Difference Without a Distinction
The panel seems to have missed the point that the efficacy endpoints were, in fact, measures of adverse events, readmissions and risks associated with secondary or tertiary surgery.
Barricaid’s data showed a dramatic drop in symptomatic adverse events and expensive repeat surgeries. But the panel determined that a non-symptomatic potential adverse event was more important.
So, a clinician could be able to reduce the risk of reherniation by more than 50% on average and serious adverse events by 33% but won’t have that choice because an FDA panel is worried about non-symptomatic endplate changes that are visible only by CT scan and occur half as often in the control group.
Bad Timing
This FDA panel vote comes just seven months after Intrinsic raised $49 million in a debt/equity deal to fund the commercialization of Barricaid.
That particular round consisted of a $28 million equity financing led by New Enterprise Assoc. and Delos Capital, plus a $21 million debt facility with CRG. Other backers included Greenspring Associates, Quadrille Capital and a “corporate strategic.”
Back in December, when Intrinsic revealed an $18 million raise in a regulatory filing, the company had filed its premarket approval application with the FDA for the Barricaid device.
Back to the FDA
Intrinsic intends to provide additional safety information to the FDA and will reiterate some of the data it didn’t have the opportunity to clarify with the 14-member Panel.
Among the data not presented to panel is the health economics analysis—which looked squarely at the issues of re-herniation and a higher rate of adverse events when NO annular closure device is used.
An independent economist conducted the analysis using two-year follow up data from the Barricaid RCT study. Here is a summary of the findings.
- Barricaid’s QALY (quality-adjusted life year) score was $6,826 versus $76,023 for conventional lumbar discectomy
- After performing 1,000 simulations as part of a sensitivity analysis, 93.3% of the simulation results were below the $100k Willingness-to-Pay threshold with
According to an Intrinsic write-up:
“Most of the cost savings—approximately 85%—came from the reduction of reoperations due to the reduction in reherniations. The majority of the remaining 15% of the cost savings came from lower rates rehospitalizations (due to fewer SAE’s). Lower rates of reoperation mean fewer diagnostic tests, less physical therapy, and reduced medication.”[1]
In health economic terms, this kind of data represents dominance over conventional lumbar discectomy—where, as the economist described it to OTW, “dominance” is defined as when a procedure is both more efficacious and cheaper than the alternative—“you get more for less.”
Stay tuned, for sure.
[1] Thomas Michal, Vice President of Market Access, Health Economics & Reimbursement Intrinsic Therapeutics, Inc. 30 Commerce Way, Woburn, MA 01801 USA
