Chronic Heart Failure Pricing, Reimbursement, and Access

  • ID: 4533518
  • Report
  • 79 pages
  • 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. Entresto should be prescribed initially by a hospital specialist.

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OVERVIEW

EXECUTIVE SUMMARY

REGULATORY LABELS AND GUIDELINES

  • Regulatory labels for Entresto
  • CHF guidelines
  • Bibliography

GLOBAL ACCESS LEVERS AND BARRIERS

  • Insights and strategic recommendations
  • The level of concern surrounding Entresto’s budget impact is moderate as physicians have been slow to adopt
  • Payers have imposed patient population and line of therapy restrictions on Entresto in all surveyed markets
  • Many European countries restrict Entresto’s prescription to specialist physicians
  • Efficiency audits may be imposed if usage increases dramatically

EVIDENCE AND VALUE

  • Insights and strategic recommendations
  • PARADIGM-HF patient population guides reimbursement restrictions
  • Payers deem PARADIGM-HF endpoints to be acceptable, but highlight certain areas for improvement
  • Real-world evidence data will likely bolster physician and payer confidence in Entresto; unlikely to impact pricing
  • Bibliography

RECENTLY APPROVED AND PIPELINE PRODUCTS

  • Insights and strategic recommendations
  • Payer appetite for Entresto in preserved ejection fraction is high
  • Payers and physicians may favor Jardiance if the therapy demonstrates comparable CV benefits in CHF patients
  • Omecamtiv mecarbil’s success may lie with unstable CHF patients
  • Bibliography

US PRICING

US REIMBURSEMENT

  • Insights and strategic recommendations
  • Commercial formularies include Entresto but vary in their tier positioning
  • Out-of-pocket costs and risk of entering the donut hole are likely to be disincentives for Medicare patients
  • Prior authorization criteria for Entresto are not overly restrictive
  • Positive ICER findings likely to increase payer acceptance of Entresto
  • Novartis has entered into multiple outcomes-based contracts for Entresto
  • Bibliography

CANADA

  • Bibliography

PRICING IN THE FIVE MAJOR EU MARKETS

FRANCE

  • Insights and strategic recommendations
  • ASMR rating has an impact on pricing
  • The price of Entresto has not yet been negotiated in France, but the drug is available under the post-ATU scheme
  • Bibliography

GERMANY

  • Insights and strategic recommendations
  • Positive assessment from the G-BA will impact price negotiations
  • Bibliography

ITALY

  • Insights and strategic recommendations
  • AIFA decides to reimburse Entresto
  • Bibliography

SPAIN

  • Insights and strategic recommendations
  • Reimbursement is dictated by both national and regional bodies
  • National and regional bodies enforce similar patient population and line of therapy restrictions for Entresto
  • Bibliography

UK

  • Insights and strategic recommendations
  • NICE and SMC determinations drive reimbursement decisions
  • Payers restrict Entresto initiation to secondary care, but longer-term shared-care agreements are in place
  • CCGs offer more detailed advice on prior ACE inhibitor treatment than NICE
  • Bibliography

METHODOLOGY

  • Primary research
  • Price assumptions
  • Exchange rates
  • Bibliography

List of Figures
Figure 1: European Society of Cardiology Heart Failure guidelines
Figure 2: American College of Cardiology/American Heart Association/Heart Failure Society of America guidelines
Figure 3: Price sources and calculations for the US and EU, by country

List of Tables
Table 1: Regulatory labels for Entresto in the US, Japan, and five major EU markets
Table 2: Reimbursement restrictions for Entresto across the US and five surveyed EU markets
Table 3: Primary and secondary care prescribing of Entresto in the five major EU markets
Table 4: Use of efficiency audits for Entresto in the five major EU markets
Table 5: Payer concerns surrounding the Phase III PARADIGM-HF patient population
Table 6: Payer views on the primary and secondary endpoints used in the Phase III PARADIGM-HF trial
Table 7: Impact of reduction in CHF hospitalization for Entresto across the US and five major EU markets
Table 8: Impact of Entresto’s HRQoL benefits across the five major EU markets
Table 9: Benefits of Jardiance versus Entresto
Table 10: US pricing of Entresto
Table 11: Formulary placement of Entresto in selected commercial formularies
Table 12: Formulary placement of Entresto in selected Medicare Part D formularies
Table 13: Prior authorization criteria for Entresto in eight major health plans
Table 14: CADTH assessment of Entresto
Table 15: Pricing of Entresto in the five major EU markets
Table 16: Transparency Committee's ASMR ratings and pricing implications
Table 17: Transparency Committee's SMR ratings and pricing implications
Table 18: Transparency Committee's assessment of Entresto
Table 19: G-BA assessment of Entresto
Table 20: Reimbursement conditions for Entresto in Italy
Table 21: National and regional reimbursement decisions in Spain
Table 22: NICE assessment of Entresto
Table 23: SMC assessment of Entresto
Table 24: Exchange rates used for calculating branded drug prices

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  • NICE
  • SMC
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