- Novartis is launching an ambitious clinical trial program for Entresto, its heart failure (HF) drug. The FortiHFy clinical program is comprised of 40 clinical trials and is enrolling patients in more than 50 countries. The goal is to expand the evidence base substantially and make the case for widespread utilization among the six million HF patients in the US, as well as HF patients in the 56 other countries where Entresto is approved.
- The trials will evaluate efficacy, quality-of-life benefits and real-world evidence. The overall program will run five years, with some studies ending as early as 2018, while others continue until 2020.
- Despite the optimism that attended the approval of Entresto in July 2015, the launch has been anemic. There has been a general reluctance among physicians to switch patients from the standard-of-care enalapril, and other ACE inhibitors, to Entresto. Novartis recently agreed to pay-for-performance deals with two of the largest payers in the nation — Aetna and Cigna.
Data from the pivotal trial used as a basis for approval, the PARADIGM-HF trial, showed that Entresto reduced the rate of hospitalization by 20% compared with enalapril in HF patients with reduced ejection fraction, and all-cause mortality was reduced by 16%.
These outcomes were compelling enough to the FDA to quickly grant an approval, but many of the treating cardiologists and primary care physicians have been slow to uptake Entresto and stalwart in their determination to continue to use the standard of care.
There was also the challenge of waiting out the six-month evaluation process that has become the norm among government and commercial payers. However, according to Novartis, coverage has increased significantly. Now roughly 91% of Medicare patients have access, with a similar level of coverage among commercialy insured patients.
Much lower-than-expected earnings, but a brighter outlook
Novartis has been forthright about its laggard early launch sales of Entresto. In the report for Q1 2016, the company stated that coverage has increased, and that expansion of the field force started in April.
When Entresto launched, CEO Joe Jimenez predicted that Entresto would have $5 billion in peak sales, but the current reality is very far away from blockbuster status. For Q4 2015, Novartis posted $15 million in revenues. Revenues were relatively flat for Entresto in Q1 2016, with just $17 million in sales. Despite the challenging start, Jimenez stands by his peak earnings projections. According to the company's first-quarter report, full-year sales for 2016 are expected to hit $200 million.