CLL is the most common form of leukaemia in England, with around 2,700 people being diagnosed with the condition each year. Half of the people who need treatment for their condition are not able to use the standard first-line treatment of fludarabine combination therapy; however, bendamustine is a NICE‑recommended alternative treatment that is already available.

Ofatumumab works by attaching itself to the surface of B‑cells (a type of white blood cell that is overproduced in CLL). This activates the immune system, enabling the B‑cells to be killed. In this preliminary guidance, NICE has recommended ofatumumab (also known as Arzerra and marketed by GlaxoSmithKline) taken with chlorambucil for untreated CLL in people who are ineligible for treatment with fludarabine combination therapy and for whom bendamustine is unsuitable.

GlaxoSmithKline have agreed to provide ofatumumab to the NHS at a reduced price; the company has agreed with the Department of Health that the size of the discount to be confidential.

Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “The key aim of first treatment for people with untreated chronic lymphocytic leukaemia is to prevent the disease from progressing and delay time to next treatment. The information provided by GlaxoSmithKline, who market the drug, showed that ofatumumab with chlorambucil is a clinically effective treatment option for those people unable to take fludarabine combination therapy or bendamustine. We are pleased to propose adding ofatumumab to the list of NICE-recommended treatment options already available for treating CLL.”

Consultees, including GlaxoSmithKline, healthcare professionals and members of the public, are now able to comment on the preliminary recommendations which are available for public consultation until 25 November 2014. Comments received during this consultation will be fully considered by the Committee, then the next draft guidance will be issued. 

Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country. 

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

1. Ofatumumab plus chlorambucil is recommended as a cost-effective use of NHS resources for untreated chronic lymphocytic leukaemia in people who are ineligible for fludarabine-based therapy, only if bendamustine is not suitable and the company provides ofatumumab with the discount agreed in the patient access scheme.

About the draft guidance

2. The draft guidance is available at /guidance/indevelopment/GID-TAG443.
3. Ofatumumab plus chlorambucil was more clinically effective than chlorambucil alone, as evidenced by statistically significantly longer progression-free survival and higher overall response rates.
4. After considering the limited clinical evidence and absence of cost effectiveness estimates for ofatumumab plus bendamustine, the Committee concluded it was unable to make a recommendation on this treatment combination.
5. Ofatumumab’s list price is £182 for a 100 mg vial and £1820 for a 1000 mg vial. Assuming 6 cycles and no drug wastage, the mean cost of a treatment course for ofatumumab at its list price is £11,466 for 6300 mg. The company has agreed a patient access scheme with the Department of Health that makes ofatumumab available with a discount on the list price. The size of the discount is commercial in confidence.
6. The Committee concluded the most plausible cost-effectiveness estimate for ofatumumab plus chlorambucil compared with chlorambucil alone using the ofatumumab patient access scheme price was £26,000 per quality-adjusted life year gained.