Cost‐Effectiveness Analysis of Sacubitril/Valsartan for the Treatment of Heart Failure with Reduced Ejection Fraction in the United States

Zueger, Patrick; Kumar, Varun; Harrington, Rachel; Rigoni, G; Atwood, Alicia; DiDomenico, Robert J.; Touchette, Daniel R.

doi:10.1002/phar.2108

Cited by 23 publications

(44 citation statements)

References 46 publications

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“… 35 The cost-effectiveness of sacubitril versus valsartan in patients with systolic heart failure ranged from $45K to $144K in separate estimates. 36 , 37 Transcatheter aortic valve replacement had ICER estimates that ranged from $39 964 to $116 500 when compared with medical management; however, it was considered a disruptive therapy for a population with no other treatment options. 38 Transcatheter aortic valve replacement ICER estimates also ranged from $32 000 to $252 400 when compared with surgical valve replacement in patients with high risk of surgical mortality.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial

Wilkoff

Boriani

Mittal

et al. 2020

Circ: Arrhythmia and Electrophysiology

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Background - In the WRAP-IT trial, adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device (CIED) infection without increased risk of complication in 6,983 patients undergoing CIED revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator (CRT-D) implant. There is limited information on the cost-effectiveness of this strategy. As a pre-specified objective, we evaluated antibacterial envelope cost-effectiveness compared to standard-of-care infection prevention strategies in the US healthcare system. Methods - A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention vs. standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years (QALYs) were discounted at 3%. An upper willingness-to-pay (WTP) threshold of $150,000 per QALY was used to determine cost-effectiveness, in alignment with American College of Cardiology and American Heart Association (ACC/AHA) practice guidelines and as supported by the World Health Organization (WHO) and contemporary literature. Results - The base-case incremental cost-effectiveness ratio (ICER) of the antibacterial envelope compared to standard-of-care was $112,603/QALY. The ICER remained lower than the WTP threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. Conclusions - The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of CIED infection.

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Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial

Wilkoff

Boriani

Mittal

et al. 2020

Circ: Arrhythmia and Electrophysiology

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show abstract

“…Likewise, cardiac resynchronization therapy and implantable cardioverter defibrillators were generally cost-effective with ICERs ranging from $20,000 to $90,000/QALY gained. The findings of this study indicated the need for new pricing strategies to improve the cost-effectiveness of SAC/VAL [25].…”

Section: Cost Effectiveness Of Sacubitril/valsartanmentioning

confidence: 82%

“…But, a higher drug acquisition cost of SAC/VAL compared to traditional therapies had made its clinical utility questionable. The cost-effectiveness of SAC/VAL is influenced by all-cause mortality benefit, SAC/VAL drug costs, probability of NYHA class progression, and assumed duration of treatment (i.e., model time horizon) [25].…”

Section: Cost Effectiveness Of Sacubitril/valsartanmentioning

confidence: 99%

“…The SAC/VAL therapy has been cost-effective primarily at WTP thresholds of $150,000/QALY gained or greater. However, other classes of drugs like ACEI, ARBs, and BBs were generally highly cost-effective (ICER <$10,000/QALY gained) [25]. Likewise, cardiac resynchronization therapy and implantable cardioverter defibrillators were generally cost-effective with ICERs ranging from $20,000 to $90,000/QALY gained.…”

Section: Cost Effectiveness Of Sacubitril/valsartanmentioning

confidence: 99%

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Sacubitril/Valsartan in Management of Heart Failure: A Review of Safety, Efficacy and Cost-Effectiveness

Ellahham¹

2018

Cardiovasc Pharm Open Access

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Heart failure (HF) is a leading cause of mortality and morbidity across the globe. High prevalence, frequent hospitalization, longterm healthcare, absenteeism from work, and death upsurge the economic burden of the HF. For almost two decades, the angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), and beta-blockers (BBs) have remained the standard care of management for HF. But despite being efficacious and cost-effective theses standard treatment were unable reduce events of rehospitalization and improve quality of life for patients with HF. Recent innovative discovery of angiotensin receptor/neprilysin inhibitor (ARNI) therapy changed the entire outlook for management of HF. Sacubitril/Valsartan an ARNI proved out to be a revolutionary drug for patients of HF. Compared to other drug classes, Sacubitril/Valsartan combination therapy is more efficacious, have lesser adverse effect, and improves overall quality of life of HF patients with reduced ejection fraction. However, the cost-effectiveness of Sacubitril/Valsartan remained questionable in developing parts of world. At the current pricing Sacubitril/Valsartan was found to be cost-effective only at specific threshold of willingness to pay of the patients. Better Federal healthcare policies, new-pricing strategies, robust long-term real-world estimates of this drug are required to improve the cost-effective profile of this drug.

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“…Currently heart failure is the most expensive diagnostic‐related group for Medicare, because cost‐effectiveness of many of the recommendation for treatment is at best controversial. For example cost effectiveness ratio of ICD for primary prevention was below $ 100 000 only when effectiveness of ICD continued for at least 7 years and replacing ACE‐I by ARNI appears to be resulting in incremental cos‐effectiveness ratio of $ 143 891/QALY gained …”

Section: Effect Of Gdmt On Morbidity Compression In Heart Failurementioning

confidence: 99%

GDMT for heart failure and the clinician's conundrum

Samarendra

2019

Clinical Cardiology

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Therapeutic advances in management of CHF have decreased mortality and have impacted progression in patients with mild to moderate heart failure. Aggressive campaigns by cardiology societies aimed at increasing implementation of these measures in routine practices have almost generalized the treatment of heart failure irrespective of individual variations of clinical status of patients and stages of heart failure. This explains why morbidity compression and quality of life improvement have not been realized fully particularly in patients with advanced disease. To examine whether GDMT for CHF is backed by unambiguous evidence of clinical efficacy for its global implementation in every patient at all stages of the syndrome. ACC/AHA, ESC Guidelines for CHF, and their updates were reviewed. Clinical trial cited in the guideline documents and other pertaining published literatures were analyzed.FindingsMany of the recommended GDMT for CHF lack unequivocal evidence of clinical efficacy in patients with diverge etiology of heart failure and concomitant comorbid conditions Some of the recommendations which are useful in early stages, lack evidence of efficacy in more advanced stages of heart failure. Application of results of research trials in patients beyond their inclusion and exclusion criteria, appears mere extrapolation, Clinicians are faced with the conundrum of implementing the recommendations without indubitable evidence of their efficacy in every patient of their practice.ConclusionA reappraisal of Guidelines is needed to address outstanding questions pertaining to the efficacy of recommendations and plug the knowledge gaps without assumption and extrapolation of results of RCTs beyond their inclusion and exclusion criteria.

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Cost‐Effectiveness Analysis of Sacubitril/Valsartan for the Treatment of Heart Failure with Reduced Ejection Fraction in the United States

Abstract: SAC/VAL is associated with clinical benefit and may be cost-effective compared with the current standard of care over realistic treatment durations from the payer perspective. Results of this analysis can inform discussions on the value and position of SAC/VAL in the current market.

Cited by 23 publications

References 46 publications

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial

Sacubitril/Valsartan in Management of Heart Failure: A Review of Safety, Efficacy and Cost-Effectiveness

GDMT for heart failure and the clinician's conundrum

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