13 January 2015
Cost to NHS of providing sipuleucel-T too high to be recommended in draft guidance
NICE has issued final draft guidance not recommending sipuleucel-T for prostate cancer in people whose disease has spread, who have few symptoms and whose disease is not yet suitable for treatment with chemotherapy.
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. The treatment involves collecting white blood cells from the patient (a process called leukapheresis). Outside the patient’s body, these cells are combined with a protein to make sipuleucel T, and then the cells are infused back into the patient.. Sipuleucel-T is the first drug for metastatic hormone-resistant prostate cancer that is not cytotoxic or based on hormone-related therapy.
Sipuleucel-T prolongs overall survival compared with a placebo treatment, but it is uncertain how well it works compared with other existing treatments. It was also not proven to delay the progression of the disease, unlike current treatments. Dendreon is asking the NHS to pay around £50,000 per patient for Sipuleucel-T.
Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient’s own immune system to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 Dendreon has so far been unable to show that it works better than other treatments currently available. Based on the evidence presented, NICE is unable to recommend the NHS provide funding for this drug, as it costs too much for the extra benefit it may provide.”
The final draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Ends
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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About the draft guidance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- The draft guidance will be available at /guidance/indevelopment/GID-TAG346 from Tuesday 13 January 2015. Embargoed copies of the draft guidance are available from the NICE press office on request.
- 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.
For the subgroup of patients who had not received 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 ERG’s analysis, the cost per QALY for sipuleucel-T compared with best supportive care was £112,000. - For the subgroup with a baseline PSA concentration of 22.1 nanogram/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 higher cost per QALYs. The ERG’s exploratory analysis resulted in a cost per QALY of £61,400 for sipuleucel-T compared with best supportive care.
- According to Dendreon, the cost of sipuleucel T is £16,141.33 per dose, including the costs of leukapheresis, patient tests associated with leukapheresis, manufacture and transportation, and excluding VAT. The summary of product characteristics states that 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 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 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.
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