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Sanofi, Regeneron’s Libtayo hits hot streak with EU green light, NICE backing

Libtayo bottle and box
Libtayo was the sixth player into the U.S. PD-1/PD-L1 market. (Sanofi Genzyme/Regeneron)

Sanofi and Regeneron’s Libtayo is two for two in the last two days—with European officials, that is. 

One day after the European Commission cleared the PD-1 drug to treat cutaneous squamous cell carcinoma, England’s cost watchdog signed off on an access agreement (PDF) for the product in adults whose disease can’t be treated with surgery or radiotherapy.

But it’s not an outright win for Libtayo at the National Institute for Health and Care Excellence (NICE). The cost-effectiveness gatekeeper will add the product to its Cancer Drugs Fund rather than cover it for routine use on the National Health Service.

And as usual, the gatekeeper has some conditions. Patients should receive Libtayo until their disease progresses or they reach the two-year mark—whichever comes sooner, NICE said.

The reason? Libtayo’s trial data “are promising but uncertain,” NICE said in a final appraisal document (PDF). While it acknowledged that living with the disease is “physically and emotionally challenging” and “there is a high unmet need for new treatments,” the cost-effectiveness estimates for Libtayo “are above what is normally considered a cost-effective use of NHS resources” and it’s not clear how long the therapy prolongs life.

NICE isn’t ruling out a jump to routine NHS use in the future, though. “If more mature data become available from an ongoing trial … and more data on life expectancy with current treatments are obtained,” Libtayo has the potential to eventually be considered a cost-effective treatment.

In England, Libtayo bears a list price of £4,650 per 350 mg vial, good for one treatment cycle. One year of Libtayo treatment rings up at £80,877. As is customary, though, NICE and Libtayo’s makers have struck a discount deal, though they’re keeping the details under wraps.

NICE’s verdict is an important one, as countries around the world look to England to set the tone when it comes to drug reimbursement. And as of Monday, when the EC bestowed a go-ahead on the drug on the back of positive phase 2 data, European Union members will have their own negotiating to do.

The EU approval follows green lights in the U.S., Canada and Brazil. The FDA doled out its clearance last September, making Libtayo the sixth member in its class of immuno-oncology drugs to reach the market.

Right now, the Sanofi-Regeneron treatment is competition-free in the CSCC market, where it’s the only approved—I-O or otherwise. But the team is aiming to expand Libtayo into the lung cancer arena, where it’ll meet with fierce rivals from Merck, Roche and others.