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Colorectal Cancer: Bad NICE News for Avastin and Erbitux

Posted on: Monday, 21 August 2006, 12:00 CDT

The UK's National Institute of Clinical Excellence has decided against making Avastin and Erbitux available for the treatment of colorectal cancer on the National Health Service, arguing that both drugs are too expensive. Although the drugs' developers may appeal the watchdog's decision, the ruling may also throw into question whether the drugs will face the same fate in other indications.

The National Institute of Clinical Excellence (NICE) has decided to reject the National Health Service (NHS) use of Genentech/Roche's Avastin and ImClone Systems/Bristol-Myers Squibb/Merck KGaA's Erbitux in metastatic colorectal cancer on the grounds of cost-effectiveness. The NICE claims that, although there is some evidence that Avastin improves survival, neither of the two drugs would represent a good use of NHS resources.

The decision has prompted outcry from charities, which is understandable given the drugs' abilities to extend lives. Erbitux has been found to extend median progression free survival to 4.1 months in metastatic patients when combined with irinotecan, while the addition of Avastin to irinotecan, fluorouracil and leucovorin has been shown to significantly improve median overall survival from 15.6 months to 20.3 months.

However, a course of treatment with Erbitux costs around GBP11,700 per patient and Avastin's survival advantage comes at cost of GBP17,700 per patient. While these costs would clearly represent a problem for the cash-strapped NHS, the watchdog's decision will be a major setback to metastatic colorectal cancer patients, for whom the five-year survival rate is just 9%.

The decision would also have an impact upon the future sales growth of Erbitux and Avastin, significantly reducing their sales potential in the UK market, where it is estimated that over 36,000 new cases of colorectal cancer will be diagnosed during 2006.

Given the reactions of charities and oncologists, it is likely that appeals will be launched before the final-stage draft guidance comes into effect in November. One argument already put forward by Merck KGaA and Roche is that, because of the poor patient prognosis at this stage of the disease, the drugs' administration period will be relatively short, and thus the overall cost will be low.

Nevertheless, with Avastin and Erbitux both seeking approval for a number of indication extensions, this NICE ruling could have wider implications. For example, Avastin's cost may double if it gains approvals in non-small cell lung cancer and breast cancer as twice the dose used in colorectal cancer is needed, which could render the drug even less cost-effective.

Source: Datamonitor

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