Proposed changes to the Stark Law that would make collaboration easier have purposely excluded pharmaceutical manufacturers, according to speakers at the Community Oncology Alliance Payer Exchange Summit.
If value-based agreements would help get the right drugs to the right patients, what is standing in the way?
It’s the lack of access to data, say pharmaceutical leaders who took part in a discussion with Bo Gamble, director of Strategic Practice Initiatives for the Community Oncology Alliance (COA), at the group’s Payer Exchange Summit in Tyson’s Corner, Virginia.
Overcoming this barrier is critical if pharmaceutical manufacturers and providers are to collaborate directly on value-based agreements, which will be necessary as practices move to 2-sided risk under the Oncology Care Model (OCM) and any successor.
COA has submitted such a model for federal review; dubbed OCM 2.0, it calls for these types of arrangements with 6 pharmaceutical manufacturers, including 4 who took part in Tuesday’s discussion: Merck, Janssen, Sanofi Genzyme, and Eli Lilly & Company.
“Data is always a huge issue,” said Patrick Davish, executive director of Public Affairs and Policy at Merck. Historically, he said, value-based agreements have emerged between pharmaceutical manufacturers and payers, who tend to tightly control their claims data.
Until recently, Davish said data sharing has been constrained by the Stark Law. While CMS has proposed changes that would ease limits on collaborating among many parts of the health system, manufacturers were left out of the reforms, “so the world has not changed in that respect,” he said.
Given that HHS Secretary Alex Azar led Eli Lilly before returning to government, there’s no question that he “knows we were excluded and did that deliberately,” Davish said. “We need to be better stewards of our reputation.”
Providers, however, can help fill in the gaps, said Daniel Lyons, senior director for Value and Access, Sanofi Genzyme. “You have the electronic medical record at your fingertips,” Lyons said. Drug companies don’t have patient-level data and can struggle to learn how drugs work in combination, he said.
Robert Redman, senior marketing director for oncology, Eli Lilly, said manufacturers would welcome value-based agreements that are evidence-based and driven by outcomes measures, whether that is overall survival or progression-free survival. But in the absence of access to data, companies rely on surrogate measures, such as the number of cycles of therapy. “We’re trying to figure out innovative ways to do that,” he said.
Dimitry Gitarts of Janssen said manufacturers are willing to be innovative as providers take on more risk. For example, because dosing of oncology therapies is often based on patient weight, Gitarts said if a practice has more overweight patients or more who are very sick, those factors could be taken into account in developing agreements that focus on outcomes. “We can work on value-based agreements [that include] cost predictability,” he said.
Building agreements around the quality measures that community oncologists are already gathering every day makes sense, and reimbursement can follow, Ditarts said.
Gamble asked the group if it would be easier to do value-based agreements with the payer and provider in combination, or just with the provider.
Davish said there are legal reasons to engage the payer, and in doing so at scale, they can help identify providers. There’s also the issue of wanting to develop the best contract and that may not happen when dealing with a smaller entity. Gitarts agreed.
And Lyons said that assuming the barriers can be removed, it’s important to include the patient in agreements. “They have a voice as well,” he said. When selecting therapies, or when deciding if a biosimilar will be used, “We do not want to restrict physician choice. … Not everyone wants to be forced to use something over something else.”
Gamble further asked where pharmaceutical manufacturers can share risk along with providers.
Redman said this would come down to taking a look at drug utilization and identifying, and where the evidence calls for it, perhaps narrowing the label. Lyons said the OCM has shown that it’s all about using data to lower spending, and drugs are part of that. “If there’s a way to lower the spend on drugs by finding the right patients, we have to have access to the data,” he said.
Gitarts said this points to the need for diagnostic testing, especially for patients who have exhausted several treatment options. Only patients who are eligible for treatments should get them, he said to Gamble, adding, “This is the easiest of the questions you’ve asked.”
Gamble commented that the arrival of 2-sided risk may bring new discussions about the total cost of care, as it becomes necessary for providers to work with pharmaceutical manufacturers.
Lyons encouraged the providers to help manufacturers avoid the soaring costs of data acquisition, and Redman said better value-based solutions came down to “data and willingness.” To this point, he said, it’s not uncommon to hear that reaching an agreement just isn’t worth all the effort.
Gitarts encouraged the physicians to “keep having conversations like this,” because there are many things happening at the practice level beyond the reach of pharmaceutical companies.
“We can’t possibly know your patients to the extent that you do,” he said.