title: Estimated burden of cardiovascular disease and value-based price range for evolocumab in a high-risk, secondary-prevention population in the US payer context.
abstract: OBJECTIVE
  To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population.
  
  
  METHODS
  Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into four cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (n = 1448), acute coronary syndrome (ACS) (n = 602), ischemic stroke (IS) (n = 151), and heart failure (HF) (n = 291) incident cohorts. The value-based price range for evolocumab was assessed using a previously published economic model. The model incorporated CPRD CV event rates and considered CV event reduction rate ratios per 1 mmol/L reduction in low-density lipoprotein-cholesterol (LDL-C) from a meta-analysis of statin trials by the Cholesterol Treatment Trialists Collaboration (CTTC), i.e. CTTC relationship.
  
  
  RESULTS
  Multiple-event rates of composite CV events (ACS, IS, or coronary revascularization) per 100 patient-years were 12.3 for the high-risk prevalent ASCVD cohort, and 25.7, 13.3, and 23.3, respectively, for incident ACS, IS, and HF cohorts. Approximately one-half (42%) of the high-risk ASCVD patients with a new CV event during follow-up had a subsequent CV event. Combining these real-world event rates and the CTTC relationship in the economic model, the value-based price range (credible interval) under a willingness-to-pay threshold of $150,000/quality-adjusted life-year gained for evolocumab was $11,990 ($9,341-$14,833) to $16,856 ($12,903-$20,678) in ASCVD patients with baseline LDL-C levels ≥70 mg/dL and ≥100 mg/dL, respectively.
  
  
  CONCLUSIONS
  Real-world CVD burden is substantial. Using the observed CVD burden in CPRD and the CTTC relationship, the cost-effectiveness analysis showed that, accounting for uncertainties, the expected value-based price for evolocumab is higher than its current annual cost, as long as the payer discount off list price is greater than 20%.
authors.affiliation: a CGH Medical Center , Sterling , IL , USA.|b Ciccarone Center for the Prevention of Heart Disease , Johns Hopkins University School of Medicine , Lutherville , MD , USA.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Toth
authors.affiliation: c Outcomes Insights, Inc , Westlake Village , CA , USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Danese
authors.affiliation: d Amgen (Europe) GmbH , Zug , Switzerland.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Villa
authors.affiliation: e Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: Yi
authors.initials: Y
authors.lastname: Qian
authors.affiliation: e Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Beaubrun
authors.affiliation: e Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: Armando
authors.initials: A
authors.lastname: Lira
authors.affiliation: f Precision Health Economics , Oakland , CA , USA.
authors.forename: Jeroen P
authors.initials: JP
authors.lastname: Jansen
mesh_terms: D054058:Acute Coronary Syndrome / Q000191:economics / Q000517:prevention & control; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000191:economics; D061067:Antibodies, Monoclonal, Humanized; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000191:economics; D050197:Atherosclerosis / Q000191:economics / Q000517:prevention & control; D002318:Cardiovascular Diseases / Q000191:economics* / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000187:drug effects; D015897:Comorbidity; D003362:Cost-Benefit Analysis; D005260:Female; D006333:Heart Failure / Q000191:economics / Q000517:prevention & control; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000191:economics; D008297:Male; D017059:Models, Econometric; D019057:Quality-Adjusted Life Years; D012307:Risk Factors; D055502:Secondary Prevention / Q000191:economics*; D020521:Stroke / Q000191:economics / Q000517:prevention & control; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C577155:evolocumab
keywords: Evolocumab; PCSK9 inhibition; burden of disease; cardiovascular disease (CVD); cost-effectiveness; low-density lipoprotein cholesterol (LDL-C); value-based pricing