The emphasis on comparative effectiveness research (CER) in U.S. health care may seem relatively new to most; for several decades, however, Analysis Group consultants have been working collaboratively with clients in the life-sciences field to perform research and epidemiological studies that examine the costs and value of therapies used to combat a range of diseases – amassing a comprehensive database of outcomes evidence in the process.
Several of our consultants contributed to wide-ranging discussions about comparative effectiveness research at the 2011 meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). They were invited to present workshops, podium sessions, and posters on a variety of CER issues.
Innovative Assessment Approaches Discussed at ISPOR
Managing Principal Eric Q. Wu, Vice President James Signorovitch, and colleagues discussed “Improved Indirect Treatment Comparisons for Comparative Effectiveness Research.” They introduced a framework for critically evaluating indirect comparisons of treatments: First, given the available data, was the appropriate adjustment methodology used? Second, are the results reported in sufficient detail for evaluation? And third, given the appropriate methodology and reporting, what can the data tell us about the reliability of the results? When subjected to this framework, “traditional methods for indirect comparison will be shown to ... rely on assumptions that are unnecessarily strong,” the consultants say.
In another workshop, Managing Principal Mei Sheng Duh; affiliates Lee-Jen Wei and James Robins, both from the Harvard School of Public Health; and colleagues discussed “New Methods to Adjust for Selective Crossover in Survival Analysis: In Assessments of Cost-Effectiveness of Cancer Therapies.” They covered four main topics: biases found with traditional approaches for assessing treatment effects on survival, in the presence of selective crossover/receipt of non-study therapy; new methods for adjusting for selective crossover and receipt of non-study therapy; the effects of using different methods on estimates of overall survival and cost-effectiveness; and areas for future research.
A CER Framework for Evaluating Colorectal Cancer Products
In their Pharmaceutical Executive article, “The Fruits of Comparative Effectiveness,” authors Managing Principals Edward Tuttle and Anita Chawla, Vice Presidents Dave Nellesen and Justin Works, describe a framework for applying comparative effectiveness evidence, at the category and individual product levels. The framework plots potential budget impact against the availability of comparable alternatives within a disease category or a product group. In the figure to the left, the framework is applied to colorectal cancer (CRC). The monoclonal antibody therapies Erbitux and Vectibix initially were categorized as having potentially high budget impact and weakly differentiated evidence. But because of evidence of the drugs’ effectiveness in the subgroup of CRC patients with wild-type KRAS tumors, these therapies could be moved to the lower left-hand quadrant (improved differentiation and reduced potential budget impact). This categorization limits the total available market for the products but greatly improves the commercial results.
A Session on Measuring Direct and Indirect Costs
In a podium presentation, Principal Howard G. Birnbaum, Vice President Jasmina I. Ivanova, and colleagues examined the “The Direct and Indirect Costs Associated with Hypogonadism Among U.S. Privately Insured Employees.” Their objective was to compare direct and indirect (work-loss) costs between privately-insured U.S. employees with hypogonadism and demographically matched controls without it. They found that employees with hypogonadism had higher comorbidity rates and costs compared with demographically matched controls.
"The adoption of a robust CER paradigm will require health care companies in particular to emphasize supporting research for their products and thorough, independent analyses to interpret the CER results."
- Principal Howard G. Birnbaum (left, with Managing Principal Andrew Parece, at the Analysis Group exhibit booth) and Managing Principal
Paul E. Greenberg
Outcomes Researchers Present 24 Posters at ISPOR
Several of the two-dozen posters presented at the 2011 meeting of ISPOR received finalist ribbons. The themes covered in the lauded works included:
- the health care resource utilization, work productivity loss, and costs associated with menorrhagia (presented by Dr. Duh, Vice President Patrick Lefebvre, Senior Economist Francois Laliberté, Associate Sujata P. Sarda, and colleagues);
- the economic burden associated with metastatic and recurrent, locally advanced head and neck cancer (presented by Dr. Wu, Vice President Christian Frois, Manager Andrew Yu, Associates Hongbo Yang and Maryna Marynchenko, and colleagues); and
- the clinical and economic impacts of uncontrolled epilepsy in a Medicaid population (presented by Dr. Duh, Mr. Lefebvre, Senior Economists Pierre Emmanuel Paradis, Ludmila Rovba and Marie-Hélène Lafeuille, Economists Natalia Mishagina, and Hélène Parisé, and colleagues).