UK cost-cutting agency stalls the use of Glivec

Patients may be denied life-saving cancer drug

By Nigel Hawkes, Health Editor
The Times of London, May 28 (Reprinted with permission)

A cancer drug that is bringing patients back from the verge of death will be denied to National Health Service patients.

The remarkable results reported with Glivec make it the most promising new cancer drug for years. Yet the National Institute for Clinical Excellence (NICE) is poised to reject it for many NHS patients, to the disbelief of the drug industry and those whose lives it has transformed.

One of them is Dr. David Cook, director of studies at the Chemistry Department at Sheffield University, who has gastrointestinal stromal tumor, an uncommon cancer.

Since he started taking Glivec last September, his tumors have disappeared. By coincidence, he has a neighbor who is also being treated with the drug, for a different cancer, chronic myeloid leukemia. His life, too, has been hugely improved by the drug.

Glivec was developed to treat chronic myeloid leukemia, and data presented at the American Society for Clinical Oncology meeting in Orlando, Florida, showed that it was three times more effective than existing treatments as a first-line therapy for that cancer.

But a preliminary assessment published on the NICE Web site in May suggested that NHS patients should not get Glivec unless their disease had already gone into the accelerated phase.

The drug costs between £19,000 and £28,500 ($28,450-$42,700) per patient per year. But the results on first chronic myeloid leukemia and now gastrointestinal stromal tumors suggest it is a life-saver.

A group of specialists led by John Goldman of the Hammersmith Hospital in London have written to The Lancet, protesting the position the institute has taken.

Professor Goldman, who has treated many chronic myeloid leukemia patients with the drug in trials, said that the decision was “mad.”

“If they had existed in 1939, they would have delayed the introduction of penicillin by at least five years,” he said. “To ignore the unanimous body of medical opinion is grotesque.”

Dr. Cook wrote to Alan Milburn, the Health Secretary, protesting at the institute’s assessment, now the subject of an appeal. “I would be astonished if the drug were not available as needed on the NHS,” he wrote.

Glivec does not have a license in Britain for treating gastrointestinal stromal tumors, but some patients, like Dr. Cook, have been able to get it as part of a trial. The disease is marked by a proliferation of tumors in the gut which are resistant to all normal cancer drugs. Before Glivec, surgery was the only option but even if all visible tumors were removed they generally recurred and typical survival was less than two years.

At last month’s U.S. oncology society meeting, data on 147 patients with gastrointestinal stromal tumors was reported. After a year on the drug, 67 percent saw their tumors shrink 50 percent or more, and another 20 percent had tumors that had shrunk to a lesser degree. Dr. Margaret von Mehren, one of the team that presented the results, said: “Before Glivec, more than half the patients would have been dead.” Doctors at the meeting were also told that the brain tumors of 14 out of 31 patients that had come back after previous treatment had been stabilized on Glivec.

Glivec works by disabling an enzyme that functions only in the tumor and not in healthy tissue. So unlike most chemotherapy it does not have such severe side effects. It has been approved in more than 65 countries for chronic myeloid leukemia treatment. At least 10,000 patients were given the drug in trials.

NICE has made clear that its assessment is not its final word. Andrew Dillon, the chief executive, said that the document in its Web site “contains preliminary views that may change after consultation.” The reason for its skepticism, he said, was a lack of evidence that Glivec was clinically effective and cost-effective in chronic myeloid leukemia as a first-line therapy.