Friday, April 29, 2011
By Robert M. Goldberg on 4.29.11 @ 6:08AM
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 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.
Posted by Brett at 11:46 AM