The United Kingdom’s health watchdog, the National Institute for Health and Clinical Excellence (NICE) earlier today published three separate pieces of guidance for the NHS on the use of the cancer drugs ofatumumab (Arzerra?, GlaxoSmithKline), temsirolimus (Torisel?, Pfizer/Wyeth Pharmaceuticals) and bendamustine (Levact?, Napp Pharmaceuticals).

The new NHS guidance for ofatumumab does not recommend the drug as a treatment for chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab.

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[1]. 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.

An important consideration for the negative opinion is that, according to the NICE advisory commitee, the benefit it offers over and above current NHS treatments does not justify its cost.

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The NICE advisory committee considered cost-effectiveness of the drug, calculated as the additional cost of one year of healthy life (expressed as the cost per quality adjusted life year, or QALY, gained), and considered that the best available estimate for the base case ICER is between more than ?60,500 and more than ?81,500 per QALY gained. According to the manufacturer, ofatumumab costs ?182.00 per 100 mg vial, excluding VAT. GlaxoSmithKline, the manufacturer of ofatumumab, did agree to a patient access scheme (PAS) with the Department of Health, in which ofatumumab would be made available to the NHS at a discounted price. However, even with this in place, ofatumumab was judged to be too costly for the uncertain benefit it may offer patients.

NICE has also published advice on the use of temsirolimus for the treatment of mantle cell lymphoma, a rare type of non-Hodgkins lymphoma, which is a cancer of the lymphatic system.

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.” According to the NICE advisory commitee, Pfizer, the manufacturer of the drug, did not submit any evidence of the drug’s effectiveness. As a result, the advisory commitee would not evaluate whether temsirolimus would be useful for this type of lymphoma and did recommend the drug. The NICE advice further states that NHS organisations should take into account the reasons why no evidence of temsirolimus’ clinical and cost-effectiveness was submitted when considering their local use of the drug.

NICE was 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 or a rituximab-containing regimen. In this case too, according to the NICE advisory board, the manufacturer, Napp Pharmaceuticals, did not submit any evidence of the drug’s effectiveness

The guidance for the terminated appraisal of bendamustine for the treatment of indolent (low grade) non Hodgkins lymphoma that is refractory to rituximab or a rituximab-containing regimen, states that because the manufacturer did not submit evidence for this appraisal NICE terminated the review. The guidance further states that the manufacturer was unable to identify relevant sources of clinical evidence suitable for a NICE appraisal in people with rituximab refractory disease, and that further research was ongoing but data would not be available in a time frame that would allow NICE to produce timely guidance.?

Sir Andrew Dillon, NICE Chief Executive, said: “The aim of our guidance is to provide clear recommendations to the NHS following a thorough evaluation of all available evidence, including research data from the manufacturer and expert opinion from clinical specialists and patient representatives. In the case of ofatumumab, the Appraisal Committee did not consider the evidence to be sufficiently robust and concluded that the benefit that ofatumumab might offer patients, compared with currently available treatment does not justify its high cost.

“We are disappointed to have to terminate the two appraisals involving temsirolimus and bendamustine but NICE is left with little choice if manufacturers choose not to submit any evidence. The guidance that we have produced about these two drugs informs the NHS that NICE is unable to recommend each treatment, includes an explanation from the relevant manufacturer as to why they did not submit evidence and advice on what to do next. Of course, if manufacturers decide to submit the evidence in the future, NICE will then take the opportunity to review our advice to the NHS.”

For more information:
[1] Office of National Statistics, Cancer Statistics series MB1 no. 35.

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