Cost to NHS of Provenge too high to be recommended, says NICE

England’s health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance not recommending US biotech firm Dendreon’s (Nasdaq: DNDN) Provenge (sipuleucel-T) for prostate cancer in people whose disease has spread, who have few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 National Health Service is being asked to pay for the drug is too high for the benefit it may provide to patients. The latest guidance confirms an earlier opinion from the NICE (The Pharma Letter October 16, 2014).

Sipuleucel-T 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 ($75,750) per patient for sipuleucel-T.

Commenting on the draft guidance, NICE chief executive Sir Andrew Dillon, said: “Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient’s own immune system to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 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The final draft guidance is now with consultees, who have the opportunity to appeal against it.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.

Cost and QALY

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.