context. What are some policies that we can work toward that improve the health of all people who live in conditions that they shouldn't be living in? For example, certain housing conditions. I have patients who tell me about the quality of their housing, and they cannot afford a better situation. How can we protect these people? These are the areas that we really need to be focused on, instead of really just describing the problem in more detail.

What do you look forward to in this field of research? 

I think that now is a really exciting time, because I feel like people are starting to open their eyes and see that there are factors, like racism, that significantly influence the health of a large population of people living in this country, including children. I'm hoping that in this movement that we're experiencing right now, people will feel even more empowered, more emboldened, but also inspired to really do something to change the situation for many of our youngsters living in this country. So I'm hopeful.

Videos

Stephanie Lovinsky-Desir, MD, MS, discusses the need for concrete changes addressing social determinants of health (SDOH) and respiratory health. 

Dr Stephanie Lovinsky-Desir on Future Directions for Addressing SDOH, Respiratory Health

 (ASCVD) are more likely than patients with 

 to experience financial toxicity (FT), but the likelihood is greatest for patients with both conditions, reports a new study in 

Financial toxicity is characterized by difficulty paying medical bills, high financial distress, cost-related medication nonadherence, food insecurity, and delayed or foregone care due to cost. Patients with cancer might experience short bursts of high expenditures due to chemotherapy treatment, while patients with ASCVD may experience long-term financial distress from drug costs, procedures, clinician visits, and hospital stays.

The present study aimed to compare the health care economic burden on patients with neither ASCVD nor cancer, ASCVD only, cancer only, and ASCVD and cancer. The researchers gleaned data from the National Health Interview Survey (NHIS) from 2013-2018 and enrolled 141,826 nonelderly (18 to <65 years) adults not protected by public insurance. The population included 6887, 6093, and 971 participants who had self-reported cancer, ASCVD, or both, respectively. 

The NHIS questionnaire contained these subsections:

The Household Composition file gathered information and relationship information about all persons in a household

The Family Core file gathered information regarding sociodemographics, indicators of health status, activity limitations, injuries, health insurance coverage, and access to and utilization of health care services

The Sample Child and Sample Adult cores contained information on 1 child and 1 adult randomly selected from each family.

The Sample Adult Core, Household Composition, and Family Core files were supplemented with demographic and socioeconomic characteristics, health status, health care services, and health-related behaviors specific to the US adult population.

Females, especially those coming from a middle- or high-income household and with a higher education level, were more likely to report having cancer. In contrast, those reporting ASCVD, regardless of cancer comorbidity, were evenly distributed by sex, education, and income levels, but had a more unfavorable cardiovascular risk profile. The most reported cancers included nonmelanoma skin, breast, cervix, prostate, and other. Similar trends were seen among patients with both ASCVD and cancer.

The proportion of patients who experienced FT ranged from 38.3% for patients with neither ASCVD nor cancer to 41.0% for patients with cancer, 54.1% for patients with ASCVD, and 54.5% for patients with both

Difficulty paying medical bills was higher for patients with ASCVD vs patients with cancer:

ASCVD with cancer: 44.8% (95% CI, 43.1%-46.5%)

ASCVD without cancer: 47.4% (95% CI, 43.1%-51.7%)

A statistically significant trend was observed for those unable to pay medical bills, with more patients with both conditions having difficulty (all 

Cancer and ASCVD: 23.2% (95% CI,19.8%-26.8%)

Patients with ASCVD with or without cancer experienced the greatest FT as measured by high financial distress, cost-related medication nonadherence, food insecurity, and delayed/foregone medical care due to cost, followed by those with ASCVD only, cancer only, and neither

Patients with both cancer and ASCVD had high likelihoods of experiencing any FT (odds ratio, 1.93; 95% CI, 1.63-2.28) and any associated FT measures

Patients with ASCVD with or without cancer had higher likelihoods for all FT measures compared with patients with cancer

The proportion of patients who experienced 3 or more FT measures simultaneously was 9% for patients with neither ASCVD nor cancer, 13% for patients with cancer, 23% for patients with ASCVD, and 30% for patients with both

“Heart disease and cancer are the leading causes of death in the United States, yet most research on financial toxicity has focused on cancer patients. It is important to consider that cancer patients may have short bursts of high expenditures for treatments, while heart disease patients are often incurring a more chronic economic burden,” said senior author Khurram Nasir, MD, MPH, MSc, chief of the Division of Cardiovascular Prevention and Wellness at Houston Methodist DeBakey Heart and Vascular Center, 

 “The financial burden created by these diseases manifests as another form of affliction. It does very little good if we can treat the cancer or the heart disease, but the patient can’t afford to eat or pay their mortgage.”

Valero-Elizondo J, Chouairi F, Khera R, et al. Atherosclerotic cardiovascular disease, cancer, and financial toxicity among adults in the United States

Articles

When comparing atherosclerotic cardiovascular disease (ASCVD) with cancer, patients with both diseases appeared to have the greatest risk of experiencing financial toxicity.


ASCVD Presents Greater Risk for Financial Toxicity Than Cancer, Study Says

Medicare value-based care programs are under great scrutiny to ensure that they can drive  demonstrable savings and quality improvement. Adoption of higher-value biosimilar drugs by participants in Medicare’s Oncology Care Model (OCM) could drive the pilot program closer to its goal of generating net savings to Medicare.

Oncology practices participating in the OCM are responsible for the quality and total cost of care—including drug spending and inpatient admissions—for their patients receiving chemotherapy.

Drug spending constitutes approximately two-thirds of the program’s total spending.

 Part B drug spending alone accounts for about 45% of OCM spending.

 The most recent program evaluation, published in January 2021, included data from 6-month episodes triggered through January 1, 2019 (performance periods [PPs] 1-5), and found that the program successfully achieved reductions in per-episode spending. However, these reductions were insufficient to cover new funds from the Center for Medicare and Medicaid Innovation (CMMI): (1) Monthly Enhanced Oncology Service (MEOS) payments made to participating practices to support care redesign and enhanced oncology services, and (2) additional performance-based payments (PBPs) that practices receive if they meet financial and quality goals.

Notably, because of the relative novelty of biosimilar drugs on the market and the significant lag in claims-based analyses, the most recent program evaluation largely predates the uptake of these lower-cost alternatives. The March 2021 release of initial PP7 OCM reconciliation data, reflecting 6-month episodes triggered between July 2, 2019, and January 1, 2020, offered the first oppor-tunity to observe most biosimilar cost comparisons, and this signals more favorable program evaluations once these data are incorporated into findings.


Because there are no clinically meaningful differences between biosimilars and their reference products and they are generally available at lower costs, biosimilars present an opportunity to reduce Medicare spending without impacting the quality of care provided to patients.

Administered by infusion or injection in a physician’s office or hospital outpatient department setting, all cancer biosimilar drugs are reimbursed under Medicare Part B, which sets drug prices using the Average Sales Price (ASP) methodology.

 CMS calculates the ASP quarterly by using the weighted average sales price data submitted by drug manufacturers; these data include discounts such as rebates and volume, prompt payment, and cash payment discounts.

 There is a 6-month lag between the payment allowance limits set by Medicare—generally 106% of ASP—and the ASP data submitted by drug manufacturers.

As an example of the price differential between biosimilars and their originator products, the current Medicare Part B payment allowance limits

 for trastuzumab (Herceptin) biosimilars range from 12.5% to 35.3% lower than that of the originator product, as shown in 

. In another example, the current Part B payment allowance limits for bevacizumab (Avastin) biosimilars range from 20.9% to 27.1% lower than that of the originator product, as shown in 

, conversion to biosimilar products as a cost savings lever largely materialized after the program went live. The only 2 biosimilar products approved by the FDA prior to the start of the OCM on July 1, 2016, were filgrastim-sndz (Zarxio), the reference product of which is filgrastim (Neupogen), and inflix-imab-dyyb (Inflectra), the reference product of which is infliximab (Remicade). Filgrastim is a supportive care medication used to treat low white blood cell count, which can occur in patients undergoing chemotherapy, and infliximab is an immunosuppres-sive drug that treats rheumatoid arthritis, among other conditions. The FDA did not approve the first biosimilar for cancer treatment, bevacizumab-awwb (Mvasi), the reference product of which is bevacizumab (Avastin), until the model’s third performance period. Of the 5 biosimilars for trastuzumab, a drug used to treat certain breast and stomach cancers, 3 were approved by the FDA during the OCM’s PP6 (episodes starting between January 2, 2019, and July 1, 2019). The length of time between a drug’s approval and its entrance to the market can vary. There is also a lag between the a drug’s approval date and its addition to the ASP drug pricing files. For example, rituximab-abbs (Truxima), the first biosimilar for rituximab (Rituxan), which treats conditions including non-Hodgkin lymphoma and chronic lymphocytic leukemia, was approved in November 2018 and added to the Medicare ASP Pricing File in January 2020. This lag in information could delay the uptake of cost-effective drugs. Once a practice adopts a biosimilar, it is not uncommon for the conversion to take a year or more.

Previewing the Full-Scale Potential of Biosimilar Conversion


The first biosimilar for filgrastim was approved in March 2015, so trends in its adoption can be observed from the start of the OCM. One of the key findings of the January 2021 OCM program evaluation was the “pronounced shift toward use of biosimilar filgrastim (vs more-costly originator filgrastim)”

 among OCM participants. The OCM evaluation described that, among episodes in which filgrastim, a granulocyte colony-stimulating factor, was used, participation in the model was associated with “faster adoption and greater use of less-costly biosimilar filgrastim.”

 This finding suggests that there may be broader adoption of biosimilars by OCM practices as more of these products become available on the market, a trend Archway Health has identified in the analysis of more recent claims data.

Emerging Results Show Savings From Biosimilars


In March, CMMI released initial PP7 reconciliation data to OCM participants. Archway analyzed these data to evaluate the cost savings impact when practices switch to certain biosimilar drugs. Three examples of the impact of biosimilar adoption on Medicare spending are as follows:

. Among breast cancer episodes in which the patient was treated with trastuzumab, the average amount Medicare spent on the drug for a 6-month episode of care was approximately $25,000 to $30,000, varying by practice. Trastuzumab is generally used in fewer than 8% of breast cancer episodes in the OCM, but the cost of the drug constitutes more than half of total episodic spending for breast cancer episodes in which the drug was used and nearly 7% to 10% of total cost of care across all breast cancer episodes. Among practices that switched to biosimilar trastuzumab-anns (Kanjinti), spending for the drug was reduced by more than 14% ($3500-$4200) per breast cancer episode in which the drug was used. For 1 medium-sized practice with a volume of 1000 breast cancer episodes per year that are covered under traditional Medicare, the conversion to trastuzumab-anns can generate $250,00 to $500,000 in savings to Medicare annually, some of which the practice can earn back in PBPs. Savings opportuni-ties will fluctuate quarterly as ASP data are updated.

 Among lymphoma episodes in which a patient was treated with rituximab, Archway found that the average 6-month episodic drug cost for rituximab ranged between $18,000 and $22,000, varying by practice. Rituximab is used in approximately 70% of lymphoma episodes in the OCM; on average, the cost of the drug constituted more than one-third of total episode spending for lymphoma episodes in which the drug was used. Practices that switched to rituximab-abbs (Truxima) saved nearly 8% of the cost of rituximab ($1400-$1700) per episode on average. 

 shows he cost differential for a 6-week course of treatment in which the patient is administered 80 units of either rituximab or rituximab-abbs per treatment. For reference, Table 3 shows the Part B payment allowance limits for rituximab and rituximab-abbs between January 1, 2020, and March 31, 2020, a time period contained within the 6-month runout period of PP7. For 1 medium-sized practice with 150 lymphoma episodes a year covered under traditional Medicare, the conversion to rituximab-abbs could generate between $150,000 and $200,000 savings to Medicare annually, some of which the practice can earn back as a bonus payment if quality goals are met.

SMALL INTESTINE/COLON CANCER AND BEVACIZUMAB. 

Among small intestine/colon cancer episodes in which the patient was treated with beva-cizumab, Archway found that the average 6-month episodic drug spend ranged between $18,000 and $23,000. On average, the cost of the drug constituted more than 40% total spending for small intestine/colon cancer episodes in which the drug was used, and the drug is used in more than one-third of these episodes in the OCM. Practices that switched to bevacizumab-awwb (Mvasi) saved nearly 14% of the cost of bevacizumab ($2500-$3100) per episode on average. Bevacizumab is used to treat a relatively large number of OCM cancer types beyond small intestine/ colorectal, including central nervous system tumor, female genitourinary cancer (ovary and other than ovary), head and neck, kidney, and lung. Cost savings to Medicare that result from the conversion to a bevacizumab biosimilar are substantial, but they vary based on the mix of cancer types treated at a given practice.

Once these data are folded into programmatic evaluations, the OCM will potentially be credited with greater savings than early reports have indicated. PP8 marked the turning point in which practices that had yet to earn PBP had to enter the 2-sided risk track or exit the program. As a result, the program shed nearly 30% of its participants, shrinking from 176 practices to 127.

 The combination of savings from biosimilar adoption along with CMMI no longer paying out MEOS to 30% of the original practice participants could put the program on a path to achieve net savings to Medicare. With the OCM sunsetting at the end of this year, it is critical for CMMI to launch the program’s successor, so momentum in the shift toward value-based cancer care is not lost.

Alignment with Aggregate Stop Loss Insurance


Because the adoption of biosimilars serves to control costs at a population level, it aligns well with a population-level approach to downside risk protection. Practices that have adopted biosimilars and are participating in or considering the 2-sided risk track in the OCM should evaluate aggregate stop loss protection, designed to limit overall losses, because aggregate policies generally have lower premiums than do specific policies, and aggregate policies can account for practice-level cost reduction efforts.

Benefits of Biosimilar Conversion in Other Value-Based Models of Care


Oncology practices that have adopted biosimilars have a strategic advantage over their competitors in other value-based models of care. In Medicare’s new Direct Contracting program, which went live on April 1, 2021, Direct Contracting Entities (DCEs) are at full risk for total cost of care for all Part A and Part B spending, including Part B drugs, and they are highly incentivized to partner with high-value specialists. There are 53 active Global and Professional DCEs, and in many cases, a single DCE has multiple geographic locations; the state of Florida has 15 active DCEs alone. Another cohort of DCEs will go live on January 1, 2022, and oncology practices should be prepared for the growing presence of DCEs in their local markets.

The adoption of biosimilars can also support value-based risk contracts with self-insured employers and commercial payers. However, one challenge that oncology practices face in the adoption of biosimilars is misalignment with commercial payers that may list different biosimilars on their formularies. On April 20, 2021, CMMI director Liz Fowler, PhD, JD, spoke

 during the spring conference of the National Association of Accountable Care Organizations about CMMI’s effort to determine how its value-based care models can transform health care delivery in the long term. In discussing CMMI’s priorities, Fowler declared that “we need to do a better job with multipayer alignment.” Ideally the successor program to OCM, expected to be announced later in 2021, will continue to incorporate a cross-payer approach to further drive value-based cancer care.

1. Oncology Care Model. CMS. Updated May 4, 2021. Accessed May 7, 2021.  https://innovation.cms.gov/innovation-models/oncology-care
2. Archway Health analysis of Medicare Part A, B and D claims data.
3. Hassol A, West N, Newes-Adeyi G, et al; Abt Associates; The Lewin Group; Harvard Medical School; Geisel School of Medicine at Dartmouth; General Dynamics Information Technology. Evaluation of the Oncology Care Model: performance periods 1-5. CMS Innovation Center. January 2021. Accessed May 8, 2021. https://innovation.cms.gov/data-and-re-ports/2021/ocm-evaluation-pp1-5
4. Dangi-Garimelli S. Saving costs while maintaining quality of care—the value of biosimilars in oncology. 

e®. November 8, 2018. Accessed May 8, 2021. https://www.ajmc.com/view/saving-costs-while-maintaining-quality-of-caremdashthe-val-ue-of-biosimilars-in-oncology.

5. Competitive Acquisition Program. HHS § 414.904 (2010). Average sales price as the basis for payment. Accessed May 8, 2021. https://www. govinfo.gov/content/pkg/CFR-2010-title42-vol3/pdf/CFR-2010-title42-vol3-sec414-904.pdf
6. Part B drugs payment systems. MedPAC. Updated October 2017. Accessed May 8, 2021. http://www.medpac.gov/docs/default-source/payment-basics/medpac_payment_basics_17_partb_final.pdf?sfvrsn=0.
7. Medicare Part B Average Sales Price: 2021 ASP drug pricing files. CMS. March 4, 2021. Accessed May 8, 2021. https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files
8. Biosimilar product information. FDA. December 17, 2020. Accessed May 8, 2021. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
9. Raths D. With CMMI at “crossroads,” director Liz Fowler re-evaluating payment models. Healthcare Innovation. April 20, 2021. Accessed May 8, 2021. https://www.hcinnovationgroup.com/policy-value-based-care/alternative-payment-models/article/21219367/with-cmmi-at-crossroads-director-liz-fowler-reevaluating-payment-models

Biosimilars Drive Savings in Medicare’s Oncology Care Model

Improving health equity. Developing practice-based solutions for reducing barriers and improving outcomes. Making the case for supportive care. Building a culture that supports professional well-being. Championing resiliency.

This would be an important agenda for any president of the Association of Community Cancer Centers (ACCC), but given the year that health care workers have just experienced, the ACCC has the right message at the right time. And that's because the group has selected a timely messenger: For only the third time in its history, the ACCC president is a social worker.

Krista Nelson, MSW, LCSW, OSW-C, took the reins of ACCC on March 5, 2021, during the group's 47thAnnual Meeting and Cancer Center Business Summit, held virtually.

 Nelson's theme for her presidency "Real-World Lessons from COVID-19: Driving Oncology Care Forward," incorporates a mission of promoting psychosocial and supportive care, not just externally but also among internal stakeholders. This fits with her call to support the needs of the multidisciplinary cancer care team. From Nelson's vantage point, the emerging care model is one where the case manager is far from an afterthought, and may, in fact, be the patient's first stop.

Nelson spoke with Evidence-Based Oncology™ (EBO) about her goals as ACCC president and why her timing couldn’t be better. This interview is edited for clarity.

: Your year as ACCC president comes at a time of unprecedented stress on the health care system due to the pandemic. Why is this the right time for a person with a social work background to lead the organization?

 As clinical social workers, we’re trained in systems, we’re collaborators, and we’re really good listeners. Right now, the suffering is so great within our community—meaning our community of providers, the people who are taking care of patients with cancer. Our workforce needs attention, and a social work perspective brings this to light. Our values as social workers teach us the dignity of the human person: to challenge injustice, and to be present with the people we work with and those we serve. I think the role of the social worker is perfect to lead ACCC at this time.

One of the agenda items you listed is working on resiliency in the cancer care workforce. Can you discuss specifically you how you want to address the issue of resiliency?

 First, I will say that resiliency is multifaceted. It’s the role of the person, and the organization, and the community. Often, we put the burden on the person [when] people are not coping well [or] are having a hard time. And I’d be remiss if I didn’t say it’s OK to be having a hard time right now. This work is really hard: It was hard before COVID-19, and it’s even harder now. People are being pulled in so many [different] ways.

At ACCC, we’re working to, first, listen to the experts—the people who are living it. [We’re] reaching out to our various communities, and hearing best practices of what people are doing: how they’re helping support their team, the changes they’re making, and how they’re addressing [issues]. One way we’re doing that is by offering coffee chats: I’m having these virtual smaller group meetings to hear how ACCC can improve the care of the provider, and therefore improve the care of the patient.

Second, we’re creating a meditation series for people within the ACCC community, and that’s something I’m passionate about. Just even taking a mindful pause can really help with resilience in our teams.

What are the other things? We’re creating business case studies to show the value of supportive care for our patients. The truth is, if we provide avenues for more supportive care for our patients and remove barriers on the provider side, then the providers will not have such a heavy burden, because a team of people is supporting the patients.

 Obviously, the pandemic has affected cancer care in countless ways. What are some specific challenges you’re hearing about today that you weren’t hearing about a year ago?

 First, the staffing shortages. There have been furloughs all through this experience, and the workforce has been through [a lot] of stress. It’s hard to find new people to replace those who have left because of stress and burnout.

What we hear the most now are concerns about screening delays and the impact this will have—we’re anticipating that patients may be diagnosed with more advanced cancer.

There’s also the financial landscape, and [the need for] mitigating the losses that the health care system experienced during [a period] of not having surgeries [and other procedures]. I think we are gaining ground, but that’s going to take time. And [the financial losses] have this downstream effect of supportive services being cut or limited. For patients, it’s probably one of the most challenging times they’ve ever experienced.

Another exciting but challenging opportunity has been telemedicine. Here, we are talking on video instead of face to face, and I think that’s the new world of how we’re working with our patients—and looking at the reimbursement issues of telehealth is really important. It’s especially important when we think about how we’re supporting our more rural communities, and making sure we’re removing barriers [to ensure] that everyone has access to quality cancer care. I think I’ve said this before, but it’s about really listening to the membership: People are doing creative things out there, and we want to hear what we can learn from them.

Let’s follow up on your point about the delays in screening. Almost from the very beginning of the pandemic, experts predicted this—and that these delays would lead to downstream delays in cancer diagnoses. Does ACCC have any specific initiatives that they’ll work on this year on this issue?

 One of our greatest strengths is that we do work within our communities, including something unique ACCC has called Innovator Awards. In the past 3 years, we’ve heard from many innovative programs around cancer screening, including ways to address health equity and injustices in cancer treatment and care. [From there], we solicit learnings from within the community and invite our members to hear those—through podcasts, through meetings, through publications. It’s really a way to share the best practices in the community. Our past president published an article in USA Today about the ways to stress the importance of cancer screening in the lung cancer population—and not to stop because of COVID-19.

 Number 1, however, is the responsibility to just get the word out to patients in our community that screening is safe, and that it’s important. I think that is the best place to start.

 You also mentioned the health equity issue, which has been an ongoing theme at ACCC even before the pandemic. Would you like to discuss progress in this area, or plans for things that you’d like to do over the next year?

Number 1, for ACCC and providers—I hope— the community is changing how we look in the lens that we see through. We need to be looking for opportunities for inclusion, We need to be educating ourselves. ACCC has an amazing collaboration going right now with the American Society of Clinical Oncology, and we’re looking at implicit bias training and a research assessment tool, both of which are designed to address barriers to patients participating in clinical trials, specifically for Black and Latino patients.

 We’re really looking at ways we can collaborate in innovative ways to work with our communities to improve access to clinical care for these patients.

Will this initiative produce data that you’ll report on, maybe in 2 years?

So, to conclude, how you see the role of the social worker in the cancer care team evolving, say, over the next 3 to 5 years?

The role of the oncology social worker has always been central, but maybe not the most visible out in the community. But some amazing innovative models are happening right now.

Both the University of Washington and the University of Texas at Austin have programs—I believe the Austin program is called CaLM—that are reinventing how we look at cancer care. They recognize that the person as a whole is the central reason why we’re here.4 It’s why we’re providing
cancer care, and the programs make sure that that person has wraparound services, and the social worker is more central in that role.

It’s really looking at, “How does this person access care? Do they have any barriers? How are they coping? Are they interested in fertility?” It’s looking at all these things, plus—can they pay their rent? All these things are important in cancer care, and but sometimes they aren’t as visible.

Are ongoing studies showing how this approach will affect patient outcomes compared with the more traditional approach?

 Absolutely. A lot of work is being done on the research side. Unfortunately, there’s not as much funding for that research. But yes, it is being done in in smaller groups.

I think one of the barriers to this model of care is the soft money to fund supportive care for patients. You know, the dietitians, the physical therapists, speech therapists: We know they—and social workers—are essential to be able to support a patient through cancer treatment, and they don’t necessarily charge for their services. So, we’re looking at how we can demonstrate the value of this, because this will also help support our patients in the long run.


1. Association of Community Cancer Centers names new president, Krista Nelson, MSW, LCSW, OSW-C, FAOSW. News release. Association of Community Cancer Centers; March 5, 2021. Accessed May 10, 2021. https://www.accc-cancer.org/home/news-media/press-releases/
news-template/2021/03/05/association-of-community-cancer-centersnames-new-president-krista-nelson-msw-lcsw-osw-c-faosw
2. Oyer RA. Don’t skip your lung cancer screenings during COVID-19. Future of Personal Health. USA Today (insert). November 11, 2020. Accessed May 11, 2021.  https://www.futureofpersonalhealth.com/lunghealth/
dont-skip-your-lung-cancer-screenings-during-covid-19/
3. Unger JM, Hershman DL, Till C, et al. “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst. 2021;113(3):244-257. doi:10.1093/jnci/djaa155
4. CaLM care team. The University of Texas at Austin: UT Health Austin. Accessed May 10, 2021. https://uthealthaustin.org/clinics/cancer/calm-care-team

A Social Worker Leads ACCC,  and Her Timing Is Perfect 

Researchers have found that when put up against traditional, or face-to-face (F2F), care, telemedicine (TM) produced comparable results among persons living with 

 in rural Georgia, thereby presenting itself as a potential way to increase access to specialty HIV care for these individuals.

Noting the difficulty persons living with HIV have at being retained in care, especially when presented with social, geographical, health system, and economic barriers, researchers from Medical College of Georgia, Massachusetts General Hospital, and Harvard Medical School investigate telemedicine’s impact in the space.

“Telemedicine is a potential tool to improve HIV care, but little is known about its effectiveness when compared with traditional care in rural populations,” they wrote. “The objective of this study was to compare the effectiveness of HIV care delivered through TM with the F2F model.”

Study participants were patients from the Dublin Department of Health HIV clinic database (n = 185; the TM cohort) and the August University HIV clinic patient database (n = 200; the F2F cohort) who were enrolled andhad visits between May 2017 and April 2018. They were matched 1:1 for gender, age, and race. Mann-Whitney 

 tests compared viral loads (VLs) and CD4 counts.

While the CD4 count was shown to be lower in the F2F cohort compared with the TM cohort—596.3 vs 643.9 cells/mm3 (

 < .001)—the results were close to equal for those with a detectable VL at baseline who achieved viral suppression: 44% and 45%, respectively. The mean changes in VL to achieve viral suppression were 3.34 x 104 and –1 to 0.24 x 104.

Statistically significant differences in VL reduction, control, and mean VL were not seen, coming in at 416.8 cp/mL for the F2F cohort and 713.4 cp/mL (

Primary study outcomes were rates of viral suppression and maintenance of it.

The authors highlighted how some patients have to travel 3 or 4 hours, one way, to access necessary care and that “travel time to access health care has been shown to reduce the use of specialty care in rural-dwelling veterans and to impact their health negatively.” This can have an especially hard impact on the South, where in 2018 alone, new HIV diagnoses outpaced the national average 18.4% to 13.3% per 100,000 individuals. Higher rates of nonadherence and poor retention care are also seen in Southern states.

Most patients in the F2F (82.0%) and TM (82.2%) cohorts were Black

Patients in both groups were 51 years or older (51.0%, F2F; 53.5%, TM)]

Medication remained the same for most patients during the study period (81.0%, F2F; 85.4%, TM)

The top 3 most common comorbidities in the F2F group were cardiac (58.5%), neuropsychiatry (37.5%), and stage 3-5 

The top 3 most common comorbidities in the TM group were cardiac (29.7%), stage 3-5 CKD (17.8%), and neuropsychiatry (17.3%)

Year-round viral suppression was similar among the groups, at 77% for patients receiving TM care and 73% receiving F2F care

Mean VL suppression change was –8.16 x 102 for the TM cohort and –3.51 x 102 for the F2F cohort (

“The results of this study are consistent with previous studies that have examined HIV outcomes when care is delivered through telemedicine by HIV-trained physicians as compared with the F2F clinic,” the authors concluded. “The unique telemedicine model makes it easier for physicians and other HIV-trained providers to deliver the same quality of care without the restrictions of geography, travel, or time.”

Future studies, with rigorous study design, should evaluate different modalities of TM for their effectiveness and acceptability among physicians and patients.

Lawal FJ, Omotayo MO, Lee TJ, Rao ASR, Vazquez JA. HIV treatment outcomes in rural Georgia using telemedicine. 

Published online May 12, 2021. doi:10.1093/ofid/ofab234

As a specialized health care service, telemedicine was shown to be comparable to traditional care for persons living with HIV in rural Georgia.

Telemedicine Effective at Care Retention Among Rural Patients Living With HIV

Earlier this month, drugmakers unveiled positive new phase 2 data for a pair of therapies targeting 2 types of non-Hodgkin lymphomas.

The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) had an overall response rate (ORR) of nearly 90% among patients with relapsed or refractory follicular lymphoma, and the humanized Fc-modified cytolytic CD19-targeting monoclonal antibody tafasitamab (Monjuvi) had an ORR of more than 50% when administered in combination with lenalidomide (Revlimid) to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Both sets of data were unveiled at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which was held earlier this month in a virtual format.

Novartis AG released the pivotal phase 2 data from its ELARA trial, showing tisagenlecleucel led to an ORR of 86% (95% CI, 78-92) in patients with follicular lymphoma, and a 66% complete response (CR) rate (95% CI, 56-75).

 None of the 97 patients evaluated for safety experienced grade 3 or 4 cytokine release syndrome (CNS), the most common adverse event associated with CAR T-cell therapies, though nearly half (49%) had grade 1 or 2 CNS.

“Our goal as researchers is to continue to explore the potential of CAR-T therapy, and the robust ELARA safety and efficacy findings suggest Kymriah may play an important role in the third-line treatment of relapsed or refractory follicular lymphoma,” said Stephen J. Schuster, MD, of the University of Pennsylvania’s Perelman School of Medicine, in a press release.

The ELARA trial had a median follow-up of 11 months, by which time the duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached. Schuster and colleagues estimated DOR for patients with CR at six months to be 94% (95% CI, 82-98) and 76% for patients with PFS at six months (95% CI, 65-84). The median number of prior therapies in the cohort was 4, though the range went from 2-13 prior therapies.

Nine percent of patients reported grade 1 or 2 neurological events, and 1 patient had a grade 4 neurological event, though all recovered. The most common grade 3 or higher adverse events in the first 8 weeks following infusion were neutropenia (28%) and anemia (13%). No treatment-related deaths were reported.

Novartis said it is committed to expanding the availability of CAR T-cell therapies, and will push forward with regulatory submissions for the indication as soon as possible.

 Meanwhile, Incyte Corp. and MorphoSys US Inc. said its phase 2 L-MIND trial showed tafasitamab had an ORR of 57.5% (46 out of 80 patients; 95% CI, 45.9-68.5) when given to patients with relapsed or refractory DLBCL in combination with lenalidomide.

 Forty percent of patients achieved CR, and the median duration of response was 43.9 months (95% CI, 26.1 - not reached) The median OS was 33.5 months (95% CI, 18.3 - not reached) and the median PFS was 11.6 months (95% CI, 6.3-45.7).

“The three-year follow-up data not only show a durable response and consistent safety profile in patients with relapsed or refractory DLBCL treated with tafasitamab plus lenalidomide, it also suggests the combination could potentially lead to durable remission,” said MorphoSys senior vice president Nuwan Kurukulasuriya, 

 “We are looking forward to sharing these long-term follow-up findings with the scientific community.”

Tafasitamab in combination with lenalidomide was approved by the Food and Drug Administration via its accelerated approval pathway last July for the treatment in adult patients with relapsed or refractory DLBCL not otherwise specified, including those arising from low-grade lymphoma, who are not eligible for autologous stem cell transplantation.

Schuster SJ, Dickinson MJ, Dreyling MH, et al. Efficacy and safety of tisagenlecleucel (Tisa-cel) in adult patients (Pts) with relapsed/refractory follicular lymphoma (r/r FL): Primary analysis of the phase 2 Elara trial. 

. 2021;39(Suppl 15): abstr 7508. doi:10.1200/JCO.2021.39.15_suppl.7508

Novartis’ Kymriah pivotal trial demonstrates strong response rates and remarkable safety profile in relapsed or refractory follicular lymphoma. News release. Novartis; June 2, 2021. Accessed June 19, 2021. 

https://www.novartis.com/news/media-releases/novartis-kymriah-pivotal-trial-demonstrates-strong-response-rates-and-remarkable-safety-profile-relapsed-or-refractory-follicular-lymphoma

Düll J, Maddocks KL, Gonzalez-Barca E, et al. Long-term analyses from L-MIND, a phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). J Clin Oncol. 2021;39(Suppl 15): abstr 7513. doi:10.1200/JCO.2021.39.15_suppl.7513

Incyte and MorphoSys announce three-year results from phase 2 L-MIND study of tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory DLBCL. News release. BusinessWire; June 4, 2021. Accessed June 19, 2021. 

https://www.businesswire.com/news/home/20210604005569/en/Incyte-and-MorphoSys-Announce-Three-Year-Results-from-Phase-2-L-MIND-Study-of-Tafasitamab-in-Combination-with-Lenalidomide-for-the-Treatment-of-Relapsed-or-Refractory-DLBCL

Phase 2 Data for Tisagenlecleucel, Tafasitamab Show Objective Responses in More Than Half of Patients

Racial disparities in health outcomes, including in cancer, are well documented. However, it’s not always clear how biological or socioeconomic factors affect these disparities, or whether advances in genomics and precision medicine have an impact.

Now, new research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting is painting a clearer picture of what drives differences in mortality and outcomes for patients with prostate cancer, which has higher incidence and mortality among Black men.

The lifetime probability of developing prostate cancer is 18.2% among Black men compared with 13.3% among White men. Black men are also significantly more likely to die of prostate cancer than White men (4.4% vs 2.4%).1

Although the advances in genomics and precision medicine promise to improve risk prediction and outcomes for many cancers, they may actually exacerbate these disparities. In a study presented as an abstract by Foundation Medicine and collaborators, Brandon Mahal, MD, assistant professor of Radiation Oncology and Assistant Director of Community Outreach and Engagement at the Sylvester Comprehensive Cancer Center, and researchers looked at how patterns of comprehensive genomic profiling and treatment varied by race.2

The data, coming from the largest known cohort of its kind, revealed that despite having similar frequency of actionable gene alterations, men of African descent were less likely than men of European ancestry to receive early comprehensive genomic profiling and be enrolled in clinical trials.

The researchers collected data on over 11,000 patients with advanced prostate cancer with comprehensive genomic profiling, including 1400 men of African descent and 9200 patients of European descent. They also analyzed real-world data from nearly 900 patients from Foundation Medicine and Flatiron Health’s clinic-genomic database.

, DNA damage response pathway genes, and actionable genes were similar across the 2 ancestry types. And while both groups were just as likely to receive immunotherapy and PARP inhibitor treatment, men of African descent were nearly 3 times less likely to receive an investigational treatment in a clinical trial compared with men of European descent (11% vs 30%). This remained true even among men with actionable alterations (1% vs 6%).

“Men of African ancestry experience the greatest burden of disease in prostate cancer, and this research indicates that differences in cancer care are not solely based on biological factors, but rather points to socioeconomic factors such as access to comprehensive genomic profiling and clinical trial enrollment,” Mahal said in a statement.3 “To ensure equitable opportunities for precision medicine, we need to expand access to and awareness of advances that impact patient care and outcomes, including timely use of genomic testing to help make informed treatment decisions.”

During a separate presentation, Mahal explained that most genomic studies are based on Eurocentric cohorts, with approximately 80% of patients included in the genome-wise association study (GWAS) being of European descent despite accounting for 16% of the population, leaving the door open to worsening disparities due to a lack of representative studies.4

Mahal outlined several approaches that could be taken to both study and address disparities in prostate cancer, including:

Transdisciplinary research that bridges basic, clinical, and epidemiological research

Precision medicine used as a means to identify mechanisms of disparity

Outreach program to bring care delivery and cutting-edge science to diverse communities.

1. Cancer Facts & Figures for African Americans 2016-2018. American Cancer Society website. Accessed June 18, 2021. 

https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html

2.Sivakumar S, Lee J, Moore J, et al. Ancestral characterization of the genomic landscape, comprehensive genomic prostate cancer: A large-scale analysis. 

. 2021;39(Suppl 15): abstr 5003. doi:10.1200/JCO.2021.39.15_suppl.5003

3. New study results presented by Foundation Medicine and collaborators at ASCO21 on cancer care underscore importance of equitable access to precision medicine advances. News release. Foundation Medicine; June 4, 2021. Accessed June 6, 2021. 

https://www.foundationmedicine.com/press-releases/aa904bd1-4854-44e9-8d03-24b5af5ff392

4. Martin AR, Kanai M, Kamatani Y, et al. Clinical use of current polygenic risk scores may exacerbate health disparities. 

New research presented at the 2021 American Society of Clinical Oncology Annual Meeting is painting a clearer picture of what drives differences in mortality and outcomes for patients with prostate cancer. Black men with prostate cancer have higher incidence of both.










Study Finds Genomics, Precision Medicine May Exacerbate Racial Disparities in Prostate Cancer

A new analysis elucidates the links between 

 (AD) and major depressive disorder (MDD), suggesting the former promotes the pathological development of MDD.

The study, which was published in the journal 

 could help better explain the pathogenesis of MDD and potentially lead to new targets for preventative therapies.

Corresponding author Xuehua Huang, PhD, of Sichuan University, and colleagues, explained that AD has a number of consequences that can intersect with quality-of-life diminishment, including irritation, itching, and sleep disturbances. However, patients with AD also have a higher prevalence of MDD, which is defined as experiencing at least 2 weeks of pervasive “low” mood. One study found as many as 1 in 3 patients with AD met the criteria of MDD.

Yet, it is not yet clear what mechanistic link, if any, exists between AD and MDD. In hopes of finding out, Huang and colleagues conducted a literature review in search of proteins, cells, functional classes, and small molecules linking AD and MDD. They then analyzed gene expression variance of MDD-regulating genes and then examined the functionality of AD-driven MDD-genetic regulators.

The analysis found 22 entities driven by AD that were upstream MDD regulators, 11 of which were genes. Four of those genes had significant expression changes in AD, and those changes were found to align with the development of MDD.

Of the 11 MDD-regulating genes driven by AD, the investigators said 8 are MDD promoters and the remaining 3 are MDD inhibitors. Four of those genes had significant expression changes in patients with AD, including one MDD promoter (

“These results support the relationship between these four genes, AD, and MDD, suggesting that AD might regulate the expression levels of these four genes to influence the pathological development of MDD,” they said.

The authors cautioned, however, that the expression data come from skin and blood samples. They said a more direct experiment should be conducted, using data from peripheral blood only.

Huang and colleagues also noted that the expression changes of 2 additional genes (

) “might not favor the development of MDD.” Thus, they said, the issue warrants additional study.

Most of the genes regulating MDD “were enriched with cytokine/chemokine regulation and neuroinflammatory response-related pathways,” which aligns with earlier findings that cytokine/chemokine overexpression, which has been linked with the pathogenesis of MDD, is present in AD.

“Our results showed that AD could influence multiple MDD regulators at different levels and drive cytokine/chemokine regulation and inflammatory response-related pathways that play important roles in the development of MDD,” Huang and colleagues wrote.

The authors said their findings also support the idea that cerebral inflammation plays an important role in the development of depression and other neuropsychiatric diseases.

“Elevated microglia activation and neuroinflammatory response have been observed in the brains of AD by using a mice model,” Huang and colleagues said, “which may add to the explanation of the AD-promoting effect on the development of MDD. Moreover, three out of the 11 AD-driven MDD regulating genes presented physical linkage to common targets, supporting their functional connection.”

The analysis identified 4 genes that were driven by atopic dermatitis (AD) and which had significant expression changes in favor of MDD development.