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The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of rituximab (MabThera, Roche Products) as a first-line maintenance treatment[1] for patients with advanced follicular non-Hodgkin’s lymphoma. In draft guidance issued today (1 March), NICE is calling for the manufacturer to provide more analyses to address uncertainties in the data relating to the survival benefit of the treatment.

This draft guidance has now been issued to consultees for a second round of consultation. NICE has not yet published final guidance to the NHS.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, said: “Using rituximab as a maintenance treatment after initial chemotherapy for follicular non-Hodgkin’s lymphoma could be a valuable option for patients because no such maintenance treatment has so far been available at this stage of the disease. The evidence has highlighted that it could keep a patient’s cancer in remission after they have had chemotherapy but it remains unclear as to exactly how long this effect lasts for and whether this can also improve the survival of patients.

“The Appraisal Committee issued a preliminary recommendation for this treatment in the first draft of guidance produced at the end of last year but requested more information from the manufacturer to address particular uncertainties relating to the cost-effectiveness of rituximab. These uncertainties have still not been fully addressed, which is why we are asking for this information again. It is important that the Appraisal Committee has as much information available as possible when making its decision to ensure the guidance is accurate and fair.”

In making its decision to request further information, the Appraisal Committee took into consideration comments received during consultation from stakeholders who strongly disagreed with the preliminary advice to recommend rituximab maintenance treatment, because they considered that there was a lot of uncertainty around the effect of treatment on survival and improved quality of life. The committee was therefore minded not to recommend rituximab as a first-line maintenance treatment unless further data is submitted to address these uncertainties.

The manufacturer has until 22 March 2011 to provide this information to NICE. Other consultees, including the public, also have until that date to comment on this draft guidance, and can do so via the NICE website. Any feedback received during this consultation will be considered by the committee and, following this meeting, the next version of draft guidance will be issued.

Final guidance for rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma is expected to be published later this year. Until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes

– This second Appraisal Consultation Document (ACD) is available to view here. (from Tuesday 1 March 2011).

– According to the draft guidance, the Appraisal Committee is minded not to recommend rituximab for first-line maintenance treatment of people with advanced follicular non-Hodgkin’s lymphoma that has responded to first-line induction therapy with rituximab in combination with chemotherapy.

– The Appraisal Committee recommends that NICE requests a revised cost-effectiveness analysis from the manufacturer that incorporates all of the following assumptions simultaneously:

- Age at first-line induction (patients with a mean age of 62.5 years at the start of treatment)
- Treatment effect (where the duration of clinical benefit from rituximab maintenance treatment is 28 months, 36 months or 48 months)
- Survival modelling (the extent that the benefit of progression-free survival translates to overall survival gain is 70%, 80% or 90%)

The manufacturer should report incremental costs and QALYs gained and provide a revised fully executable economic model amenable to both verification of the above-listed revisions and further exploratory sensitivity analyses.

– In earlier draft guidance, published in December 2010, the Appraisal Committee recommended rituximab for this indication but stated that it expected the manufacturer to address uncertainties in their analysis and provide a revised cost-effectiveness analysis.

– Non-Hodgkin’s lymphoma is a cancer of the lymphatic system. This system is spread throughout the body and helps to circulate white blood cells (lymphocytes). Follicular non Hodgkin’s lymphoma affects a type of white blood cell called B-cell lymphocytes. This type of cancer makes these cells grow and divide abnormally, creating tumours and weakening the immune system. The term ‘follicular’ means that the cancer cells are grouped together rather than being spread out.

– Current clinical practice for managing follicular non-Hodgkin’s lymphoma that has responded to first-line induction treatment with chemotherapy involves ‘observation’ or ‘watchful waiting’. This is when doctors wait until the cancer begins to grow again before giving patients more treatment.

– Rituximab works by targeting a protein called CD-20 that is found on B-cell lymphocytes. The drug kills these cells allowing normal white blood cells to grow and replace those destroyed. It is given intravenously through a drip once every two months.

[1] A maintenance treatment is used to stop a cancer from returning following initial chemotherapy

Source:
NICE

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