Com­pas­sion­ate Use/Ex­pand­ed Ac­cess pro­grams: Three steps to im­prove their im­ple­men­ta­tion for the ben­e­fit of all

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Com­pas­sion­ate Use or Ex­pand­ed Ac­cess is a treat­ment op­tion for pa­tients in des­per­ate need which can be in­de­pen­dent­ly re­quest­ed by a treat­ing physi­cian, pro­vid­ing ac­cess to lo­cal­ly un­li­censed med­ica­tions when all ap­proved treat­ment op­tions have been ex­haust­ed and en­roll­ment in a clin­i­cal tri­al is not pos­si­ble. There is no doubt about the hu­man val­ue of these pro­grams for pa­tients with no oth­er op­tion, and it’s al­so in­creas­ing­ly clear just how ben­e­fi­cial they can be for the en­tire health care ecosys­tem in ad­dress­ing the un­met med­ical needs of pa­tients. But many stake­hold­ers, from gov­ern­ments, health­care in­sti­tu­tions to phar­ma com­pa­nies, are not set up to make the best use of com­pas­sion­ate use. The time to change that is now.

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