Evidence mapPaperPMID 31166576Full record

Trial reportJAMA cardiology2019

Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease.

Gregg C Fonarow, Ben van Hout, Guillermo Villa, Jorge Arellano, Peter Lindgren

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in JAMA cardiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01764633. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01764633 phase3completed

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Ran2013Enrolled27,564Registered outcomes9Posted comparisons9ConditionsDyslipidemiaArmsEvolocumab, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Clinical Considerations for Healthcare Provider-Administered Lipid-Lowering Medications.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
    Review
  8. Article
  9. Measuring Costs of Cardiovascular Disease Prevention for Patients with Familial Hypercholesterolemia in Administrative Claims Data.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2024
    Article
  10. Cost-effectiveness of Evolocumab in Cardiovascular Disease: A Systematic Review.Current therapeutic research, clinical and experimental · 2024
    Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Gregg C FonarowDivision of Cardiology, David Geffen School of Medicine, University of California, Los Angeles Medical Center, Los Angeles.
Ben van HoutScHARR School for Health and Related Research, University of Sheffield, Sheffield, England.
Guillermo VillaAmgen (Europe) GmbH, Zug, Switzerland.
Jorge ArellanoAmgen Inc, Thousand Oaks, California.
Peter LindgrenThe Swedish Institute for Health Economics, Lund, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: In October 2018, evolocumab was made available at a reduced annual list price of $5850 in the United States. This 60% reduction was aimed at improving patient access by lowering patient copays. Shortly thereafter, the 2018 American College of Cardiology/American Heart Association cholesterol management guideline was released. An updated cost-effectiveness analysis of evolocumab in the United States may be therefore of interest to payers and prescribers. Objective: To present an updated cost-effectiveness analysis of evolocumab added to standard background therapy compared with standard background therapy alone in patients with very high-risk atherosclerotic cardiovascular disease, reflecting the 2018 ACC/AHA guideline definition and using the new evolocumab list price. Design, Setting, and Participants: This study used the Markov model originally used in a previous study by Fonarow et al in 2017. A US societal perspective was considered, and a range of baseline cardiovascular event rates were modeled to reflect varying risk profiles in clinical practice within patients with very high-risk atherosclerotic cardiovascular disease. Exposures: Addition of evolocumab to standard background therapy, including maximally tolerated statin therapy (ie, the maximum intensity of statin therapy a patient can safely receive), with or without ezetimibe. Main Outcomes and Measures: Major cardiovascular events (myocardial infarction, ischemic stroke, and cardiovascular death), costs, quality-adjusted life-years, and incremental cost-effectiveness ratios. Results: Evolocumab was associated with both increased costs and improved outcomes when added to standard background therapy. Incremental costs ranged from $22 228 to $3411, depending on the varying level of risk within the defined population. Incremental quality-adjusted life years ranged from 0.39 to 0.44. Incremental cost-effectiveness ratios ranged from $56 655 to $7667 per quality-adjusted life-year gained. For a range of baseline cardiovascular event rates in patients with very high-risk atherosclerotic cardiovascular disease, incremental cost-effectiveness ratios were below the generally accepted willingness-to-pay thresholds. Moreover, the ratios were below the threshold of $50 000 per quality-adjusted life-years gained for any baseline rate of 6.9 or more events per 100 patient-years. Conclusions and Relevance: At its current list price, the addition of evolocumab to standard background therapy meets accepted cost-effectiveness thresholds across a range of baseline cardiovascular event rates in patients with very high-risk atherosclerotic cardiovascular disease as defined by the 2018 ACC/AHA guideline.

Indexed as

Antibodies, Monoclonal, HumanizedAnticholesteremic AgentsAtherosclerosisCost-Benefit AnalysisFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleQuality-Adjusted Life YearsRisk FactorsAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsevolocumabHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID31166576
PMCPMC6551584

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.