NICE says lung cancer breakthrough Opdivo too expensive

BMS's Opdivo has been rejected by NICE for use in patients with advanced lung cancer, the cost-effectiveness watchdog saying its price is too high to merit routine use.

Opdivo and its close rival, Merck's Keytruda are at the forefront of a step change in cancer care, the PD-1 immunotherapy treatments promising to extend the lives of patients with many different types of cancer.

Opdivo gained rapid approval in the US after having gained 'Breakthrough Therapy Designation', and was also identified as a promising innovative medicine (PIM) for lung cancer by the UK's drug regulator in 2015.

Despite this, NICE says Opdivo's list price of £31,960 ($46,132) for an average course of treatment is too high a cost to justify a positive recommendation. This is less than half the cost of the drug in the US, where its list price is $12,500 a month.

Phase 3 trial data shows Opdivo helped extend the lives of patients compared to existing second line chemotherapy - 39% were still alive at 18 months compared with 23% of those treated with docetaxel, and with fewer adverse events.

The drug would be used as a second line treatment for non-squamous non-small cell lung cancer (NSCLC) patients whose disease has advanced after chemotherapy, and NICE says docetaxel and Boehringer's Vargatef (nintedanib) are "more cost effective more cost effective than nivolumab at its current pricing."

BMS says it has offered "a number of pricing proposals" for Opdivo to NICE and the Department of Health, and believes this provides value to the NHS in lung and other cancers.

One proposal was for costs to the NHS being capped after patients have one year of treatment, but NICE have rejected this offer.

While the cost effectiveness body doesn't directly negotiate on price, its process has become a de facto price negotiation between pharma companies and the NHS.

Opdivo gained NICE approval in its first indication, advanced melanoma, in February this year, where it was judged to be cost effective.

NICE's preliminary decision on Opdivo comes just ahead of the long-awaited Accelerated Access Review (AAR) which the UK pharma industry hope could guarantee uptake of 'breakthrough' drugs like Opdivo.

However it won't adjust NICE's strict methodology, and huge financial pressure on the NHS is also impacting drug spending.

"While today's decision is disappointing for lung cancer patients, it is also a setback for British cancer care because it shows that the system which is intended to provide UK patients with new medicines has denied them yet again." said Johanna Mercier, General Manager, Bristol-Myers Squibb UK & Ireland.

"Unfortunately, NHS lung cancer patients are still not able to access this potentially life-extending medicine. We hope that NICE and the Department of Health will recognise the potential of nivolumab to increase survival in cancer and we will continue to work with them to find an answer for patients and their families."

Charity the Roy Castle Lung Cancer Foundation said it was disappointed at the decision.

"Not all lung cancer patients are appropriate for this new immunotherapy or will benefit from it - but it does represent a new option for some lung cancer patients," a spokesman commented.

"Advanced lung cancer remains a devastating disease for many patients. They do not have time to wait."

The charity added that "cost is the big issue here" and said it hoped that NICE, NHS England and BMS could negotiate a deal.

A consultation period will now run until 3 June, with NICE's second appraisal committee meeting scheduled for 15 June.