Cotellic is Roche's latest cancer med to hit a snag at NICE

Roche hasn’t had an easy go of it when it comes to getting its cancer therapies past England’s cost-effectiveness gatekeepers--and that trend continued Thursday.

In draft guidance, the National Institute for Health and Care Excellence shot down Roche’s Cotellic, used in tandem with the company’s Zelboraf to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation.

The way NICE sees it, while adding Cotellic to Zelboraf does increase overall survival by 4.9 months, that’s not enough to justify its cost. A list price of £4,275.67 for 63 tablets brings the price per quality-adjusted life year--or QALY, a favorite NICE metric--to more than £100,000, which sits “substantially above the range usually considered to be a cost-effective use of NHS resources,” it said.

But there’s still room for Roche to negotiate. As NICE was quick to point out, the Swiss pharma giant already provides a discount to Zelboraf when used on its own, but the parties hadn’t agreed on a price break for Cotellic when NICE penned its appraisal.

It’s not the first time lately that the Basel-based drugmaker has felt the heat from NICE. Less than a month ago, the watchdog gave the cold shoulder to breast cancer med Perjeta, saying in draft guidance that the med’s long-term benefits were “too uncertain” to score its backing.

Roche, though, needs its younger cancer meds to come through as some of its stalwarts prepare to face biosimilar foes. Just a couple weeks back, at the American Society of Clinical Oncology annual meeting, copycat Mylan rolled out data showing its knockoff of blockbuster Herceptin had matched the Roche original in a Phase III study at treating advanced, HER-2 positive breast cancer in terms of both efficacy and safety.

But it wasn’t all bad news out of the company’s home continent Thursday. Gazyvaro, the follow-up to superstar Rituxan, nabbed a green light in Europe in combination with Teva’s Treanda for treating patients with previously treated follicular lymphoma.

- read the NICE guidance (PDF)
- read the Gazyvaro release

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