NICE changes its attitude on Roche's Gazyvaro

Months after it gave a preliminary thumbs-down to Roche's ($RHHBY) Gazyvaro for chronic lymphocytic leukemia (CLL), the U.K.'s drug price watchdog changed its headwind to a tailwind for the oncology drug. The National Institute for Health and Care Excellence (NICE) is now set to recommend the drug in new draft guidance with a few strings attached.

NICE is planning to greenlight Gazyvaro (obinutuzumab) for patients who do not respond to other forms of therapy, but only if Roche offers the drug at a lower cost. Gazyvaro's list price rings in at £26,496 ($42,850) per treatment course for the U.K.'s National Health Service and the company will provide a discount--although Roche and the Department of Health are staying mum on the size of the rebate, NICE said in a statement.

Gazyvaro, a follow-up to Roche's Rituxan, is already approved in the U.S. and recently got a signoff from European regulators. In July, the European Commission approved the drug for the treatment of CLL, two months after Europe's Committee for Medicinal Products for Human Use (CHMP) recommended it for use with chemo drug chlorambucil.

NICE's new guidance bodes well for Roche, as it has faced its fair share of battles with the U.K.'s cost gatekeepers over cancer drugs. In August, NICE shot down the company's heralded breast cancer med Kadcyla due to pricing concerns, and in October the agency gave Roche a preliminary thumbs-down for Gazyvaro, citing "too many uncertainties in the company's submission," NICE CEO Sir Andrew Dillon told the press in the U.K.

NICE's Carole Longson

Roche stepped up to the plate with new data regarding Gazyvaro's price and efficacy, and the agency did an about-face. "We are pleased that Roche responded to our consultation and provided further analyses to allow us to propose recommending obinutuzumab as a treatment option for untreated chronic lymphocytic leukaemia," NICE's director of health technology evaluation, Carole Longson, said in a statement.

NICE's stamp of approval could also help Roche stay one step ahead of its competition, as archrivals Gilead ($GILD) and Janssen move forward with their own CLL treatments. Gilead's Zydelig and Janssen's Imbruvica do not have NICE approval, and the agency is set to review the drugs in 2015.

NICE will take comments from the public on its preliminary recommendations for Gazyvaro until Jan. 6, 2015, on its website before issuing its next draft guidance, the agency said in a statement.

- read NICE's statement
- here's NICE's draft guidance
- get more from Pharmaphorum

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