The FDA's Oncologic Drugs Advisory Committee (ODAC) concluded
that bevacizumab (Avastin) conveys little benefit in advanced
breast cancer, but the occasional patient has prolonged remission
with little toxicity. This is the patient subset that may stand to
lose the most, should the FDA withdraw the label for
bevacizumab.
Lori Baur, a patient with triple-negative breast cancer from
Sleepy Hollow, New York, belongs to this group. She told The ASCO
Post, "I'm just 41 years old and I have an aggressive cancer,
including brain lesions that have disappeared but will probably
rebound if I go off [bevacizumab]. I am pleading with the FDA not
to take this drug away from patients like me who are responding to
it."
But interviews with several private insurers offer some
reassurance to patients like Ms. Baur, and the oncologists who
treat them. Lee Newcomer, MD,
Senior Vice President, Oncology, at UnitedHealthcare, told this
newspaper that he agrees with ODAC's recommendation, but his
company will not stop covering bevacizumab for current
responders.
"We think ODAC's opinion was important. We never felt bevacizumab
should have been approved originally because the data show no
increase in overall survival (OS), and now there is the emergence
of toxicity. The drug is an important step scientifically, but it
is not ready for the clinic in breast cancer," he said in an
interview.
Coverage Decisions
Dr. Newcomer's personal opinion aside, UnitedHealthcare bases
coverage decisions on the recommendations of the National
Comprehensive Cancer Network (NCCN), he pointed out. "This takes
the decision-making to the academic experts who we feel are best
qualified to make the call, and secondly, the process is
transparent," he said. "So for us, the NCCN would also need to
withdraw its recommendation, which I am sure it will consider if
the FDA sides with the panel. If the NCCN still believes we should
cover bevacizumab, we will."
UnitedHealthcare is currently developing a new review process
for bevacizumab using NCCN recommendations. "We are no longer just
matching the drug with the diagnosis. We are looking at three other
specific things that NCCN recommends: which drug it is paired with,
what line of therapy, and when to discontinue it [upon
progression]," he said.
In 2009, UnitedHealthcare provided coverage for bevacizumab to
55% of patients not meeting all the NCCN recommendations. The
company will now enforce all three recommendations as a requirement
for coverage. Meanwhile, any patient insured by UnitedHealthcare
who has been started on bevacizumab, regardless of future policy
changes, will be allowed to continue until disease progression, he
emphasized.
Aetna's position is similar. "If breast cancer is removed by the
FDA as an indication for bevacizumab, Aetna would consider removing
coverage, but we would also consider the position of the NCCN on
this issue, as we have covered drugs for indications in NCCN's
Compendium with a consensus rating of 2b or greater," said James Cross, MD, Head of National
Medical Policy and Operations.
Aetna will make provisions to allow continued coverage, however,
for persons already completing a course of therapy, he added.
Otherwise, the drug would not be covered. "Participating physicians
who wish to prescribe bevacizumab for breast cancer would have to
inform patients in writing that this would not be covered by their
health plan, and they would be afforded the opportunity to appeal
any adverse determination. We would continue to cover bevacizumab
for breast cancer where mandated by applicable legal requirements
of a state, or CMS requirements for Medicare and Medicaid members,"
he told The ASCO Post.
NCCN Guideline Process
The importance of the NCCN Breast Cancer Panel, therefore,
becomes clear. Panel member Harold
Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston,
said that should the FDA withdraw the indication, as part of its
regular review the NCCN panel would reconsider the appropriateness
of keeping bevacizumab plus paclitaxel as an acceptable
regimen.
"The NCCN has a sophisticated guideline process, and there will
be opportunities to review any FDA decision. We meet annually to
review recent data and hear new opinions. And we often meet ad hoc
when the FDA approves a new drug, though I can't say we have ever
met because the FDA withdrew a drug," Dr. Burstein said. He noted
that FDA approval does not dictate the NCCN's recommendations.
"There are breast cancer drugs on our list of recommended
treatments for advanced breast cancer that are not FDA-approved for
this indication. For example, we list as single agents doxorubicin,
epirubicin, pegylated liposomal doxorubicin (Doxil), vinorelbine,
and cisplatin, which are not FDA-approved, and gemcitabine, which
is approved only in combination. We also list
paclitaxel/carboplatin/trastuzumab (Herceptin) and
trastuzumab/capecitabine, which are not FDA-approved regimens."
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