Friday, July 1, 2011

Medicare will Continue to Cover Avastin...So What's Avastin?

The US Food and Drug Administration has taken a hard look at Avastin, a drug used in cancer treatment. It is used in therapy for several forms of the disease, but on June 29, 2011, an advisory committee for the FDA voted unanimously to rescind the drug's approval in breast cancer treatment, stating the risks outweigh the advantages. Don McLeod, a Medicare spokesperson, stated that they will continue to pay for the drug if it is revoked: “The label change will not affect our coverage."

Avastin is marketed by the Switzerland-based Roche--the world's largest biotech company. According to Roche, "Avastin is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and over 32 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year."

An article by Reuters states "Some 17,000 U.S. patients take Avastin, which costs about $8,000 a month. Using Avastin for metastatic breast cancer costs about $88,000 a year, based on people taking it for approximately 11.3 months."

The high cost may not be as much of an issue if the evidence of its effectiveness were more concrete. Avastin belongs to a family of drugs called "monoclonal antibodies", which are designed to inhibit the growth of tumors by blocking the production of new blood vessels--basically "starving" the cancer. It is not considered chemotherapy medication, as it does not directly attack cancer cells, though it is only approved for use in combination with chemotherapy.

Safety information from the Avastin website states, "The most common side effects of Avastin that occurred at >10% and at least twice the control rate include nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin."

While these side effects seem unpleasant, these are not the most severe. It is no wonder that the FDA is alarmed when reviewing the other side-effects that may occur:

Gastrointestinal Perforation: The development of a hole in the intestines or stomach.
Slow/Incomplete Wound Healing: Since the drug inhibits the growth of veins, surgical wounds heal slowly.
Various Serious Bleeding Issues: Stomach, coughing up blood, bleeding in the brain, and vaginal bleeding.
Stroke/Heart Issues: Includes heart attack, blood clots, mini-stroke, and chest pain.
Abnormal Passage Formation from one part of the body to another
Kidney Issues: Avastin increases protein in urine which can lead to serious or fatal kidney problems.
Vision and Nervous System Issues: Includes sluggishness, seizure, blindness, tremors, and confusion.

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