• Ariel Hammerman, Yoel Lipschitz, Joseph Pliskin, and Dan Greenberg.
• Department of Health Systems Management, Ben-Gurion University of the Negev, Beer Sheba. arielha@clalit.org.il
• Harefuah. 2011 Feb 1;150(2):163-7, 204.

AbstractOff-label use of drugs is common in all areas of medicine, but is specifically prevalent in pediatrics, oncology and in treating rare diseases. Such use may benefit patients, but on the other hand, there is concern about the safety aspects of these treatments. Besides the legal, ethical and safety issues associated with off-label use, arises the issue of whether such prescribing should be reimbursed by public funds. According to Ministry of Health (MoH) guidelines, the committee in charge of updating the National List of Health Services (NLHS) did not discuss, from its inception and until its deliberations at the end of 2008, off-label indications. This policy was to protect the Israeli pharmaceutical registration mechanism, prevent registration bypass mechanisms and not grant use of public funds for reimbursing treatments for which there were insufficient evidence on safety and efficacy. The patients most affected by this policy were the ones that could not benefit from a drug that was not in the NLHS for their medical condition and had to pay for it out of pocket. Occasionally, health plans agreed to subsidize critically needed off-label treatments, although they did not receive public funding for off-label indications. In this article we review the problems associated with off-label prescribing, the reasons why the MoH changed its policy at the beginning of 2009 to permit, in very special circumstances, reimbursement of off-label treatment. We also provide a brief summary of off-label policies in a few western countries.

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