The UK's National Institute for Health and Clinical Excellence (NICE) has published final draft guidance as part of its appraisal of bevacizumab (Avastin) in combination with chemotherapy (oxaliplatin and either 5-fluorouracil or capecitabine) for treating metastatic colorectal cancer. The recommendations do not support the use of bevacizumab for this indication, on the basis of the current offer from the manufacturer, Roche Pharmaceuticals.

Draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance.

In response to the latest draft guidance NICE Chief Executive, Sir Andrew Dillon, said: "Bevacizumab (Avastin) is a very expensive drug and so patients and NHS should expect substantial benefits from using it. The evidence we have suggests that patients receiving bevacizumab and chemotherapy for this indication may survive on average for six weeks longer than patients receiving chemotherapy and placebo. This means half of those patients who receive any benefit, will receive less than six extra weeks of life.

"We have held two consultations on our initial draft decision on bevacizumab for metastatic colorectal cancer, inviting the manufacturer and other stakeholders to submit further information in support of bevacizumab for this indication. Unfortunately, no new information or opinion submitted during either consultation has provided evidence to enable the committee to recommend the drug; therefore they have not been able to change the original recommendation.

"NICE has recommended expensive drug treatments before, but the independent Committee that makes the final decision needs to be certain that the benefits offered justify the cost the NHS is being asked to pay."

The manufacturer estimates that approximately 6,500 people per year might be eligible for the drug and, with the proposed patient access scheme, Roche is currently asking the NHS to pay around £20,800 per patient. If all these eligible patients received bevacizumab, the total cost to the NHS could potentially be as much as £135 million per year.

In the original proposed patient access scheme, bevacizumab would be supplied at a fixed cost of approximately £20,800 per patient for one year and would be free after 12 months of cumulative treatment. The cost of oxaliplatin would also be reimbursed. The new scheme included all these elements plus an additional upfront payment to the NHS for each person starting first-line treatment with bevacizumab.

Both the independent Appraisal Committee and the Department of Health felt the patient access scheme proposed by the manufacturer was complex and the administrative costs were underestimated in the manufacturer's calculations.

Sir Andrew continued: "The very complex patient access scheme proposed by the manufacturer did not reduce the cost effectiveness estimates by anywhere near as much as the manufacturer suggests. Using the price that the NHS actually pays for oxaliplatin, the cost per QALY would actually be around £70,000 and not £25 - £30,000 as suggested by Roche."

"We have recommended several treatments for various stages of colorectal cancer, including cetuximab for the first-line treatment of metastatic colorectal cancer. We are disappointed not to be able to add to this range of treatment options,but we have to be confident that the benefits justify the considerable cost of this drug, and the evidence for bevacizumab is just not as clear as it is for other treatments."

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. People who are currently receiving bevacizumab should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Source: National Institute for Health and Clinical Excellence