Produced by Laura Joszt and The Center for Biosimilars®
Tesh Khullar: Community Oncologists Need to Understand Impact of Biosimilars on Their Business
Tesh Khullar serves as Flatiron Health’s senior vice president for provider solutions. He said that biosimilars for core therapeutics are being approved and community oncologists must understand how that affects their business and reimbursement.
What potential changes should community oncologists keep an eye on that might affect their business?
Biosimilars are coming out. In fact, the first biosimilar in a core therapeutic just got approved, and it’s Avastin [bevacizumab]. Before this, we’ve only seen biosimilars in supportive care. It’s easier for an oncologist to make the jump of, “Hey, it’s not core chemo, I’m going to be using a biosimilar as a supportive care, and using a, let’s say, Zarxio instead of a Neupogen.” But now that they’ve got to make that same jump from a core chemotherapy drug like Avastin, which is a monoclonal antibody, it’s a lot more difficult to recreate. But with the argument on the biosimilar front, it’s going to be interesting to see how this all pans out. What is Amgen going to do around contracting with the oncology practices, trying to create differential against the incumbent, which is Genentech? It will be really interesting to see what happens.
There’s a public policy decision—the comment period, unfortunately, already ended—but they’re trying to link the J code associated with all the biosimilars. So, biosimilar Teva will have the same J code as biosimilar Dr. Reddy, which will have the same as the biosimilar that Amgen makes. The issue with that is it’s going to lead to the ASP [average sales price] dropping faster, and from an economic standpoint, you won’t have the financial benefit anymore. Maybe that’s OK in a value-based care world. I just don’t think we’re there yet. And the government should understand, as long as fee-for-service still exists and the core reimbursement mechanism of ASP still exists, they shouldn’t just delink and learn from biosimilars. They should treat it like the generic it’s probably closer to, like the European Union does, and then let community oncology unfold and understand the economics from that perspective.
I know the American Medical Association already wrote a letter against this; pharma has commented on it as well. Legislation like that, around key things that affect the business, need to be understood by community oncology.
Amanda Forys on the Need for Clarity in Biosimilars
Amanda Forys, MSPH, discussed the critical lack of clarity in the US biosimilars marketplace and policy issues that are being overlooked.
Is there a specific policy that’s missing from the biosimilars market?
I think there are several areas that manufacturers are looking for clari cation in and bringing biosimilars to market around the patent dance and a lot of other different things that the FDA still has to put out guidance on. But one of the biggest payment policy issues that I think is being ignored right now, that will be an issue as more products come to market, is how biosimilar products are being treated under Medicare Part D. Currently, if you are taking a branded product and you hit the doughnut hole, and you’ve spent—now you’re responsible technically to pay the full cost of your drug—well, the coverage gap is closing now and manufacturers can o er this discount for you to help you get out of the doughnut hole but not have to pay the full cost of your drug.
So, if a drug was $100 before, the patient would have paid $100 and that money would have counted toward their true out-of-pocket and gotten them through to the catastrophic [coverage limit]. Once they get into catastrophic coverage, they are only responsible for 5% of their drug cost. Well, with the coverage gap discount program, the manufacturer said, we will now pay 50% of the drug cost, the patient will pay 45% of the drug cost, and then the plan kicks in the final 5%. That’s how the coverage gap will close by 2020. That money though, that the manufacturer is giving to the patient, counts as their true out-of-pocket cost. Biosimilars are not considered branded products in the eyes of Medicare for non–low-income subsidy beneficiaries. So, when they hit that coverage gap, the drug will be treated as a generic product instead of as a branded product. Now the patient will have to pay a higher percentage relative to what they would have paid if the product was treated as a branded product and what the plan is picking up. Now it’s a share between what the plan and the patient have to pay. What the plan is picking up does not count toward that troop and helping the patient get into the doughnut hole, because we are seeing a lot of these products coming out right now that are on the Part B side and not on the Part D side.
There really hasn’t been a final answer on was that the intent of this or have we just not addressed it yet? I think manufacturers will be looking for that guidance moving forward. For low-income subsidy [LIS] patients, a biosimilar is counted as a branded product, so they do pay a higher co-pay when they access the drug if someone is an LIS beneficiary. This inconsistency is definitely something that will need to be addressed in the future. Not just LIS, but for the Medicare program as a whole.
Dr Ira Klein Outlines the Biggest Challenge of Value-Based Drug Pricing
Ira Klein, MD, MBA, FACP, senior vice president of healthcare quality strategy for the Strategic Customer Care Group at Janssen Pharmaceuticals, reported that the healthcare industry is becoming more proficient at value-based pricing arrangements. Even if they never dominate the market, Klein said there is a place for them.
What are some challenges of value- based drug pricing?
I think the biggest challenge is that of acquiring the appropriate information to make sure that if you’re in a value-based agreement, you’re hitting your quality marks, your outcomes measures, [and] your cost measures. The sheer difficulty in aggregating data over time in a select population has made it tough to get value-based agreements to become the norm. Because if you think about the amount of money either saved or lost, if the administrative burden is larger than the gains or losses, then respective parties will decide not to have those agreements in place.
However, I believe that we are learning how to do these agreements in ways that are more administratively efficient, to focus on areas of mutual agreement, where both parties can actually have elements of outcomes and performance that are desired for their end goals and thus will have some additional value-based agreements in the marketplace.
It may never dominate the marketplace, but it will always be a factor because it’s a signal and a harbinger for other things that need to change in our healthcare delivery world and in the entire supply chain—from manufacturer to [group purchasing organization] to provider to patient.
Terrill Jordan: Education and Data Are Key for OCM Success
Education is the key to success in the Oncology Care Model (OCM), but presenting data in a simple format for clinicians to use is also critical, said Terrill Jordan, CEO, of Regional Cancer Care Associates.
What are some best practices for implementing the OCM?
Our best practices have been the education of our clinicians. You must consistently educate, educate, educate. We also learned that the data were important, being able to get data and then make it simple on very simple dashboards. We have clinicians who work anywhere from 12- to 15-hour days, their staff is stretched thin, they don’t have a lot of time to go through lots of data. So, you have to simplify it so they can spend their time focused on just what they need so they can get back to their patients.
We do find that data is what they’re looking for. They find it enlightening and sometimes surprising. And it’s always exciting to see how they respond to it.
Teri Kovach on What to Do During an EHR Disruption
A practice must be ready for any disruption to its electronic health record (EHR) and have a plan in place, even if this does not occur often, said Teri Kovach, RN, OCN, compliance officer and charge nurse at Salish Cancer Center, in Fife, Washington.
What is the disruption in a practice if the EHR isn’t working or there is a glitch in the system?
The disruption if your EHR is not working is that you’re going to go to paper and pencil, and that’s going to slow everything down because pharmacy has all their boxes that they need to tick off before they will take a drug and put it into circulation. And the computer systems speak to each other, so when one is not speaking, nobody is speaking, and then it just kind of shuts everything down and everyone runs around like they’re chasing their tail because they can’t gure out “What do we do now? How do we do this?”
It’s old school. You just go back to, “Here are the forms.” We have a hold down time policy that I wrote before we ever went live so that we would be ready in the event that that’s happened, and we have not had to use it. It’s there if we need it, but we haven’t had to use it yet.
What’s the best way to ensure a smooth implementation of a new EHR?
Keep the staff involved the entire time. We had certain people that were involved in the process, and they were the key people from departments and a lot of the peripheral staff, which should have been involved from day 1 [but] were not involved. So, as they’re learning, they’re seeing it for the first time and it didn’t flow very well. You really have to have every single person that’s going to be touching that EHR to be involved and be working in the practice field. If that means you have to sit down and look over their shoulder and watch them go through the process to see that they can do it, [that] would be perfect.
Dr Amy Abernethy on Improving Patient Access to Oncology Clinical Trials
As oncology moves toward deeper diagnostic testing and as standard of care continues to quickly evolve, technology advancements are necessary to continue to improve patient access to clinical trials, explained Amy Abernethy, MD, PhD, the chief medical officer, chief scientific officer, and senior vice president of oncology at Flatiron Health.
How does oncology benefit from improving patient access to clinical trials? How does oncology benefit more from the technology innovations of now and in the future than perhaps other therapeutic areas? I think it’s several things. First, what we are seeing in oncology is more and more deep diagnostic testing, such
as next-generation sequencing testing. The more that we have details of the patient and specific requirements for each protocol, such as a specific biomarker and finding that out in the patient’s biomarker testing and those 2 things can be linked up—that’s going to be specific to disease areas like oncology and rare disease. So, I think that’s one place where trials have been particularly tough. It’s sort of this rare patient finding, the needle-in-the-haystack problem, that is pretty unique to oncology.
Another place that is particularly hard within oncology is that the standard of care is rapidly changing, and so clinical trials that have control arms that reflect standard of care from yesteryear, that’s not going to work for us in oncology. I can’t afford to take care of my patient and my patient can’t afford for me to take care of him or her using old fashioned treatments. Being able to design clinical trials in oncology that either use data and data-informed standard of care so that it’s as contemporary as possible and perhaps doesn’t even need to expose this particular patient to that kind of standard of care, but rather just the novel treatments, are the kinds of things they need in oncology.
Documenting When a Patient Falls Outside a Recommended Pathway
Documenting when a patient falls outside of a recommended pathway has the dual benefits of improving the algorithm and helping a provider get reimbursed faster, explained Torrie K. Shields, MPH, senior program manager of Palliative Care Program Design & Implementation for Blue Shield of California.
How does digital data help when a patient falls outside of a recommended pathway?
When a patient falls outside of that pathway, the rst thing is making sure it’s documented why you made a di erence choice. That can feed back into the algorithm that helps people better understand what types of patients respond to what types of treatment, and it could essentially create a new pathway, and a more nuanced focus on personalized medicine. So, we’re able to feed data back in when we are able to document somebody falling outside that.
It helps a provider in terms of audit, or in explaining to a payer, a nancier, about why they went outside of that pathway, and that creates a dialogue that really focuses on change or quality improvement, rather than on incentives and mandates. When a payer, especially when we’re moving to value-based payment, knows why somebody went outside of a pathway, they’re able to look at it di erently and assess and respond and pay/reimburse faster.