$2B AbbVie-Roche leukemia pairing gets a vexing thumbs-down from NICE

England's cost watchdog said it couldn't determine a “most plausible cost-effectiveness estimate” for Venclexta, whose list price for a 12-pack is £4,789.47, or about $6,100. (AbbVie)

AbbVie is counting on oncology drug Venclexta to drive serious growth, especially as biosimilars to top seller Humira advance. But England's cost-effectiveness gatekeepers have other plans.

The National Institute for Health and Care Excellence (NICE) published draft guidance rejecting the product, in tandem with Roche’s Rituxan, as a treatment for relapsed or treatment resistant chronic lymphocytic leukemia (CLL). And the news gets worse for the drugmakers—NICE isn’t recommending the combo for its backup Cancer Drugs Fund, either.

The reasoning behind the cold shoulder? The NICE panel couldn’t determine, based on available evidence, that the one-two punch does a better job at fighting off CLL than Imbruvica, another AbbVie drug that’s the usual choice for treating the disease.

And NICE has problems with AbbVie’s “economic model inputs,” too. “Inconsistencies” between the clinical- and cost-effectiveness data in AbbVie's models prevented the watchdog from coming up with a “most plausible cost-effectiveness estimate” for Venclexta, whose list price for a 12-pack is £4,789.47, or about $6,100.

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The Venclexta-Rituxan pairing picked up its FDA approval this July, eliminating the need for chemo in those patients and putting the drugmakers in line for a multibillion-dollar boost to peak sales. Venclexta, in particular, won a much broader market with the FDA nod; previously, the agency had cleared it only in patients with a genetic mutation known as the 17p deletion, which affects about 10% of all CLL patients.

At the time, Leerink analyst Geoffrey Porges predicted the green light would pad Venclexta sales by $690 million this year, and industry watchers say that by the end of the decade, the indication could swell its sales by $1.5 billion to $2 billion.

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If AbbVie and Roche want to see the combo succeed in England, though, they’ll have to change minds at NICE. On that front, discounts have been known to do the trick—a fact Roche knows well after multiple rejections from the cost-effectiveness gatekeeper. The agency will be taking comments on its draft guidance until the middle of next month, and its appraisal committee will meet again at the end of November.

While AbbVie is "disappointed with the outcome of the draft decision," a spokesman for the Illinois pharma noted by email that "this is not the final step in the appraisal."

"Our priority now will be to work collaboratively with NICE to ensure they have all the necessary data to inform a robust evaluation and our aim remains to facilitate NHS access to venetoclax plus rituximab as quickly as possible via routine commissioning or the Cancer Drugs Fund," he said.