Chronic Heart Failure Pricing, Reimbursement, and Access Report 2018: Positive ICER Findings Likely to Increase Payer Acceptance of Entresto
DUBLIN, May 11, 2018 /PRNewswire/ --
The "Chronic Heart Failure Pricing, Reimbursement, and Access" report has been added to ResearchAndMarkets.com's offering.
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 b. The author also require Entresto to be prescribed initially by a hospital specialist.
Key Topics Covered:
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
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