The Pipeline

Fast-tracking the next generation of robots, pharmaceuticals, and scanners


Caitlin Visek

At the Care Innovation Summit yesterday, we learned a lot about the idea of “value” and what changes might help make our health system less expensive and cumbersome.

One problem that several of our panel experts discussed was how regulatory, approval, and coverage decision processes governing the development of new therapies can hinder innovation—and how that can be fixed.


Long and convoluted approval processes raise costs

As our experts discussed, the years of clinical trials often preceding approval from the FDA can substantially raise the total cost of developing new therapies and discourage innovation. Moreover, often the data related to clinical safety and efficacy required by the FDA to approve a therapy is different than the data required by CMS and private payors to make a coverage decision.

As such, additional research is also needed to secure reimbursement, raising the overall time and cost associated with getting a device into the hands of patients.

Our panelists also debated three potential solutions to address these problems:


1. Better coordination, less duplication

One potential way to streamline the approval process would be to make sure that the trials therapies go through to obtain FDA approval also produce data which can be used by payors to determine coverage, reducing the need for additional testing after FDA clearance.

This is something the FDA and CMS are already working to address through their parallel approval process.


2. The end of randomized control trials?

Another tantalizing idea that emerged was that randomized control trials—long considered the gold standard of medical research—might be overemphasized in our current approval processes.

Several of our panelists suggested that in certain cases—very rare diseases, for example, or cases whether the risk to patients is relatively low—there should be greater flexibility in the degree of evidence required for approval. However, the consensus was that RCTs still play an important role in the majority of cases.


3. Looking overseas

There may also be room to expedite approvals for therapies already in use in places like the European Union or Australia. However, there would still be concerns that data from foreign trials would not be applicable to the US due to population differences.

More from the Summit

Check out some of the other ideas we uncovered in our highlights from the Care Innovation Summit.