LONDON, UK (GlobalData), 02 April 2012 - Many people have been prescribed a medication for “off-label” use. Patients who have battled cancer were most likely prescribed a drug for something other than its approved indication. Off-label drug use can be akin to “recycling” of drugs, in that the drug was approved by the Food and Drug Administration (FDA) for one indication, but is being used to treat another. This is becoming more commonplace, but what are the behind-the-scenes activities when drugs are prescribed for off-label uses? It is likely that most consumers and prescribers are unaware of a drugs’ history.
All drugs must be approved through the FDA or another regulatory body, therefore demonstrating a level of safety for therapeutic use. In addition, most drugs show a variety of possible uses during preclinical and clinical trials, but drug makers are made to pick one indication to bring to market, leading many drugs to be used for other, off-label conditions.
There are two categories of off-label usage. Firstly, a drug can be used to treat a completely different disease than what was indicated. For example, the antidepressant Citalopram can be used to treat symptoms of Irritable Bowel Syndrome. The other method of off-label usage uses a drug to treat another condition, but within the realm of indication. For instance, beta-blockers are approved to treat hypertension, but can also be prescribed for patients with heart failure, as both conditions are cardiac related.
Repurposing drugs for different uses has been a common topic in the news lately. Minocycline, which is a bacteriostatic semisynthetic derivative of tetracycline which inhibits protein synthesis, and is used as a broad-spectrum antimicrobial, entered clinical trials in Texas and the United Kingdom for treatment of schizophrenia. This antimicrobial has high hopes of providing antipsychotic effects in these patients, and will hopefully lead to other treatments for psychiatric conditions such as bipolar disorder.
This is exciting news, and if successful will join the ranks of other well-known recycled drugs such as Topamax, which was originally meant to control seizures and is now prescribed for migraines. But do consumers know the history of some of these recycled drugs, and are they available to everyone to use, particularly if the patient has failed other treatments? For some patients, these off-label drugs are their only source of treatment or their last line of therapy.
A national study conducted by the University of Chicago in 2007-2008 revealed that 55% of physicians polled (599 primary care physicians and 600 psychiatrists) did not know the on/off-label usage of 22 specified FDA approved drugs. Today, off-label usage is common practice in therapy areas spanning autoimmune diseases, neurological disorders and oncology. In oncology, many drugs show multiple-use through clinical trial data, and therefore over half are used as off-label to target areas such as pain management, chemotherapy side-effects, and other tumor indications within cancer treatment.
Most healthcare insurance covers off-label usage, but some government insurers such as Medicare will not cover off-label drug prescription unless used for cancer treatment. Medicare Part D requires the consumer to provide medical data that shows the drug to be effective and safe for the target indication to support that use of the drug. Unfortunately, obtaining this data is not free, and can only be sourced via drug compendias or encyclopedias of drug chemicals. This process is time consuming and stressful for the average consumer, as they must contact the drug plan, have the support of the prescriber, compile the supporting data, and file evidence for multiple reviews from the insurance plan to even stand a chance of gaining approval.
GlobalData analysis shows that, with restructured guidelines from Medicare, off-label usage may one day be made available to anyone, especially if they have failed conventional treatments. On the other hand, prescribing physicians need to be held accountable for understanding off-label usages, and discouraged from taking a “community standards of practice” approach, as drug companies are not allowed to promote or market for off-label usage.
Re-Bi-Cycling Drugs for Those Who Need It Most
This expert insight was written by GlobalData’s immunology and neurology analyst, Dina Rufo. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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