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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Bob L who wrote (1436)	1/18/1998 2:53:00 PM
From: Pseudo Biologist	Respond to of 1762

Bob L, Maurice, Scott, DMB, First, thanks for reviving this thread with excellent points and questions. I still have my doubts on how insurance/HMOs fit in all this, especially for not explicitly approved indications. I learned over the weekend that a number of states (21 by the beginning of 97) have introduced explicit legislation to force 3rd party payors to cover, for example, reasonable off-label use. They did this upon public pressure and despite oposition from insurance lobbies. Why now, one may ask. Well, because in recent times some of these 3rd party payors have been dragging their feet in providing this coverage. For example, from the American Society of Clinical Oncologists (ASCO) web site, asco.org I am copying the piece below (this was apparently last revised in 1993; I do not know if things have getting better or worse since): "In recent years, third-party payors -- including in some instances Medicare carriers -- have declined to reimburse the cost of anticancer drugs prescribed for indications not on the FDA-approved label on the ground that such uses are "experimental" or "investigational." This trend has been criticized by FDA, NCI, the Institute of Medicine and others as depriving patients of the most effective therapy as well as discouraging drug development. FDA has made it clear that the drug's label is in no way intended to regulate or restrict the ability of practicing physicians to use the drug for other purposes consistent with their professional judgment. Many of the off-label uses are for a combination of drugs used as a therapy. The FDA does not routinely approve combinations of drugs as therapy. " The last sentence in the first paragraph supports the views expressed by Scott before. Yet, it seems some HMOs/insurance cos, etc. may try to get away with less. PB