In This Game, Patients and Doctors Lose

The leading cause of blindness among those 55 and older is a condition called advanced wet macular degeneration, or AMD. Wet AMD may not be a household name like glaucoma or cataracts, but two million Americans suffer from the condition — and physicians estimate another 7 million are at risk. If left untreated, wet AMD, which involves painful bleeding and leaking of fluid behind the central portion of the retina, results in partial and then permanent blindness.

Fortunately, good treatments are available. The most commonly prescribed are Lucentis and Avastin, both products of the pharmaceutical giant Roche. The National Institutes of Health’s National Eye Institute (NEI) just released the highly anticipated results of a three-year study comparing the two drugs head-to-head for effectiveness and safety.

Lucentis was developed specifically to treat wet AMD, whereas Avastin was originally intended for colorectal cancer. Though Avastin is FDA approved for that and several other kinds of cancer, doctors often prescribe it “off label” for wet AMD because it so much cheaper per dose than Lucentis — $50 a treatment for Avastin versus $2,500 for Lucentis. Avastin now makes up 60 percent of all wet AMD prescriptions.

It’s no secret that healthcare spending is on a collision course with financial realities. Saving money wherever possible has been a top priority for years for every bean counter in Washington, DC. The idea that every $2,500 Lucentis bill could be replaced by a $50 Avastin one is enticing, especially considering that most of these patients are older and receive benefits through Medicare.

Enter the NEI. If a prestigious NIH-affiliated study demonstrates that Avastin’s effectiveness and safety are on a par with Lucentis, private and public insurers — most notably Medicare — might have what they need to institute a “fail-first” policy: a provision that would prohibit doctors from writing a prescription for Lucentis before demonstrating that Avastin has failed.

Why is that a problem? Because while Lucentis and Avastin are similar, they are not identical. There is a reason why 40 percent of wet AMD patients use Lucentis, and that is because their physicians have decided that in their particular cases, Lucentis is the better option. Our system has long been based on the freedom of doctors and patients to decide on the best course of treatment — and not to be overruled on the point by government bureaucracies.

This concern became even more acute earlier this month when details of a John Hopkins study comparing the two eye treatments emerged. The full report, to be released on May 3, is expected to show that patients prescribed Avastin were at a 57 percent higher risk for a hemorrhagic cerebrovascular accident and an 11 percent higher chance for death than their Lucentis-prescribed counterparts.

Patients obviously have the most to lose from a “fail-first” policy favoring Avastin. But their doctors will also suffer when they are slapped with malpractice claims over treatment decisions they don’t control.

It’s impossible to know the fate of either Lucentis or Avastin until at the very least both of these reports are released. What some U.S. Senators have been doing in the meantime, thankfully, is to protect the doctor-patient relationship against government mandates that favor cost-containment over quality of care.

Sen. Jon Kyl (R-AZ) and co-sponsors have recently introduced the “Preserving Access to Targeted, Individualized, and Effective New Treatments and Services Act” or PATIENTS Act of 2011. The purpose of this bill is to take a stand against the kind of comparative effectiveness research like the NEI’s Lucentis-Avastin study that could lead to dangerous “fail first” policies and a severe limitation on physician-patient freedom.

Studies of drug effectiveness and safety are critically important in determining what medications should be available for doctors to prescribe. But doctors, not government bureaucrats out to pinch pennies, should be the ones doing the prescribing.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.