NICE is still not backing Pierre-Fabre’s Javlor for a certain type of bladder cancer that has spread to other part of the body.
Specifically, the watchdog has not recommended Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract, which has progressed following prior treatment with platinum-containing chemotherapy.
It had made the same decision in November last year, but the drug’s manufacturer won a partial appeal against this decision to compare Javlor to best supportive. NICE, however, still did not find in favour of the drug.
It said that although there is some evidence to indicate that Javlor can extend life for patients with transitional cell carcinoma, it added that there was “considerable uncertainty” around the estimates provided by the manufacturer.
NICE said that Javlor, compared with best supportive care, would have a QALY in excess of £120,000, well above anything that NICE has previously accepted as cost effective, and far higher than the normal threshold of £20,000 - £30,000 per QALY gained.
The firm has not offered a patient access scheme to help lower the price of its drug for NHS use, something that is becoming more common amongst pharma trying to gain a positive NICE recommendation, especially with expensive cancer medicines.
NICE’s chief executive, Sir Andrew Dillon, said: “When we recommend the use of expensive treatments designed to extend life, we need to be confident about the nature and the extent of the benefit they bring. In the case of vinflunine, the manufacturer has been unable to provide the Appraisal Committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care.”
Pierre-Fabre estimated that around 800-1,500 would be eligible to receive its drug according to its licence.
The acquisition cost of Javlor for a course of treatment is about £9817.50, excluding administration costs - this is based on an average of 4.2 cycles of treatment.