In a potentially significant move, Blue Cross of California is no longer paying for the Avastin medication to treat breast cancer. The decision suggests that the recent FDA effort to yank the breast cancer indication for the Genentech drug has already begun to erode support among insurers, which had been expected to wait until the agency made a final determination.
The move comes just a few months after the completion of an extraordinary, two-day FDA advisory committee hearing in which panelists voted 6-to-0 to pull the breast cancer indication for Avastin. The drugmaker had appealed a decision last December by the agency to pull the indication, prompting a heated debate over the veracity of the FDA accelerated approval program (see here and here).
The FDA has not yet indicated when a final decision may be made, reflecting the highly charged issue in which some women and their families have petitioned the agency to retain the breast cancer indication. They argue the drug has successfully kept them alive and should remain as a viable option for others (back story).
Meanwhile, Genentech and its parent, Roche, offered the FDA what it is called a ?middle-ground proposal? that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients who display ?aggressive disease? and have the fewest treatment options. Also suggested was a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide.
Even if the FDA pulls the indication, the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage (see here). But Blue Shield isn?t waiting. A note posted on its web site says reimbursement will end Oct. 17, although exceptions may be considered on a case-by-case basis (read here). ?We agreed with the FDA panel,? Blue Cross spokesman Stephen Shivinsky tells The New York Times, which first reported the decision. The insurer, however, will continue to cover Avastin drug for women who were already using the drug.
At an estimated annual cost of $88,000, a lack of insurance will make the med unaffordable to many women. A Genentech spokesman tells the Times that the biotech is aware of three other insurers that have decided to withdraw coverage ? Regence, which operates Blue Cross Blue Shield plans in the Northwest; Excellus BlueCross BlueShield in Rochester; and Dakotacare in South Dakota. But the spokesman tells the paper those insurers acted before the recent FDA advisory committee meeting.
At issue were clinical studies showing Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh serious risks, such as severe high blood pressure; bleeding and hemorrhage. The drug did delay progression by one to three months, which has caused divided opinion over the breast cancer indication, with some advocacy groups arguing evidence is lacking (read this).
Since the June FDA panel met, however, the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was ?an appropriate therapeutic option for metastatic breast cancer.? This decision is significant because the NCCN panel of oncologists carries great weight with other specialists and, as the Times notes, both Medicare and UnitedHealthcare are supposed to pay for drugs listed in NCCN guidelines.
However, as we have noted previously, 10 of the 33 members of the NCCN breast cancer panel members have ties to Roche or Genentech, either as advisory board members, speakers, consultants, expert witnesses or having received clinical research support. The NCCN notes these ties on its web site, although the organization never explained the extent to which those panelists with ties had voted to endorse Avastin use for breast cancer (look here).
Much is at stake for Roche and Genentech, of course, because using Avastin to treat breast cancer has typically generated about $1 billion or more in annual sales. Overall, Avastin 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.
Source: http://www.pharmalot.com/2011/10/insurer-wont-pay-for-avastin-breast-cancer-use/
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