PHARMACOECONOMICS Reimbursing off-label drug use Reimbursement for off-label use of drugs is an 'important medical and financial issue', say Drs DF Thompson and CC Keefe from the US. A problem arises where drug package labelling lags behind current clinical practice and the literature, and insurance companies refuse to reimburse for unlabelled or non-FDA approved indications. One possible solution is the development of a reimbursement policy where 'authoritative drug compendia' are used to determine the eligibility of a particular off-label use. Drs Thompson and Keefe compared off-label indications for antineoplastics among 3 compendia [seefigure]. The American Hospital Formulary Service - Drug Information identified> 50% more off-label uses and 3-fold more unique indications (those not found in either of the other 2 sources), compared with the other sources. 300 250 g ;; c .: 150 o 100 E 50 o Off-label drug uses AHFS' USP " Source 01 Informallon ·...",.nc.on FOflNIIart __ DNv In!"""" "U 1M! S", .. p"._ . 1 __ u, Amencan MeocaJ ANocIaUOr'l • DnIg Eva1u.tlOnl AMA '" Based on these results, Thompson and Keefe suggest that the American Hospital Formulary Service - Drug Information would be 'an important source' for those trying to establish if an off-label use is established in the literature and possibly reimbursable. Thompson DF. Keefe CC. Antineoplastic agents: comparing off-label uses among authoritative drug compendia. Hospital Fonnulary 28: 641·647. Jul 1993 """",.7 ISSN 0156-270319310814-OO91$l.rxf' AlII. international Ltd 9 INPHARMA 8 14 Aug 1993

Reimbursing off-label drug use

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PHARMACOECONOMICS

Reimbursing off-label drug use Reimbursement for off-label use of drugs is an

'important medical and financial issue', say Drs DF Thompson and CC Keefe from the US. A problem arises where drug package labelling lags behind current clinical practice and the literature, and insurance companies refuse to reimburse for unlabelled or non-FDA approved indications. One possible solution is the development of a reimbursement policy where 'authoritative drug compendia' are used to determine the eligibility of a particular off-label use.

Drs Thompson and Keefe compared off-label indications for antineoplastics among 3 compendia [seefigure]. The American Hospital Formulary Service - Drug Information identified> 50% more off-label uses and 3-fold more unique indications (those not found in either of the other 2 sources), compared with the other sources.

300

~ 250 g

~200 ;; c .: 150 o

~ 100 E ~ 50

Off-label drug uses

AHFS' USP"

Source 01 Informallon

·...",.nc.on ~taI FOflNIIart __ DNv In!"""" "U 1M! S", .. p"._ . ~ 1 __ u, Amencan MeocaJ ANocIaUOr'l • DnIg Eva1u.tlOnl

AMA'"

Based on these results, Thompson and Keefe suggest that the American Hospital Formulary Service - Drug Information would be 'an important source' for those trying to establish if an off-label use is established in the literature and possibly reimbursable. Thompson DF. Keefe CC. Antineoplastic agents: comparing off-label uses among authoritative drug compendia. Hospital Fonnulary 28: 641·647. Jul 1993 """",.7

ISSN 0156-270319310814-OO91$l.rxf' AlII. international Ltd

INPHARMA8 14 Aug 1993