Dendreon’s Provenge too expensive to be recommended, says NICE in draft guidance

In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has not recommended US biotech firm Dendreon’s (Nasdaq: DNDN) Provenge (sipuleucel-T) for prostate cancer in people whose disease has spread, who have few symptoms and when chemotherapy would not yet have been given.

The available evidence showed that the price the National Health Service is being asked to pay for the drug is too high for the benefit it may provide to patients. The independent Appraisal Committee concluded that funding the treatment would not be the best use of limited NHS resources.

NICE chief executive Sir Andrew Dillon 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.”

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.

Due to complex administration, it is unclear if the NHS would incur additional costs

Dendreon, provided information on the cost of sipuleucel-T, which included undertaking leukapheresis and the tests associated with the process; the transportation of white blood cells; and the manufacture and transportation of sipuleucel-T. However, because the administration of sipuleucel-T is complex and there is no experience in the UK of using this treatment, it is unclear if the NHS would incur additional costs in using the treatment, said NICE.

Additionally, Dendreon only plans to offer sipuleucel-T in a limited number of treatment centres initially which 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.

Sir Andrew added: “Dendreon, which markets sipuleucel-T, now has the opportunity to respond to this preliminary guidance and offer clarification where needed.” Consultees, including the company, health care professionals, patient groups and members of the public are now able to comment on the preliminary recommendations which are available for public consultation.