title: Cost-effectiveness of Evolocumab in Patients With High Cardiovascular Risk in Spain.
abstract: OBJECTIVE
  Our objective was to assess the cost-effectiveness of evolocumab in patients at high risk of cardiovascular (CV) events from the Spanish National Health System perspective.
  
  
  METHODS
  A Markov model was used to assess the cost-effectiveness (incremental [∆] cost per ∆ quality-adjusted life-year [QALY]; or cost utility) of evolocumab plus standard of care (SoC; statins) versus SoC, assuming lifetime treatment. Cohorts with baseline LDL-C >100 mg/dL and familial hypercholesterolemia (FH) or CV event history (secondary prevention [SP]) were considered. Lifetime CV event rates were predicted either (1) using risk equations considering local risk factors (Spanish Familial Hypercholesterolemia Cohort Study) adjusted to reflect the increased risk of FH patients or (2) using CV event rates from local registries (Information System for the Development of Research in Primary Care) for SP patients. LDL-C relative reductions from evolocumab trials (Evolocumab 140 mg Q2W (bi-weekly) and 420 mg QM (monthly)) were converted into CV event reductions using rate ratios per millimole per liter (mmol/L; 38.67 mg/dL) from a meta-analysis of statin trials (Cholesterol Treatment Trialists' Collaboration).
  
  
  RESULTS
  Predicted 10-year/lifetime CV risks were 50%/95% (FH) and 62%/82% (SP) for SoC and 27%/83% (FH) and 44%/69% (SP) for evolocumab plus SoC. Predicted 10-year/lifetime major CV event risks were 42%/86% (FH) and 47%/67% (SP) for SoC and 21%/68% (FH) and 31%/52% (SP) for evolocumab plus SoC. Predicted per patient-year rates of non-fatal/fatal CV events were 2.2/0.8 (FH) and 1.1/0.6 (SP) for SoC and 1.2/0.6 (FH) and 0.7/0.5 (SP) for evolocumab plus SoC. Predicted CV event reductions per mmol/L were 17% (FH) and 15% (SP). Evolocumab treatment was associated with increased QALYs and costs compared with SoC (FH: ∆cost, €65,369; ∆QALY, 2.12; incremental cost-effectiveness ratio [ICER], €30,893; SP: ∆cost, €42,266; ∆QALY, 0.93; ICER, €45,340).
  
  
  CONCLUSIONS
  Evolocumab plus to SoC may provide a cost-effective option for LDL-C lowering in FH and SP patients in Spain.
authors.affiliation: Economic Modeling CoE, Amgen, Zug, Switzerland. Electronic address: guillermo.villa@amgen.com.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Villa
authors.affiliation: Economic Modeling CoE, Amgen, Zug, Switzerland.
authors.forename: Mickael
authors.initials: M
authors.lastname: Lothgren
authors.affiliation: Global Health Economics, Amgen, Zug, Switzerland.
authors.forename: Lucie
authors.initials: L
authors.lastname: Kutikova
authors.affiliation: Swedish Institute for Health Economics, Lund, Sweden; Karolinska Institutet, Stockholm, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Lindgren
authors.affiliation: Global Health Economics, Amgen, Thousand Oaks, California.
authors.forename: Shravanthi R
authors.initials: SR
authors.lastname: Gandra
authors.affiliation: University of California, Los Angeles, California.
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: Health Economics, Amgen, Barcelona, Spain.
authors.forename: Francesc
authors.initials: F
authors.lastname: Sorio
authors.affiliation: Vascular Medicine and Metabolism Unit, Research Unit on Lipids and Atherosclerosis, "Sant Joan" University Hospital, Universitat Rovira i Virgili, IISPV, Reus, Spain; Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Madrid, Spain.
authors.forename: Lluis
authors.initials: L
authors.lastname: Masana
authors.affiliation: Hospital Germans Trias i Pujol, Barcelona, Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: Bayes-Genis
authors.affiliation: University of Sheffield, Sheffield, United Kingdom.
authors.forename: Ben van
authors.initials: BV
authors.lastname: Hout
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000191:economics* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002318:Cardiovascular Diseases / Q000191:economics* / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy* / Q000191:economics*; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012307:Risk Factors; D013030:Spain
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D008078:Cholesterol, LDL; C577155:evolocumab
keywords: LDL-C; PCSK9 inhibitors; cardiovascular disease; cost-effectiveness; evolocumab; hypercholesterolemia