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What types of real‐world evidence studies do U.S. commercial health plans cite in their specialty drug coverage decisions?
Author(s) -
Panzer Ari D.,
Margaretos Nikoletta M.,
Lai Rachel C.,
Enright Daniel E.,
Chambers James D.
Publication year - 2020
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4992
Subject(s) - medicine , specialty , clinical trial , alternative medicine , family medicine , pathology
Purpose To examine the RWE U.S. commercial health plans cite in their specialty drug coverage decisions. Methods We used the Tufts Medical Center Specialty Drug Evidence and Coverage Database to identify specialty drug coverage decisions (n = 7267) issued by 17 large commercial health plans. We categorized the clinical evidence plans cited in these coverage decisions (n = 5227) as randomized controlled trials (RCTs), RWE studies, and other clinical studies (studies other than RCT or RWE study). We categorized RWE studies with respect to study type, for example, case series, studies based on medical records, and so on. We compared the frequency that plans cited different categories of RWE, cited RWE for different diseases, and cited RWE for drugs on the market for different time periods. Results RWE comprised 16% of cited clinical studies. Health plans cited RWE with different frequencies (5%‐31% of the cited clinical evidence). Overall, plans cited RWE categorized as medical records most often (26% of cited RWE studies). Plans varied in the frequency they cited different RWE categories. Plans most frequently cited RWE for gastroenterological diseases (35% of clinical study citations) and least frequently for respiratory diseases (11% of clinical study citations). Plans cited RWE more for drugs that have long been on the market. Conclusions Health plans varied with respect to the number and types of RWE studies they cited in their specialty drug coverage decisions. Plans cited RWE more often for some diseases than others, and cited more RWE for older drugs.