Mary Brainerd: Hope, at high cost

Patients deserve access to a new generation of drugs, and it's up to Congress to help them get it.

By Mary Brainerd

Last update: December 8, 2007 - 4:42 PM

Two years ago, a friend and colleague learned first hand about new miracle drugs. Although only in her 50s, she has an aggressive form of a disease that causes painful joint deformities and can, within a few years, destroy the ability to conduct simple daily tasks such as buttoning a shirt, opening a jar and walking. ¶ Fortunately, she continues to live a full, pain-free life, thanks to a new kind of medication called biologics. Like many advances in medicine, it comes with a high price: $71,000 per year on average. Biologics are one of the fastest growing areas in medicine. If we want them to be affordable, Congress needs to pass the Access to Life Saving Medicine Act.

What are biologics? Most medicines are made from chemicals; biologic drugs are made from human or animal proteins. They've been around for years in the form of vaccines for polio, chicken pox or the flu.

The new generation of biologics blocks diseases early in their development. The FDA has approved more than 150 biologics for conditions like rheumatoid arthritis, multiple sclerosis, cancer, diabetes and anemia. But they're very expensive, and the price is going up. One study found that spending for biologics is rising faster than any other area in health care except diagnostic imaging.

Twenty years ago, prices of traditional brand-name medicines were also rising at double-digit rates every year. Then generics became widely available and cost about $125 less than their brand-name counterparts (a savings of more than 80 percent, or millions of dollars every year).

This success story wouldn't have happened had it not been for the vision and bipartisan support of two lawmakers. They saw that even though 150 brand-name drugs lost patent protection between 1962 and 1984, not one generic had entered the U.S. market.

So in 1984, GOP Sen. Orrin Hatch and Democrat Henry Waxman sponsored federal legislation that paved the way for generic competition. The bill reduced the barriers that made it too expensive and too time-consuming for manufacturers to introduce generics. As a result, more than six in 10 prescriptions written in Minnesota today are for generic drugs.

A similar situation now exists for biologics. The FDA has approved more than 150 new biologics, which are usually injected. Because there is no process in the United States to approve bio-generics, the price of biologics will remain high and out of reach for many patients, even after patents expire. Compare that scenario to drugs like Zocor, which saw a price drop of 90 percent after its patent expired.

Critics argue that making similar versions of biologics is more complicated, so manufacturing bio-similar drugs probably won't result in the same dramatic price cuts. But even a price difference of 25 percent would save patients and payers billions of dollars a year.

Europe is far ahead of the United States on this issue. Last year the European Commission approved the first two bio-generic drugs for human growth hormones. Now Congress has a similar opportunity. The Access to Life Saving Medicine Act would establish a process through which the FDA will be able to approve lower-cost copies of biotech drugs. More than 60 groups support this legislation, including AARP, the Consumers Union, all three American automakers and the National Association of Chain Drug Stores. The two groups opposing it represent pharmaceutical manufacturers and the biotechnology industry.

Fortunately, my friend has health insurance and can afford the $45 per day that her medications cost. Every Minnesotan who suffers from a serious illness deserves the same access to affordable medications. It will take years to develop bio-generics, but legislation now will get us moving in the right direction.

Mary Brainerd is president and CEO of HealthPartners.

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