A clinical audit of high-cost and off-label drug use in dermatology.
OBJECTIVE
The use of high-cost, off-label, unsubsidised drugs has become valuable in the management of dermatology patients with challenging conditions unresponsive to conventional therapy. Currently, there is no dedicated funding and a paucity of evidence for such drugs. The aim of this audit was to review outcomes and costs.


METHODS
A retrospective clinical audit of high-cost off-label dermatology drug applications to the High Cost Drug's Subcommittee was undertaken at a tertiary public hospital in Brisbane, Queensland, between 2002 and 2013.


RESULTS
Of 28 applications, 25 were approved. The medications included thalidomide, mycophenolate mofetil, cyclosporin, infliximab, rituximab and adalimumab. Over 70% of patients responded to treatment. Individual annual costs for these medications ranged from $2068 to $36 984. Adverse effects resulted in drug withdrawal in five cases.


CONCLUSIONS
Despite the absence of dedicated funding for high-cost drugs and a rigorous committee approval process, most applications were approved, of which >70% benefited from treatment. This audit provides useful clinical experience with off-label use of high-cost drugs in difficult dermatological conditions.
Department of Dermatology, Princess Alexandra Hospital, Brisbane, Australia.|Dermatology Research Centre, The University of Queensland, School of Medicine, Translational Research Institute, Brisbane, Australia.
Natalie
N
Ong
Department of Dermatology, Princess Alexandra Hospital, Brisbane, Australia.|Dermatology Research Centre, The University of Queensland, School of Medicine, Translational Research Institute, Brisbane, Australia.
Erin
E
McMeniman
Department of Clinical Pharmacology, Princess Alexandra Hospital, Brisbane, Australia.
Peter
P
Pillans
Department of Dermatology, Princess Alexandra Hospital, Brisbane, Australia.|Dermatology Research Centre, The University of Queensland, School of Medicine, Translational Research Institute, Brisbane, Australia.
H Peter
HP
Soyer
D000068879:Adalimumab / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016572:Cyclosporine / Q000191:economics / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000191:economics* / Q000627:therapeutic use*; D003880:Dermatology; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000191:economics / Q000627:therapeutic use; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000191:economics / Q000627:therapeutic use; D056687:Off-Label Use; D011793:Queensland; D012189:Retrospective Studies; D000069283:Rituximab / Q000191:economics / Q000627:therapeutic use; D012871:Skin Diseases / Q000188:drug therapy*; D013792:Thalidomide / Q000191:economics / Q000627:therapeutic use
D003879:Dermatologic Agents; D000069283:Rituximab; D013792:Thalidomide; D016572:Cyclosporine; D000069285:Infliximab; D000068879:Adalimumab; D009173:Mycophenolic Acid
adalimumab; biologic agent; clinical audit; cyclosporin; dermatology; drug; infliximab; mycophenolate mofetil; rituximab; thalidomide