The rise and fall of gabapentin for bipolar disorder: a case study on off-label pharmaceutical diffusion.
BACKGROUND
Rising drug costs have increased focus on how new pharmaceuticals diffuse into the marketplace. The case of gabapentin use in bipolar disorder provides an opportunity to study the roles of marketing, clinical evidence, and prior authorization (PA) policy on off-label medication use.


METHODS
Observational study using Medicaid administrative and Verispan marketing data. We examined the association between marketing, clinical trials, and prior authorization on gabapentin use.


METHODS
Florida Medicaid, bipolar disorder-diagnosed enrollees ages 18 to 64 for fiscal years 1994 to 2004.


RESULTS
Gabapentin prescriptions increased from 8/1000 enrollees per quarter in 1994 to a peak of 387/1000 enrollees in 2002. Its uptake tracked marketing efforts towards psychiatrists. The publication of 2 negative clinical trials in 2000 and the discontinuation of marketing expenditures towards psychiatrists were associated with an end to the steep rise in gabapentin prescriptions. After these events gabapentin use remained between 319/1000 and 387/1000 enrollees per quarter until the PA policy, which was associated with a 45% decrease in prescriptions filled. After 1 year, scientific evidence and marketing discontinuation were associated with a 5.4 percentage point decrease in the predicted probability of filling a gabapentin prescription and the PA policy, a 7.1 percentage point decrease.


CONCLUSIONS
Pharmaceutical marketing can influence off-label medication prescribing, particularly when pharmacologic options are limited. Evidence of inefficacy and/or the cessation of pharmaceutical marketing, and a restrictive formulary policy can alter prescriber behavior away from targeted pharmacologic treatments. These results suggest that both information and policy are important means in altering physician prescribing behavior.
Fullerton
Catherine A
CA
Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA 02478, USA. fullerton@hcp.med.harvard.edu
Busch
Alisa B
AB
Frank
Richard G
RG
D000293:Adolescent; D000328:Adult; D000588:Amines / Q000627:therapeutic use*; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D005260:Female; D005431:Florida; D000077206:Gabapentin; D006801:Humans; D033181:Information Dissemination; D016015:Logistic Models; D008297:Male; D008389:Marketing of Health Services / Q000639:trends; D008484:Medicaid; D008875:Middle Aged; D019370:Observation; D056687:Off-Label Use; D014481:United States; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
D000588:Amines; D014151:Anti-Anxiety Agents; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin