- Insurance payers and government agencies in Europe reimburse more quickly for new drugs than their counterparts in the U.S., according to David Epstein, head of Novartis' pharmaceuticals division, in remarks reported by Reuters.
- In particular, Novartis is concerned over delays in making its new heart failure drug Entresto available to insured patients. Entresto notched only $5 million in sales in Q4.
- Epstein cited delays put in place by insurers and Medicare on new drug coverage as they work to evaluate the drugs following FDA approval.
In a time of pricing pressures, payers are attempting to control costs by using evidence-based guidelines to determine which drugs will be covered and how they will be tiered on formularies. Payers need to decide whether a new therapy is better than existing ones, and which patients should be eligible for the new therapies.
Novartis believes this dynamic is slower in the U.S. than in Europe and cites it as a reason why Entresto grossed only $5 million in Q4 2015. 2016, however, is looking better for Novartis' US prospects. Entresto is now covered for 70% of patients in Medicare and 77% of patients in commercial plans, according to comments reported by Reuters.
The FDA approved 45 new drugs last year, the highest since 1996. Approvals, however, don't automatically translate into coverage from health insurers or Medicare.