One drug, two federal agencies, and the future of patient access
to the best possible medical treatment: That’s the drama playing
out in Washington right now.
Avastin is an innovative biologic used primarily to
treat various forms of late-stage cancer. It’s currently at the
center of a landmark comparative study conducted by the National
Institutes of Health (NIH), as well as a high-profile battle with
the FDA — both of whose outcomes have the potential to affect the
healthcare of every single American.
First up, on May 1st, the NIH will release the initial
results of a study conducted by its National Eye Institutes
comparing the safety and efficacy of Avastin and Lucentis for the
treatment of an eye condition known as advanced wet macular
degeneration (AMD).
Nearly two million Americans and a quarter of the over-80
population suffer from wet AMD, in which blood vessels behind the
retina grow under the macula and leak fluid. If left untreated, wet
AMD causes a central blind spot known as a scotoma, and eventually
permanent blindness. Though it isn’t as well-known as cataracts or
glaucoma, AMD affects more older Americans than both
combined.
Avastin, which was not developed for the purpose of
treating AMD — and is not FDA-approved to do so — has shown to be
a worthy alternative to Lucentis, an AMD-specific
biologic.
But beyond broadening a doctor’s options for treating AMD,
Avastin is attractive for another reason, especially to government
bean counters, and that is its much lower cost. At just $50 per
dose, compared with Lucentis’ $2,500 price tag, it’s no wonder that
nearly 60 percent of all AMD patients are prescribed
Avastin.
The motivation for the study, which was commissioned in
2008, is crystal clear: to prove Avastin is equally effective as
Lucentis. The “benefit” of such irrefutable proof? With this study
in hand, insurers will be able to implement a “fail-first” policy,
restricting patients’ access to Lucentis until their doctors
prescribe Avastin first — and it doesn’t work.
If this happens, the first and last word on a patient
would rest with a provision in an insurance policy, not a doctor’s
best judgment. This is a precedent sure to be loved only by those
whose top priority in health care is saving money, not patient
care.
To preempt outcomes like this, Sen. Jon Kyl (R-AZ) has
introduced and garnered bipartisan support for the “Preserving
Access to Targeted, Individualized, and Effective New Treatments
and Services Act” — also called the PATIENTS Act of 2011. Its
intent is to protect patients from government use of data obtained
from comparative effectiveness research to deny or delay health
coverage under federal programs like Medicare and
Medicaid.
The second Avastin storyline involves the FDA — and a
similar battle over cost with similar, wide-reaching
implications.
Last December, the FDA stripped Avastin of its temporary
approval for treatment of metastatic or late-stage breast cancer.
To reach this conclusion, the FDA had to disregard the results of
clinical trials and patient testimonials demonstrating Avastin to
be effective for more than 50 percent[1] of patients
— whose survival is extended on average, by a few months, but in
some cases for years.
This decision, in practical terms, almost certainly means
that for the thousands of women currently relying on Avastin to
prolong their lives, insurers will stop covering its cost. While
Avastin is a cheap treatment for wet AMD, it’s needed in a much
higher volume and concentration for breast cancer. The annual cost
of an Avastin regimen can reach upwards of $90,000. Without
insurance coverage, the only breast cancer patients who will have
access will be those who can afford it out of pocket. This result
would be a textbook illustration of healthcare
rationing.
Although the FDA claims its approval process looks solely
at safety and efficacy, it’s clear in this case that cost is a
driving factor.
Predictably, the FDA’s decision caused an outcry among
patients, family members, and doctors. In February, they got some
good news: a two-day hearing scheduled for the end of June, when
Avastin’s manufacturer Genentech will have the opportunity to call
witnesses to support its appeal.
In the coming weeks and months, it’s in the interest of
every American concerned about their own health care to pay
attention to this story. Whether you’re a senator or an everyday
citizen, the health of your health care is on the line.
