It's final: Tasigna in, Sprycel out in NICE guidelines

The National Institute for Health and Clinical Excellence has struck again. Despite two appeals of its draft recommendations, the agency let in only one new drug for chronic myeloid leukemia. Novartis' ($NVS) Tasigna won NICE's recommendation as a first-line treatment for resistant CML, while Bristol-Myers Squibb's ($BMY) Sprycel did not.

It helped that Novartis offered a discount on Tasigna. No doubt it hurt Sprycel when BMS didn't. "CML is a chronic condition, meaning the drugs will be used for a long period of time," noted NICE's Carole Longson, "and at over 30,000 pounds per patient per year, [Tasigna] is expensive. However, the manufacturer has agreed to provide it to the NHS at a discounted price."

This cost reduction triggered the approval, Longson added. What with NICE's well-known hard line on costs, submitting a discount plan is becoming de rigueur for drugmaker hopefuls. In fact, GlaxoSmithKline ($GSK) recently offered a discount plan up front on Benlysta--it didn't wait for an initial rejection from the agency--and got the boot anyway. BMS might have known better; NICE recently stiff-armed its highly touted new melanoma drug Yervoy, hinting that a discount plan might change its mind.

Novartis didn't come out of the CML review unscathed, however. High doses of the company's older cancer drug Glivec (sold as Gleevec in the U.S.) had been up for CML that's resistant to standard doses. NICE didn't recommend that option. The agency said its new guidelines would be published ASAP, given that it rejected those two final appeals.

- check out the NICE statement
- read the Dow Jones story

ALSO: NICE confirmed its recommendation for Bydureon, the long-acting diabetes drug from Amylin Pharmaceuticals ($AMLN). Report