The National Institute for Health and Clinical Excellence has published preliminary recommendations rejecting the use of Roche’s cancer drug Avastin on the National Health Service for patients with advanced bowel cancer.

While an appraisal committee for the cost regulator ruled that for the first-line treatment of metastatic colorectal cancer Avastin (bevacizumab) in combination with oxaliplatin-containing regimens “gave a modest benefit in terms of effectiveness compared with regimens without bevacizumab”, it found this benefit was not enough to justify the expense to the National Health Service.

NICE noted that the acquisition cost of Avastin (excluding VAT and assuming wastage) for a patient weighing 70kg is £924.40 at a dosage of 5mg/kg every two weeks and £1409.72 at a dosage of 7.5 mg/kg every three weeks, and that even taking a patient access scheme proposed by Roche into account the cost of the drug equates to £36,400 per QALY gained, overshooting its £30,000 threshold.

The committee also stressed that QALY estimates for the drug were “at the lowest end of a range” and that plausible adjustments to the cost model inputs would boost the ICER (incremental cost-effectiveness ratio) substantially. And it is because of “the great deal of uncertainty” surrounding the ICER that it was concluded the therapy “could not be recommended as a cost-effective use of NHS resources for the first-line treatment of metastatic colorectal cancer”, it said.

But Roche argues that the cost per QALY for Avastin in this setting is only just over the ceiling value of £30,000, which, it points out, has not changed since the birth of NICE a decade ago, despite inflation.

Furthermore, the company claims that regimens containing Avastin “are recognised globally as a standard of care for advanced bowel cancer and provide the best possible survival benefit for such patients”, and it says the UK “is now virtually the only country in the developed world not to provide Avastin for bowel cancer through the state healthcare service”.

To illustrate its point, the company highlighted recent data collated by the Organisation for Economic Cooperation and Development which shows that, shockingly, cancer patients living in the UK are more likely to loose their lives than those elsewhere in Europe - with 20% more deaths from the disease per 100,000 people in this country than across the continent.

More than 37,500 people are diagnosed with the bowel cancer in the UK every year and it is now the second biggest cause of cancer deaths in the country. While not offering a cure for the disease, clinical trials have shown that Avastin - which works by blocking angiogenesis to prevents tumour growth and spread – can shrink tumours and extend overall survival.

Survival benefits
News of the drug’s rejection, while not final, will come as a blow to bowel cancer patients across the UK, particularly as studies have demonstrated that adding Avastin to oxaliplatin-based chemotherapy boosts median overall survival to 21.3 months versus 19.9 months with chemotherapy, and that, when the drug is added to capecitabine and oxaliplatin, 78% of patients experienced the shrinkage or disappearance of liver metastases, making them eligible for potentially life-saving surgery, Roche said.

“Having Avastin available in the NHS would give me and my colleagues an important additional treatment for bowel cancer and would bring new hope to the many patients for whom this offers a proven increased chance of living longer with a better quality of life,” noted Professor Will Steward, Head, Department of Cancer Studies and Molecular Medicine University of Leicester.

“The clinical efficacy of bevacizumab and its benefit to patients with metastatic colorectal cancer is well proven," said Dr Rob Glynne Jones, Chief Medical Advisor at Bowel Cancer UK, and he called on "all the relevant parties - NICE, the manufacturers and the Department of Health - to continue to work on the details of a Patient Access Scheme that will meet the necessary criteria and ensure that NICE approves this drug for NHS use”.