`Miracle' biotech drugs growing in use and cost

Prescription: With the new Medicare benefit and FDA approval of new drugs, the tab is expected to continue to balloon.

March 16, 2004|By Cyril T. Zaneski | Cyril T. Zaneski,SUN STAFF

Judith Levinson-Warsaw whispers this prayer every time she takes the medicine she credits with rescuing her from crippling rheumatoid arthritis: "Miracle drug, miracle drug. Thank you, science, and God above."

The 59-year-old Rockville resident had been on disability for almost a decade and was reeling from 14 operations and a string of side effects from traditional medication when she was introduced in 1999 to a new biotech medicine, etanercept. Now - after more than 530 treatments - Levinson-Warsaw says she's "in the go mode," working as a glass artist in her studio and looking forward to dancing at her daughter's wedding this summer.

"If I hadn't got into this drug, I'd need a scooter to get around, and I'd have to have somebody come in and help me get dressed in the morning," she said. "But now, I'm out and around. My husband called me his Energizer Bunny."

The cost of Levinson's "miracle" is $17,300 a year.

Etanercept, which Amgen Inc. markets as Enbrel, is one of many new bio-pharmaceuticals that treat relatively few patients but carry whopping price tags that account for a large and rapidly rising percentage of the nation's medical costs. Americans spent almost $30 billion on such specialty drugs in 2002, or 18 percent of U.S. spending on all prescription drugs that year, according to Medco Health Solutions, the nation's largest pharmacy benefit manager.

Beyond treating rheumatoid arthritis, the new drug therapies are being used to treat types of cancer, HIV/AIDS, multiple sclerosis, hepatitis C, infertility and other disorders. Spending on those drugs is growing at between 20 percent and 25 percent a year, or about double the projected rate of growth this year of spending for conventional pharmaceuticals.

The tab for specialty drugs is expected to continue to balloon as the federal government begins subsidizing their use under a Medicare prescription benefit in 2006 and as the Food and Drug Administration approves new biotech drugs. Last month, the FDA approved two drugs for treating colon cancer - Genentech Inc.'s Avastin, which is expected to cost more than $4,000 a month, and ImClone Systems Inc.'s Erbitux, which is expected to cost $10,000 a month. Annual costs for patients on specialty drugs can be as much as $250,000, compared with $550 for people on traditional medications, Medco reports.

Why are the drugs so expensive? Bio-pharmaceuticals - derived from genetic engineering or other natural sources - are less stable and more difficult to handle than conventional synthetic drugs, which themselves can cost more than $800 million to develop and bring to market, according to the Tufts Center for the Study of Drug Development.

Most biotech drugs are protein-based and must be administered by injection or infusion, which adds to their cost. Moreover, there are no lower-price generic alternatives for biotech drugs as there are for old-line medications. The FDA does not even have rules for marketing a biotech generic drug.

And unlike so-called lifestyle drugs that help people battle toenail fungus or hair loss, which are easy targets for cost-cutting pharmacy benefit managers, "there are no easy answers for lowering prices on these drugs," said Joshua Cohen, a senior research fellow at the Tufts drug study center.

"The high prices for drugs clearly do impact society, and they surely affect insurers' ability to reimburse, yet they can't be denied to people who really need them because these truly are lifesaving drugs," Cohen said.

`Be using up life savings'

Levinson-Warsaw is lucky. She has insurance that helps her pay for Enbrel and nine other prescriptions that cost a total $26,234 a year, which includes $4,488 she pays out of pocket. "If I didn't have insurance, I'd be using up my life savings," she said. "But I couldn't imagine being without this drug."

Her drug is a protein-based medication called a biologic response modifier. Biologics are designed to either inhibit or supplant immune system components called cytokines. If taken early enough, experts say, these treatments might prevent or lessen severe damage to joints.

The discovery of biologics came too late to save Levinson's joints. Levinson, whose rheumatoid arthritis was diagnosed about 20 years ago, was forced to take disability leave from her job as a secretary in 1991. She tried all the usual drugs and treatments. She had gold injections once a month for a decade and took the steroid prednisone and the antirheumatic drug minocycline.

"With prednisone, you blow up. I blew up 20 pounds in three months," she said. "You look in the mirror, and you see this round-faced person looking back at you. And minocycline turned my skin gray, gave the whites of my eyes a blue tint and discolored my teeth."

Another drug made her hair fall out. "I stood there in the shower, and I watched my hair going down the drain," she said.

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