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Payers’ views on the heterogeneity of treatment effect in oncology
Objectives
The heterogeneity of treatment effect (HTE) refers to the nonrandom variability in response to treatment. This study describes how US payers use HTE evidence when formulating coverage policies for oncology drugs.
Study Design
We employed a qualitative approach using semistructured, in-depth interviews with 15 payers.
Methods
An interview guide was developed based on theory and pilot interviews. Themes that emerged from this content analysis were summarized along with verbatim quotes from payers.
Results
All payers agreed that HTE is important to incorporate into coverage policies of oncology treatments. The FDA label is the most overwhelming determinant of whether HTE evidence gets incorporated into a coverage policy. If not in the FDA label, payers find it difficult to use HTE evidence due to the inability to precisely differentiate responders from nonresponders and the logistical difficulty to operationalize HTE. All payers reported that randomized controlled trials are the most trusted source to establish HTE evidence. In addition to the FDA label, payers also consider treatment guidelines, the quality/magnitude of HTE evidence, the availability of effective alternative substitutes, treatment line, cancer aggressiveness, and politics. When a biomarker and a companion diagnostic are involved, the degree to which HTE evidence is incorporated into coverage policies will also depend on the clinical and analytic validity of the test and the ability to accurately and pragmatically distinguish responders from nonresponders.
Conclusions
Payers’ oncology coverage decisions are affected by a myriad of factors. Payers require more definitive HTE evidence to make more efficient coverage decisions.
Authors
A Abdalla, D Yoder, F Pradel, D C Mullins
Journal
The American Journal of Pharmacy Benefits
Therapeutic Area
Oncology
Center of Excellence
Real-world Evidence & Data Analytics
Year
2017
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