AN AUDIT OF 106 ECONOMIC ANALYSES CONTAINED IN AMCP DOSSIER SUBMISSIONS 2002-2005
Author(s)
Peter J. Neumann, ScD, Professor1, Fernando Colmenero, MD, ScD Candidate2, Carmen Brauer, MD, Research Associate2, Sean D. Sullivan, PhD, Professor3, John B Watkins, RPh, Pharmacy Manager41Tufts University School of Medicine, Boston, MA, USA; 2 Harvard University, Boston, MA, USA; 3 University of Washington, Seattle, WA, USA; 4 Premera BC, Mountlake Terrace, WA, USA
OBJECTIVES To investigate the quality of economic analyses submitted by pharmaceutical manufacturers to health plans under the Academy of Managed Care Pharmacy (AMCP) Format for formulary submissions. To compare quality of economic analyses between high-cost and other products, and between “me-too” and other drugs. METHODS We reviewed all economic analyses included in AMCP-Format dossiers submitted by pharmaceutical companies to Premera Blue Cross (Mountlake Terrace, WA, enrollment 1.5 million) between January 2002 and September 2005. Economic analyses were defined as research studies or mathematical models that combined clinical and cost data to estimate the value of a drug for an indication. We assessed analyses' compliance with several criteria recommended by the Panel on Cost-Effectiveness in Health and Medicine. RESULTS Of 115 dossiers submitted, 55% included economic analyses. We found 106 analyses supporting economic claims for drugs on specific indications. Of these, 89% adopted a payer perspective, 48% were cost minimization analyses, 58% had time horizons < 2 years. 14% applied discounting; 20% stated all assumptions clearly; 37% compared relevant alternatives; 21% reported resource quantities separately, 13% productivity losses, and 26% incremental results; 42% performed some form of sensitivity analysis; 18% mentioned caveats to conclusions. Analyses of high-cost products were more likely to be cost effectiveness or cost consequence analyses (OR=12.5, p=0.004) and to compare relevant alternatives (OR=6.4, p=0.008). Analyses of me-too drugs were less likely to state all assumptions clearly (OR=0.23, p=0.016), compare relevant alternatives (OR=0.09, p=0.0001), report sensitivity analyses (OR=0.19, p=0.006) or incremental results (OR=0.28, p=0.03). No other significant differences found. CONCLUSIONS Most AMCP-Format dossier submissions included economic analyses, but these had low levels of compliance with accepted recommendations. Analyses of me-too drugs appeared particularly prone to bias.
Conference/Value in Health Info
2006-05, ISPOR 2006, Philadelphia, PA
Value in Health, Vol. 9, No.3 (May/June 2006)
Code
FP3
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Formulary Development
Disease
Multiple Diseases