NikoLetta M. Margaretos, BA, and colleagues conducted a study to examine policies among commercial health plans for coverage of erythropoiesis-stimulating agents (ESAs) for patients with anemia associated with chronic kidney disease (CKD). Results of the study were reported in the Journal of Managed Care Specialty Pharmacy [2021;27(9):1221-1229]. The secondary study objective was an examination of the evidence that the plans reviewed when formulating their coverage policies.
The researchers identified coverage policies issues for ESAs by 17 of the largest US commercial health plans using the Tufts Medical Center Specialty Drug and Evidence and Coverage Database. Drugs indicated for anemia were darbepoetin alfa, methoxy polyethylene glycol-epoetin beta, epoetin alfa (available as two brands), and epoetin alfa-epbx. Coverage policies were current as of May 2019.
The researchers examined whether the health plans applied any restriction, such as step therapy protocols or patient subgroup restrictions in their coverage policies. The evidence cited to support the plans’ policies were sorted into seven categories: (1) randomized controlled trials; (2) real-world evidence studies (studies based on data collected in a real-world setting); (3) other clinical studies (single arm trials); (4) systematic reviews and/or meta-analyses; (5) clinical or treatment guidelines; (6) health technology assessments; and (7) economic evaluations.
The researchers categorized 72.5% of coverage policies (58/80) as equivalent to the FDA label and 27.5% (22/80) as more restrictive. In the restrictive policies, the most common requirements were step therapy protocols (18/22 policies), followed by prescriber requirements (4/22 policies), and patient subgroup restrictions (3/22 policies). Five health plans applied restrictions in at least half of their coverage policies; seven did not apply restrictions in any policy.
Of the plans that cited evidence, an average of 10 citations were reviewed across ESA coverage policies (range, 1-29 studies). There was variation with regard to the types of cited studies: at least 50% of evidence cited by five health plans was randomized controlled trials; half or more of the evidence cited by four health plans was clinical or treatment guidelines.
In conclusion, the authors said, “Health plans varied on how they covered ESAs for patients with anemia due to CKD and in the evidence cited in their coverage policies. Inconsistencies in plans’ coverage policies may have implications for patients’ access to ESAs.”
This study was funded by Otsuka Pharmaceutical Development and Commercialization.