Israel's Health Ministry is to examine the possibility of adding off-label medications to the list of drugs and medical technologies paid for by the state.
Off-label medications are those that were originally approved for use for certain illnesses but have been found effective in treating other conditions as well. The additional uses have been approved by institutions in other countries, the U.S.'s FDA or the European EMEA, but not in Israel.
Until these uses are approved in Israel, they cannot currently be included in the list of drugs paid for by the taxpayer, known as the health basket.
But a Health Ministry team recently recommended to ministry director general Moshe Bar Siman Tov to reexamine the decision “as long as [the medicines] meet accepted standards of treatment in leading countries or according to clinical directions.”
Opinions in the Health Ministry are divided over this recommendation. On the one hand, if it is adopted, many patients could receive subsidies for potentially life-altering drugs. On the other, it could make the position of Israeli authorities redundant and make regulation more difficult.
When drug companies apply to the Health Ministry for approval, they are guided by commercial considerations including the size of the target group for specific treatments.
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“We’re talking about hundreds of off-label uses,” says Dr. Yossi Lomanitzky, head of pharmaceutical services at the Maccabi HMO. One example he cites is Avastin, used to treat cancer of the large intestine, but also used elsewhere in the world to treat age-related eye degeneration. This off-label use is not approved in Israel and therefore cannot receive public funding.