The final day of AdvaMed’s annual conference in San Jose featured top officials from the Centers for Medicare and Medicaid to discuss how the agency is looking at everything from covering new technologies to real-world evidence and to alternative payments.
Among them was Tamara Syrek Jensen, director of the Coverage and Analysis group. So in the Q&A session with attendees, I took the opportunity to ask the following question (slightly edited):
How do you look at covering liquid biopsy and large-panel gene testing like the ones done by Foundation Medicine and Guardant Health?
Jensen (smiling): Your question is actually very, very timely. One of our Parallel Review projects is with Foundation Medicine next-generation sequencing. We’re actually working on the decision and I had a briefing with Carol (Blackford, director, Hospital & Ambulatory Policy Group at CMS) on what we think the decision is and going to meet Demetrios (Kouzoukas, CMS Principal, Deputy Admin and Director, CMS) next week to bring him up to the date on that decision. I also briefed Jeff Shuren (director, Center for Devices and Radiological Health, FDA) at the back of the room on that decision.
MedCity: You are not going to make any news today?
Jensen (smiling): I am not going to make any news today. We have to, for one, make sure that FDA approves it and if they approve it, CMS can announce what we are going to do as well.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In August last year, Cambridge, Massachusetts- based Foundation Medicine announced that it’s Foundation One test had been accepted into the Parallel Review program.
For those who are unaware, Parallel Review is a program that companies can undergo to simultaneously seek FDA approval and CMS National Coverage Decision for a novel product. The first example of this was Exact Sciences and it’s Cologuard product back, which got FDA approval in 2014. But while both FDA and CMS officials urged the medtech industry to engage both agencies in Parallel Review, Jensen said only five companies are currently taking advantage of that program for their product, including Foundation Medicine.
FDA’s Shuren weighed on why that is.
“There’s real consternation and fear that they may not like what they get (when they get both agencies in the same room),” said FDA’s Shuren, Tuesday after a joint CMS-FDA panel discussion at the conference. “It’s not true but you can’t convince people.”
On that Tuesday panel Jensen stressed that it’s in the company’s best interest to engage FDA and CMS early on, perhaps even do a joint meeting with both regulators.
“FDA and CMS talk whether you invite us or not,” she said.
