Macular degeneration is a common cause of blindness in older populations and a debilitating condition that affected my own mother later in life. Regulators around the world continue to debate whether Lucentis or Avastin, a drug developed to treat cancer, should be the preferred treatment for patients suffering from wet age-related macular degeneration, or AMD.
However, government bureaucrats should not be having this discussion as they are far removed from patient care, and, as a result, easily prioritize cost above patient safety. The Lucentis-Avastin situation is a stark reminder of the danger of a federal government that makes decisions based solely on dollars, thereby stifling access to medicines that are “best” for us — even when we, or our physicians, know otherwise.
Because AMD impacts older patients, many American seniors rely on Medicare to cover the cost of their treatments. This is the U.S. government’s underlying basis for involvement and whose authority falls under the new Patient Centered Outcomes Research Institute (PCORI) established under the Affordable Care Act.
Today, some European regulators are pushing for reimbursements of the cheaper off-label Avastin. Such action is obviously motivated by a desire to cut healthcare costs. While the European system is different from ours, the fundamental principle is universally the same: Any way you look at it, increased government control of patient treatment equals less patient choice.
For the treatment of wet macular degeneration, Lucentis and Avastin, both manufactured by Genentech, differ in several ways. First, Lucentis is FDA approved to treat AMD via an injection into the eye. Avastin is not. However, it’s approved as a treatment for certain cancers by intravenous injection. In part because of this difference, Lucentis is pricier than Avastin.
The National Institutes of Health funded a study of the two drugs, and concluded that both are similarly effective at treating sufferers of the eye condition, though Avastin patients yielded “higher rates of serious adverse events,” ranging from eye infection to stroke and heart attack. As officials at the Centers for Medicare and Medicaid Services (CMS) are being pressed to reduce costs, Medicare patients may soon find themselves without a choice.
The patient safety debate between Lucentis and Avastin is ongoing: Scientists who have studied the two drugs note that in many ways the current studies are inconclusive — for example, “The interpretation of the persistence of higher rates of serious adverse events with [Avastin] bevacizumab is uncertain because of the lack of speciﬁcity to conditions associated with” wet AMD on the NIH-sponsored CATT study.
Others have noted the manufacturer, Genentech, has plainly stated its position — that Lucentis is the best option for most AMD patients:
Avastin and Lucentis are different medicines. We specifically designed Lucentis to be cleared more quickly from the bloodstream to minimize side effects. The data reported by the authors today state that “the rate of serious adverse events, primarily hospitalizations, was higher among bevacizumab-treated (Avastin) patients than among ranibizumab-treated (Lucentis) patients.” These findings from CATT add to an emerging body of evidence from much larger analyses that suggest the risk of systemic adverse events may be higher when injecting Avastin into a person’s eye compared to Lucentis.
This pointed conflict over patient safety provides an example of the danger that government regulation can bring to the quality of healthcare. Regardless of the drug, condition, or patient in question, individualized care is essential. The most effective medical system is one where patients and physicians have access to a wide array of treatments, and can make informed choices without fear of penalty.
As I have written in the past:
Ultimately, the choice of treatment should be left up to individual doctors and their patients. By restricting health coverage and limiting treatment options, government bureaucrats are intruding on the doctor-patient relationship and putting peoples’ health at risk.
An off-label drug may help one patient but not others. But overreaching regulators, with their one-size-fits-all ideology and focus on cost effectiveness rather than medical effectiveness, are a danger to every patient.
Sally C. Pipes is president and CEO of the Pacific Research Institute. Her latest book is The Pipes Plan: The Top Ten Ways to Dismantle and Replace Obamacare(Regnery 2012).