Evidence-Based Oncology August 2019
Evidence-Based Oncology August 2019
Ellen Matloff, CGC, MS; Danielle Bonadies, CGC, MS; Meagan Farmer, CGC, MS, MBA
COTA Collaboration: Helping FDA Figure Out What's Possible and What's Not in Embrace of Real-World Evidence
L. Patrick James, MD
Kelly Owens, PhD; Lisa Schlager; and Piri L. Welcsh, PhD
Laura Joszt, Mary Caffrey, Jaime Rosenberg, and Alison Rodriguez
Joseph Alvarnas, MD
AJMC®TV interviews let you catch up on what’s new and important about changes in healthcare, with insights from key decision makers—from the clinician, to the health plan leader, to the regulator. When every minute in your day matters, AJMC®TV interviews keep you informed. Access the video clips at ajmc.com/interviews.
Sue Friedman, DVM, Executive Director of FORCE: Facing Our Risk EmpoweredWhy is it important for people to know more about genetic testing, especially those with a family history of cancer?
There are a lot of reasons why it’s important to know this information, and one of the things that’s been exciting coming out of this [2019 American Society of Clinical Oncology Annual Meeting], but also other conferences over the years, have been these new agents, known as PARP [poly (ADP-ribose) polymerase] inhibitors, that are really targeted therapies and they were designed specifically with BRCA mutations, although now they’re looking at how they work in other mutations, as well.
Right now, these agents are approved for people with mutations and in some cases without mutations, for ovarian cancer and metastatic breast cancer. We’re really excited because there’s some data presented here about treated in pancreatic cancer in patients with inherited mutations. These studies are particularly exciting to FORCE, because we were part of the efforts to recruit patients and accrue for these clinical trials. So, watching the data mature and be presented and watching that they’re every promising and hopeful is very exciting to us and it allows us to go back to the community and share that hopeful information with them.
Are there any misconceptions we can address regarding genetic testing and family cancer risk?
One of the biggest misconceptions that we see is that these genes don’t affect men. And there was some research presented [at ASCO] about prostate cancer. That’s another area where there is a lot of research. So, men with mutations, when they do get prostate cancer, they tend to get a more aggressive prostate cancer—it’s more likely to be metastatic. And the agents that I mentioned before called PARP inhibitors, they’re looking at them for metastatic prostate cancer in men with mutations.
Some of these men have inherited mutations—so they inherited it from their mother or father, and they can pass it on to their children. But some men get what’s called acquired mutations. So, these mutations develop within their prostate cancer, and actually this can happen in all the different cancers, but when we’re talking about prostate cancer then obviously, we’re talking about men. But there is just this real general impression that these genes don’t affect men and I think part of that is you know, sometimes we refer to BRCA1/2 as the breast cancer genes even though they’re associated with other cancer risks and another term that people use is the “Angelina Jolie gene” because she’s one of the most famous people who has a mutation. And that can lead to the misconception that these genetic mutations are not important to men and they are.
Another important thing for people to be aware of is that genetic testing isn’t just about BRCA1/2, and it’s not just about breast and ovarian cancer. I talked a little bit about pancreatic and prostate cancer. There are other hereditary cancer syndromes. There’s a syndrome called Lynch syndrome that’s associated also with colorectal cancer and endometrial and uterine cancer in women, as well as ovarian cancer.
So, it’s important. And this is the type of information people will get when they see a genetics expert, and they can make sure the right test is ordered.
Neil Goldfarb, President and Chief Executive Officer, Greater Philadelphia Business Group on HealthHow are employers viewing the changing landscape as we see more precision medicines come to market that require genetic and diagnostic testing? What are they doing to manage these new, ballooning costs?
I think employers still rely very heavily on their vendors, their benefit consultants, their PBMs [pharmacy benefit managers], specialty PBMs to advise them on these kinds of issues. And I think there’s still some question about for some of the precision medicine strategies, are they going to be inflationary or cost saving, quality improving or really no enhancement of value. So, we have to really judge each new technology independently. And I think that things are shifting where employers are recognizing that yes, every technology needs to be evaluated in some sort of a value framework, whether it’s by the employer, one of their vendors, or some value measuring institute.
I think it’s still fairly early on and employers, what I do know is their willing to cover these technologies even if they’re expensive, if they’re going to significantly improve the patient experience or the patient outcome. It’s going to then be a question of is the price reasonable for the outcome that’s being delivered?
Iuliana Shapira, MD, Chief Medical Officer, Regional Cancer Care Associates (RCCA)How have data analytics improved your revenue cycle?
Data analytics is a fabulous tool because by collecting data, we know at what point in the revenues cycles we have problems. So, we know if problems are at various stages and how to address those barriers. Is data analytics ready for prime time? It depends what data comes in. A way to scrub and curate the data as it relates to revenue cycle is needed. A lot of the problems we have in revenue cycle nowadays are handled by highly specialized individuals who have training in billing, coding, insurance verification, benefits verification, and other areas of the revenue cycle. However, it would be fantastic if we could address with artificial intelligence and big data certain aspects of the revenue cycle, such as insurance verification. We collect insurance information at the first patient visit, but if in between the visits, in that time interval the patient changes insurance, we do not have a mechanism right now to capture that. I don’t think artificial intelligence is ready to capture that right now. However, I know there are many software products and companies that are working diligently to improve that situation.
How is RCCA managing the higher cost of immuno-oncology drugs in value-based care?
First of all, there is an old myth that you should not give up on a patient until you’ve given them immunotherapy. We have more and more knowledge in the literature that immunotherapies do not work in certain cancers, and that data is rapidly incorporated into our care pathways. There is a problem in giving immunotherapy to patients that have certain cancers with specific mutations because immunotherapy may actually worsen the patient’s survival and may actually make that cancer more aggressive, in addition to the fact that immunotherapy, just like any other therapy, has side effects. When we take the brakes off of our immune system, our immune system starts attacking normal organs. So, that is a limitation of immunotherapy to patients.
Certain patients should not get immunotherapy because they already have an immune-mediated disease. So, their immune system is already [compromised]. Giving them immunotherapy might just stimulate that pathology that already exists. That’s one way to mitigate costs associated with unnecessary immunotherapy.
Following strict national guidelines of cancer care is very important. The second important development in controlling the cost of immunotherapy has just happened, when Novartis agreed with one of the larger insurers in Germany to give the money back for immunotherapy that did not work in a patient. Novartis has a CAR [chimeric antigen receptor] T-cell therapy that has a cost of about $500,000 per patient, and Novartis agreed that if that patient dies, or his disease or her disease progresses within a certain time limit, they will give back the money to the insurance company. Obviously, that type of arrangement, a value-based arrangement, should be translated in the United States. We strongly believe that the patient should have a money-back guarantee when using medication.
In addressing the high costs of prescription medication immunotherapy and any other medications that are out of reach, we should not bankrupt the patient, and we should not bankrupt the system. If the drugs do not fulfill their promise, the money should be reimbursed to the patient and the insurer. This can happen because we as oncologists follow national standardized guidelines. So, if the promised drug is the drug that we use in the condition and under circumstances and we’re approved to use the drug, if the drug doesn’t do the job, the drug company has to reimburse the money. That’s one way to reduce costs.
The second way is to provide price transparency. Patients have the right to know how much immunotherapy costs versus another immunotherapy. They have to know that upfront, not have a bill sent at the end of treatment. Price transparency ensures that the patients know the cost and they have options to choose among different medications that are recommended by their physicians. I think that these are 2 interventions—price transparency, choice, and moneyback guarantee—that will ensure our healthcare doesn’t go bankrupt with treatments that do not fulfill their promise.
Jeanne Tie, MBChB, FRACP, MD, Medical Oncologist and Associate Professor, Walter+Eliza Hall Institute of Medical ResearchYou are working on a blood test that could detect early stages of cancer. How does the test work and how is it advanced beyond current tests that are already in use?
So, the CancerSEEK blood test is a combination of circulating tumor DNA analysis—so using genotyping in patients’ blood—in addition to protein bar marker in the blood to detect 8 common cancer types. What we’ve shown is that this blood test can detect up to about maybe 70% to 80% of current, common cancer types that doesn’t have available screening method.