Methods. We assumed a linear trajectory for increases or decreases in utilities and applied a shortterm decrement associated with hospitalizations. However,Jeffrey S. Borer, MD, of SUNY Downstate Medical Center in Brooklyn, sided with Sandhu's group on a more favorable interpretation. A prior independent analysis by the nonprofit Institute for Clinical and Economic Review had estimated a cost per QALY of about $58,000 for the device, which it called "excessive" given "insufficient" evidencefor overall patient outcome improvement. CardioMEMS HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart . Additional resources and information available on the reimbursement page. 1,2 Since its approval in 2014 by the Food and Drug Administration, more than 5,500 devices have been implanted in the US. This MarketScan data analysis, as well as other published studies,25, 26 were used for costs of HF and nonHF hospitalizations. This is an implantable PAP monitoring device that allows a direct monitoring of the PAP via a sensor implanted in the PA. 2 The sensor monitors changes in the PAPs and communicates via . Since these new technology payments have expired, CMS has established both inpatient and outpatient reimbursement mechanisms for the CardioMEMS HF System implant procedure. RevisionType: View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833) Changes to manuals that are designated as "safety" were made to address safety issues. Factors associated with variations in hospital expenditures for acute heart failure in the United States. A Markov model was developed to estimate costeffectiveness of the CardioMEMS HF System compared with usual care over a 5year period. Beyond ICER's evaluation of the technology's body of evidence, the authors go on to note that the $17,750 list price for CardioMEMS is too high, based on cost-effectiveness thresholds and impact on the health care system budget. Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. It is possible that this could doublecount decrements in utilities. Sandhu's study found that a $190 monthly fee for the CardioMEMS would limit costs per QALY to $100,000. Value Health QALY Consensus Development Workshop The use of CardioMEMS was associated with a reduction of hospitalizations of HF patients, but the acquisition cost could be high in low-and-middle income countries. Dr. Fonarow has served as a consultant to St. Jude Medical. Beyond ICER's evaluation of the technology's body of evidence, the authors go on to note that the $17,750 list price for CardioMEMS is too high, based on cost-effectiveness thresholds and impact on the health care system budget. The costeffectiveness estimates generated from this model have leveraged trial data, considered the natural history of disease in the decrements and change over time in utilities, and the model was also designed to allow users to enter personalized inputs to reflect individual payers situations. The implantable sensor is a completely sealed . In a conference call with analysts on Thursday, St. Jude Medical revealed what the average selling price of this technology is. These were considered in the sensitivity analyses. This material reproduces information for reference purposes only. Multivariate and threshold analyses explored additional scenarios to include alternative inputs or to identify input values that would make the cost/QALY meet or exceed various thresholds (Supporting Information, Table, in the online version of this article and Figure Figure22). This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Specifically, the CardioMEMS system reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The CardioMEMS HF System consists of an implantable, battery-free sensor that is implanted into the distal pulmonary artery to continuously measure the heart rate along with systolic, diastolic, and mean pressures. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, reasonable and medically necessary guidelines. 602-698-5820. Differences in hospital lengthofstay, charges, and mortality in congestive heart failure patients. 10.1002/clc.22696 Our analysis used hospital costs that were similar to those used by Martinson et al,24 as we found these to be the most recent and relevant cost estimates available in the literature. Beside the opportunity presented for managing patients with less time, there are other potential benefits. Background The CardioMEMS sensor is a wireless pulmonary artery pressure device used for monitoring symptomatic heart failure (HF). Positive results have been demonstrated in a clinical trial involving a recently Food and Drug Administration (FDA)approved implantable wireless pulmonary artery pressure monitoring system (CardioMEMS). Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. To contact the HE&R team, please email or call the Reimbursement Hotline at (855) 569-6430. This posthospitalization state is not represented as a separate health state in this visual representation of the model. Anderson JL, Heidenreich PA, Barnett PG, et al. The CardioMEMS HF system is the worlds first implantable wireless pulmonary artery pressure sensing device for heart failure patients. However, Stoltenberg notesthat CardioMEMS was granted a new technology add-on payment that went into effect on October 1, 2014 and also gained Transitional APC Pass-Through Payment Status on January 1, 2015. Heidenreich PA, Albert NM, Allen LA, et al; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. As of July 1st, 2020, Novitas Solutions, Inc. (NOVITAS) and First Coast Service Options, Inc. (FCSO) retired their local non-coverage policies (. Registered in England and Wales. Pandor A, Gomersall T, Stevens JW, et al. The tough reimbursement enviroment later led a Cigna executive to counter that while cost is an important factor, what's more important is clinical value. 3,4,5 The presymptomatic data provided by the CardioMEMS HF System allow for proactive changes in medical therapy before . The purpose of this study was to develop a Markov simulation model to estimate the costeffectiveness of the CardioMEMS HF System at up to 5 years compared to usual care in the indicated population. These assumptions are detailed in the Supporting Information, Appendix, in the online version of this article. Third, this analysis was operationalized as a deterministic model. The impact of hospitalization on utilities was not directly assessed in the CHAMPION trial; thus, other published sources were reviewed for guidance. The multiple ways in which this model varied utilities to reflect the natural history of disease had little influence on outcomes. Indicates a trademark of the Abbott group of companies. An official website of the United States government. Virginia, 2 90305907 Rev. The CardioMEMS system has been heralded as a new approach to heart failure, pinpointing worsening congestive heart failure (CHF) earlier to allow physicians to treat patients more effectively. Remote monitoring technologies have come under consideration for their ability to slow progression of symptomatic HF.6 Review articles findings have been mixed; in general, there is support for the concept of remote monitoring with differences in reported effectiveness of specific programs and technologies.7, 8, 9 Telemonitoring was not shown to reduce readmission rates significantly in 2 recent large studies.10, 11 Remote monitoring may be more beneficial for certain populations than others,12 although few studies have examined this question in detail. CRT Group Foundation is a not for profit corporation dedicated to providing educational services in the field of cardiology through the website, CRTonline.org and the Cardiovascular Research Technologies (CRT) annual symposium. Patients with HF enter the model. The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA [New York Heart Association] Class III Heart Failure Patients (CHAMPION) trial17, 18 utilized a singleblind, randomized design to compare patients who received the CardioMEMS device and pulmonary artery (PA) pressureguided management for a minimum of 6 but an average of 18 months, with control patients who received the device but did not transmit data, essentially receiving usual care. CAUTION: These products are intended for use by or under the direction of a physician. $71,462 per QALY gained and $48,054 per life-year gained, "excessive" given "insufficient" evidence. For HF patients meeting current indications, the CardioMEMS HF System may represent an important clinical advance, while at the same time being a costeffective treatment for HF. A recently approved implantable wireless pulmonary artery pressure remote monitor, the CardioMEMS HF System, has been shown to be effective in reducing hospitalizations among New York Heart Association (NYHA) class III HF patients. The challenges of treating HF should not be understated. By Prescription Only. Being able to see this data regularly and spot trends earlier allows physicians to modify treatment plans and medications before symptoms set in. Exponent received a grant from St. Jude Medical to evaluate the costeffectiveness of its implantable remote monitoring system. Details of the approach appear in the Supporting Information, Appendix, in the online version of this article. Post-marketing surveillance data on the device's durability will further clarify its value. "The reduction in hospitalizations with the CardioMEMS device ultimately should lead to cost reductions relative to the benefits of using the device. . A recent study of the CardioMEMS device monitoring at a single site collected data on the time required for nurses and physicians to review patient data20; these data can be used to develop an analysis of time savings on the part of healthcare providers that might be associated with remote monitoring. Back in May, St. Jude Medical exercised its option to buy Atlanta-based startup, CardioMEMS, the moment the latter's product won FDA approval. The CHAMPION trial collected utilities from patients at baseline, 6 months, and 12 months using the EuroQol (EQ)5D3L.21 Health utilities are a measure of wellbeing that range from 0 to 1, with 0 indicating immediate death and 1 indicating perfect health. -- By Arundhati Parmar, Senior Editor, MD+DI[emailprotected]. Findings on costeffectiveness of treatments to manage HF range widely, in terms of the incremental costeffectiveness ratios that they present as well as the interventions and patient groups compared. The cost per QALY gained was $82,301 in patients with reduced . Forums. Private payors typically follow the lead of CMS when it comes to reimbursing new technologies and it will be interesting to see whether the pattern will continue. In a clinical trial with 550 patients, the CardioMEMS device implanted on the pulmonary artery showed a 28% reduction in the heart failure hospitalizations at six months, and a similar 37% reduction during an average, 15-month follow-up period. FCSO is the MAC for FL, Puerto Rico, and the Virgin Islands. Some of these differences are due to the different hospital and outpatient cost inputs utilized. Other authors have also reported higher QALYs and cost-effectiveness when CardioMEMS is compared to standard therapy (20,21). Dr. Monique Tanna is a Penn Medicine heart failure cardiologist with special expertise in the CardioMEMS system. The CardioMEMS Heart Failure (HF) System, manufactured by St. Jude Medical, is an FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used to help patients manage heart failure. By using this site, you consent to the placement of our cookies. official website and that any information you provide is encrypted Our model also attempted to follow the natural history of the disease more closely and used longer and larger decrements in health utilities for each hospitalization. So far, the only FDA-approved remote monitoring system for patients with HF is Cardio-Microelectro-mechanical system (CardioMEMS; Abbott, Sylmar, CA, USA). CardioMEMS HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA . 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