Dr. Michael Seiden is president of The US Oncology Network, one of the nation’s largest networks of integrated, community-based oncology practices who treat over 995,000 cancer patients annually. He was formerly chief medical officer for McKesson and The US Oncology Network, and chief executive officer and president of Fox Chase Cancer Center in Philadelphia.
OBR spoke to him about some topics that would impact cancer patients and providers going forward.
OBR: We’re hearing more about artificial intelligence (AI) in particular, Watson and its abilities. Is this technology going to improve outcomes and quality of care?
MS: Artificial intelligence has begun to improve patient outcomes, but the overall impact is modest right now. As a larger proportion of patients get more comprehensive genomic testing, and as we learn more about the function of genes and biology, it will become paramount to utilize artificial intelligence systems. Oncologists will undoubtedly be the tip of the spear of the use of artificial intelligence in medicine.
However, the full impact of artificial intelligence will take time. Watson is a good first step to build larger databases, but for artificial intelligence to work in value-based medicine it has to save oncologists time. At the moment, electronic tumor boards, downloading information into smart devices takes too long. We need to be able to instantly, seamlessly grab information from electronic health records to quickly view easily interpretable data.
Artificial intelligence will impact the quality of care, but it will take longer for material changes to affect the outcome of the average cancer patient. To deliver this at scale is probably a decade away.
OBR: More oncology biosimilars have been approved by the FDA. Are you seeing uptake and confidence in these products? Do you think they will help to reduce the cost of oncology drugs in the future?
MS: Biosimilars used to be a boutique topic of interest to a small section of oncology. Now they have become a mainstream topic among payers, manufacturers and clinical oncologists. The uptake of biosimilars among community oncologists has been high for Neupogen and moderate for Neulasta. At The US Oncology Network, we have active, ongoing discussions with manufacturers and payers about upcoming Herceptin and Rituxan biosimilars.
Clearly, manufacturers who own branded drugs are creating brand-defense strategies to mitigate the potential uptake of biosimilars. However, I expect a shift toward biosimilars and anticipate new biosimilars will receive a greater uptake. Biosimilar manufacturers will work hard to level the playing field with originator products.
The current federal government focus on reducing drug costs will be a tailwind for patients and payers, and the market will be competitive for biosimilars. They are more likely to be adopted than they would have been five years ago.
OBR: Do you see community oncology practices helping to get new, unapproved cancer therapies to patients and to play a bigger role in clinical trials? What are some of the advantages/disadvantages of community practices participating as clinical trial sites?
MS: Between 80%-90% of cancers are diagnosed in the community. Big Pharma can’t afford to ignore that, and strategies to involve the community in drug development will become more important. Between 4%-6% of patients diagnosed with cancer go on to clinical trials, leaving lots of potential to enroll more patients. The majority of cancer patients say they would be interested in clinical trials. Within The US Oncology Network, we have more than 155 locations and over 1,000 investigators participating in clinical research.
Cancer patients express concerns about receiving a placebo and paying for clinical trials, but few oncology clinical trials include a placebo arm, and most payers pay for the trial.
Some headwinds make community involvement in clinical trials difficult. Clinical trials are becoming more complicated, including specific biomarkers, biopsies or patient-reported outcomes. Starting a clinical trial takes time and effort, possibly more staff, special equipment and perhaps extended hours in what are often modestly sized facilities with limited staff. To accelerate trial accrual, it will be important that sponsors pay close attention to the infrastructure and operational needs associated with the planned trial if they hope to have robust community involvement.
The bottom line, I believe, is that we will see more clinical research in the community in the years ahead. Advantages will outweigh disadvantages. Awareness and education using technology to inform physicians and patients are improving.
OBR: Two immuno-oncology (IO) researchers captured the Nobel Prize this past year. Based on some of the pivotal research in 2018, what do you expect to see happen next in this research area? Will costs play a role?
MS: IO absolutely, undeniably has completely changed the landscape in melanoma and kidney cancer, with a modest but real impact in many other solid tumors. These drugs have rapidly escalated to the top three or four oncology drugs used in oncology in record time.
Most research has examined the efficacy of single-agent IO therapy in a variety of solid tumors. Five years from now, we may prefer two or three IO agents at the same time. Combinations of vaccines, monoclonal antibodies and other small molecules with checkpoint inhibitors have led to intriguing results. Various trials show combination therapy of doublets have reported response rates that are superior to responses with monotherapy.
How to pay for this is not clear. A number of manufacturers are talking about novel pricing mechanisms. For example, if you order Drug A for $10,000 and Drug B is also $10,000, could you prescribe the combination for specific indications for $14,000? Such pricing strategies cannot be accomplished in our current regulatory and distribution models, so translating the above scenario into action will take some innovation on the part of manufacturers, distributors, regulators, and payers. Manufacturers are talking to The US Oncology Network and regulatory agencies about how to piece together paying for two or three novel branded drugs, particularly if they are widely adopted, such as IO drugs.
A handful of centers offer chimeric antigen receptor (CAR) T-cell therapy in volume, but these mostly hospital-based providers deliver therapy at a considerable loss. This is likely unsustainable. Payers need to figure out how to reimburse for CAR T-cell therapy. It’s too early to tell how this will pan out.
OBR: The FDA is approving more cancer drugs than ever before and has recently announced a slew of new initiatives related to oncology. What would you tackle first in terms of regulatory priorities that impact cancer patients and their care?
MS: FDA Commissioner Scott Gottlieb, MD, has done a good job ensuring a robust generic drug pipeline and speedy application reviews for biosimilars. Common nomenclature and standards have been developed for molecular and precision medicine tests, and real-world evidence now is being considered for accelerated approvals. He has a good idea of where the FDA achieves the biggest bang for the buck.
Drug pricing is more contentious. Sustainable, enforceable changes in drug pricing must come through legislation in this politically charged environment. Republicans and Democrats must keep patient interests at the center of legislation. The American public could get behind that.