Arzerra ofatumumab regulatory update

The U.K.'s NICE issued preliminary draft guidance recommending Arzerra ofatumumab from GlaxoSmithKline with chlorambucil to treat previously untreated chronic lymphocytic leukemia (CLL) in patients who are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. ...