The use of medicines in exceptional circumstances in Spain: adding perspective to early access
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The use of medicines in exceptional circumstances refers to the use of non-authorized medicines or those used outside the authorized conditions, and comprises three different situations: (1) the use of medication in research or for compassionate use; (2) the use of foreign medicines (medicines unauthorized in one country but authorized in others); and (3) off-label use (prescription of drugs for conditions other than that for which they have been officially approved). In Spain, we intend to regulate the period between authorization and pricing through the use of therapeutic positioning reports containing standard criteria. In our opinion, the key to managing this period could be restrictive access based on the therapeutic positioning reports, prespecified agreements on acquisition cost, and restrictive time framework (for use or for decision making, e.g. orphan medicines).
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