[Lolly]

Hi Sarah,
Herceptin is approved for use in metastatic bc, and is used as either a first-line therapy alone or with chemo, or as a maintenance therapy alone or with chemo. It’s been standard-of-care since trials in the mid-90’s. I myself have been Stage IV since 2001 and have been on Herceptin since then, sometimes with chemo, sometimes with long intervals of just Herceptin maintenance.

And Sarah and AA,
Here’s a excerpt with an explanation of “off-label” that says it more clearly than I could (J), and I believe you may be right in that if a physician thinks Herceptin use is warranted and orders it, it would have to be covered…


"Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisfed that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert. However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine and so the physician makes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label. Exceptions to this are certain controlled substances, such as opiates, which cannot be legally prescribed except for approved purposes (at least in the U.S.). In Australia, amphetamines are included in these drugs which cannot be prescribed off-label.
Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off label and more than half of cancer patients received at least one drug for an off-label indication. Frequently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathicpain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.

Off-Label Use and the Law
In the United States, FDA regulations permit physicians to prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, i.e., illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceuticalcompanies are not allowed to promote a drug for any other purpose without formal FDA approval.
However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective; they are not limited to its official, FDA-approved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is usually extensive medical literature to support the off-label use..."

Hope this helps.
<3 Lolly