Insight From: Adam Brufsky, MD, PhD, Pittsburgh

Insight From: Adam Brufsky, MD, PhD, PittsburghÂ

Insight From: Adam Brufsky, MD, Pittsburgh

Insight From: Cathy Eng, MD, MD Anderson&nbsp

Insight From: Cathy Eng, MD, MD Anderson Jessica Mitchell, RN, CNP, MPH Mayo&nbsp

Insight From: Cathy Eng, MD, MD AndersonÂ

Insight From: Ezra Cohen, MD, UCSD

Insight From: Joanne L. Blum, MD, PhD, Texas Oncology

Insight from: John Sweetenham, MD, Huntsman

Insight From: Noopur Raje, MD, Dana-Farber

Insight From: Primo N. Lara, Jr, MD, UC Davis

Insight From: Robert L. Ferris, MD, PhD, Pittsburgh

Insights from: Wells A. Messersmith, MD, FACP,  University of Colorado Cancer Center

Winston Churchill once said, “Americans can be counted on to do the right thing, once they’ve exhausted all other alternatives.” In our healthcare delivery system, we’ve embraced this principle through many false starts and unfulfilled promises in the fields of clinical informatics and integration. A few shining stars were mentioned in the recent presidential debates, but not every system can be the Mayo Clinic or Cleveland Clinic. Healthcare delivery is like politics: it’s all local. The unifying principle for care delivery in every situation should ideally be centered on complete clinical information, coupled with evidence-based medicine, and filtered through clinical decision support tools for best healthcare outcomes tailored to individual patients. That is where we want to be overall as a healthcare delivery system. In clinical oncology, that era of informatics may be coming very shortly.

		Figure 1. Cost of Cancer Care Versus US Gross Domestic Product

: Reprinted with permission from National Cancer Institute. Cancer costs projected to reach at least $158 billion in 2020: new NIH study projects survivorship and costs of cancer care based on changes in the US population and cancer trends. 

	Healthcare System Reacts to Cost Pressures

The background on why oncology practice would act as a leading edge for medical informatics includes three interdependent factors. These are (in no particular rank order): new and expensive drug therapies, Centers for Medicare & Medicaid Services (CMS) responses to cost rise trend pressures in oncology, and advances in health information technology (HIT) coupled with federal legislation (Affordable Care Act). This confluence of clinical, cost, HIT, and legislative factors is immensely powerful, squeezing the structure of oncology care delivery into something new. The resulting yield is a huge potential expansion of efficiency and quality through the application of informatics.

From 2000 until 2011, 40 new cancer drugs were approved by the US Food and Drug Administration (FDA) in the United States. As documented by a recent New York Times editorial,

 the typical new cancer drug coming on the market a decade ago cost about $4500 per month (in 2012 dollars); since 2010 the median price has been around $10,000. The majority of new drugs in the pipelines of every major pharmaceutical company in the world are targeted at either cancer or a rheumatologic/immunologic condition. The costs of new drugs approved by the FDA continue to rise, with an annual increase of 20%. No sign of abatement is seen, given the swollen phase II and phase III pipelines and associated companion diagnostic biomarker tests for many of them (

The CMS response to the rising cost of cancer care was to completely change drug reimbursement to oncologists in 2004. As of 2005, Medicare recipients constituted 70% of Part B drug reimbursement by most oncology practice volume,

 with an incidence of cancer in the 6 to 8 per 1000 range of Medicare population, versus a commercial population incidence of 1 to 1.5 per 1000. The shift in drug payment pricing over to an Average Sales Price (ASP) + 6% methodology has ratcheted down the profitability portion of drug “buy and bill” hugely, with a net effect being an average effective payment cut on drugs of 46.9% as of 2010.

Community oncology practices, which were the predominant site of service early in the previous decade, responded in two ways. One, they sought to increase the volume of patient flow through their offices. Two, those practices that could not wring out more efficiencies or carefully manage the millions of dollars of oncology drugs in their infusion services inventory elected to merge with other practices or sell their practices to local hospital systems.

	Private Employers, Payers, and Community Practices Take a Hit

This was happening at the same time that hospitals were increasingly applying for and obtaining “340b” certification. The government certification program was designed to allow for more access to oncology care in underserved populations by requiring drug manufacturers to sell to hospitals at significant double-digit discounts. Hospitals could then reprice these drugs in their newly purchased oncology practices at the richer hospital outpatient site-of-service pricing and generate large windfalls of profit.

As the site-of-service moved from the community to hospital outpatient—and drug prices soared&mdash; costs to private insurance payers and self-insured employers doubled or tripled.

During this same time frame, the amount of private payer precertification oversight increased to manage the costs of the pipeline of newer, very expensive, and highly specific drugs coming onto the market.

As a result, oncology practices needed to hire more full-time employees to manage patient flow. Struggling community oncology practices saw office practice salary expenses grow just as profits sagged. Hospital-based systems, however, absorbed those costs easily using their 340b arbitrage profits.

In the midst of these changes in oncology business economics, the federal government sought to promote technology solutions as an overall balm to healthcare cost rises. The 2010 Affordable Care Act (ACA) facilitated new delivery and payment systems, such as accountable care organizations (ACOs). ACOs can only function successfully in an environment of data sharing and interchange, with processing and distribution of data linked to outcomes and evidence-based medicine. Government funds were disseminated to create this environment. Since early 2012, $2 billion has gone to physicians and hospitals to increase the use of electronic health records (EHRs), and another $28 billion has been dedicated to informatics anticipated by 2015.

However, an informal survey in 2010 of oncology practices showed that a significant proportion lacked complete oncology-specific office practice systems (non-clinical decision support—focused). Thus, a gap in technology and oncology-specific business solutions was being recognized at the same time as the need for sophisticated and personalized medicine for oncology care was becoming acute.

The shift to accountable care models and other integrated delivery systems that pay for value instead of volume will accentuate a lack of business viability to any provider entity not able to input, process, and output the full spectrum of member-specific clinical and demographic information. Many in the informatics industry recognize this point of inflection in oncology care and the opportunity to build administrative and clinical decision support tools that can support population health.

Early trials using electronic clinical decision support in oncology include the US Oncology study with Aetna in 2009 on non—small cell lung cancer patients. Using an evidence-based pathways software system, the outpatient costs of care in the community setting were reduced by 35%,

 with no evidence of change of outcomes (

Subsequent studies by P4 with CareFirst and other evaluations have validated the use of pathways as part of an overall and bigger goal of using informatics to deliver efficient, holistic, and evidence-based cancer care. Sometimes the results are not straightforward, as drug cost savings may evaporate when new, high-priced, and truly differentiating therapies become available as best care options.

		Figure 2. Study on Outpatient Costs of NSCLC

		Purpose: Evaluate the cost effectiveness of evidence-based treatment pathways for patients with NSCLC.

		Conclusions: Results of this study suggest that treating patients according to evidence-based guidelines is a cost-effective strategy for delivering care to those with NSCLC.

		NSCLC indicates non—small cell lung cancer.

		Source: Reprinted with permission from Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. 

Some would argue that drugs should be completely voided from the efficiency portion of the care equation (drug costs zeroed out), per the episodes of care pilot. The argument is that avoidable hospital and emergency department visits will certainly diminish with improved coordination of care, and savings should start in this area. However, market benchmarks, patient case acuity mix, and practice starting points differ. Additionally, the cost and utilization parameters of measurement of oncology care quality and efficiency for any one practice, outside of a Kaiser and Mayo Clinic environment, resides among multiple private healthcare payers and CMS. Therein lies both the key problem and the seeds to a universal informatics solution.

Vertically integrated, staff-model health maintenance organizations that own provider assets and self-contained integrated delivery systems have a powerful informatics advantage: a single data highway through which all patient-specific information can flow. What if all payers of healthcare services could use a payer-agnostic data highway to portage information to and from provider sites of care? This would allow an oncologist’s office to see a range of patients with all types of insurance coverage, unencumbered by a heterogeneous set of inputs. They could obtain pretreatment information populated on a patient-specific electronic medical record (EMR), with knowledge of lab values, prescription drug history, and radiology test results available. The ideal system would be able to plug into hospital EMR systems such as Centricity and Epic.

Oncologists would have a holistic view of complex patients who may require multiple hand-offs to different specialists. Different private payers could also craft their own pay-for-value contract terms with providers, without creating a need for multiple payer-specific work flows in the office. Furthermore, this health information highway, or exchange (HIE), could be the place where consult and referral applications reside, to be pulled off of “the cloud” at any time for use with colleagues. Payer-specific applications related to networks and services would also help providers help patients. Lastly, this HIE becomes the foundation for interactions with ACOs and other risk-bearing entities (

		Communication and services are arrayed around the patient’s care; simplified and streamlined, connected to all involved in care, and ACO capable.

		ACO indicates accountable care organization.

As pay for value supplants traditional fee for service as the predominant method of financial interaction in the public and private marketplace, having the capabilities to build and deploy HIT in an oncology office and connect to an HIE becomes critical to maintaining a growing business. Creation of a payer-agnostic HIE, coupled with ownership of additional technology and actuarial analytics, will furnish both the platform for doing business and the outcomes-based reimbursement requirements that can be payer-specific. The traditional functions of disease management and care management will migrate to these information-rich platforms, with more informed and incisive engagement opportunities.

Most importantly, by providing this technology at low or no cost in a revenue-neutral or revenue-positive arrangement for oncology providers, the private market is removing a major barrier for adoption of healthcare informatics at the provider level. The key oncology points are the need for a multi-payer solution, housed on a single platform, with a solution that keeps pace with the science, and is holistic in supporting a team approach, biomarker technology, patient education, and care management and bioethics capabilities.

Addressing oncology-specific needs in a streamlined approach to evidence-based cancer care is the goal of any informatics solution specific to oncology practice. The practicing oncologist cares about delivering the highest quality of care to his or her patients, doing it in a practice environment that has simplified work flows, generating enough revenue to stay in business or grow, and maintaining viability for the foreseeable future.

As explained earlier, the old “buy and bill” environment is going away. The revenues generated in the past allowed practices to create widespread access to community-based office infusion services (economical and patient-centric). However, knowledge-intensive services (payment for cognitive services) were de-emphasized as a revenue driver. A system that captures all costs, granular patient-specific information, and all related care activities can measure and reward cognitive services on a comparative basis. This could change contracting terms with hospital-based systems, and help community oncologists maintain autonomy through pay-for-value incentives. Now, an HIE-empowered practice, with applications that have oncology clinical decision support capabilities, can have revenue opportunities and work flow simplification.

	Structured Information Exchange Eliminates Drug Precertification

	The Power of Information at Your Fingertips

At the office practice level, the most flexible software tools are those that are Web-based, requiring only Internet access to use. Understanding the recent history of oncology practice and the present business environment, Aetna is piloting a “next generation” oncology software application by eviti, a clinical decision support vendor; the program offers the most complete and unbiased digital library of more than 1200 evidence-based treatment regimens for more than 120 cancer types. The regimens are compiled from government and industry data and take into account costs, effectiveness, side effects, and outcomes. In addition, the library includes more than 9000 federally registered clinical trials. The eviti software is used as a Web-based application or as a part of EHR software. Aetna is supplying the health information highway in the form of the payer-agnostic iNexx platform from Medicity. Both services are provided free of charge, with only a commitment-for- use agreement necessary by the practices entering the pilot.

A significantly attractive feature of the eviti tool is the cross-walking of Aetna’s clinical policy bulletins into the software that allows for realtime, automated preauthorization approval when evidence-based protocols that are patient specific (including genomic markers and performance status) are chosen. This reduction in administrative work will allow an oncology practice to dedicate less staff to preauthorization tasks, and more to patient education and monitoring.

The flexibility of pulling “apps” that provide sorted data in useful and actionable information from an HIE portal, such as iNexx, and using them to improve connectivity among healthcare providers, payers, and patients is a transformative event. Oncology practice is one of the most clinically intensive practice activities in medicine, made more complex and expensive with huge growth in biologic drugs. Oncology is ideal to lead the way in this technology construct because clinical benefits will be yielded in the short term. The economics of oncology practice also pressure a change from pay-for-volume to pay-forvalue. And now, a platform exists that can take on the needed monitoring and measuring. Lastly, the entire architecture of healthcare delivery is changing, and creating the voluntary HIE pipes in oncology will lead to more rapid adoption elsewhere.

Many vendors focused on clinical decision support and consumer engagement are eager to jump on the health information highway. We are eager to support them and the innovation that comes from competition. All agents in the system—payer, provider, and patient&mdash;win when better, cheaper, effective, and easier-to-use tools are brought to market. We support these efforts, and look to work collaboratively with others who think likewise. Innovation is best done with an understanding of the history and workings of the marketplace. Aetna is a change agent and committed to building a better healthcare delivery system for everyone.

The unifying principle for care delivery in every situation should ideally be centered on complete clinical information, coupled with evidence-based medicine, and filtered through clinical decision support tools.

Oncology Enters the Informatics Era: Many Eager to Jump on the Health Information Highway

Ira M. Klein, MD, MBA

Ira Winer, MD, PhD, associate professor, Division of Gynecologic Oncology, Wayne State University, Barbara Ann Karmanos Cancer Institute, discusses the tolerability of ALKS 4230 plus pembrolizumab (Keytruda) in ovarian cancer. 

Findings from the ongoing phase 1/2 ARTISTRY-1 trial were presented during the 

The results demonstrated objective responses with the combination of ALKS 4230, an investigational engineered cytokine, and pembrolizumab in patients with heavily pretreated, platinum-resistant ovarian cancer. 

The ARTISTRY-1 regimen is intensive, but patients appeared to tolerate the combination well, says Winer. 

Ira Winer, MD, PhD, discusses the tolerability of ALKS 4230 plus pembrolizumab in ovarian cancer. 

Dr. Winer on the Tolerability of ALKS 4230 Plus Pembrolizumab in Ovarian Cancer

Ira Winer, MD, PhD

	Irene Ghobrial, MD, director, Michele & Stephen Kirsch Laboratory, senior physician, Dana-Farber Cancer Center Institute, discusses the use of monoclonal antibodies for the treatment of multiple myeloma.

	Antibodies offer limited toxicity and can be used in combination together for maximum result. 

	The anti-CXCR4 antibody ulocuplumab has exciting potential, says Ghobrial. The antibody has shown promising results in combination with lenalidomide (Revlimid) plus dexamethasone, or with bortezomib plus dexamethasone in patients with relapsed or refractory multiple myeloma.

Irene Ghobrial, MD, director, Michele & Stephen Kirsch Laboratory, senior physician, Dana-Farber Cancer Center Institute, discusses the use of monoclonal antibodies for the treatment of multiple myeloma.

Dr. Ghobrial on Antibodies for Multiple Myeloma Treatment

Irene Ghobrial

As you think about it even in your own experience, sometimes issues of diversity, and equity, inclusion. We hear so much about DEI. I often say DEI is political, personal, or professional. I try to take the political bit out and focus on the personal and the professional. That this isn't just what we do every day, but that there is a personal commitment that's involved with this, and understanding looking at your own inner circle, how diverse is your circle? How much interest are you, even as Crag said, when you're looking in the chart and trying to learn about someone, are you taking an interest in someone's culture and background? That's a notion of sensitivity and even humility, to listen, to understand, to hear things better. That is an area where if each of us have that - I'm not going to say epiphany, but that commitment individually, that will influence on others. I look at the 4 of you doing this panel with me and I know how many medical students, residents, fellows, and junior faculty are influenced by you. And they'll see you and they'll emulate that as we go through. But time's nearly gone, let's just do a quick circle around here. I'll start with you, Irene. Any final thoughts, things that you want to conclude on as we get to the end of our time together here?

: No, I just enjoyed this discussion we had today. It enlightens me more, and the passion everyone has to make a difference is so critical. As everyone said, early diagnosis, early access to care, caring about every individual without the biases that we all carry. And hoping to chip through all of this to make a difference, and to help every patient we see. And hopefully that can make the difference.

 Absolutely, ditto. Whatever Irene said, perfectly said. But I'll leave our group with a thought of a forward looking or a forward vision kind of a thought. In the very beginning, we said where do we take this field? How do we take that next step? I'll give you a very quick example of something that we're doing which I'm quite proud of how we put that together, is one of the forthcoming cooperative group, a CTEP sponsored clinical trial through the cooperative groups around the country is going to be for newly diagnosed, transplant ineligible, 'elderly frail' population. Which is looking at the various frontline therapies and comparing them randomized phase 3 trial head to head comparison. It's going to be through SWOG ECOG alliance, et cetera. But we have actually spent hours and hours together to say in this NCI sponsored CTEP driven trial, what are we going to do to make a difference? The inclusion criteria have been completely revamped. If a patient is not on dialysis, and that was for some technical issue, that patient will be allowed to go on the trial. No longer is 8g the cut off, we'll drop the hemoglobin cut off to 7g. Frankly, all of us sitting on this panel and those who are listening to us, if that patient shows up to our clinic, we're not going to say, "Hey sir, your hemoglobin is 7.5, sorry I can't treat you, go to the next person." We're going to treat that patient. Why should that patient not get on a clinical trial? We are building a DEI plan on the sideline of that trial right now when the trial is being written, to say what do I expect to enroll in this national clinical trial? Am I meeting that criteria or not? And if I'm not enrolling, and this is for maybe about 200, 250 sites where this study is going to be open across the country, why are we not hitting the mark? We're putting that plan together, and hopefully as the trial opens up, we get to talk about it. But those kind of forward-thinking thoughts will move our field together in addition to when Craig said addressing the bias, in addition to when Tondre said let's get the patient to the right treatment and let's leave our bias at the door when we enter that room to see our patient.

Beautiful work, Sikander. Congratulations on doing it. We anticipate that coming. I know that it's been in the works, and I appreciate that you're not looking if you will, the clinical aspects, but the bigger aspects of the study like that. Craig, I'm going to come to you. And before you give your closing statement too, maybe you can answer another question that's come in saying do we have any advice for in-patient health disparities improvement? Are there things that we should maybe keep in mind specifically when it comes to in-patients? And then feel free to make some concluding thoughts. And we'll come to you last, Tondre.

 There was a study that looked at in-patients with myeloma based on race. And there were some striking things that came of that, and one thing was that there were more hospitalizations of African Americans. There were more deaths in Hispanic people with myeloma. One thing I thought was striking was that people of color had less engagement of palliative care and pain care in the hospital. And the one disparity that we didn't talk about is just around pain, and the disease that affects the bones. That we must be cognizant that again some of those little biases are where is this patient going to go if I give them pain medications? We must leave all that behind. Treat just like Dr Buck said, treat our patients like our family, and don't make these assumptions. And with in-patients, that we know that these patients may have more anemia, they may have more renal sufficiency, but make sure that we're treating their pain adequately. And for my final statement, what can we do to help? Being on this call, being on this podcast, being on this live MedLive®, you're already being informed, aware, and helping the process. Because you'll leave this call today and you'll start making changes armed with the information that we talked about today. Which makes me excited because the world and this field is changing, thank goodness.

Well said, Craig. Always with such passion. Tondre, I'll give you the last word before I close off, my friend.

: Once again guys, it's been great. But my approach has always been a simple approach, and it's kind of like what Craig just said. You treat every patient with respect and remember what we're here for. We're here to hopefully make someone's life better. And as it related to myeloma, the first step is to recognize that we have a problem in terms of disparity. That's the first step, and my solution is that I hope we can create a hundred Craigs, and Joes, and Irene’s, and Sikander’s, and just keep pumping out in this disease that disproportionately affects African American patients. My short term ask would be to keep up the good fight, and just one patient at a time, and keep going. And anything that I can do to help facilitate that.

Beautifully said. It's hard for me to add much more to that after you've said it so well. We trust everyone has enjoyed the program today, and it's been helpful to you. We've discussed so many things today. We started with what is the problem, the magnitude of the disparity, how it's based not only in biology but in the society, how it's manifest in so many ways from timing to diagnosis, access to the key therapies that we need, and even bias within the healthcare provider population. And then we tried to think about some ways that we can solve that, some ways with greater awareness, with awareness in both the lay and the medical side, with a very dedicated approach to access to clinical trials, and transplants, and novel therapies that requires more resources, that requires a sensitivity. But a passion all the way along, and indeed ultimately something that each of us have to take on individually as healthcare practitioners. We trust all of this is not just some academic discussion, but something that can genuinely help. As we see as Sikander shared and Irene shared, the future of the research and the work that we're doing, and it's evolving. We may reach a day where we do screen people at certain high risks for this disease where we hopefully can intervene even earlier to make a difference. I want to thank this incredible panel for your insights, I want to thank all who have been listening. We hope you found this OncLive® peer exchange program of value to you. We appreciate your feedback, and your evaluation is always critical to us as we move forward. And we trust that as more and more of these programs are carried out, that we'll have a greater impact in bridging this gap and reducing the size of the health disparity that we've described today. Thank you.

Expert panelists share their closing thoughts on the path to improve health equity in multiple myeloma management for racial and ethnic minority groups.

Disparities in Multiple Myeloma Care: The Path Toward Health Equity

Irene Ghobrial, MD

Isaac Perlmutter Cancer Center

Isabel Preeshagul, DO, MBS, and colleagues share updates from across the lung cancer space as discussed in a recent State of the Science Summit.

Lung Cancer State of the Science Summit Recap

 on Lung Cancer chaired by Isabel Preeshagul, DO, MBS, she and colleagues highlight key takeaways from their presentations, which covered updates from across the lung cancer treatment paradigm. Preeshagul is a thoracic medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center.

Preeshagul discusses the clinical implications of 

data from the phase 3 ADRIATIC trial (NCT03703297)

, which showed that patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy experienced a median overall survival of 55.9 months (95% CI, 37.3-not evaluable) when treated with durvalumab (Imfinzi; n = 264) compared with 33.4 months (95% CI, 25.5-39.9) when given placebo (n = 266; HR, 0.73; 95% CI, 0.57-0.93; 

 = .0104). Based on these data, In August 2024, 

 to the supplemental biologics license application seeking the approval of durvalumab for the treatment of patients with LS-SCLC whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

Next, Alissa J. Cooper, MD, a thoracic medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, highlights the evolving understanding of the role of antibody-drug conjugates in the treatment of patients with non–small cell lung cancer (NSCLC). Cooper expands on the challenges posed in the clinical study of these agents and how biomarkers could help refine the understanding of which patients may benefit most from these agents.

Kathryn C. Arbour, MD, a thoracic medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, then delves into the current treatment paradigm for patients with NSCLC harboring 

 G12C mutations. She details the prevalence of 

 mutations in this patient population and how ongoing research could build upon the targeted therapies available for those with 

Interested in attending a future State of the Science Summit or Institutional Perspectives in Cancer meeting? 

Lung Cancer State of the Science Summit Recap | Chaired by: Isabel Preeshagul, DO, MBS

Isabel Preeshagul, DO, MBS

Isabella C. Glitza, MD, assistant professor at MD Anderson Cancer Center, discusses a single-center phase I/Ib trial of concurrent intravenous and intrathecal nivolumab (Opdivo) for patients with metastatic melanoma and leptomeningeal disease.

At the 2019 International Congress of the Society for Melanoma Research, Glitza shared the safety findings for the intrathecal approach to treating leptomeningeal disease, while efficacy data will be presented at a later date. Overall, there were no added toxicities with the intrathecal approach and no additional grade 3/4 adverse events in general, she says.

Investigators are very pleased with these data as they established the safety for the intrathecal approach to treating leptomeningeal disease, as well as the feasibility of this type of trial.

Isabella C. Glitza, MD, discusses a single-center phase I/Ib trial of concurrent intravenous and intrathecal nivolumab for patients with metastatic melanoma and leptomeningeal disease.

Authors