OneOncology Speakers Make Case for Community Setting in Research, Value Delivery

The community oncology setting offers great value and is an untapped resource for clinical trials, according to speakers from OneOncology who discussed the merits of community practice to open the second day of Patient-Centered Oncology Care® 2021, which took place in OneOncology’s home of Nashville, Tennessee.

Duncan Allen, MHA, is senior vice president, clinical services, for OneOncology, a network of independent practices that a year ago launched OneR, a national, nonexclusive trial site management organization. Allen off ered perspectives on how community oncology practices can be a resource for pharmaceutical companies that are studying increasingly rare cancers, and thus need more resources to identify patients eligible for trials.

Then, Jeffrey Patton, MD, the CEO of OneOncology, spoke about how the recent implementation of a law requiring hospitals to disclose pricing information has shed more light on distortions caused by the 340B drug pricing program. Even though community oncology practices off er greater value, Patton argued, federal policies have put community practices at a disadvantage—but he is optimistic the tide will turn.

Building a Research Culture
Patients who want to take part in oncology clinical trials would prefer to do so close to home, Allen said. Putting trials in the community has not always been easy, but the numbers point to why it’s necessary: data show that with 1500 new trials per year—mostly in phase 2 as researchers dig into narrower cancer subtypes—patients that meet specific criteria are harder to find.

The focus on targeted therapies to treat rare cancers, he said, “has been a key driver to fueling this precision medicine era that we live in. While that comes with a lot of excitement, I think it also comes with additional complexity that has to be tackled.”

Today, Allen said, there are more than 1000 products in late-stage development and more than 2000 in early stage. “This is an astounding statistic.” It requires practices to adapt to keep up with it all, but with this rapid change comes opportunity.

Despite the progress in the development of oncology therapeutics, he explained, the success rate of clinical trials remains very low. “This furthers the need to grow clinical trials in the community, and make sure that we’re continuing to launch therapeutic development at a rapid pace so that we can keep up with the good work that that’s coming out of the manufacturers,” Allen said.

“Community oncology, I would say, really represents the single biggest opportunity to help sponsors develop these treatments.”

Why aren’t more trials in the community setting? Study selection protocols are one reason. Engagement by physicians is another. But as therapies become more complex, these are hurdles that must overcome, for the sake of patients. Chimeric antigen receptor (CAR) T-cell therapy, now approved in multiple blood cancers, “is a great example of having that increased operational burden.”

In this area, community oncology off ers several “strategic advantages,” Allen said:

• ACCESS. Practices can deliver care close to home.
• DIVERSITY. Community oncology can off er a study population closer to a “real-world” experience than academia.
• SCALE. The nature of community oncology allows practices to manage study panels that are the right size for rare indications.
• INNOVATION. Allen said this “diff erentiator” is key—community oncology is more nimble to try new approaches in car delivery and patient experience.

Because OneR is a nonexclusive network, there are now 9 members conducting phase 2 and 3 studies in a multi-sided trial network. “That type of structure, we think, serves all parties well, because it creates some real skin in the game from our practices,” he said.

Key to the success has been building a research culture that focuses on recruiting scientifi c talent. A clinical advisory board of chief medical officers of the practices is an essential governance piece.

“From feasibility to back offi ce functions, like budgets, contracts, and regulatory [compliance], we’ve really tried to make sure our cadre of services is comprehensive in nature,” Allen said.

“Lastly, we must never forget that culture eats strategy for lunch—and any research strategy must start with a nurturing culture of research at the site level.”

Transparency Reveals Value
Patton followed with a talk about the “value equation” in community oncology—a topic he’s addressed in the past at PCOC. This time, however, Patton came with insights gleaned from the first wave data to emerge from a rule implemented January 1, 2021, that requires hospitalized to post what they charge online. For years, community oncology groups have argued that the 340B drug discount program is being abused in a manner that allows
hospitals to use it to pad revenue and undercut community oncology providers, until they have no choice but to join the hospital system or fold.

When it comes to costs in cancer care, Patton said, the cost of drugs is pretty much the story: drugs are less toxic, so there’s less need for supportive care he said—but the drugs themselves cost far more. For those in the 340B program, however, the ability to buy drugs at a discount and bill at a higher rate puts them at an greater advantage over community oncology. Patton noted how hard the American Hospital Association fought against the
transparency rule.

“Transparency is a great thing, unless you have something to hide. So, you don’t fight transparency, unless you’ve got a story that you don’t want people to know about,” he said.

The limited data released thus far confirm the arguments that community practices have been making, Patton said. The situation is driving up costs
across the board and harming everyone—patients who must self-pay are hit extremely hard. Local dynamics matter.

“If a hospital has a dominant market share in a market, they get away with charging more for their drug,” he said. “If they don’t have dominant market
share, and the payer has dominant market share, they get paid less because that’s the negotiation and market share is everything in these in these local negotiations.”

The dynamics can create little incentive to embrace biosimilars, which OneOncology has done fully, he said.

As a result, he said, an article published by the Employee Benefit Research Institute found that having a therapy administered in a hospital outpatient
setting cost 200% more than at a community oncology practice. Data from UnitedHealthcare claims show an estimate of $4 billion in overpayments a year because of site of service differentials, Patton said.

Despite the loss of community oncology practices, it’s taken a remarkably long time for those paying for claims to awaken to the situation. But Patton is optimistic that the transparency rule will finally offer that moment.

“The fact that we can deliver outstanding care that is more convenient close to where patients live at half the cost or less—how can that not get realized
and rewarded?” he asked. “I think transparency is going to do it.”