 |
|
Problems With the Interpretation of Pharmacoeconomic Analyses
A Review of Submissions to the Australian Pharmaceutical Benefits Scheme
Suzanne R. Hill, PhD, FAFPHM;
Andrew S. Mitchell, MMed Sci;
David A. Henry, MBChB, FRCP
JAMA. 2000;283:2116-2121.
Context Pharmacoeconomic analyses are being used increasingly as the basis for reimbursement of the costs of new drugs. Reports of these analyses are often published in peer-reviewed journals. However, the analyses are complex and difficult to evaluate.
Objective To describe the nature of problems encountered in the evaluation and interpretation of pharmacoeconomic analyses used as a basis for reimbursement decisions.
Data Sources All major submissions to the Department of Health and Aged Care (DHAC) by the pharmaceutical industry for funding made under the Australian Pharmaceutical Benefits Scheme. Specifically, the DHAC's database of submissions that were received between January 1994 and December 1997 were reviewed.
Study Selection Of a total of 326 submissions, 218 had serious problems of interpretation and were included in the analysis. The nature of the serious problems reviewed were classified as estimates of comparative clinical efficacy, comparator issues, modeling issues, and calculation errors.
Data Extraction All submissions in the DHAC's database were reviewed and data were extracted if both the DHAC evaluators and technical subcommittee considered problems to have a significant bearing on the decisions of the parent committee.
Data Synthesis Of a total of 326 submissions, 218 (67%) had significant problems and 31 had more than 1 problem. Of the 249 problems identified, 154 (62%) related to uncertainty in the estimates of comparative clinical efficacy, and 71 (28.5%) related to modeling issues, which included clinical assumptions or cost estimates, used in the construction of the economic models. There were 15 instances of disagreement over the choice of comparator, and serious calculation errors were found on 9 occasions. Overall, 159 problems (64%) were considered to be avoidable.
Conclusions Significant problems were identified in these pharmacoeconomic analyses. The intensive evaluation process used in the Australian Pharmaceutical Benefits Scheme allowed for identification and correction of pharmacoecomomic analysis problems, but the resources that are required may be beyond the capacity of many organizations, including peer-reviewed journals.
Author Affiliations: Discipline of Clinical Pharmacology, School of Population Health Sciences, Faculty of Medicine and Health Sciences, The University of Newcastle, New South Wales (Drs Hill and Henry); and Pharmaceutical Evaluation Section, Pharmaceutical Benefits Branch, Department of Health and Aged Care, Woden, Australian Capital Territory (Mr Mitchell), Australia.
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati
What's this?
RELATED LETTER
Problems in Pharmacoeconomic Analyses
Michael Stafford, Andrea Messori, Sabrina Trippoli, Paola Dæalessandro, Domenico Di Giorgio, Francesca Tosolini, Suzanne Hill, David Henry, Andrew Mitchell, Drummond Rennie, and Harold S. Luft
JAMA. 2000;284(15):1922-1924.
EXTRACT
| FULL TEXT
RELATED ARTICLES
Outcomes of Ancrod in Acute Ischemic Stroke
Darren Orbach, David Levine, Jean-Marc Orgogozo, Marc Verstraete, Richard Kay, Michael Hennerici, Gian-Luigi Lenzi, David G. Sherman, and David E Levy
JAMA. 2000;284(15):1926-1927.
EXTRACT
| FULL TEXT
Pharmacoeconomic Analyses: Making Them Transparent, Making Them Credible
Drummond Rennie and Harold S. Luft
JAMA. 2000;283(16):2158-2160.
EXTRACT
| FULL TEXT
April 26, 2000
JAMA. 2000;283(16):2179-2180.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
The Role of Value for Money in Public Insurance Coverage Decisions for Drugs in Australia: A Retrospective Analysis 1994-2004
Harris et al.
Med Decis Making 2008;28:713-722.
ABSTRACT
Cost-Effectiveness Analysis of Periacetabular Osteotomy
Sharifi et al.
JBJS 2008;90:1447-1456.
ABSTRACT
| FULL TEXT
The use of cost-effectiveness by the National Institute for Health and Clinical Excellence (NICE): no(t yet an) exemplar of a deliberative process
Schlander
J. Med. Ethics 2008;34:534-539.
ABSTRACT
| FULL TEXT
6-STEPPPs: A Modular Tool to Facilitate Clinician Participation in Fair Decisions for Funding New Cancer Drugs
Browman et al.
J Oncol Pract 2008;4:2-7.
ABSTRACT
| FULL TEXT
Bias in published cost effectiveness studies: systematic review
Bell et al.
BMJ 2006;332:699-703.
ABSTRACT
| FULL TEXT
A Call for Fairness in Formulary Decisions
Levinson and Laupacis
Arch Intern Med 2006;166:16-18.
FULL TEXT
Addressing Resource Allocation Issues in Recommendations From Clinical Practice Guideline Panels: Suggestions From an American College of Chest Physicians Task Force
Guyatt et al.
Chest 2006;129:182-187.
ABSTRACT
| FULL TEXT
Drug Prices and Value for Money: The Australian Pharmaceutical Benefits Scheme
Henry et al.
JAMA 2005;294:2630-2632.
FULL TEXT
Analytic Choices in Economic Models of Treatments for Rheumatoid Arthritis: What Makes a Difference?
Drummond et al.
Med Decis Making 2005;25:520-533.
ABSTRACT
Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle
Taylor et al.
BMJ 2004;329:972-975.
FULL TEXT
Evidence-Based And Value-Based Formulary Guidelines
Neumann
Health Aff (Millwood) 2004;23:124-134.
ABSTRACT
| FULL TEXT
Quantitative analysis of sponsorship bias in economic studies of antidepressants
Baker et al.
Br. J. Psychiatry 2003;183:498-506.
ABSTRACT
| FULL TEXT
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Lexchin et al.
BMJ 2003;326:1167-1170.
ABSTRACT
| FULL TEXT
Economic Evaluations of Immunoprophylaxis in Infants at High Risk for Respiratory Syncytial Virus: Shedding Light or Creating Confusion?
Klassen
Arch Pediatr Adolesc Med 2002;156:1180-1181.
FULL TEXT
Quality of Systematic Reviews of Economic Evaluations in Health Care
Jefferson et al.
JAMA 2002;287:2809-2812.
ABSTRACT
| FULL TEXT
Quality of economic evaluations in health care
Jefferson and Demicheli
BMJ 2002;324:313-314.
FULL TEXT
A Cost-Effectiveness Approach To Drug Subsidy And Pricing In Australia
Birkett et al.
Health Aff (Millwood) 2001;20:104-114.
ABSTRACT
| FULL TEXT
Effectiveness, efficiency, and NICE
Sculpher et al.
BMJ 2001;322:943-944.
FULL TEXT
Interpreting the results of secondary end points and subgroup analyses in clinical trials: should we lock the crazy aunt in the attic?
Freemantle
BMJ 2001;322:989-991.
FULL TEXT
Cost-Effectiveness Analyses: Making a Pseudoscience Legitimate
Rennie
Journal of Health Politics, Policy and Law 2001;26:383-386.
Cost-Effectiveness of Sildenafil
Smith and Roberts
ANN INTERN MED 2001;134:250-251.
FULL TEXT
Problems in Pharmacoeconomic Analyses
Stafford et al.
JAMA 2000;284:1922-1924.
FULL TEXT
Pharmacoeconomic Analyses: Making Them Transparent, Making Them Credible
Rennie and Luft
JAMA 2000;283:2158-2160.
FULL TEXT
|
