New Cancer Drugs Are Driving Up Cost of Care

Nearly two years ago, Mary Vaughan was diagnosed with a recurrence of an aggressive breast cancer that had invaded her skin and lymph nodes. Because she already had had a mastectomy, surgery was not an option, so Vaughan entered a research study testing a combination of two drugs that target cancer cells.

Today, her disease has all but disappeared. Vaughan, 56, is still on medication but is strong enough to work as a nurse near her home in Santa Barbara. "Most people have no idea I'm sick," she said.

Because Vaughan is in a clinical trial, the cost of her treatment is heavily discounted. That's fortunate, because otherwise her drugs, Avastin and Herceptin, would cost her nearly $8,000 a month — more than Vaughan says she can afford, even with her insurance.

A new generation of drugs is revolutionizing cancer care, but at a staggering expense. By next year, global spending on cancer drugs will total $31.7 billion, up from $22.3 billion in 2004, according to projections by consulting firm Bain & Co. That makes cancer the fastest growing drug category, according to Bain.

The new drugs specifically target cancer cells, unlike chemotherapy, which also attacks healthy tissue. The "targeted" drugs are seen as an advance because they are easier on patients than the harsh drugs used in chemotherapy.

Just a handful of targeted drugs have reached the market, but new ones are under intense study at pharmaceutical firms. Research on targeted drugs is expected to dominate the annual meeting of the American Society of Clinical Oncology, which started Friday in Orlando, Fla.

One question hanging over the gathering is captured by the title of a planned seminar: "Can Society Afford State-of-the-Art Cancer Care?" Scheduled speakers include an executive from Genentech Inc., the maker of Avastin and Herceptin.

"These drugs are dramatically driving up the cost of caring for patients," said Leonard Saltz, a cancer specialist at Memorial Sloan-Kettering Cancer Center in New York. "We really haven't addressed the question of how much society is willing to pay for them."

Manufacturers acknowledge their drugs are expensive, but say they are products of costly research in a tricky field.

Dr. Gwendolyn Fyfe, the Genentech vice president who oversees clinical trials of cancer drugs, said Avastin was in development for 15 years and failed in several human tests before it was shown to benefit colon cancer patients. The intravenous drug was approved as a treatment for advanced colon cancer in 2004, but is being studied in patients such as Vaughan who have other cancers.

Fyfe, an oncologist, said Avastin and other targeted biotechnology drugs also were difficult to manufacture. Genentech's top-selling cancer drugs are large proteins made in hamster cells that have been genetically engineered to function as miniature drug factories. The cells must be kept at precise temperatures and be fed specific nutrients to produce drugs, Fyfe said — and many things can go wrong during the process.

Studies presented at the meeting Friday showed that Avastin and Herceptin improved the odds for breast cancer patients. Genentech, based in South San Francisco, announced last month that the results were positive, but provided few details until Friday.

Researchers said that Herceptin prolonged the lives of women who used it to prevent the recurrence of breast cancer after surgery. Women who received a combination of Herceptin and chemotherapy lowered their risk of death by one-third compared with those on chemotherapy alone. The research included two studies funded by the National Cancer Institute involving 5,000 patients and a European study of 5,000 patients.

All the women had received treatment for early-stage cancer with a particular genetic mutation targeted by Herceptin, which is approved only for advanced breast cancer.

Compared with the treatment of chemotherapy alone, "The difference is very large," Gabriel Hortobagyi, a breast cancer specialist at M.D. Anderson Cancer Center in Houston, said at a news conference.

Also Friday, a different group of researchers said Avastin appeared to improve the life expectancy of advanced breast cancer patients. The doctor who led the study, Kathy Miller of Indiana University in Indianapolis, said patients taking Avastin with chemotherapy had a one-third lower risk of death than those given only chemotherapy. The study, also funded by the National Cancer Institute, involved 722 patients.

Taken together, the studies mean that there soon may be more effective treatment options for breast cancer patients. But the drugs must be added to chemotherapy because they aren't powerful enough to work on their own, and that will add many thousands of dollars to treatment costs.

That's what happened in the case of advanced colon cancer. Until recently, the standard therapy for colon cancer was fluorouracil, administered with a vitamin called leucovorin. The treatment cost $500 all told in today's dollars, Saltz said. Now patients with inoperable colon cancer are treated with a combination of newer chemotherapy drugs and targeted therapies, including Avastin and ImClone Systems Inc.'s Erbitux. The average life expectancy of patients has doubled to 22 months, Saltz said, but the cost of treatment has swollen 500 times to $250,000.

Lee Vermeulen, an expert in clinical economics at the University of Wisconsin at Madison, said the benefits of the drugs were minimal relative to the cost. Given that the drugs have been shown to extend life, on average, by only a matter of months, "these drugs are overpriced," he said in a telephone interview.

Many hope the targeted therapies can one day be combined so cancer can be controlled as a manageable disease, as is diabetes. The trial that Vaughan is participating in is a step in that direction, said Mark Pegram of UCLA's Jonsson Comprehensive Cancer Center, who is leading a study that combines Avastin with Herceptin.

Vaughan is one of five women in the study of nine patients who saw significant shrinkage of her tumors. The women all have advanced cancer and the mutation targeted by Herceptin.

Though Vaughan is doing well, she said the Avastin had elevated her blood pressure. Also, Herceptin can cause congestive heart failure, so she must get her heart checked regularly. "Cancer as a manageable disease is not necessarily easy," she said.

Pegram said more studies were needed to be certain the combination of drugs is safe and effective. If the therapy works, the next hurdle will be deciding how to pay for it.

"We have limited resources for healthcare," Pegram said, "and it is going to boil down to a difficult decision."