The National Institute for Health and Clinical Excellence (NICE) has issued final guidance not recommending the use of Roche's Avastin (bevacizumab), Merck Serono's Erbitux (cetuximab) or Amgen's Vectibix (panitumumab) for the treatment of metastatic colorectal cancer that has progressed after first-line chemotherapy.
NICE has already recommended six treatments for various stages of colorectal cancer and it is disappointed not to be able to add these three drugs, said the Institute's chief executive, Sir Andrew Dillon.
However, he added, "we have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them," and the independent appraisal committee which drafted the recommendations did not feel it had enough evidence, especially in the case of Avastin, to feel confident in recommending these drugs for use on the NHS.
The uncertainties generated by the evidence were:
- the overall survival gain with Avastin plus non-oxaliplatin chemotherapy as second- or third-line treatment for people with metastatic colorectal cancer who had not responded to first-line or second-line chemotherapy;
- the estimates of overall survival for Erbitux plus irinotecan based on the mixed treatment comparison; and
- the magnitude of the survival benefit of Vectibix relative to best supportive care.
NICE also notes that none of the treatments met the criteria to be considered under its special arrangements for end-of-life treatments. Although Vectibix currently meets the criteria, the small-population criterion will not be fulfilled for much longer because the manufacturer has applied for a license extension.
The Institute points out that none of these three treatments have been approved in Scotland for second-line use in metastatic colorectal cancer.
- In other final guidance, NICE has called for the setting-up of a clinical trial to establish how effective Merck Sharp & Dohme's Daxas (roflumilast) is for adults with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis, as an add-on to bronchodilator treatment people with a history of frequent exacerbations.
Daxas is most likely to be used in addition to triple therapy - long-acting muscarinic antagonists (LAMA) plus long-acting beta2 agonists (LABA) plus inhaled corticosteroids (ICS) - but there was no directly relevant clinical evidence for the drug's use in this way for NICE's independent appraisal committee to consider. Therefore, the panel concluded that a clinical trial providing robust data about Daxas' clinical and cost-effectiveness at this point in the treatment pathway would be beneficial to the NHS, it says.
There are currently 1 million people with COPD in England and Wales, and it is estimated that almost 88,000 would be eligible for treatment with Daxas by 2015.
"There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time. This meant that a high degree of uncertainty about the clinical and cost-effectiveness was not acceptable to the committee," said Professor Carole Longson, director of NICE's health technology evaluation centre.
"A new clinical trial is a good opportunity to gather robust evidence to help inform future clinical practice," she added.
