NICE recommends GSK’s Arzerra for chronic lymphocytic leukemia

Confirming an earlier preliminary guidance, medicines cost watchdog for England, the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma major GlaxoSmithKline’s (LSE: GSK) Arzerra (ofatumumab) with chlorambucil for untreated chronic lymphocytic leukemia (CLL).

CLL is the most common form of leukemia in England, with around 2,700 people being diagnosed with the condition each year. The aim of treatment is to prevent the disease from progressing and delay time to next treatment. The standard first treatment is a NICE-recommended fludarabine combination therapy. For those who are unable to take this NICE-recommended bendamustine is available as an alternative.

NICE is proposing to recommend ofatumumab for those people who are unable to take a fludarabine combination therapy or bendamustine. In preliminary draft guidance published in 2010, NICE rejected Arzerra, questioning the robustness of clinical data on overall survival rates.

Carole Longson, director of the NICE centre for Health Technology Evaluation, said: “Ofatumumab has been shown to be a clinically effective treatment option for people unable to take fludarabine combination therapy. GlaxoSmithKline has also agreed to provide ofatumumab to the NHS [National Health Service] at a reduced price. We are pleased to propose adding ofatumumab to the list of NICE-recommended treatment options available for treating CLL.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Ofatumumab pricing

Ofatumumab’s list price is £182 (£274) for a 100mg vial and £1,820 for a 1,000mg vial. Assuming six cycles and no drug wastage, the mean cost of a treatment course for ofatumumab at its list price is £11,466 for 6,300mg.