title: Budget Impact of Adding Ivabradine to Standard of Care in Patients with Chronic Systolic Heart Failure in the United States.
abstract: BACKGROUND
  Heart failure (HF) costs $21 billion annually in direct health care costs, 80% of which is directly attributable to hospitalizations. The SHIFT clinical study demonstrated that ivabradine plus standard of care (SoC) reduced HF-related and all-cause hospitalizations compared with SoC alone.
  
  
  OBJECTIVE
  To estimate the budget impact of ivabradine from a U.S. commercial payer perspective.
  
  
  METHODS
  A budget impact model estimated the per-member-per month (PMPM) impact of introducing ivabradine to existing formularies by comparing a reference scenario (SoC) and a new drug scenario (ivabradine + SoC) in hypothetical 1 million-member commercial and Medicare Advantage plans. In both scenarios, U.S. claims data were used for the reference cumulative annual rates of hospitalizations (HF, non-HF cardiovascular [CV], and non-CV), and hospitalization rates were adjusted using SHIFT data. The model controlled for mortality risk using SHIFT and U.S. life table data, and hospitalization costs were obtained from U.S. claims data: HF-related = $37,507; non-HF CV = $28,951; and non-CV = $17,904. The annualized wholesale acquisition cost of ivabradine was $4,500, with baseline use for this new drug at 2%, increasing 2% per year.
  
  
  RESULTS
  Based on the approved U.S. indication, approximately 2,000 commercially insured patients from a 1 million-member commercial plan were eligible to receive ivabradine. Ivabradine resulted in a PMPM cost savings of $0.01 and $0.04 in years 1 and 3 of the core model, respectively. After including the acquisition price for ivabradine, the model showed a decrease in total costs in the commercial ($991,256 and $474,499, respectively) and Medicare populations ($13,849,262 and $4,280,291, respectively) in year 1. This decrease was driven by ivabradine's reduction in hospitalization rates. For the core model, the estimated pharmacy-only PMPM in year 1 was $0.01 for the commercial population and $0.24 for the Medicare Advantage population.
  
  
  CONCLUSIONS
  Adding ivabradine to SoC led to lower average annual treatment costs. The negative PMPM budget impact indicates that ivabradine is an affordable option for U.S. payers.
  
  
  BACKGROUND
  This study was funded by Amgen. Patel is employed by Amgen; Kielhorn was employed by Amgen at the time of the study but is no longer affiliated with Amgen. Borer, Böhm, Ford, and Komajda have received scientific support, consultative fees, and/or speakers honoraria from Servier and Amgen in connection with SHIFT, the trial underlying this analysis. Borer also has received consultative fees from Celladon, Pfizer, ARMGO, Cardiorentis, Novartis, and Takeda USA. Kansal, Dorman, Krotneva, and Zheng are employees of Evidera, which was hired to assist with this study. Tavazzi has received research grants and consultation fees from Servier in connection with this study and has had advisory board memberships with Boston Scientific, Servier, Cardiorentis, Medtronic, St. Jude Medical, and CVie Therapeutics. Study concept and design were contributed by Dorman and Keilhorn, along with the other authors. Tavazzi, Komajda, Ford, BÖhm, and Borer oversaw collection of the data. Tavazzi, Komajda, Ford, BÖhm, and Borer (along with Karl Swedberg) formed the Executive Committee of SHIFT, the trial underlying this analysis. The manuscript was written by Kansal, along with the other authors, and revised by Borer and Patel, with assistance from the other authors.
authors: 1 The Howard Gilman Institute for Heart Valve Diseases and Ronald and Joan Schiavone Cardiovascular Translational Research Institute, State University of New York Downstate Medical Center, Brooklyn and New York, New York.
authors: Jeffrey S
authors: JS
authors: Borer
authors: 2 Evidera, Bethesda, Maryland.
authors: Anuraag R
authors: AR
authors: Kansal
authors: 3 Evidera, Montreal, Canada.
authors: Emily D
authors: ED
authors: Dorman
authors: 3 Evidera, Montreal, Canada.
authors: Stanimira
authors: S
authors: Krotneva
authors: 2 Evidera, Bethesda, Maryland.
authors: Ying
authors: Y
authors: Zheng
authors: 4 Amgen, Thousand Oaks, California.
authors: Harshali K
authors: HK
authors: Patel
authors: 5 Maria Cecilia Hospital, GVM Care & Research, and Ettore Sansavini Health Science Foundation, Cotignola, Italy.
authors: Luigi
authors: L
authors: Tavazzi
authors: 6 Pitié-Salpétrière Hospital, Pierre and Marie Curie University, and IHU ICAN, Paris, France.
authors: Michel
authors: M
authors: Komajda
authors: 7 Robertson Centre for Biostatistics, University of Glasgow, United Kingdom.
authors: Ian
authors: I
authors: Ford
authors: 8 Saarland University Hospital, Homberg, Germany.
authors: Michael
authors: M
authors: Böhm
authors: 4 Amgen, Thousand Oaks, California.
authors: Adrian
authors: A
authors: Kielhorn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001552:Benzazepines / Q000191:economics* / Q000627:therapeutic use; D002017:Budgets / Q000639:trends; D002317:Cardiovascular Agents / Q000191:economics* / Q000627:therapeutic use; D016527:Drug Costs / Q000639:trends; D005260:Female; D054143:Heart Failure, Systolic / Q000188:drug therapy / Q000191:economics* / Q000453:epidemiology; D006801:Humans; D007345:Insurance Claim Review / Q000191:economics* / Q000639:trends; D007348:Insurance, Health / Q000191:economics / Q000639:trends; D000077550:Ivabradine; D008297:Male; D020398:Medicare Part C / Q000191:economics / Q000639:trends; D008875:Middle Aged; D010602:Pharmacopoeias as Topic; D012189:Retrospective Studies; D059039:Standard of Care / Q000191:economics* / Q000639:trends; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D001552:Benzazepines; D002317:Cardiovascular Agents; D000077550:Ivabradine