Novartis' LCZ696 scores another victory with early-access blessing in U.K.

Novartis ($NVS) won't have to wait for European regulators to do a full-force data sift before its new heart failure drug becomes available in England. The U.K. will allow Novartis to roll out its Entresto drug under an early-access scheme begun last year.

That makes the heart failure med--which delivered impressive survival benefits in a key clinical trial--the first drug outside the cancer field to win early-access approval.

It's just the latest victory for the Swiss drugmaker's heart failure treatment, which Novartis execs have touted as a "megablockbuster" in the making. Entrust won FDA approval 6 weeks early after those survival benefits pumped up anticipation for the drug. The company has pegged peak sales at $5 billion, but analysts have put much higher sales estimates on the drug, with some predicting as much as $10 billion annually.

Under the Early Access to Medicines Scheme (EAMS), U.K. regulators backed Entresto for quick use, based on data from a late-stage trial dubbed Paradigm-HF. Formerly known as LCZ696, the drug beat Merck & Co.'s ($MRK) standard ACE-inhibitor therapy enalapril by a wide margin. Patients taking the drug were 20% less likely to die from a cardiovascular cause than those in the control arm.

The EAMS nod comes before the European Union has granted final approval for the drug, putting U.K. patients in line for the treatment now. As PMLiVE notes, about 550,000 people in the U.K. have heart failure, and the disease costs England's National Health service about £2.3 billion per year. Heart failure patients are often hospitalized, one reason why the disease's costs are so high.

"It's very encouraging that LCZ696 will be available via the EAMS, allowing patients in the UK with this debilitating condition to gain benefit," Novartis' regional chief Hugh O'Dowd told the pub. "We are working closely with the NHS to ensure eligible patients have rapid access under the scheme while we await the final European licensing decision."

Payer enthusiasm in the U.K. is another sign of Entresto's appeal, in spite of its $12.50-per-pill price. When the drug won the FDA's official green light, doctors and clinical trial investigators predicted that pharmacy benefits managers and insurers would have a tough time rejecting the med, given the evidence backing it up. In addition to the usual payer negotiations, Novartis has been experimenting with some new types of reimbursement proposals, including pay-for-performance schemes that would use remote-monitoring technology to keep tabs on patients' health. 

- get the EAMS scientific opinion
- see the PMLiVE story

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