By Merrill Matthews
One of the many concerns about President Obama’s health care legislation is that it will encourage–if not eventually require–the government to approve the cheapest rather than the best medical therapy.
Indeed, the government already engages in some price rationing in the health insurance programs it controls: Medicare, Medicaid and the Veterans Administration. You can expect rationing to explode once the new health care law is fully implemented.
Take the current debate over Avastin and Lucentis–two drugs owned by San Francisco-based Genentech, which is part of the much larger drug company Roche.
Avastin, a biologic approved for various types of cancer, was in the headlines recently because the U.S. Food and Drug Administration (FDA) was considering removing its approval to treat breast cancer because of concerns that the benefits didn’t outweigh the risks. No decision has been made, and even if the FDA did remove that approval, Avastin would still be approved for other cancers.
Because Avastin is an FDA-approved drug, eye specialists have been using it “off-label” (i.e., for a condition it isn’t approved for) to treat age-related macular degeneration (AMD). That’s a condition where blood vessels begin to form in the back of the eye near the macula, causing a person to lose his sight.
Even though some doctors have been using Avastin to treat age-related macular degeneration, Genentech developed and received FDA approval in 2006 for Lucentis, a new drug specifically designed for that disease. Lucentis is similar but has a smaller molecule than Avastin, which scientists hope will help it penetrate the retina easier and improve outcomes.
Lucentis has been proven to stop the visual deterioration caused by AMD, and in some cases may even lead to a slight improvement. Many doctors think the same is true for Avastin. However, Lucentis is much more expensive than the non-AMD approved Avastin, and that raises concerns about the poor and uninsured.
Avastin is a cancer drug and isn’t dosed for AMD, so doctors using it send it to a compounding pharmacy that has to significantly scale down the dosing portions, adding a potential risk factor because of the extra handling. Doctors then inject very small amounts into the eye.
Since age-related macular degeneration primarily affects the elderly covered by Medicare, the government has a financial stake in the decision over which drug to use.
It’s hard to get past the irony here. The FDA is considering removing Avastin’s breast cancer approval because of risk-benefit concerns. Plus some think that Avastin’s high cost is playing at least some role in that reconsideration.
But with age-related macular degeneration, the thinking is just the reverse: Avastin may be more cost effective than the FDA-approved drug, but may also impose some additional risks. No one knows for sure, which is why the National Institutes of Health (NIH) initiated a study in 2008 to compare the two drugs. The results are supposed to be released around mid-2011.
It isn’t uncommon for the medical community to be convinced that an unapproved therapy helps patients–until the double-blind, placebo-controlled trials prove there is little or no benefit. That’s why it was critically important for the NIH to conduct a clinical trial comparing the two drugs.
But the government’s growing quest to control exploding health care costs is also why some think President Obama insisted on including what’s called comparative effectiveness research (CER) in his health care bill. Indeed, he even included a billion dollars for CER efforts in his stimulus bill in February of 2009–a year before the health care bill passed. When Republicans tried to insert specific language in the stimulus bill prohibiting cost considerations in determining comparative effectiveness, Democrats shot that down. That action raised red flags about some of the proponents underlying motives.
I should say that I have a vested interest in this issue. My father had macular degeneration for the last few years of his 83-year life. I have no idea if I too will get it, but I want the FDA and the government to get this right.
Comparative effectiveness research has been done for years. Federal agencies like the NIH and the National Cancer Institute regularly fund such studies. But the goal has always been to find the most effective (or safest, or least invasive, or fewest side effects, etc.) therapy. The cost factors were properly left up to the practicing physicians who had to take into consideration the patients’ finances and health coverage. That practice should continue.
Since Lucentis is available and FDA approved, cost is surely a key factor in the NIH’s decision to compare it with Avastin. That could be a problem in the future.
When the government is the primary payer, budgets are tight, and benefits have been overpromised, the lines between cost and quality can get blurred. And with the massive new role ObamaCare will play both in determining coverage and financing of care, cost considerations won’t be just an afterthought, they will be the primary goal.
Merrill Matthews is a resident scholar with the Institute for Policy Innovation in Dallas, Texas.
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