Pricey biologic drugs raise hopes - and questions

In this undated photo provided by Dendreon Corp.,

In this undated photo provided by Dendreon Corp., an employee works on the company's prostate cancer drug Provenge at a plant in Morris Plains, N.J. Photo Credit: AP

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Richard Hamablet of Levittown had suffered from prostate cancer for years until a vaccine quickly made the disease disappear.

The vaccine, which is called Provenge, isn't cheap and is actually so expensive that some doctors have refused to prescribe it.

"It's $33,000 per procedure and there are three of them," said Hamablet, 78, who was infused last year with the innovative vaccine, also known as a biologic medication.

The cancer, which had spread to his spine, vanished shortly after his third treatment.

Biologic drugs, so named because they are derived from proprietary biological processes, such as genetic engineering, or patients' own cells, are some of the most expensive medications on the market.

And they are increasingly becoming the types of medications that best treat a growing number of conditions -- rheumatoid arthritis, several forms of cancer, HIV and multiple sclerosis, to name a few.

The questions vexing doctors and advocates are the stratospheric costs, the lack of price controls on U.S. pharmaceutical products and the growing number of new biologic drugs.

A group of 100 cancer doctors from nearly 20 countries recently wrote an editorial in the journal Blood labeling the cost of cancer medications unsustainable.

Referring to the 12 approved last year for a variety of different types of cancer, the doctors noted that 11 were priced above $100,000 -- all of them biologics.

In Europe, the doctors noted, universal health coverage "shields patients from the direct economic anxieties of illness."

But not so in the United States, where patients might pay an average of 20 percent of drug costs out-of-pocket.

Cancer isn't the only illness marked by the high costs of biologics.

Amy Melnick, vice president for advocacy at the Arthritis Foundation, said biologics designed for rheumatoid arthritis have been transformative for patients, but prices have been unbearable.

"Do I wish they cost less? Absolutely," Melnick said.

The most expensive biologic -- for a rare genetic condition -- costs as much as a house: $400,000 for a year of therapy.

Even though patents have expired on some biologics, experts say, there have been no price reductions.

The number of biologic medications is now growing at twice the rate of traditional medications, which are produced through chemical synthesis.

Some biologics cost 50 times the price of chemically synthesized drugs, studies show.

Claire Sheahan, spokeswoman for the Generic Pharmaceutical Corp. in Washington, said there are no generics for biologic medications.

Her organization's research indicates that if generic versions could be made of the few biologics with expired patents, medical expenses would decline by billions of dollars nationwide.

In New York alone, Sheahan's pharmaceutical group found that 689,870 prescriptions were written in 2011 for biologic therapies, the most recent year for complete statistics.

"There is a real moral issue here," said Dr. Brian Harper of the NYIT College of Osteopathic Medicine in Woodbury.

"To some extent, health care is becoming a commodity where, basically, if you can afford it, then you can have it," Harper said. "From my perspective as a physician, I feel a patient in need should have whatever medicine is required."

Hamablet has thrived as a result of the Provenge therapy.

He was fortunate to be enrolled in Medicare, which paid for the treatment.

Without the federal insurance program for people 65 and older, Hamablet said he would have had to resort to drastic measures.

"I would have had to sell my house to afford it," the retired electrician said.

The Centers for Medicare and Medicaid Services, the federal agency that administers Medicare, deemed Provenge vital to men's survival. The agency announced in July 2011 that full coverage would be available to recipients. The drug was approved by the U.S. Food and Drug Administration in 2010.

Provenge is designed for men with advanced prostate cancer -- metastatic disease -- that has spread to other parts of the body and resists conventional treatment.

"Provenge is important to survival," said Dr. Jeff Vacirca, Hamablet's physician.

The vaccine is made from a patient's own dendritic cells, immune system components that are treated in a laboratory, that are then infused back into the patient as a vaccine.

In the lab, the cells are genetically engineered to recognize and destroy errant prostate cancer cells.

A product of Seattle-based Dendreon, a biotechnology company, the vaccine's $99,000 cost, Vacirca said, reflects both the sophisticated nature of the science that gave rise to it and the highly technical labor involved in manufacturing it.

Vacirca, a specialist in prostate cancer and chief of research at North Shore Hematology Oncology Associates in East Setauket, said he is well aware that some doctors have not prescribed Provenge because of the expense.

He defends the $99,000 expense for the three-dose therapy, noting Provenge's cost is concentrated in a four- to six-week period.

Standard chemotherapy costs about the same, Vacirca said, but is spread over one to two years, which makes the cost seem lower.

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