Drug law change could save patients big bucks

WASHINGTON -- After decades of suffering as her body gnarled and stiffened from rheumatoid arthritis, Bonnie Cramer began taking a new drug around 2002.

It wasn't a pill, but an injection - a medicine derived from the living cells of a small hamster, blended with human DNA and whipped into a brew that Cramer shot into her body twice a week.

The morning after she took it for the first time, Cramer climbed out of bed without help.

"I took the drug for over six years; during that time, I felt as though I had no arthritis," said Cramer, a former director of the division of aging for the state of North Carolina and national board chairwoman for the American Association of RetiredPersons.

The biologic drug Enbrel cost $2,000 a month, and Cramer, of Raleigh, says she was lucky to afford it on the health insurance she enjoyed as a state worker.

By law, no generic alternative to Enbrel or any other biologic drug, a product made from living organisms instead of chemicals, is available in United States, because the Food and Drug Administration has no authority to approve them. But under health reform legislation in Congress, generic biologic drugs would become legal in this country - potentially saving patients thousands of dollars in drug costs in the fastest-growing market in pharmaceuticals. Some of the brand-name biologic drugs, such as those used to treat cancer, can cost nearly $50,000 a year.

Pharmaceutical companies and many lawmakers, including Sen. Kay Hagan, a Greensboro Democrat, say they support the change. But they want to ensure that health reform gives brand-name drugmakers years of protection from competitors. Under the legislation, the availability of generic biologic drugs wouldn't come immediately. The bill would allow brand-name drug companies to have 12 years of exclusivity before generics could come onto the market - a period some patient advocates argue is unnecessarily long.

"If we don't do something about the costs in this area, we'll simply continue to see this big explosion," said Nora Super, AARP's lobbyist in Washington. "[Patients] will just know they cost a fortune and they can't afford them."

What is long enough?

Generic drug companies are eager to invite generic biologic drugs into the U.S. market, but they, too, say the 12-year exclusivity is too long. And they were supported in June when the Federal Trade Commission said the exclusivity was unnecessary, and that competition from generics could lower drug costs by as much as 80 percent. The Obama administration supports a seven-year exclusivity.

Pharmaceutical companies say the industry needs that time to recoup the billions it spends on developing biologic drugs.

"It's very important in North Carolina because of our emergent companies in the bio field," said Sam Taylor, president of the N.C. Biosciences Organization, a trade group in Research Triangle Park. The state has the third-largest biotech industry in the nation with more than 500 companies that employ 58,000 people.

AlphaVax, which has 80 workers in Research Triangle Park, is one of many startup companies in the state developing biologic drugs. Although the decade-old company has half a dozen potential drugs in the pipeline, it has not yet sent any to the market, said Janice Kimpel, vice president for business development.

"Obviously, if and when we finally launch a product, legislation that makes it very easy for someone to copy that ... is difficult for investors to get comfortable with," Kimpel said.

Few biologics on market

Biologic drugs are different from small-molecule chemical drugs - such as those found in pills - because they are derived from living cells and can comprise thousands of atoms.

It takes $80 million to $150 million to develop a successful biologic drug, Taylor said. Only a few make it to market.

Hagan helped write the amendment on exclusivity for brand-name biologic drugs that was included in the health-reform bill being debated next week in the Senate. In an interview, Hagan said the 12 years of exclusivity would protect investments from going overseas.

"The jobs that come out of biopharmaceutical companies are good jobs in North Carolina," Hagan said. "I want to make sure we don't lose our talent."

Patients usually take biologics through injections or intravenously. Some doctors and patient advocates say they've seen heartbreaking stories about patients who can't afford the pricey medicines.

"I was amazed at the number of people in my doctor's office who were trying to find ways to afford [Enbrel], who were in the same situation I was in," said Cramer, the Raleigh patient with rheumatoid arthritis. "They had run out of options, and they were getting more disabled."

She recalls talking with a fellow patient who didn't have insurance. "It was one of those days when you leave the doctor's office with tears in your eyes. She had no hope of getting this drug."

Help for patients

Debbie Smith, a case manager at the Buddy Kemp Caring House in Charlotte, a resource for cancer patients, tries to match needy patients with financial resources, including some assistance programs run by drug companies themselves. Still, she said, families often continue to face hardship.

"I've had some patients who can't afford the medication. So, they don't get the treatment," Smith said.

Just as brand-name biologic companies in North Carolina want to protect their investments, some generic companies with a presence in the state also are following the bill closely.

Hospira, an Illinois-based company, makes generic small-molecule drugs and medical devices at plants that employ 2,000 workers in Rocky Mount and 300 in Clayton.

The company already manufactures biosimilars in Europe, and it has lobbied to do the same in the United States - though officials say that it's too soon yet to say whether any new bio-manufacturing plant would land in North Carolina.

Even more troublesome than the 12-year exclusivity is a loophole in the legislation for "evergreening," said Juliana Reed, Hospira's lobbyist. That means that a brand-name company could make a minor tweak to its drug and tack on another 12 years of protection.

She hopes lawmakers in Congress will eject the evergreening provision before the bill goes to the White House.

"This bill is not done until it's signed by the president," she said.

Latest Comment View all comments