In the preliminary guidance, uncertainties in the company’s data mean that the committee proposes not to recommend obinutuzumab combination therapy for people who are not able to take the standard fludarabine-based therapy.

CLL is a type of cancer that affects the cells in the bone marrow (where blood cells develop) and causes overproduction of abnormal white blood cells. The abnormal white blood cells replace the normal cells in the bone marrow but are unable to function properly. Signs and symptoms can include fatigue, breathlessness, bruising and bleeding. The condition can develop slowly with many people not suffering any symptoms at all in the early stages. Obinutuzumab works by attaching itself to the surface of abnormal white blood cells, which then causes the cells to die.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “Chronic lymphocytic leukaemia is the most common form of leukaemia in the UK, with around 2,700 people being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 therapy.  NICE recommended alternative treatments are already available.

“Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources. It is disappointing that we are not able to add this to the range of treatments already available. However, with limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS.”

Consultees, including the company, healthcare professionals and members of the public are now able to comment on the preliminary recommendations via the NICE website. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued. 

This is preliminary guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

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

Notes to Editors

About the draft guidance

1. Obinutuzumab in combination with chlorambucil is not recommended for adults with untreated chronic lymphocytic leukaemia who have comorbidities that make full-dose fludarabine-based therapy unsuitable for them.
2. The draft guidance is available at /guidance/indevelopment/GID-TAG451. 
3. The Committee noted that the most likely incremental cost-effectiveness ratio (ICER) for obinutuzumab plus chlorambucil compared with chlorambucil monotherapy was £31,000 per quality adjusted life year (QALY) gained, £28,000 per QALY gained compared with chlorambucil plus rituximab, £49,000 per QALY gained compared with bendamustine monotherapy and £48,000 per QALY gained compared with bendamustine plus rituximab. The Committee was aware that because of uncertainties in some of the model parameters these figures were likely to be higher.
4. The Committee acknowledged that obinutuzumab plus chlorambucil is a clinically effective treatment but noted that the most plausible ICERs were above the range that would normally be considered a cost-effective use of NHS resources.
5. The price of obinutuzumab is £3312 per 1000 mg vial (excluding VAT; company’s submission). The company stated that a course of treatment costs £26,496 (£9936 for cycle 1 and £3312 for cycles 2 to 6, excluding VAT).
6. The company did not provided any evidence to indicate the drug would meet the standards to be considered under the end-of-life criteria.
7. Around one-third of people with chronic lymphocytic leukaemia are asymptomatic and may not need immediate treatment. Fludarabine combination therapy is the standard first-line treatment for people needing immediate treatment, but may be unsuitable for around half of the people needing treatment. If fludarabine combination therapy is not appropriate, people may have bendamustine either as monotherapy or with rituximab. If bendamustine is not appropriate, people may have chlorambucil or rituximab plus chlorambucil.
8. The Scottish Medicines Consortium has not published advice on the use of obinutuzumab for this group of patients as yet: https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/obinutuzumab_Gazyvaro.