NICE nixes Roche's new leukemia drug Gazyvaro despite discount offer

NICE CEO Sir Andrew Dillon

Roche ($RHHBY) just can't win with the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). In August, the agency decided the company's heralded breast cancer drug Kadcyla was too expensive for the country's health system to cover. Now NICE has slapped Roche with a preliminary thumbs-down on Gazyvaro, its new drug to treat chronic lymphocytic leukemia (CLL).

The rejection came despite Roche's offer to discount the drug's list price of £26,496 ($42,850) per treatment course for the U.K.'s National Health Service (NHS).

NICE CEO Sir Andrew Dillon told the press in the U.K. that although data provided by Roche showed the drug to be clinically effective, "there were too many uncertainties in the company's submission and we cannot be confident that it is an effective use of NHS resources," according to Reuters. NICE is now accepting comments on the draft guidance and will be holding a second meeting on the drug in November.

Gazyvaro (obinutuzumab), the follow-up to Roche's highly successful Rituxan, was approved by the FDA last November for sale in the U.S., where it is marketed as Gazyva. The European Commission approved the drug for the treatment of CLL in July, just two months after the Committee for Medicinal Products for Human Use (CHMP) there recommended it in combination with the chemo drug chlorambucil as a first-line treatment against the disease.

NICE's negative decision has drawn ire from some oncologists. Chris Bunce, research director at Leukaemia and Lymphoma Research in the U.K., blasted Dillon's comment, telling the Nursing Times that it "brings into question whether the mechanisms for NICE to work with drug companies prior to submissions for final assessment are appropriate. For the benefit of patients it is important that NICE is a body that drug companies can work with and not just a hurdle they have to surpass."

There's little question that NICE has been a major hurdle, and not just for Roche. In August, NICE said "no" to broadening the use of Johnson & Johnson's ($JNJ) prostate cancer pill Zytiga. The outcry over that rejection and the negative Kadcyla decision prompted Dillon to go on the offensive, telling the press that the NHS shouldn't be thought of as a "bottomless pit" and that drugmakers should think seriously about pricing their products more reasonably.

In September, NICE said it might bypass drug companies altogether in making future assessments, and request clinical trial data directly from European regulatory agencies, particularly if it determines companies aren't providing enough information to support sound coverage decisions.

Some companies have found ways to get NICE to do an about-face on negative preliminary assessments. Celgene ($CELG), for example, handed the agency new data to support its blood cancer drug Revlimid for the treatment of rare bone marrow disorders called myelodysplastic syndromes. Then it vowed to cap the cost of the drug, providing it for free to any patient who needs more than 26 monthly treatment cycles. That did the trick: NICE turned a preliminary "no" into a "yes" in August.

To what extent Roche will be able to wheel and deal its way out of this latest NICE rejection remains to be seen. The company tells Reuters it's disappointed but will be working with the agency to find a way to get Gazyvaro on the market in the U.K.

- access NICE's preliminary guidance here
- here's the Nursing Times story
- read more at Reuters

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