ARTICLE | Clinical News

Arzerra ofatumumab regulatory update

November 10, 2014 8:00 AM UTC

The U.K.'s NICE issued preliminary draft guidance recommending Arzerra ofatumumab from GlaxoSmithKline with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL) in patients who are ineligible for fludarabine-based therapy. Arzerra is recommended only when bendamustine is unsuitable and GSK provides the human mAb against CD20 at an undisclosed discount under a patient access scheme (PAS). NICE said it was unable to make a recommendation for Arzerra with bendamustine. Arzerra is approved in the EU in combination with chlorambucil or bendamustine for untreated CLL in patients who are ineligible for fludarabine-based therapy.

NICE said the most plausible incremental cost-effectiveness ratio (ICER) for Arzerra under the PAS with chlorambucil compared with chlorambucil alone is L26,000 ($41,590) per quality-adjusted life year (QALY). The committee noted the combination therapy had statistically significantly longer progression-free survival (PFS) and higher overall response rates than chlorambucil alone. Comments are due Nov. 25, with a second appraisal committee meeting scheduled for Jan. 21. ...