A treatment for an aggressive type of cancer that develops in the body's immune system has been given the green light in final draft guidance from the National Institute for Health and Care Excellence (NICE). It says the drug pixantrone (Pixuvri, made by Cell Therapeutics) should be funded by the NHS to treat certain people with aggressive non-Hodgkin's B-cell lymphoma.

Non-Hodgkin's B-cell lymphoma starts in the body's B-cells (white blood cells found in bone marrow) and affects the lymphatic system. The guidance recommends that the treatment is only recommended for people with this type of cancer whose disease has either returned after treatment (relapsed) or become resistant to current therapy (refractory) and:

• have previously been treated with the drug rituximab (MabThera) and
• is receiving third or fourth line treatment.

The NICE guidance also says that the drug can only be funded if the manufacturer provides it at a discounted rate, as agreed between Cell Therapeutics and the Department of Health.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Non-Hodgkin's lymphoma is the sixth most common cancer and our draft recommendation that pixantrone should be funded for some people with a form of this disease in England will be welcome news for patients and their families. We are pleased that the manufacturer was able to provide a patient access scheme; pixantrone will be a useful addition to the treatment options available.”

Consultees now have until Thursday 23 January 2014 to appeal against the draft recommendation if they believe there are sufficient grounds to do so. If no appeals are lodged, publication of the final guidance is expected the following month (February). Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

Notes to Editors

About the guidance

1. The draft guidance, called a Final Appraisal Determination (or FAD), will be available at /guidance/indevelopment/GID-TAWave2513 from Tuesday 31 December 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.

2. When considering the clinical effectiveness of pixantrone, the independent Appraisal Committee considered data from the PIX031 clinical trial submitted by the manufacturer and heard evidence from clinical experts and patient representatives. The committee noted a number of uncertainties associated with the clinical trial however, it also noted that there was limited evidence to show that pixantrone works better than other, currently available treatments for both patients who had previously been treated with rituximab and patients receiving third or fourth line treatment.

3. The Appraisal Committee also noted that the manufacturer's patient access scheme (the details of which are commercial-in-confidence) improved the cost-effectiveness of pixantrone. The committee concluded that the treatment would be cost-effective for patients who had previously been treated with rituximab and patients receiving third or fourth line treatment; the drug's incremental cost-effectiveness ratio (ICER) was estimated to be under £22,000 per QALY gained for both groups.

4. Pixantrone has a conditional European marketing authorisation ‘as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy'. This means it is approved for patients who have received at least two previous lines of treatment. This marketing authorisation is linked to results being provided from a phase III clinical trial (PIX306), which is investigating pixantrone plus rituximab versus gemcitabine plusrituximab in patients with relapsed or refractory aggressive non-Hodgkin B-cell lymphoma who have previously received a rituximab-containing regimen.

5. Pixantrone is a drug that is administered intravenously. The recommended dosage is 50 mg/m² on days 1, 8, and 15 of each 28-day cycle for up to six cycles. According to the manufacturer, it costs £553.50 per 20 ml vial (which contains 29 mg free base pixantrone, which is equivalent to 50 mg pixantrone dimaleate). This is excluding VAT. The estimated cost of a course of treatment is £19,926 (costs calculated over four cycles using an average of three vials per dose based on the median length of treatment in the PIX301 trial). Costs may vary in different settings because of negotiated discounts.

About NICE

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