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March 30, 2011 | Posted By Bruce D. White, DO, JD

The March 25th New York Times carried an article titled “Approval for Drug That Treats Melanoma” which reported the benchmark FDA approval of a new drug that benefits patients with almost-always fatal skin cancer. Click the photo below to be taken to the article. 


(photo from www.nytimes.com)

The novel infusion drug, YERVOY™ (ipilimumub, Bristol-Myers-Squibb), “is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” as stated in the article by Dr. Gerald P. Linette, an Assistant Professor of Medicine at Washington University in St. Louis, who participated in the clinical trials.

In the prospective randomized studies that led to FDA approval, patients with metastatic melanoma lived about 10 months as compared with 6.4 months for those patients in the control group that received standard therapy.

Other skin cancers are more common than melanoma; however, 75% of patients who die from skin cancer have melanoma. About 160,000 new melanoma cases are diagnosed each year; about 48,000 deaths from the disease occur worldwide annually. When melanoma has metastasized distantly, the cancer is generally considered incurable. The five-year survival rate is less than 10%. The median survival is 6-12 months. More lay information is available by clicking this link.

According to the New York Times article, Bristol-Myers-Squibb said it will charge about $120,000 for a complete course treatment for YERVOY™. The complete course is four infusions given over a three-month period.

On average for metastatic melanoma, that would tally to about $8,500 for each week of additional life. And, on average, the patient receiving YERVOY would live about 14 weeks longer than the patient who received standard treatment for a fatal disease.

One wonders how patients might be able to afford the treatment. Will those patients who have traditional medical insurance be able to pay for the drug with its co-pays and deductable? Will traditional insurance plans even cover the drug or add the drug to their drug formularies? Will Medicare and Medicaid plans cover the drug? If Bristol-Myers-Squibb charges $120,000 per treatment course, how much will oncologists, cancer treatment centers, hospitals, long-term care facilities, pharmacies, and other treatment and access sites charge?

The approval of YERVOY™ may be just the latest dramatic example that illustrates the cost of therapy – and by extension, perhaps the value of life – in the health care cost debate. One might recall a similar situation with HERCEPTIN™ (trastuzumab, Genentech).

The FDA approved HERCEPTIN™ in 1998 for breast cancer. It costs about $70,000 per full treatment course. Genetech’s gross revenue from HERCEPTIN™ in 2007 was reported at $327 million. More lay information about trastuzumab is available here.

For those first-world countries and nationalized health services – United Kingdom, Australia, and New Zealand – providing HERCEPTIN™ to breast cancer patients has proven a fiscal challenge. A controversial decision by the Swinton Primary Care Trust not to provide the drug to a breast cancer patient led to UK court case in 2006 and is reported on the Internet at this site.

With limited resources and tense fact patterns dealing with patients with fatal illnesses and the availability of more wonder drugs, the debate about the cost of care and the value of human life is certain to heat up.

2 comments | Topics: Bioethics in the Media, Health Insurance, Pharmaceuticals

Comments

benita

benita wrote on 03/30/11 5:48 PM

And then we come back to the issue of 'how much profit is enough profit?' And how often is the drug provided free to a person in need - compassionate use? Many questions surround this and will continue as drug makers find they can reap great benefits, socially and financially from new treatments that extend lives. Who is to say a few months isn't worth it? The list of questions goes on.
John Kaplan

John Kaplan wrote on 04/04/11 2:44 PM

This is a fascinating and cotroversial area. Also in the news is KV Pharmaceuticals who have released a brand name progesterone based compound for prevention of premature birth. This compound used to be prepared by pharmacists for $10-20 and KV is pricing the drug, Makena, at $1,500 a dose. They have reduced this to $690 a dose after the outraged response. Still seems outrageous to me.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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