Cost and Value in Contemporary Heart Failure Clinical Guidance Documents

John W. Ostrominski, MD; Sameer Hirji, MD, MPH; Ankeet S. Bhatt, MD, MBA; Javed Butler, MD, MPH, MBA; Mona Fiuzat, PHARMD; Gregg C. Fonarow, MD; Paul A. Heidenreich, MD, MS; James L. Januzzi, JR, MD; Carolyn S.P. Lam, MBBS, PHD; Thomas M. Maddox, MD, MS; Christopher M. O'Connor, MD; Muthiah Vaduganathan, MD, MPH

Disclosures

JACC Heart Fail. 2022;10(1):1-11.

Conclusions

Although most contemporary HF CGDs contain at least 1 cost/value statement, these CGDs have generally focused on the economic impact of HF, with less explicit consideration of cost/value in clinical guidance recommendations. To promote cost-sensitivity and value-based care efforts, we propose potential opportunities for future HF-focused CGDs.

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Abbreviations and Acronyms
ACC = American College of Cardiology; ADA = American Diabetes Association; AHA = American Heart Association; CGD = clinical guidance document; CMR = cardiac magnetic resonance; HF = heart failure; TTE = transthoracic echocardiography

Table 1. Key Opportunities for Cost/Value Consideration in Future HF Clinical Guidance Documents
Key Opportunities	Examples in Practice
Opportunities to manage society costs
Prioritize the generation of and inclusion of high-quality cost/value data in CGD development	• NICE's performance of dedicated cost/value evidence reviews and publication of short summary cost/value evidence statements • Use of validated tools, such as the Quality of Health Economic Studies instrument, to adjudicate the quality of existing cost/value studies • ACC/AHA's emphasis on the importance of conducting independent high-quality cost-effectiveness analyses where cost/value evidence is lacking
Where high-quality data are available, improve integration of cost/value into CGDs by providing a LOV for all Class I and IIa recommendations	• Cost-effectiveness–based LOV published for PCSK9 inhibitors in the 2018 ACC/AHA CPG on the management of blood cholesterol
Improve transparency regarding relative benefit of recommended interventions	• American Society of Clinical Oncology's Value Framework highlighting head-to-head comparisons whenever possible
Improve alignment between patients and clinicians on value propositions of cardiovascular therapies	• Inclusion of patients and caregivers on CGD development committees, as well as their involvement in value determinations
Opportunities to manage patient costs
Promote and improve price transparency	• Reporting of median wholesale price and drug acquisition cost ranges for antihyperglycemic therapies in the American Diabetes Association's Living Standards of Medical Care • National Comprehensive Cancer Network's visual representation of the affordability of recommended drugs or drug regimen in its Evidence Blocks system
Where possible, highlight available programs for cost reduction	• ACC's 2021 ECD for Optimizing HF Care mentions GoodRx, a free-to-use platform for drug coupons and cost comparison
Develop clinical pathways for HF management when cost is a barrier to access for the patient	• The American Diabetes Association's explicit diabetes management pathways for when "cost is a major issue"
Provide explicit guidance for cost-based discussions between patients and providers	• Consensus guidelines for patient-physician communication, including cost discussions, as published by the American Society of Clinical Oncology
Develop resources for the identification and management of financial toxicity in patients with HF	• Development and use of clinic-based checklists
Consider development and implementation of multicomponent patient-centered value frameworks	• The American Society of Clinical Oncology Value Framework • European Society for Medical Oncology's Magnitude of Clinical Benefit Scale
Consider systems-level guidelines and recommend evidence-based structural interventions to navigate cost issues and improve access	• Patient navigator and pharmacist programs in cardiovascular clinics
Consider highlighting important advocacy opportunities or policy issues in CGDs to promote cost-management interventions or systems	• ACC's 2017 and 2021 ECDs for Optimizing HF Care suggested advocacy for automatic transparent cost-sharing systems • ESC's 2019 clinical practice update for HF used informal sections, such as "Practical Comments." alongside guidance recommendations to subserve discussion of cost-related or advocacy issues

ACC = American College of Cardiology; AHA = American Heart Association; AUC = appropriate use criteria; CGD = clinical guidance document; ECD = expert consensus document; ESC = European Society of Cardiology; HF = heart failure; LOV = level of value; NICE = National Institute for Health and Care Excellence; PCSK9 = proprotein convertase subtilisin/kexin type 9.

Table 2. Median Monthly Cost of Selected Pharmacologic Therapies for HFrEF in the United States
Class	Compound(s)	Dosage Strength, mg	Median AWP (min-max), $^a	Median NADAC, $^a	Medicare Part D Coverage, %^b	Copayment Range, $^b	Target Daily Dose^c
β-Blocker	Bisoprolol	5	68 (37–68)	14	99	0–1	10 mg once daily
	Bisoprolol	10	68 (37–68)	15	99	0–1	10 mg once daily
	Carvedilol	3.125	127 (3–128)	1	100	0–1	25–50 mg twice daily
		6.25	127 (3–128)	1	100	0–1
		12.5	127 (3–128)	2	100	0–1
		25	128 (4–128)	2	100	0–1
	Metoprolol succinate	25	32 (5–106)	4	100	0–1	200 mg once daily
		50	33 (9–84)	4	100	0–1
		100	48 (9–88)	6	100	0–1
		200	76 (9–92)	14	100	0–2
Vasodilators	Hydralazine	10	36 (11–37)	4	100	0–1	75 mg 3 times daily
		25	46 (13–46)	4	100	0–1
		50	51 (15–51)	5	100	0–1
		100	91 (25–91)	9	100	0–1
	Isosorbide dinitrate	5	89 (85–89)	33	99	0–57	40 mg 3 times daily
		10	98 (66–98)	35	99	1–85
		20	107 (77–107)	37	99	1–62
		30	118 (118–140)	51	96	1–38
		40	1,904 (1,849–1,960)	—	88	0–1,960
ACE Inhibitors	Captopril^d	12.5	140 (108–154)	63	92	0–58	50 mg 3 times daily
		25	150 (59–168)	62	92	0–61
		50	261 (128–261)	75	92	0–101
	Enalapril^e	2.5	79 (11–87)	10	100	0–1	10–20 mg twice daily
		5	102 (15–111)	9	100	0–1
		10	117 (15–117)	8	100	0–1
		20	157 (22–166)	12	100	0–1
	Lisinopril	2.5	19 (190 20)	1	100	0–1	20–40 mg once daily
		5	29 (2–29)	1	100	0–1
		10	30 (2–30)	1	100	0–1
		20	32 (2–32)	1	100	0–1
		30	45 (43–45)	2	100	0–1
		40	46 (5–47)	1	100	0–1
ARB	Losartan	25	50 (5–92)	2	100	0–1	150 mg once daily
		50	69 (5–73)	3	100	0–1
		100	92 (6–99)	4	100	0–1
	Valsartan	40	233 (97–700)	14	99	0–1	160 mg twice daily
		80	278 (116–367)	16	99	0–1
		160	300 (125–395)	16	99	0–1
ARNI	Sacubitril/valsartan	24–26	699	559	100	1–10	97–103 mg twice daily
		49–51	699	559	100	1–10
		97–103	699	559	100	1–10
SGLT2 Inhibitor	Dapagliflozin	10	639	511	45	5–613	10 mg once daily
SGLT2 Inhibitor	Empagliflozin	10	658	526	93	3–19	10 mg once daily
MRA	Eplerenone	25	125 (123–130)	30	92	1–50	50 mg once daily
	Eplerenone	50	125 (125–130)	30	92	1–50	50 mg once daily
	Spironolactone	25	13 (6–14)	2	100	0–1	25–50 mg once daily
	Spironolactone	50	24 (23–26)	4	100	0–1	25–50 mg once daily
Selective I_f Inhibitor	Ivabradine	5	590	470	100	2–9	Target HR 50–60 beats/min; max dose 7.5 mg twice daily
Selective I_f Inhibitor	Ivabradine	7.5	590	476	100	2–8	Target HR 50–60 beats/min; max dose 7.5 mg twice daily
sGC Stimulator	Vericiguat	2.5	699	—	0	714	Max dose 10 mg once daily
		5	699	—	0	714
		10	699	—	0	714

Prices are n or median (IQR), unless otherwise indicated. ^aCalculated for 30-day supply (AWP or NADAC unit price × number of doses/day × 30 day); median AWP or NADAC listed alone if only 1 product/price available. Used NADAC unit prices published in February 2021. Generic prices used if commercially available. ^bPercent Medicare Part D and Medicare Advantage plans covering selected drug and typical copayment ranges for monthly supply of selected drug obtained through GoodRx. ^cTarget doses of selected agents extracted from Maddox et al (1). ^dPrices calculated for 3 times daily dosing. ^ePrices calculated for twice daily dosing.
ACE = angiotensin-converting enzyme; ARB = angiotensin receptor blocker; ARNI = angiotensin receptor and neprilysin inhibitor; AWP = average wholesale price; I_f = funny current; HFrEF = heart failure with reduced ejection fraction; max = maximum; min = minimum; MRA = mineralocorticoid antagonist; NADAC = National Average Drug Acquisition Cost; sGC = soluble guanylate cyclase; SGLT2 = sodium-glucose cotransporter 2.

Authors and Disclosures

John W. Ostrominski, MD^a, Sameer Hirji, MD, MPH^b, Ankeet S. Bhatt, MD, MBA^a, Javed Butler, MD, MPH, MBA^c, Mona Fiuzat, PHARMD^d, Gregg C. Fonarow, MD^e, Paul A. Heidenreich, MD, MS^f, James L. Januzzi, JR, MD^g,h, Carolyn S.P. Lam, MBBS, PHDⁱ, Thomas M. Maddox, MD, MS^j,k, Christopher M. O'Connor, MD^d,l and Muthiah Vaduganathan, MD, MPH^a

^aDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; ^bDivision of Cardiac Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; ^cDepartment of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi, USA; ^dDivision of Cardiology, Duke University, Durham, North Carolina, USA; ^eAhmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, California, USA; ^fDivision of Cardiovascular Medicine, Stanford Cardiovascular Institute, Stanford University, Stanford, California, USA; ^gDivision of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; ^hBaim Institute for Clinical Research, Boston, Massachusetts, USA; ⁱNational Heart Centre Singapore, Duke-National University of Singapore, Singapore; ^jDivision of Cardiology, Washington University School of Medicine in St Louis, St Louis, Missouri, USA; ^kHealthcare Innovation Lab, BJC HealthCare/Washington University School of Medicine, St Louis, Missouri, USA; and the ^lInova Heart and Vascular Institute, Falls Church, Virginia, USA.

Address for Correspondence
Dr Muthiah Vaduganathan, Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, Massachusetts 02115, USA. E-mail: mvaduganathan@bwh.harvard.edu.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors' institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

Funding Support and Author Disclosures
Dr Bhatt has received an honorarium from Sanofi Pasteur; and is supported by National Heart, Lung and Blood Institute T32 postdoctoral training grant T32HL094301. Dr Butler has received personal fees as a consultant from Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Berlin Cures, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceuticals, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Roche, Sanofi, SC Pharma, V-Wave Limited, and Vifor outside the submitted work. Dr Fonarow has received consulting fees from Abbott, Amgen, AstraZeneca, Bayer, CHF Solutions, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr Januzzi is supported in part by the Hutter Family Professorship; is a Trustee of the American College of Cardiology; has received grant support from Novartis Pharmaceuticals, Innolife, Applied Therapeutics, and Abbott Diagnostics; consulting income from Abbott, Janssen, Novartis, Pfizer, Merck, and Roche Diagnostics; and participated in clinical end point committees or data safety monitoring boards for Abbott, AbbVie, Amgen, Bayer, CVRx, and Takeda. Dr Lam is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; served as consultant or on the advisory board, steering committee, or executive committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, Darma, Applied Therapeutics, MyoKardia, WebMD Global, Radcliffe Group, and Corpus. Dr Maddox has received funding from the National Institutes of Health National Center for Advancing Translational Sciences (grant 1U24TR002306-01) and honoraria and/or expense reimbursement in the past 3 years from New York Presbyterian, Westchester Medical Center, Sentara Heart Hospital, the Henry Ford Health System, and the University of California, San Diego; advises Myia Labs in his role as a cardiologist and the executive director of the Healthcare Innovation Lab at BJC HealthCare/Washington University School of Medicine, for which his employer receives equity compensation in the company; and receives no individual compensation from the company; he is also a compensated director of a New Mexico–based foundation, the J.F. Maddox Foundation. Dr Vaduganathan has received research grant support from or has served on advisory boards of American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Relypsa, and Roche Diagnostics; has had speaker engagements with Novartis and Roche Diagnostics; and participates on clinical end point committees for studies sponsored by Galmed and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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