U.K. cost regulator confirms final approval for Novartis' Entresto
- The U.K.'s National Institute for Health and Care Excellence (NICE) issued a final recommendation supporting the use of Novartis' heart-failure med Entresto, which has fallen short of sales expectations in the U.S. since its launch last year.
- NICE's action confirms an earlier preliminary recommendation. However, the cost regulator recommended Entresto as a treatment option for only a limited slice of patients.
- Despite promising clinical results, Entresto has seen limited uptake in the United States with only $21 million in sales over the first six months. However, Novartis has pointed to delays in getting the drug covered and hopes new deals and expanded access will boost the drug's performance.
While the recommendation helps expand access to Entresto, there are a number of caveats. NICE's recommendation supports the use of Entresto as an option only for those patients with New York Heart Association class II to IV symptoms, left ventricular ejection fraction of 35% or less, and are already taking other angiotensin meds.
The regulator did, however, conclude Entresto was innovative and offered a "small step-change in the management of this condition." Based on phase 3 trial evidence (from the PARADIGM-HF trial), it determined the drug was more clinically effective than the beta blocker enalapril, offering potential benefits to those undergoing treatment.
A three week clock now starts for stakeholders to appeal on ground of factual inaccuracies. If none are received, the guidance will be published by NICE in April.
Novartis believes the med can help lower the rate of heart failure-related hospitalizations. In the U.S., the Swiss drugmaker signed pay for performance deals with the insurers Aetna and Cigna, tying the price of Entresto to the reduction in the proportion of patients hospitalized with heart failure.
Follow Ned Pagliarulo on Twitter