The vote – 24 in favor, none against and one abstention – comes one month after an FDApanel voted 6-to-0 to revoke the breast cancer indication for Avastin, which is sold by Roche (read the statement here). The drugmaker appealed a decision last December by the agency to yank the indication for the best-selling med, prompting an unusual two-day hearing that drew outbursts from cancer patients and their families (see this).
The endorsement by the NCCN is important because, as a practical matter, this means oncologists will likely continue to use Avastin even if FDA commish Margaret Hamburg decides to rescind the breast cancer indication. That would mean Avastin treatment for breast cancer would be relegated to off-label use, forcing third-party payers to decide whether to provide coverage.
For Roche, the NCCN endorsement is likely to be a boon, since treatment for breast cancer has typically generated about $1 billion or more in annual sales. Avastin rings registers – worldwide sales last year totaled about $6.8 billion and rose 9 percent, which meant this one drug accounted for 14 percent of total Roche sales.
A recent survey of 55 third-party payers found that 81 percent are covering Avastin for breast cancer, according to Reimbursement Intelligence, a market research firm, which conducted its survey shortly before the June 29 FDA hearing. Of those providing coverage, payers responded by saying they will take cues from either the FDA or the NCCN.
Meanwhile, the Centers for Medicare & Medicaid Services earlier this month indicated that coverage will continue, even if treatment amounts to off-label usage. CMS is not bound by whatever choice is ultimately made by Hamburg. The agency, of course, is required to cover FDA-approved indications for cancer drugs, but off-label coverage is not required (back story).
In explaining their initial decision, FDA officials cited the results of clinical studies and determined the data indicate Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; development of perforations in the body, including in the nose, stomach, and intestines; swelling of the brain, and heart attack or heart failure (read the memo).
But the NCCN decided that Avastin, “in combination with paclitaxel, is an appropriate therapeutic option for metastatic breast cancer with the evidence designation 2A,” which means more payers are likely to cover Avastin for breast cancer, according to Rhonda Greenapple of Reimbursement Intelligence. (You can read the guidelines here, but have to register first).
This is how UnitedHealth applies the designation: “This recommendation is based on lower level evidence, but there is uniform consensus that this is appropriate. But recommendations carry the implicit recognition that they may be superseded as higher-level evidence becomes available or as outcomes-based info becomes more prevalent” (read this).
The NCCN also added a footnote: “Randomized clinical trials in metastatic breast cancer document that the addition of (Avastin) to some first or second line chemotherapy agents modestly improves time to progression and response rates, but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with (Avastin) in combination with weekly paclitaxel.”
It is worth noting, by the way, that 10 of the 33 members on the NCCN breast cancer panel have various ties to Roche and its Genentech unit as advisory board members, speakers, consultants, expert witnesses or having received clinical research support. The connections are not a secret – NCCN discloses this info for all panels and staff members on its web site (see here).