Prostate cancer immunotherapy Provenge rejected by NICE

Dendreon's prostate cancer immunotherapy Provenge has been rejected by NICE in draft guidance, which said its high price and weak evidence based meant it could not be recommended.

Provenge (sipuleucel-T) is an autologous cellular immunotherapy, which involves removing immune cells from a patient's blood, priming them to recognise prostate cancer, and then returning them to the body.

Each treatment must be tailor-made for each patient, and begins with the process of filtering out the white blood cells (dendritic cells) in a process called leukapheresis. The white blood cells are then mixed with a protein to create sipuleucel-T. When infused back into the body, the treatment stimulates the body's T-cells to attack the cancer. Sipuleucel-T is the first drug for metastatic hormone-resistant prostate cancer that is not cytotoxic or based on hormone-related therapy.

Provenge was launched in the US in 2010, and despite optimism about its technological advances, the drug has not been a success in the US. Its high price, complicated administration and limited benefits for patients means it has enjoyed relatively modest sales.

Moreover, a number of oral treatments for prostate cancer – such as Janssen's Zytiga and Astellas' Xtandi have emerged as much stronger contenders.

Dendreon's shareholders had hoped Provenge's launch in Europe would boost sales, but NICE has rejected it even before its launch in the UK.

The cost for a course of treatment is £47,132.68, based on a mean of 2.92 doses per patient – significantly higher than an annual cost of Zytiga of around £36,000 (before a patient access scheme discount).

NICE says Provenge's cost was provided by the company, but is conditional on the treatment being launched and may be subject to change. NICE says any change will be reflected in the next iteration of the technology appraisal.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient's own immune system to attack the cancer cells – but based on the evidence presented so far, it costs too much for the benefit it provides.

"It was shown to prolong overall survival compared with a placebo treatment, but there were uncertainties in the evidence about how well sipuleucel-T works compared with some other existing treatments. It was also not proven to delay the progression of the disease unlike current treatments, and this can potentially affect a person's quality of life.

"The independent Appraisal Committee concluded that funding the treatment would not be the best use of limited NHS resources."

In addition to the uncertainty of the clinical effectiveness of sipuleucel-T, there were also uncertainties about the amount of money the NHS might have to pay for the treatment.

Dendreon, provided information on the cost of leukapheresis and other necessary tests, but NICE's committee ruled that the complexity and novelty of the procedures meant that it was unclear if the NHS would incur further costs in using the treatment.

NICE also pointed out that Dendreon only plans to offer Provenge via a limited number of treatment centres at first, which it says may make it difficult for all patients in England to access treatment, and may result in high travel costs for the individual or the NHS.

Dendreon and other consultees now have the opportunity to respond to this preliminary guidance and offer clarification where needed.