Source: Pharmafocus.com

Author: Staff

Erbitux has failed to win NICE approval for the treatment of head and neck cancer, due to doubts over its cost and clinical effectiveness compared to existing treatments.

It was rejected under NICE’s new scheme to make more end-of-life drugs available by extending the threshold at which they are considered cost-effective, making it an extra heavy blow for manufacturer Merck Serono.

Chief executive Andrew Dillon defended NICE’s decision, saying the alternative of approving the medicine for the health service was unviable.

He added: “This would mean the NHS making significant funds available for a very expensive treatment which may or may not benefit individual patients. Those funds would not then be available for treating other conditions with greater and more certain benefits for other patients.”

Erbitux is a monoclonal antibody and one of a new class of cancer drugs which target genetic mutations that allow cancer cells to multiply, and are designed to bypass many of the unpleasant side-effects associated with traditional chemotherapy.

Licensed also in colorectal cancer, in 2008 the drug made global sales of nearly $1.6 million in 2008, and is expected to reach sales of $3.4 million by 2014.

In the latest appraisal, Erbitux was rejected as a treatment of recurrent and/or metastatic squamous cell cancer of the head and neck and NICE recommended against its use in combination with platinum-based chemotherapy in patients with this cancer.

The appraisal committee were uncertain over the clinical effectiveness of the drug and the cost of the treatment when compared to those currently available.

In the cost-effectiveness analysis submitted by Merck Serono, treatment with Erbitux and chemotherapy compared with chemotherapy alone would result in the cost of an extra QALY – the equivalent price of providing one additional year of healthy life – at £121,367.

With this extra cost the predicted gain in overall survival of patient prescribed Erbitux would only be just over two months.

The appraisal board also took into account the supplementary advice provided by NICE when appraising treatments at the end of life, noting that Erbitux was used for a small population with a short life-expectancy, and therefore the threshold at which the drug is considered cost-effective should be extended.

But it concluded the treatment still did not offer sufficiently greater benefits to these patients compared to existing treatments.

The decision is a blow for Merck Serono, which has come to expect much from the ascendant oncology drug, now ranked fifth in the world’s top cancer treatments.

The company received more positive news from NICE recently, when it approved Erbitux in another indication, making it a first-line therapy for many patients with a certain type of metastatic colorectal cancer.