title: Development and evaluation of an algorithm to identify users of Prolia(®) during the early postmarketing period using health insurance claims data.
abstract: OBJECTIVE
  The goal of this study is to develop and validate an algorithm to identify Prolia(®) users within a health insurance claims database.
  
  
  METHODS
  Patients with a denosumab-specific or nonspecific administration claim during the early period of Prolia availability in the USA (June 1, 2010 to March 31, 2012) were classified as definite, probable, possible, and nonusers of Prolia using an algorithm consisting of nine different components based on claims patterns consistent with Prolia use. Medical record review confirmed a sample of definite, probable, and possible users and the positive predictive value (PPV) was estimated.
  
  
  RESULTS
  The PPV of the claims-based algorithm components varied (17.8-95.8%). Requiring claims for a bone or cartilage disorder or osteoporotic fracture after excluding claims for cancer prior to a denosumab-specific administration code gave the highest PPV (95.8%), followed by requiring a Prolia National Drug Code on the same claim as a denosumab-specific or nonspecific administration code (88.2%). Among the 87 confirmed Prolia users, osteoporosis diagnoses were seen more frequently in the medical record than in claims (83% vs 62%).
  
  
  CONCLUSIONS
  Prolia users are most accurately identified with administration code claims in conjunction with claims for Prolia National Drug Code and bone disorder treatment and diagnosis codes. Osteoporosis diagnoses may be under-recorded in claims data. The algorithm may require reassessment as uptake for more recently approved indications increases.
authors: Optum Epidemiology, Ann Arbor, MI, USA.
authors: Veena
authors: V
authors: Hoffman
authors: Fei
authors: F
authors: Xue
authors: Betsey
authors: B
authors: Gardstein
authors: Kathleen
authors: K
authors: Skerry
authors: Cathy W
authors: CW
authors: Critchlow
authors: Cheryl
authors: C
authors: Enger
mesh_terms: D000465:Algorithms; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data*; D000069448:Denosumab; D006801:Humans; D007348:Insurance, Health / Q000706:statistics & numerical data; D011237:Predictive Value of Tests; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013997:Time Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069448:Denosumab
keywords: Prolia®; health insurance claims data; pharmacoepidemiology; positive predictive value; validation