Dendreon’s immunotherapy Provenge (sipuleucel-T) is too expensive to be used as a treatment for advanced prostate cancer on the National Health Service in England, cost regulators have ruled.

In preliminary draft guidelines out this morning, the National Institute for Health and Care Excellence has rejected the drug’s use to treat patients with metastatic prostate cancer before they have received chemotherapy.

Offering a novel approach to treating the disease, Provenge is the first drug for metastatic hormone-resistant prostate cancer that is not cytotoxic or based on hormone-related therapy. Around 4, 600 patients in England would be eligible for treatment as per its licence.

But NICE says available evidence shows “the price the NHS is being asked to pay for the drug is too high for the benefit it may provide to patients”.

Clinical uncertainties

“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,” said the Institute’s chief executive Andrew Dillon, further explaining that the drug “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 Committee noted that, for the subgroup of patients who had not had prior chemotherapy, 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 Provenge compared with Johnson & Johnson’s (discounted) Zytiga (abiraterone). 

When Zytiga was not included in the ERG’s analysis, the cost per QALY for the drug compared with best supportive care was - at £112,000 or £61,400 for a subgroup of patients with certain levels of prostate-specific antigen levels - still well above normal cost-effectiveness thresholds. 

Additional costs?

Aside from clinical uncertainties, there were also fears that the NHS may incur additional costs because of the treatment’s complex administration, of which the UK has no experience, NICE noted.

In a statement to PharmaTimes Digital, Sarah Cant, Director of Policy and Strategy at Prostate Cancer UK, said “there’s no denying that there are too few treatment options available for men living with advanced prostate cancer and this is something that desperately needs changing".

But she also stressed that "although we strongly welcome the development of new drugs for this group of men, the treatments need to be affordable for the NHS and the benefits for men need to be clear".