PPD partners with Anthem subsidiary to focus on post-approval research

The collaboration will see PPD leverage HealthCore’s electronic health record data, while combining the two companies’ expertise in HEOR (health economics outcomes research) to help sponsors conduct the type of research that can enable reimbursement.

“The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies’ ability to provide high-quality evidence of how products will perform for patients in a real-world setting​,” said Michael Pollock, VP of real-world outcomes at PPD.

Pollock told Outsourcing-Pharma.com that the post-approval research market is now growing two to three times faster than the Phase II/III space, and PPD is looking to build out its expertise in this area so that companies who are working with PPD in late-phase research can continue with them into post-approval research.

Companies are also beginning to assess real-world research earlier in the development of compounds, particularly in countries where a drug’s approval doesn’t necessarily mean that it will be reimbursed for.

Real-world studies offer a higher degree of certainty for the payer, Pollock added, noting there’s a certain level of risk when reimbursement is guaranteed only on the Phase III data after an approval.

He noted the companies are working on a more pragmatic view of post-approval research, which means they would be more relevant to either the practitioner base or the population that’s being studied.

“One of the challenges that exists in the current design is that trials built for drug approval aren’t built to answer the questions that practitioners, patients and the payer marketplace are asking for​,” said Mark Cziraky, VP of research for HealthCore.

HealthCore also has a database built from claim data that can be leveraged to help PPD understand more about the populations of interest for particular trials.

“When you’re designing a pragmatic study, you have to understand what the world looks like, so the database provides a really good starting point to design a study to replicate what’s going on in the real world​,” Pollock added.

The partnership is also expected to progress to earlier clinical research.

“As we get to know one another a bit better and get underway, there will be a lot more opportunities in earlier phase work​,” Pollock told us.