CLL is the most common form of leukaemia in England, with around 2,700 people being diagnosed with the condition each year.

In earlier preliminary guidance, NICE had been unable to recommend obinutuzumab due to uncertainties in the company’s submission. In response to the consultation Roche submitted revised cost-effectiveness analyses and a patient access scheme which allowed the committee to recommend obinutuzumab combination therapy for some people with CLL¹.  

Commenting on the draft guidance, Professor Carole Longson, centre for health technology evaluation director at NICE, said: “We are pleased that Roche responded to our consultation and provided further analyses to allow us to propose recommending obinutuzumab as a treatment option for untreated chronic lymphocytic leukaemia.

“Half of the people who need treatment for their condition are not able to use the standard first-line treatment of fludarabine combination therapy. NICE recommends alternative treatment with bendamustine but there are some patients for whom this is also unsuitable. Obinutuzumab is a clinically effective treatment which is associated with fewer adverse events and provides another option to help prevent people’s disease from progressing.”

Obinutuzumab works by attaching itself to the surface of abnormal white blood cells, which are overproduced in CLL, and then causes the cells to die.

NICE recommends obinutuzumab for some people with CLL¹ on the basis that Roche provides the treatment to the NHS at a reduced price. The company has agreed with the Department of Health that the size of the discount is to be confidential.

Consultees, including the company, healthcare professionals and members of the public now have until Tuesday 6 January 2015 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received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.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About the draft guidance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 recommended as an option for adults with untreated chronic lymphocytic leukaemia who have comorbidities that make full-dose fludarabine-based therapy unsuitable for them, only if:
   • bendamustine-based therapy is not suitable and
   • the company provides obinutuzumab with the discount agreed in the patient access scheme.
2. The draft guidance is available at /guidance/indevelopment/GID-TAG451.
3. The company has agreed a patient access scheme with the Department of Health that makes obinutuzumab available with a discount. The size of the discount is confidential and therefore the ICERs cannot be presented here.
4. The list price of obinutuzumab is £3,312 per 1000 mg vial (excluding VAT; company’s submission). The company stated that a course of treatment costs £26,496 (£9,936 for cycle 1 and £3,312 for cycles 2 to 6, excluding VAT).
5. The Committee concluded that treatment with obinutuzumab plus chlorambucil did not fulfil the criterion for short life expectancy of the end of life considerations.
6. Chronic lymphocytic leukaemia 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.
7. Fludarabine combination therapy is the standard of care for people needing immediate treatment, but it 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.