A Learning Curve Ball

"The cost of a thing is the amount of what I call life which is required to be exchanged for it, immediately or in the long run."

-- Henry David Thoreau

Firsts can be tough. Avastin marks the first time the FDA has convened a hearing to withdraw an indication under its accelerated approval regulations – and there are unique administrative and procedural difficulties contributing to the agency's delay in releasing the formal FR notice.

Karen Midthun, FDA's presiding officer for the June 28-29 hearing, has indefinitely postponed the submission deadline for written summaries of the parties' arguments.

The summaries had been due on May 5. However, in a May 2 letter to counsel for Genentech and CDER, Midthun said the submissions will instead be due one week after the formal hearing notice is posted for public review in the Federal Register.

Midthun concedes that the formal notice "will be issued somewhat later than we had intended," but that delaying submission of the parties' written arguments "will give you a better opportunity to address the issues as framed in the notice."

When the notice will be published remains in question. "We do not, at this point, know the exact date on which the notice will be posted," Midthun tells the parties. "A copy will, however, be sent to you on that date."

And speaking of Avastin, a new 1200 patient NIH trial has confirmed that it’s “just as effective” as Lucentis. The related news is that a new model for Medicare payments (ACOs, scheduled to launch in January 2012) may offer another way to address the cost differential.

(Note: The study found no major differences in major adverse events between patients taking the two treatments. However, patients prescribed Avastin were slightly more likely to experience non-specific serious adverse events, primarily hospitalizations, than those given Lucentis (24.1% versus 19%. Add to that a Genentech-sponsored study, suggesting an 11% higher risk in mortality and 57% higher risk of hemorrhagic cerebrovascular accident in patients treated with Avastin versus Lucentis and “just as effective” is put in a better perspective.)

CMS released a proposed rule in late March laying out a framework for the first phase of an ACO program, which is being established under the Affordable Care Act.  (An ACO is an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries in their care and in the traditional fee-for-service program.

“The cost of living is going up and the chance of living is going down.”

-- Flip Wilson