Should Medicare Cover Avastin For Breast Cancer? // Pharmalot

The FDA may want to yank the breast cancer indication for Avastin, but the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage. ?As long as doctors continue to prescribe it, we will continue to pay, even for an off-label use, until and unless some time in the future we decide to change our coverage policy. We have no such thing underway at this time,? a CMS spokesman tells us. ?We often pay for off-label use of drugs, but not always.?

The move will, no doubt, cheer many breast cancer patients and their loved ones, who feared the FDA would soon put Avastin out of reach (look here), now that an agency advisory panel unanimously voted - once again - to rescind the indication. The vote came earlier this week after an unusual two-day hearing forced by Roche and its Genentech unit, which stand to lose up to $1 billion in sales (see here), although Avastin remains approved to treat several other cancers.

The FDA wants to revoke the indication after results of clinical studies showed 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. However, these studies emerged after Avastin was granted accelerated approval, which prompted the hearing to become something of a referndum on the program (read more here).

But CMS is not bound by whatever choice is ultimately made by FDA commish Margaret Hamburg. The agency, of course, is required to cover FDA-approved indications for cancer drugs, but off-label coverage is not required. And this is an expensive drug that costs roughly $90,000 a year. So why then would CMS decide to cover Avastin for breast cancer treatment? In a word, tradition.

?The tradition is that off-label indications that are listed in compendia are covered, although that is not a legal requirement,? says Sean Tunis, a former CMS chief medical officer who now heads the non-profit Center for Medical Technology Policy. ?But it?s virtually always the case that CMS defers to off-label indications that appear in approved compendia, such as NCCN.?

And what is the NCCN? This is the National Comprehensive Cancer Network, a non-profit group of oncologists whose guidance is closely followed by leading treatment centers. However, eight of the 33 members on its 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 and here).

An FDA decision to pull the breast cancer indication could prompt a review of industry guidelines from groups such as the NCCN. So far, though, NCCN has not given any indication that its recommendation, which was last issued in October, will change (read this). This appears to reflect the thinking among many oncologists that Avastin remains a useful choice for some breast cancer patients.

Of course, as GoozNews points out, private insurers follow suit. Private insurers, of course, are loathe to appear to make decisions purely based on costs, especially when it comes to life-threatening conditions. This is why insurers rely on NCCN guidelines, which provide coverage of a different sort.

This raises an uncomfortable question for many people - should coverage be provided for Avastin as a breast cancer treatment? Of course, this raises the specter of rationing. In fact, such concerns are expected to prompt the House Energy and Commerce Committee to address the issue next week at a hearing about FDA user fees, according to The Wall Street Journal.

As for the CMS, the agency covers Avastin for various cancers as ?reasonable and necessary? under law and any FDA action on changing the label would not immediately affect this. The CMS spokesman reiterates that ?it would be incorrect to say that a decision has been made on coverage of Avastin?As the situation evolves we will continue to evaluate and consider our options.?

So the door may be left open, but tradition is tradition. On the other hand, there is the expense - and a problem with the nation?s finances. So what do you think? Should Medicare provide coverage?

Source: http://www.pharmalot.com/2011/07/should-medicare-cover-avastin-for-breast-cancer/

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