Literature DB >> 35041480

Perks and Pitfalls of Performance-Linked Reimbursement for Novel Drugs: The Case of Sacubitril-Valsartan.

Alexander T Sandhu1,2, Paul A Heidenreich1,2, John Lin3, Justin Parizo1, Jay Bhattacharya4, Jeremy D Goldhaber-Fiebert4.   

Abstract

BACKGROUND: Rising drug costs have increased interest in performance-linked reimbursement (PLR) contracts that tie payment to patient outcomes. PLR is theoretically attractive to payers interested in reducing the risk of overpaying for expensive drugs, to manufacturers working to improve early drug adoption, and to patients seeking improved access. Multiple PLR contracts were developed for sacubitril-valsartan. We evaluated how the characteristics of a PLR contract influence its performance.
METHODS: We used a published cost-effectiveness model of sacubitril-valsartan. We evaluated hypothetical PLR contracts that adjusted drug payment based on observed therapy effectiveness. Ideally, these contracts reduce the uncertainty around the value obtained with purchasing sacubitril-valsartan. By reducing the financial risk in covering an ineffective therapy, PLR incentivizes insurers to increase patient access. We measured the uncertainty in value as the SD of the incremental net monetary benefit (INMB), an estimate of therapy value incorporating costs and clinical benefits. We evaluated the change in INMB SD under a variety of different assumptions regarding contract design, therapy effectiveness, and population characteristics.
RESULTS: Over 2 years, sacubitril-valsartan led to 0.042 additional quality-adjusted life-years at an incremental cost of $4916. Using a willingness-to-pay of $150 000 per quality-adjusted life-year, this led to a mean INMB across simulations of $1416 (SD, $1720). A PLR contract that adjusted payment based on cardiovascular mortality reduced the INMB SD moderately by 20.7% while a contract based on all-cause mortality was more effective (INMB SD reduction of 27.3%). A contract based on heart failure hospitalization reduction was ineffective. PLR effectiveness increased with greater uncertainty regarding therapy effectiveness or in sicker cohorts (eg, New York Heart Association Class III/IV heart failure). Contracts required precise estimates of treatment effect in addition to trust or verifiability between manufacturers and payers concerning patient selection.
CONCLUSIONS: The development of accurate prospective estimates of treatment effectiveness using actual enrollee characteristics will be critical for successful PLR. If able to meet these requirements, PLRs could incentivize insurers to expand access to expensive treatments by reducing financial risk.

Entities:  

Keywords:  costs and cost analysis; drug costs; economics; heart failure; prescription drugs

Mesh:

Substances:

Year:  2022        PMID: 35041480      PMCID: PMC9070107          DOI: 10.1161/CIRCOUTCOMES.121.007993

Source DB:  PubMed          Journal:  Circ Cardiovasc Qual Outcomes        ISSN: 1941-7713


  33 in total

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Authors:  Louis P Garrison; Adrian Towse; Andrew Briggs; Gerard de Pouvourville; Jens Grueger; Penny E Mohr; J L Hans Severens; Paolo Siviero; Miguel Sleeper
Journal:  Value Health       Date:  2013-07-19       Impact factor: 5.725

Review 2.  Linking payment to health outcomes: a taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers.

Authors:  Josh J Carlson; Sean D Sullivan; Louis P Garrison; Peter J Neumann; David L Veenstra
Journal:  Health Policy       Date:  2010-03-11       Impact factor: 2.980

3.  Updating cost-effectiveness--the curious resilience of the $50,000-per-QALY threshold.

Authors:  Peter J Neumann; Joshua T Cohen; Milton C Weinstein
Journal:  N Engl J Med       Date:  2014-08-28       Impact factor: 91.245

Review 4.  Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers.

Authors:  Josh J Carlson; Katharine S Gries; Kai Yeung; Sean D Sullivan; Louis P Garrison
Journal:  Appl Health Econ Health Policy       Date:  2014-06       Impact factor: 2.561

5.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
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6.  Early Adoption of Sacubitril/Valsartan for Patients With Heart Failure With Reduced Ejection Fraction: Insights From Get With the Guidelines-Heart Failure (GWTG-HF).

Authors:  Nancy Luo; Gregg C Fonarow; Steven J Lippmann; Xiaojuan Mi; Paul A Heidenreich; Clyde W Yancy; Melissa A Greiner; Bradley G Hammill; N Chantelle Hardy; Stuart J Turner; Warren K Laskey; Lesley H Curtis; Adrian F Hernandez; Robert J Mentz; Emily C O'Brien
Journal:  JACC Heart Fail       Date:  2017-04       Impact factor: 12.035

7.  Factors associated with variations in hospital expenditures for acute heart failure in the United States.

Authors:  Boback Ziaeian; Puza P Sharma; Tzy-Chyi Yu; Katherine Waltman Johnson; Gregg C Fonarow
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Review 8.  Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers.

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Journal:  BMC Health Serv Res       Date:  2010-06-07       Impact factor: 2.655

9.  Angiotensin-neprilysin inhibition versus enalapril in heart failure.

Authors:  John J V McMurray; Milton Packer; Akshay S Desai; Jianjian Gong; Martin P Lefkowitz; Adel R Rizkala; Jean L Rouleau; Victor C Shi; Scott D Solomon; Karl Swedberg; Michael R Zile
Journal:  N Engl J Med       Date:  2014-08-30       Impact factor: 91.245

10.  Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

Authors:  Aaron S Kesselheim; Bo Wang; Jessica M Franklin; Jonathan J Darrow
Journal:  BMJ       Date:  2015-09-23
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