Chronic Heart Failure Market and Forecast Analysis to 2024
Author: Hannah Cohen, Niharika Dandamudi, Louisa Joseph
Publisher: Datamonitor Healthcare
- Highlights
- Description
- Contents
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Key Questions Answered
- Why is uptake of Entresto on the rise?
- Why did Corlanor fail to alter the current CHF treatment paradigm?
- What are the current unmet needs in CHF?
- Which pipeline candidates will differentiate themselves from marketed therapies, allowing them to make an impact on current treatment practices?
- Which SGLT-2 inhibitor will gain the greatest share of the CHF market?
Market Highlights
- Increasing disease prevalence and uptake of branded therapies will result in considerable growth of the CHF market over the 2017–26 forecast period, with sales increasing from $2.9bn to $8.3bn.
- Entresto has now overcome initial barriers in the form of reimbursement delays and physicians’ reluctance to shift from traditional treatment practices. Its sales have risen to over $1,028m in 2018, primarily driven by the class I recommendation in US and EU treatment guidelines.
- Current treatment practices for CHF are dominated by generic therapies, placing pressure on the pipeline to demonstrate strong cost/efficacy profiles.
- Despite the dominance of generics, there is significant commercial potential for novel therapies that demonstrate a benefit in patients with CHF with preserved ejection fraction, which accounts for 50% of the CHF population. This is a major unmet need as the heterogenous nature of the disease renders it difficult to identify promising modes of action.
- The high co-occurrence of diabetes with CHF means that the cardiovascular benefit of SGLT-2 inhibitors could facilitate significant uptake in this population. Studies investigating use in non-diabetic populations could further expand the target population.
Disease Overview
Chronic heart failure (CHF) is a serious medical condition in which the heart is unable to adequately fill with and eject blood. CHF can result from functional abnormalities such as ventricular dysfunction or arrhythmias, but structural disorders of the heart muscle or valves are also common causes. While current therapies have helped to improve patient outcomes, CHF still remains a major public health issue and is associated with high mortality rates and a poor prognosis.
Market Snapshot
- Increased use of Entresto and a full pipeline will revitalize the mature CHF market.
- Novel CHF treatments have yet to alter prescribing practices from traditional ACE inhibitors and beta blockers.
- CHF prevalence rises with age, with 55–84 years comprising three-quarters of all diagnosed prevalent cases in adults.
- Entresto has overcome initial barriers to uptake and has the potential to change CHF treatment practices.
- Despite a full pipeline it is unlikely that any candidates have the potential to significantly change treatment practices.
- Entresto’s budget impact is moderate due to lower than expected physician uptake.
CONTENTS
12 FORECAST: CHRONIC HEART FAILURE (Published on 21 March 2019)
12 OVERVIEW
13 RECENT FORECAST UPDATES
14 MARKET DYNAMICS
23 FORECAST AND FUTURE TRENDS
33 MARKET DEFINITION AND METHODOLOGY
39 PRIMARY RESEARCH METHODOLOGY
43 BIBLIOGRAPHY
47 PRODUCT PROFILE: CORLANOR
58 PRODUCT PROFILE: ENTRESTO
72 PRODUCT PROFILE (LATE STAGE): FARXIGA
84 PRODUCT PROFILE (LATE STAGE): JARDIANCE
94 PRODUCT PROFILE (LATE STAGE): OMECAMTIV MECARBIL
104 PRODUCT PROFILE (LATE STAGE): VERICIGUAT
114 TREATMENT: CHRONIC HEART FAILURE (Published on 21 March 2019)
114 OVERVIEW
116 PRIMARY RESEARCH METHODOLOGY
118 DISEASE DEFINITION AND DIAGNOSIS
125 PATIENT SEGMENTATION
133 CURRENT TREATMENT OPTIONS
136 PRESCRIBING TRENDS: CHF WITH REDUCED EJECTION FRACTION
154 PRESCRIBING TRENDS: CHF WITH PRESERVED EJECTION FRACTION
168 COMPLIANCE RATES
169 EPIDEMIOLOGY: CHRONIC HEART FAILURE (Published on 03 January 2019)
169 OVERVIEW
170 DISEASE BACKGROUND
172 METHODOLOGY
179 FORECAST
184 BIBLIOGRAPHY
186 APPENDIX: ADDITIONAL SOURCES
188 MARKETED DRUGS: CHRONIC HEART FAILURE (Published on 21 March 2019)
188 OVERVIEW
189 PRODUCT OVERVIEW
191 ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
195 ANGIOTENSIN RECEPTOR BLOCKERS
197 BETA BLOCKERS
200 ALDOSTERONE ANTAGONISTS
202 OTHER DRUG CLASSES
204 PRODUCT PROFILE: CORLANOR
215 PRODUCT PROFILE: ENTRESTO
229 CHRONIC HEART FAILURE PRICING, REIMBURSEMENT, AND ACCESS (Published on 13 April 2018)
229 OVERVIEW
230 EXECUTIVE SUMMARY
231 REGULATORY LABELS AND GUIDELINES
234 GLOBAL ACCESS LEVERS
242 EVIDENCE AND VALUE
253 ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS
257 PRICING
258 US
266 CANADA
270 FRANCE
277 GERMANY
282 ITALY
285 SPAIN
288 UK
296 METHODOLOGY
299 PIPELINE: CHRONIC HEART FAILURE (Published on 21 March 2019)
299 OVERVIEW
300 CLINICAL PIPELINE OVERVIEW
301 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES
302 PRODUCT PROFILE (LATE STAGE): ARRY-797
310 PRODUCT PROFILE (LATE STAGE): FARXIGA
322 PRODUCT PROFILE (LATE STAGE): JARDIANCE
332 PRODUCT PROFILE (LATE STAGE): MPC-150-IM
340 PRODUCT PROFILE (LATE STAGE): MAVACAMTEN
352 PRODUCT PROFILE (LATE STAGE): OMECAMTIV MECARBIL
362 PRODUCT PROFILE (LATE STAGE): VERICIGUAT
LIST OF FIGURES
15 Figure 1: Datamonitor Healthcare’s assessment summary of key marketed and pipeline drugs for chronic heart failure
24 Figure 2: Chronic heart failure drug sales across the US, Japan, and five major EU markets, by country, 2017–26
25 Figure 3: Entresto sales for chronic heart failure across the US, Japan, and five major EU markets, by country, 2017–26
26 Figure 4: Sales of Jardiance and Farxiga in the US, Japan, and five major EU markets, 2017–26
28 Figure 5: Sales of vericiguat and omecamtiv mecarbil in the US, Japan, and five major EU markets, 2017–26
29 Figure 6: Chronic heart failure drug sales in the US, by class, 2017–26
30 Figure 7: Chronic heart failure drug sales in the five major EU markets, by country, 2017–26
31 Figure 8: Chronic heart failure drug sales in the five major EU markets, by class, 2017–26
32 Figure 9: Chronic heart failure drug sales in Japan, by class, 2017–26
35 Figure 10: Methodology flow for Datamonitor Healthcare’s chronic heart failure forecast
37 Figure 11: Price sources and calculations, by country
53 Figure 12: Datamonitor Healthcare’s drug assessment summary of Corlanor for CHF
54 Figure 13: Datamonitor Healthcare’s drug assessment summary of Corlanor for CHF
56 Figure 14: Corlanor sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
66 Figure 15: Datamonitor Healthcare’s drug assessment summary of Entresto for CHF
67 Figure 16: Datamonitor Healthcare’s drug assessment summary of Entresto for CHF
70 Figure 17: Entresto sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
78 Figure 18: Datamonitor Healthcare’s drug assessment summary of Farxiga for CHF
79 Figure 19: Datamonitor Healthcare’s drug assessment summary of Farxiga for CHF
82 Figure 20: Farxiga sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
89 Figure 21: Datamonitor Healthcare’s drug assessment summary of Jardiance for CHF
90 Figure 22: Datamonitor Healthcare’s drug assessment summary of Jardiance for CHF
92 Figure 23: Jardiance sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
99 Figure 24: Datamonitor Healthcare’s drug assessment summary of omecamtiv mecarbil for CHF
100 Figure 25: Datamonitor Healthcare’s drug assessment summary of omecamtiv mecarbil for CHF
102 Figure 26: Omecamtiv mecarbil sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
110 Figure 27: Datamonitor Healthcare’s drug assessment summary of vericiguat for CHF
111 Figure 28: Datamonitor Healthcare’s drug assessment summary of vericiguat for CHF
113 Figure 29: Vericiguat sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
121 Figure 30: Diagnostic flow chart for patients with suspected heart failure
122 Figure 31: Percentage incidence of co-morbidities among chronic heart failure patients in the US, Japan, and five major EU markets, by co-morbidity/risk factor
123 Figure 32: Percentage of CHF patients across the US, Japan, and five major EU markets who are over the age of 65, diagnosed with hypertension, or diagnosed with CAD
127 Figure 33: Percentage of CHF patients diagnosed with HFrEF and HFpEF across the US, Japan, and five major EU markets, by country
130 Figure 34: Percentage of patients with HFrEF in each NYHA class, by country
131 Figure 35: Percentage of patients with HFpEF in each NYHA class, by country
137 Figure 36: Percentage of HFrEF patients receiving each treatment type, by NYHA class
139 Figure 37: Percentage of regimens containing ACE inhibitors for the first-line treatment of HFrEF, by NYHA class and country
140 Figure 38: Percentage of regimens containing beta blockers for the first-line treatment of HFrEF, by NYHA class and country
141 Figure 39: Percentage of regimens containing ARBs for the first-line treatment of HFrEF, by NYHA class and country
142 Figure 40: Percentage of regimens containing ARBs for the treatment of HFrEF, by NYHA class and line of treatment
143 Figure 41: Percentage of regimens containing diuretics for the first-line treatment of HFrEF, by country and NYHA class
144 Figure 42: Percentage of regimens containing MRAs for the first-line treatment of HFrEF, by country and NYHA class
145 Figure 43: Percentage of regimens containing SGLT-2 inhibitors for the first-line treatment of HFrEF, by country and NYHA class
146 Figure 44: Percentage of regimens containing the SGLT-2 inhibitors Jardiance and Farxiga for the first-line treatment of HFrEF, by NYHA class
147 Figure 45: Top three drug regimens for first-line treatment of class I HFrEF, by country
148 Figure 46: Top three drug regimens for second-line treatment of class I HFrEF, by country
149 Figure 47: Top three drug regimens for first-line treatment of class II–III HFrEF, by country
150 Figure 48: Top three drug regimens for second-line treatment of class II–III HFrEF, by country
151 Figure 49: Top three drug regimens for first-line treatment of class IV HFrEF, by country
152 Figure 50: Top three drug regimens for second-line treatment of class IV HFrEF, by country
155 Figure 51: Percentage of HFpEF patients receiving each treatment type, by NYHA class
156 Figure 52: Percentage of regimens containing ACE inhibitors for the first-line treatment of HFpEF, by NYHA class and country
157 Figure 53: Percentage of regimens containing ARBs for the first-line treatment of HFpEF, by NYHA class and country
158 Figure 54: Percentage of regimens containing beta blockers for the first-line treatment of HFpEF, by country and NYHA class
159 Figure 55: Percentage of regimens containing diuretics for the first-line treatment of HFpEF, by country and NYHA class
160 Figure 56: Percentage of regimens containing MRAs for the first-line treatment of HFpEF, by country and NYHA class
161 Figure 57: Top three drug regimens for first-line treatment of class I HFpEF, by country
162 Figure 58: Top three drug regimens for second-line treatment of class I HFpEF, by country
163 Figure 59: Top three drug regimens for first-line treatment of class II–III HFpEF, by country
164 Figure 60: Top three drug regimens for second-line treatment of class II–III HFpEF, by country
165 Figure 61: Top three drug regimens for first-line treatment of class IV HFpEF, by country
166 Figure 62: Top three drug regimens for second-line treatment of class IV HFpEF, by country
168 Figure 63: Compliance rates of chronic heart failure patients in the US, Japan, and five major EU markets, by country and ejection fraction
183 Figure 64: Trends in diagnosed prevalent cases of CHF in the US, Japan, and five major EU markets, by country, 2018–38
210 Figure 65: Datamonitor Healthcare’s drug assessment summary of Corlanor for CHF
211 Figure 66: Datamonitor Healthcare’s drug assessment summary of Corlanor for CHF
213 Figure 67: Corlanor sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
223 Figure 68: Datamonitor Healthcare’s drug assessment summary of Entresto for CHF
224 Figure 69: Datamonitor Healthcare’s drug assessment summary of Entresto for CHF
227 Figure 70: Entresto sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
232 Figure 71: European Society of Cardiology Heart Failure guidelines
233 Figure 72: American College of Cardiology/American Heart Association/Heart Failure Society of America guidelines
297 Figure 73: Price sources and calculations for the US and EU, by country
307 Figure 74: Datamonitor Healthcare’s drug assessment summary of ARRY-797 for CHF
308 Figure 75: Datamonitor Healthcare’s drug assessment summary of ARRY-797 for CHF
316 Figure 76: Datamonitor Healthcare’s drug assessment summary of Farxiga for CHF
317 Figure 77: Datamonitor Healthcare’s drug assessment summary of Farxiga for CHF
320 Figure 78: Farxiga sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
327 Figure 79: Datamonitor Healthcare’s drug assessment summary of Jardiance for CHF
328 Figure 80: Datamonitor Healthcare’s drug assessment summary of Jardiance for CHF
330 Figure 81: Jardiance sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
337 Figure 82: Datamonitor Healthcare’s drug assessment summary of MPC-150-IM for CHF
338 Figure 83: Datamonitor Healthcare’s drug assessment summary of MPC-150-IM for CHF
349 Figure 84: Datamonitor Healthcare’s drug assessment summary of mavacamten for CHF
350 Figure 85: Datamonitor Healthcare’s drug assessment summary of mavacamten for CHF
357 Figure 86: Datamonitor Healthcare’s drug assessment summary of omecamtiv mecarbil for CHF
358 Figure 87: Datamonitor Healthcare’s drug assessment summary of omecamtiv mecarbil for CHF
360 Figure 88: Omecamtiv mecarbil sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
368 Figure 89: Datamonitor Healthcare’s drug assessment summary of vericiguat for CHF
369 Figure 90: Datamonitor Healthcare’s drug assessment summary of vericiguat for CHF
371 Figure 91: Vericiguat sales for CHF across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
14 Table 1: Chronic heart failure – current and future market dynamics analysis
38 Table 2: Exchange rates used for calculating prices
40 Table 3: Cardiologists surveyed for the chronic heart failure primary research study, 2018
40 Table 4: Cardiologists surveyed for the chronic heart failure primary research study, 2017
48 Table 5: Corlanor drug profile
49 Table 6: Approval history of Corlanor for CHF in the US and major EU markets
50 Table 7: Corlanor pivotal trials for CHF
52 Table 8: Corlanor for CHF – SWOT analysis
59 Table 9: Entresto drug profile
59 Table 10: Approval history of Entresto for CHF in the US and major EU markets
61 Table 11: Entresto pivotal trials for CHF
64 Table 12: Entresto for CHF – SWOT analysis
73 Table 13: Farxiga drug profile
75 Table 14: Farxiga pivotal trials for CHF
77 Table 15: Farxiga for CHF – SWOT analysis
85 Table 16: Jardiance drug profile
87 Table 17: Jardiance pivotal trials for CHF
88 Table 18: Jardiance for CHF – SWOT analysis
95 Table 19: Omecamtiv mecarbil drug profile
97 Table 20: Omecamtiv mecarbil pivotal trials for CHF
98 Table 21: Omecamtiv mecarbil for CHF – SWOT analysis
105 Table 22: Vericiguat drug profile
107 Table 23: Vericiguat pivotal trial for CHF
109 Table 24: Vericiguat early trials for CHF
109 Table 25: Vericiguat for CHF – SWOT analysis
116 Table 26: Cardiologists surveyed for the chronic heart failure primary research study, 2017
119 Table 27: Common laboratory test abnormalities in chronic heart failure
125 Table 28: Definitions of HFrEF and HFpEF
128 Table 29: New York Heart Association functional classification based on severity of symptoms and physical activity
129 Table 30: Comparison of ACCF/AHA stages of HF with NYHA functional classification
134 Table 31: Treatments available for chronic heart failure across the US, Japan, and five major EU markets
170 Table 32: NYHA functional classes I–IV, classification summary
173 Table 33: Sources used for the epidemiological analysis of CHF in the US, Japan, and five major EU markets, by country
175 Table 34: Sources used for the previous epidemiological analysis of CHF in the US, Japan, and five major EU markets, by country (published 9 October 2017)
180 Table 35: Diagnosed prevalent cases of CHF in the US, Japan, and five major EU markets, by country, 2018–38
190 Table 36: Profiled key marketed drugs for chronic heart failure
191 Table 37: Angiotensin-converting enzyme inhibitors in CHF, class overview
195 Table 38: Angiotensin receptor blockers in CHF, class overview
197 Table 39: Beta blockers in CHF, class overview
200 Table 40: Aldosterone antagonists in CHF, class overview
202 Table 41: Other drug class overview
205 Table 42: Corlanor drug profile
206 Table 43: Approval history of Corlanor for CHF in the US and major EU markets
207 Table 44: Corlanor pivotal trials for CHF
209 Table 45: Corlanor for CHF – SWOT analysis
216 Table 46: Entresto drug profile
216 Table 47: Approval history of Entresto for CHF in the US and major EU markets
218 Table 48: Entresto pivotal trials for CHF
221 Table 49: Entresto for CHF – SWOT analysis
231 Table 50: Regulatory labels for Entresto in the US, Japan, and five major EU markets
237 Table 51: Reimbursement restrictions for Entresto across the US and five surveyed EU markets
238 Table 52: Primary and secondary care prescribing of Entresto in the five major EU markets
240 Table 53: Use of efficiency audits for Entresto in the five major EU markets
243 Table 54: Payer concerns surrounding the Phase III PARADIGM-HF patient population
245 Table 55: Payer views on the primary and secondary endpoints used in the Phase III PARADIGM-HF trial
246 Table 56: Impact of reduction in CHF hospitalization for Entresto across the US and five major EU markets
249 Table 57: Impact of Entresto’s HRQoL benefits across the five major EU markets
255 Table 58: Benefits of Jardiance versus Entresto
257 Table 59: Pricing of Entresto in the US and five major EU markets, by country
259 Table 60: Formulary placement of Entresto in selected commercial formularies
261 Table 61: Formulary placement of Entresto in selected Medicare Part D formularies
263 Table 62: Prior authorization criteria for Entresto in eight major health plans
267 Table 63: CADTH assessment of Entresto
271 Table 64: Transparency Committee’s ASMR ratings and pricing implications
271 Table 65: Transparency Committee’s SMR ratings and pricing implications
272 Table 66: Transparency Committee’s assessment of Entresto
279 Table 67: G-BA assessment of Entresto
283 Table 68: Reimbursement conditions for Entresto in Italy
286 Table 69: National and regional reimbursement decisions in Spain
289 Table 70: NICE assessment of Entresto
293 Table 71: SMC assessment of Entresto
298 Table 72: Exchange rates used for calculating branded drug prices
300 Table 73: Profiled pipeline products in development for chronic heart failure
303 Table 74: ARRY-797 drug profile
305 Table 75: ARRY-797 clinical trials for CHF
306 Table 76: ARRY-797 for CHF – SWOT analysis
311 Table 77: Farxiga drug profile
313 Table 78: Farxiga pivotal trials for CHF
315 Table 79: Farxiga for CHF – SWOT analysis
323 Table 80: Jardiance drug profile
325 Table 81: Jardiance pivotal trials for CHF
326 Table 82: Jardiance for CHF – SWOT analysis
333 Table 83: MPC-150-IM drug profile
335 Table 84: MPC-150-IM clinical trials for CHF
336 Table 85: MPC-150-IM for CHF – SWOT analysis
341 Table 86: Mavacamten drug profile
344 Table 87: Mavacamten pivotal trial for CHF
346 Table 88: Mavacamten Phase II trials for CHF
347 Table 89: Mavacamten for CHF – SWOT analysis
353 Table 90: Omecamtiv mecarbil drug profile
355 Table 91: Omecamtiv mecarbil pivotal trials for CHF
356 Table 92: Omecamtiv mecarbil for CHF – SWOT analysis
363 Table 93: Vericiguat drug profile
365 Table 94: Vericiguat pivotal trial for CHF
367 Table 95: Vericiguat early trials for CHF
367 Table 96: Vericiguat for CHF – SWOT analysis
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