Featured Health Business Daily Story, Dec. 23, 2016; Featured in Government News of the Week, Dec. 12, 2016

FDA Same-Day Approval of New Diabetes Therapies Should Help Payers

Reprinted from DRUG BENEFIT NEWS, biweekly news and proven cost management strategies for health plans, PBMs, pharma companies and employers. Sign up for an $86 two-month trial subscription today.

By Angela Maas, Managing Editor
December 9, 2016Volume 17Issue 23

When the FDA approved Novo Nordisk A/S’s Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection) and Sanofi’s Soliqua 100/33 (insulin glargine 100 units/mL and lixisenatide injection 33 mcg/mL) on Nov. 21 (see story, p. 1), those approvals came a few months after originally expected, but their timing will benefit payers.

“While both manufacturers…were in heated competition to get their product FDA-approved first, the FDA’s same-day approval of both products took away the primary edge that either company would have had in marketing their product first,” Lynn Nishida, area vice president of pharmacy at Solid Benefit Guidance, tells DBN. “The approvals will surely raise revenues for both competitors amid a challenging pricing environment for diabetes drugs. In a Nov. 22 note, Jefferies analysts anticipated peak sales of Xultophy to reach $1.7 billion and Soliqua to reach $1.5 billion.” Sanofi says Soliqua will launch in January, and Novo expects Xultophy to launch in the first half of 2017.

Payers stand to benefit by the simultaneous approvals. “As result of the market competition, payers should be more favorably positioned in negotiating contract terms for either product,” Nishida says. This wasn’t the case, for example, within the hepatitis C class, when Sovaldi (sofosbuvir) had about a year with the market all to itself — and its $1,000-per-day price — before competitors spurred more aggressive contracting by payers (DBN 1/9/15, p. 1). Approved in late 2013, Sovaldi managed to bring in $8.5 billion in U.S. sales in 2014.

Drug Benefit News

An FDA advisory committee backed the approval of both drugs in late May, but Soliqua initially had the head start to approval, with an FDA action date in late August. The agency, though, extended its review for three months — a step it also took with Xultophy two weeks later.

“The reason behind the delay in Xultophy’s assessment wasn’t made public, but was thought to be related to dosing in the fixed ratio of degludec to liraglutide. The delay in approval for Soliqua was due to concern over patient confusion over the use of two pens with different concentrations (100/33 and 100/50). The FDA subsequently only approved the 100/33 pen for Soliqua,” explains Eamonn O’Connor, a director on the cardiovascular, metabolic and renal disorders team at Decision Resources Group, specializing in type 2 diabetes. “In terms of the timelines of approval, I don’t think there should be any significance attached to the specific timelines,” which, he says, may relate to “the volume of data involved in each submission. Given that Soliqua’s submission included data for both the 100/33 and 100/50 pens, the longer time to approval may be related to the decision not to approve the 100/50 pen. From a payer perspective, I don’t think there is any significance to this.”


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