For many community oncology practices, 2018 was the year that value-based care became a financial and clinical reality. For example, CMS provided those participating in the Oncology Care Model (OCM) program with results from their first two “performance periods.” Practices received not only detailed feedback on their success against measures – but, in many cases, demands for hefty recoupments of funds that CMS had paid to manage episodes of care subsequently deemed unqualified for the program.

How will this evolving landscape in community oncology impact pharma leaders in the year ahead?  We sat down with Dr. Jeffrey Scott, Chief Medical Officer, and Ash Malik, President of the Life Sciences Division of Integra Connect, for three questions about the shifting landscape.

What are the biggest takeaways for pharma leaders from what transpired in value-based oncology care in 2018?

Dr. Scott:  2018 saw continued steps down the path toward true value-based oncology care. Most community oncology practices continued to live primarily in a fee-for-service world, with resource-based utilization metrics added to the mix through programs like the OCM. Pharma leaders need to understand that physicians are increasingly aware of drug cost as they try and figure out the new requirements of value-based care. Moreover, as physicians assume accountability for episodes of care, they are more interested than ever in a drug’s total cost of care.

Ash: Conceptually, we still saw pharma leaders struggling with whether value-based care would take root in the US or not and what that would mean for manufacturers. They were very curious about whether physicians and/or payers were behaving differently as a result of the CMS-administered programs.

One of the main takeaways from 2018 was that, yes, we are beginning to see changes and there are new focus areas that are becoming top-of-mind for all stakeholders within the healthcare ecosystem: beyond drug cost to total cost of care, outcomes analysis, and use of real-world data. We intend to share some new data in the coming weeks that breaks these changes down in more detail.

What do you predict will be most important issues for pharma leaders to track in the year ahead?

Dr. Scott: Efficacy will still be the most important thing. Making drugs that provide meaningfully better outcomes for patients will remain top priority. That said, physicians are looking more critically and comprehensively at what defines meaningful outcomes for their patients.

Ten years ago, a two-month improvement in progression might have been sufficient to become standard of care. Today, physicians are looking for more impact – say, a six-month improvement – in order to consider it a meaningful improvement for patients and not just a numerical one.

In addition, it will be critical to monitor the OCM as it reaches new milestones. That includes the delivery of additional performance period results back to participating practices, as well as the mandate to achieve performance-based payments by mid-2019 in order to remain in one-sided risk.

Ash: For life sciences, the most important issue for pharma leaders to track is drug cost from the use of combination therapies, that are becoming more relevant in cancer care. For example, using PD-L1s as a baseline therapy will be a very expensive endeavor unless the pricing model for combination therapies changes, therefore it becomes more critical than ever to gather and analyze granular data in patient cohorts and leverage clinical laboratory data results, new clinical trials around targeted therapies to document outcomes. Utilizing real-world data enables an even more granular look at care management performance across different subpopulations. This bolsters clinical trial submissions and ultimately aligns with what the physician and payer communities increasingly need from pharma.

What actions should pharma leaders take to advance the understanding of value of their therapies in 2019 ?

Dr. Scott:  They need to look at real-world evidence, total cost of care, and a range of outcomes beyond progression-free and survival. That could mean patient out-of-pocket expenses and other resource utilization beyond the use of a drug. For example, if two drugs come to market and one requires growth factor support, realize that increasingly has negative implications for episode costs when practices are participating in value-based models.

Ash: I fully agree that resolving to use real-world data in order to demonstrate value is priority number one. In addition to what was mentioned earlier, physicians are asking us for a better perspective on impact on patient quality of life as expressed through monitoring adverse events and hospitalizations.

A second point is to more actively engage the FDA on the use of real-world data, whether that is to support label expansions or conduct real-world supported synthetic controls arm around clinical trials. That’s where the world is headed. It’s also key to better engaging community oncologists, since even today close to 60-70% percent of US cancer patients are treated in community settings rather than in academic centers and hospitals.

If you can use real-world data synthetic control arms, then you need half the patients to do clinical trials or can conduct the same trials twice as fast. That has a tremendous beneficial impact on helping oncologists to get the most impactful treatments to the right patients in alignment with the industry’s greater shift toward precision medicine.