Avastin is the canary in the health technology assessment (HTA) coal mine. If we can’t get HTA right on Avastin, then science-based reimbursement may be doomed. As I blogged previously:
the FDA will have a public hearing on June 28-29, 2011 (FDA-2010-N-0621), where Roche/Genentech will present their studies on the safety and efficacy of Avastin for metastatic HER2-negative breast cancer. One hurdle for the company will be the recent review article in JAMA, demonstrating statistically significant increased mortality with Avastin.
The media really needs to cover this story carefully, without unwarranted implications. Today, for example, Fierce Pharma reports that
Avastin sales fell by 15 percent, measured in francs, as regulators put the cancer drug under greater scrutiny, Bloomberg said. The FDA said it intended to pull Avastin’s approval as a treatment for metastatic breast cancer last year–a decision Roche is appealing–and European regulators put new restrictions on that indication for the drug.
But Bloomberg didn’t blame the decline on regulators. Have you been to Switzerland lately? The franc is at historic highs against the dollar. Bloomberg reports that “Avastin sales fell by 15 percent in franc terms” but much of that was because the franc “strengthened by 15 percent against the dollar [and]… 9.4 percent against the euro.” Sales of Avastin are projected to actually increase from 6.46 billion francs last year to about 7 billion this year.
- Blaming the FDA for Swiss currency appreciation is unfair.
- If Avastin is a great drug, sales should increase; it not, sales should decrease.
- Let’s wait and see what the FDA committee says before we judge #2.