Novo Nordisk bet big on its GLP-1 med Saxenda in obesity, despite rivals' failures to expand the global market. But payers in England have put up a roadblock that could hurt the Danish drugmaker's sales efforts.
The National Institute for Health and Care Excellence (NICE) rejected Saxenda for use on England's NHS, citing its list price and lack of long-term efficacy data in draft guidance (PDF) published Friday.
While Saxenda, which shares its active ingredient with Novo's diabetes med Victoza, showed clinical effectiveness in preventing the development of Type 2 diabetes, NICE argued that "its long-term effectiveness, particularly on the risk of cardiovascular disease, is unknown."
The cost watchdog also didn't care for Saxenda's price—listed at £196.20 ($256.43) for 5 x 6 mg/ml 3-ml (18 mg) pre-filled pens—despite a confidential discount from Novo.
Saxenda was the centerpiece of Novo's push two years ago to expand the global obesity market through a concerted win approvals in additional countries and have obesity designated as a chronic disease. And since then, sales have been on the uptick: In the first nine months of 2019, the drug posted DKK 4.12 billion ($607 million) in sales—a 56% increase from the same time period the previous year.
Novo has posted those gains despite playing in a diabetes market that hasn't exactly been a cakewalk over the last several years. Vivus, which led a group of next-gen obesity drugmakers with an OK for Qsymia back in 2012, has suffered major field force cuts on underperforming sales. And two of its rivals have bailed altogether: Arena, developer of Belviq, hived that struggling drug off to marketing partner Eisai in 2016, and Orexigen last year sold Contrave and other assets to Nalpropion Pharma, a company funded by Pernix Therapeutics.
As in diabetes, though, Novo is looking to its next-gen GLP-1s to take up the mantle. The drugmaker is testing semaglutide—already on the market as a once-weekly injection called Ozempic and in daily pill form as Rybelsus—to see if it can spur the type of weight-loss benefits in non-diabetic obesity patients that it's produced in diabetic patients.
In March 2018, the company touted phase 2 results showing that subcutaneous semaglutide injections helped patients lose up to 13.8% of their body weight after 52 weeks, versus just 2.3% for placebo.