The era of precision oncology, in which molecular biomarkers are used to help guide drug delivery, has dovetailed with the emerging issues of value-based care and cost containment. To shed light on these issues and more, The ASCO Post spoke with Hanna K. Sanoff, MD, MPH, Clinical Medical Director of the North Carolina Cancer Hospital and Associate Professor in the Division of Hematology/Oncology at the University of North Carolina (UNC) at Chapel Hill School of Medicine.
Hanna K. Sanoff, MD, MPH
Please tell our readers about your current position and work.
I am a gastrointestinal (GI) medical oncologist and clinical researcher. My chief academic focus is on improving the quality of cancer care delivery through health services research and value and quality initiatives at the UNC Health System. I serve as Clinical Medical Director for outpatient cancer services at the North Carolina Cancer Hospital. I am also a clinical trialist and have served as the principal investigator on a number of industry, cooperative, and investigator-initiated clinical trials. I am an active member of the Alliance for Clinical Trials in Oncology.
Treatment Cost, Value, and Benefit
In 2016, you were part of a study looking at sorafenib in advanced hepatocellular carcinoma, in which you found concerning issues about survival and cost. Please reflect on that study and its implications, if any, for current drug approval methods as they relate to clinical care.
There have been several studies similar to ours on sorafenib in advanced liver cancer, looking at value and cost. In our work, we found that the median survival for a group of Medicare patients on sorafenib was 3 months, which was significantly lower than the median survival of nearly 11 months for patients treated with sorafenib on a phase III clinical trial. Furthermore, sorafenib comes with significant side effects and a cost to patients and insurers of thousands of dollars a month.
So, I think the takeaway from this body of work underscores the fact that establishing the effectiveness of therapies outside of trial settings is complicated but important if we want to understand the value of cancer therapies. Translating the benefits of treatments into a real-world setting isn’t always easy.
The U.S. Food and Drug Administration (FDA), unlike regulatory agencies in some other countries, does not factor cost into its approval process. I’ve actually had the honor to sit on several FDA drug advisory committee meetings, and cost is not allowed to enter the discussion. If there is some efficacy and no additional harm, the FDA’s position seems to be that it then becomes a decision between patients and physicians. Then there is the Right-to-Try legislation that makes it possible for patients to try drugs before they are approved.
That said, we have seen cost-vs-value issues addressed in certain clinical practice guidelines and with programs such as Choosing Wisely. However, the government still rejects the notion that cost should be part of the drug approval process.
Drug Approval Standards
For a cancer drug to be included in the World Health Organization (WHO) Essential Medicines List, it must provide 4 to 6 months of quality life. What are your thoughts on that as a standard for approval?
That’s an interesting question in that, although we have tools and metrics to assess various increments of quality of life in the continuum of care on an aggregate level, it is still very subjective on the patient level. For some, simply being alive regardless of how they feel counts as quality of life, whereas others do not feel that the impaired quality of life they experience during treatment is worth it, even if there is survival prolongation. So, how could we define “quality of life” in a way that represents what patients want, to make that decision for the WHO Essential Medicines List?
Another thing that makes it difficult to set a hard-and-fast survival period for approval is that with some of the newly approved immunotherapies or targeted drugs, median survival isn’t a good metric. Should a drug be rejected if it doesn’t change the median, yet 15% of patients have a durable response with prolonged cancer control for years?
It is important to have a conversation about these things with your patients so they are aware of the clinical realities they’re up against—that many of our drugs offer only a modest chance for benefit, which has to be balanced against a real detrimental effect on quality of life. Most patients are willing to take the risk, but for a regulatory body, its pretty clear the FDA wants that discussion in the exam room, not at the FDA.
Colorectal Cancer Prevention and Treatment
What promising developments are we seeing in colorectal cancer treatment?
It remains a challenging clinical setting, but there are some bright spots. The first is in prevention, not treatment. Over the past decade, we’ve seen an increase in colorectal cancer in younger patients, so the American Cancer Society (ACS) recently released new screening guidelines. Adults who are at average risk for colorectal cancer used to start having regular colonoscopies when they turned 50. Now the ACS recommends that colorectal cancer screenings begin at age 45. So, we’ll wait to see whether that initiative helps address this disturbing trend.
On the treatment side, although we haven’t seen a huge number of new drug approvals in colorectal cancer, we have recognized that it is actually a disease of subgroups. To that end, we are seeing research and development for meaningful drugs to target the various subgroups. It’s important to note that since I began my fellowship, which was in the era when oxaliplatin and irinotecan were approved, there’s been a sea change in our ability to treat patients with colorectal cancer. With the developments in immunotherapy and novel targeted agents, it is only getting better. It’s an exciting time in oncology.
Big Data and Patient Outcomes
On the outcomes side, we have big data. Where are we in our ability to translate them into better outcomes for our patients with cancer?
As far as optimizing big data for translation into the clinic, we’re not there yet. For one, although our electronic medical record systems have gotten much more efficient since their inception, they are still not streamlined and interoperative within a central network. So, most of the data valuable to clinicians are still collected in notes, not in a structured accessible format.
There has been investment in that area, such as ASCO’s CancerLinQ and others, which are eventually going to get us to that place of sharable high-value data. We’re much closer than we’ve been, but there’s a lot of work ahead before we have large interconnected clinical data sets.
Please share some closing thoughts on the state of cancer care.
Given the COVID-19 pandemic has, among other things, highlighted our across-the-board shortages in health care, I’m coming out of this difficult period with a lot of optimism. For one ting, I just came off a 2-week stint in our inpatient oncology service, which I hadn’t done for a couple of years, and I was thoroughly impressed by how our medical culture has changed for the better, putting the patient at the center of a highly cooperative setting. I am also extremely impressed by the burgeoning culture of safety and quality across the spectrum of cancer care, much of which was inspired by the new oncology care model.
I think we’ll take this attitude into the clinic and ensure that many of these very exciting new therapies will be delivered to our patients with the utmost regard for safety and effectiveness, regardless of whether it’s in a high-volume center in a major city or in a rural community clinic. So, despite lots of challenges on multiple fronts, oncology care is rapidly improving.
DISCLOSURE: Dr. Sanoff reported no conflicts of interest.