Chronic Heart Failure Pricing, Reimbursement, and Access
Chronic Heart Failure Pricing, Reimbursement, and Access
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Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected.
Publisher: Datamonitor Healthcare
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Overview
Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected. Payers suggest that it will take some time for routine prescribing habits to change to incorporate Entresto, as physicians have been treating chronic heart failure patients with cheap angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for many years. If physicians begin requesting Entresto on a frequent basis, then payers across the US and five major EU markets (France, Germany, Italy, Spain, and the UK) indicate that their approaches to the drug’s reimbursement may change.
Payers across Europe and the US have implemented patient population and line of therapy restrictions for Entresto, to various degrees, which tend to be in line with the patient characteristics of the Phase III PARADIGM-HF trial. However, access to Entresto in the first-line treatment setting is significantly more open in the US than in Europe, suggesting that US insurers are not as concerned about the potential budget impact of Entresto. This is likely due to the low physician demand for the product, the deterrent of high patient co-pay, and/or the drug’s relatively reasonable cost in comparison to other cardiovascular therapies such as the proprotein convertase subtilisin kexin 9 inhibitors. In addition to patient population and line of therapy restrictions, the majority of the markets surveyed by Datamonitor Healthcare also require Entresto to be prescribed initially by a hospital specialist.
CONTENTS
7 OVERVIEW
8 EXECUTIVE SUMMARY
9 REGULATORY LABELS AND GUIDELINES
9 Regulatory labels for Entresto
9 CHF guidelines
11 Bibliography
12 GLOBAL ACCESS LEVERS
12 Insights and strategic recommendations
12 The level of concern surrounding Entresto’s budget impact is moderate as physicians have been slow to adopt
14 Payers have imposed patient population and line of therapy restrictions on Entresto in all surveyed markets
15 Many European countries restrict Entresto’s prescription to specialist physicians
18 Efficiency audits may be imposed if usage increases dramatically
20 EVIDENCE AND VALUE
20 Insights and strategic recommendations
20 PARADIGM-HF patient population guides reimbursement restrictions
22 Payers deem PARADIGM-HF endpoints to be acceptable, but highlight certain areas for improvement
29 Real-world evidence data will likely bolster physician and payer confidence in Entresto; unlikely to impact pricing
29 Bibliography
31 ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS
31 Insights and strategic recommendations
31 Payer appetite for Entresto in preserved ejection fraction is high
32 Payers and physicians may favor Jardiance if the therapy demonstrates comparable CV benefits in CHF patients
33 Omecamtiv mecarbil’s success may lie with unstable CHF patients
33 Bibliography
35 PRICING
36 US
36 Insights and strategic recommendations
36 Commercial formularies include Entresto but vary in their tier positioning
37 Out-of-pocket costs and risk of entering the donut hole are likely to be disincentives for Medicare patients
39 Prior authorization criteria for Entresto are not overly restrictive
41 Positive ICER findings likely to increase payer acceptance of Entresto
41 Novartis has entered into multiple outcomes-based contracts for Entresto
42 Bibliography
44 CANADA
47 Bibliography
48 FRANCE
48 Insights and strategic recommendations
48 ASMR rating has an impact on pricing
53 The price of Entresto has not yet been negotiated in France, but the drug is available under the post-ATU scheme
54 Bibliography
55 GERMANY
55 Insights and strategic recommendations
55 Positive assessment from the G-BA will impact price negotiations
59 Bibliography
60 ITALY
60 Insights and strategic recommendations
60 AIFA decides to reimburse Entresto
62 Bibliography
63 SPAIN
63 Insights and strategic recommendations
63 Reimbursement is dictated by both national and regional bodies
64 National and regional bodies enforce similar patient population and line of therapy restrictions for Entresto
65 Bibliography
66 UK
66 Insights and strategic recommendations
66 NICE and SMC determinations drive reimbursement decisions
71 Payers restrict Entresto initiation to secondary care, but longer-term shared-care agreements are in place
73 CCGs offer more detailed advice on prior ACE inhibitor treatment than NICE
73 Bibliography
74 METHODOLOGY
74 Primary research
74 Price assumptions
75 Exchange rates
76 Bibliography
LIST OF FIGURES
10 Figure 1: European Society of Cardiology Heart Failure guidelines
11 Figure 2: American College of Cardiology/American Heart Association/Heart Failure Society of America guidelines
75 Figure 3: Price sources and calculations for the US and EU, by country
LIST OF TABLES
9 Table 1: Regulatory labels for Entresto in the US, Japan, and five major EU markets
15 Table 2: Reimbursement restrictions for Entresto across the US and five surveyed EU markets
16 Table 3: Primary and secondary care prescribing of Entresto in the five major EU markets
18 Table 4: Use of efficiency audits for Entresto in the five major EU markets
21 Table 5: Payer concerns surrounding the Phase III PARADIGM-HF patient population
23 Table 6: Payer views on the primary and secondary endpoints used in the Phase III PARADIGM-HF trial
24 Table 7: Impact of reduction in CHF hospitalization for Entresto across the US and five major EU markets
27 Table 8: Impact of Entresto’s HRQoL benefits across the five major EU markets
33 Table 9: Benefits of Jardiance versus Entresto
35 Table 10: Pricing of Entresto in the US and five major EU markets, by country
37 Table 11: Formulary placement of Entresto in selected commercial formularies
39 Table 12: Formulary placement of Entresto in selected Medicare Part D formularies
41 Table 13: Prior authorization criteria for Entresto in eight major health plans
45 Table 14: CADTH assessment of Entresto
49 Table 15: Transparency Committee’s ASMR ratings and pricing implications
49 Table 16: Transparency Committee’s SMR ratings and pricing implications
50 Table 17: Transparency Committee’s assessment of Entresto
57 Table 18: G-BA assessment of Entresto
61 Table 19: Reimbursement conditions for Entresto in Italy
64 Table 20: National and regional reimbursement decisions in Spain
67 Table 21: NICE assessment of Entresto
71 Table 22: SMC assessment of Entresto
76 Table 23: Exchange rates used for calculating branded drug prices
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