A new multibillion dollar drug, Benlysta (belimumab) for Lupus. It’s available in the U.S., approved by the FDA in November. And now is approved for marketing in Europe.
The drug is given IV every four weeks and costs $35,000 in the U.S. It has some efficacy but (from the Times):
Benlysta reduced symptoms in two clinical trials. But about 11 patients would have to be treated in order for one to benefit. The staff of the F.D.A. and some committee members questioned the drug’s effectiveness, pointing out that many patients with the most severe symptoms were excluded from the trial.
In the trial that did, Americans and Canadians did not seem to get as much benefit from the drug as people from other regions. Some panel members expressed concern that the trial did not include enough African-Americans, who tend to have more aggressive forms of the disease and did not appear to gain any benefit from Benlysta.
“It’s unsettling to me to contemplate approval of a drug for patients in the United States, for practitioners in the United States, that does not seem to work for patients in the United States,” said Dr. David Blumenthal, a committee member and rheumatologist at Case Western Reserve University. He voted against approval.
One company-funded study showed 43 percent of patients given a high Benlysta dose with standard therapies felt relief, and had no further organ damage after one year of treatment.
That compared with nearly 34 percent with a placebo and standard therapies, which typically include immunosuppressant drugs such as Roche’s CellCept and steroids such as prednisone.
Benlysta, known generically as belimumab, is given once a month by intravenous infusion. In the United States, the drug costs an average of $35,000 per patient a year.
The manufacturers have yet to set a price in Europe but Schoenebaum said he was assuming it would be around $23,000. Costly modern biotech medicines are often priced lower in Europe than in the United States.
Medicynical Note: One can only admire the chutzpah of drug manufacturers charging $12,000 more for a drug in the U.S. than elsewhere. A drug that has proven less effective in U.S. patients and one that proves only a slight benefit (9%) over standard therapy.
The pharmaceutical industry is a triumph of marketing over reason. Marginally effective drugs sold at a huge premium to desperately ill people.
We in the U.S. are perfect fools for paying more for these drugs than any other country in the world. American exceptionalism strikes again!
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I turned down one of the biologic agents, Herceptin, because the benefit was off set by the potential heart toxicity. That drug is about 50,000 dollars a year and is now commonly used in early stage Her2+ BC. Relative statistics are used to tout it, the absolute tell another story. Another consideration, in this country, is that the oncologists buy the drugs whole sale and sell them to the patients. Would seem to be a bit of a conflict of interest.
Drugs used to be a major profit center for oncologists. In recent years Medicare and other insurers have put in tighter controls and there is very little mark-up allowed on drugs, but oncology offices can now charge more for services provided in infusion centers and offices. That is another type conflict but may be unavoidable.
After 76 weeks, the clinical trial data shows that Benlysta is no better than a placebo, yet GSK and HGS want Lupus patients to take Benlysta for life.
@Medicynical Note: One reason (amongst others) why drugs in the US are so expensive is that companies budget for potential law suits.
It is easy and has no financial risk to sue a company in the US and of course this not a bad thing. The bad thing is that mainly lawyers make tremendous money out of this and that the desperate ill people pay it indirectly…
You are wrong. Suits are a very minor expense to drug companies relative to their incomes. I suggest you read Marcia Angell. This article is a particularly good primer on drug company practices: http://www.nybooks.com/articles/archives/2004/jul/15/the-truth-about-the-drug-companies/?pagination=false
Unfortunately, your bold answer indicates that you did not read my message right… Never mind