The available evidence showed that the price the NHS is being asked to pay for the drug is too high for the benefit it may provide to patients.

Sipuleucel-T, also known as Provenge and marketed by Dendreon, is a cell-based therapy which stimulates the patient’s own immune cells to identify and attack prostate cancer cells.

A procedure called leukapheresis is used to remove white blood cells from the body, which 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.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient’s own immune system to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.

The company, 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.

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, healthcare professionals, patient groups and members of the public are now able to comment on the preliminary recommendations which are available for public consultation.

Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft of guidance will be issued. 

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

Sipuleucel‑T is not recommended within its marketing authorisation for treating adults who have asymptomatic or minimally symptomatic metastatic non-visceral hormone-relapsed prostate cancer for which chemotherapy is not yet clinically indicated.

The Committee concluded that sipuleucel-T compared with placebo extended life for people with asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer for which chemotherapy is not yet clinically indicated, but it had no effect on disease progression.

The Committee concluded that there was uncertainty surrounding the results of the indirect comparison, but that it would be reasonable to assume that sipuleucel‑T and abiraterone had similar effectiveness in prolonging overall survival.

The Committee noted that, for the subgroup of patients who had not had prior chemotherapy and using a discounted price for abiraterone, the cost per QALY (quality-adjusted life year) was at least £512,000 (company’s analyses) or at least £244,000 (Evidence Review Group’s analyses) for sipuleucel-T compared with abiraterone. When abiraterone was not included in the Evidence Review Group’s analysis, the cost per QALY for sipuleucel‑T compared with best supportive care was £112,000.

For the subgroup with baseline prostate-specific antigen levels of 22.1 ng/ml or below, the company’s original analyses resulted in a cost per QALY of £48,700 for sipuleucel‑T compared with best supportive care. The company’s revised analyses resulted in a higher cost per QALY. The Evidence Review Group’s exploratory analysis resulted in a cost per QALY of £61,400 for sipuleucel-T compared with best supportive care.

The Committee considered that the mean life expectancy for people with metastatic hormone-relapsed prostate cancer for which chemotherapy is not yet indicated was unlikely to be less than 24 months, so sipuleucel-T at this stage in the treatment pathway did not meet the first end-of-life criterion for short life expectancy. 

The cost of sipuleucel‑T is £16,141.33 per dose, including the costs of leukapheresis, patient tests associated with leukapheresis, manufacture and transportation. This excludes VAT. The recommended course of treatment is 3 doses at approximately 2‑week intervals. The cost for a course of treatment is £47,132.68, based on a mean of 2.92 doses per patient. The cost of sipuleucel‑T was provided by the company to NICE but is conditional on the treatment being launched and may be subject to change. Any change will be reflected in the next iteration of the technology appraisal.

The company estimated that sipuleucel-T was licensed for a population of about 4600 patients in England.

The Scottish Medicines Consortium (SMC) is not currently considering the use of sipuleucel-T for this indication.