The NICE ( National Institute for Health and Clinical Excellence ) has published three separate pieces of guidance for the NHS ( National Health Service ) on the use of the cancer drugs Ofatumumab ( Arzerra ), Temsirolimus ( Torisel ) and Bendamustine ( Levact ).
The new NHS guidance for Ofatumumab does not recommend the drug as a treatment for chronic lymphocytic leukaemia that is refractory to the drugs Fludarabine ( Fludara ) and Alemtuzumab ( MabCampath ), because the benefit it offers over and above current NHS treatments does not justify its cost.
NICE has also published advice on the use of Temsirolimus for the treatment of mantle cell lymphoma. This follows the termination of the appraisal because the manufacturer did not submit any evidence of the drug's effectiveness. This means that NICE cannot evaluate whether Temsirolimus is useful for this type of lymphoma and, as a result, is unable to recommend the drug.
NICE is also unable to recommend Bendamustine for use in the NHS for the treatment of low grade non-Hodgkin's lymphoma that is refractory to Rituximab ( MabThera ) or a Rituximab-containing regimen. Again, this is because the manufacturer did not submit any evidence and the appraisal has now been terminated.
According to the guidance, Ofatumumab is not recommended for the treatment of chronic lymphocytic leukaemia that is refractory to Fludarabine and Alemtuzumab. It also states that people currently receiving Ofatumumab for the treatment of chronic lymphocytic leukaemia that is refractory to Fludarabine and Alemtuzumab should have the option to continue treatment until they and their doctor consider it appropriate to stop.
Nearly 2,000 people were diagnosed with chronic lymphocytic leukaemia in England in 2004. It affects the body's immune system by encouraging a type of white blood cell called B lymphocytes to grow abnormally, causing anaemia and an increased susceptibility to infection. The condition is termed refractory if it does not respond to treatment. This can happen either at the beginning of, or during, treatment.
The guidance states that given the rarity of the condition, the complex clinical management of mantle cell lymphoma and the large number of comparator regimens used in the single randomised clinical trial, the manufacturer did not believe that an adequate assessment of the clinical and cost effectiveness of Temsirolimus would be possible.
Mantle cell lymphoma is a rare type of non-Hodgkins lymphoma, which is a cancer of the lymphatic system. This system is spread throughout the body and helps to circulate lymphocytes. Mantle cell lymphoma specifically targets B-cell lymphocytes, making them grow and divide abnormally, creating tumours and weakening the immune system.
The manufacturer of Bendamustine was invited to submit evidence for this appraisal but informed NICE that it would not be doing so because it was unable to identify relevant sources of clinical evidence suitable for a NICE appraisal in people with Rituximab refractory disease.
Non-Hodgkins lymphoma is a cancer of the lymphatic system. This system is spread throughout the body and helps to circulate lymphocytes. There are several different types of non Hodgkin's lymphoma but they all affect the body's white blood cells.
Source: NICE, 2010
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