NICE finalises record-breaking Opdivo/Yervoy appraisal

NICE has given its fastest ever verdict for Bristol-Myers Squibb's immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), recommending it for the treatment of adult patients with advanced skin cancer.

The UK cost-effectiveness watchdog backed the dual-therapy treatment in final guidance on the condition of an undisclosed discount for high-priced drug Yervoy, which is usually listed at £15,000 per 40-ml vial.

Based on the CheckMate 067 and 069 trials comparing Opdivo and Yervoy together with Yervoy alone, the combination proved a promising new advance in the treatment of melanoma irrespective of the patient's BRAF mutation status.

An 18-month overall survival rate was reported at 69% - nearly double the 35% rate of Yervoy alone - with progression-free survival averaging at 11.5 months for the combination compared to Yervoy's 2.9 months.

NICE has, however, specified that the immuno-oncology drugs are only for the treatment of people doctors believe are fit enough to tolerate what it called the “considerable related adverse effects”. Among those reported, liver damage was one of the most common side effects, and the UK body has indicated belief in a greater short-term benefit for the drugs.

 This final guidance follows the approval of Opdivo for use as a melanoma treatment on the NHS earlier this year, though it has since been rejected for use in kidney cancer and lung cancer due to the drug's price. Opdivo is currently under review in the US and EU for treatment of an aggressive form of head and neck cancer.

Yervoy, meanwhile, has been on the market in the EU since 2011 but was not approved for NHS use by the UK watchdog until a year later, with a mark against it for its hefty £80,000 per patient price tag.

Competing for sales with BMS's dual-therapy is Merck & Co's Keytruda (pembrolizumab), which is currently playing catch-up to the market leading Opdivo.

However, the PD-1 inhibitor recently received a boost when results from a lung cancer study showed the drug as more effective than chemotherapy in previously-untreated patients with non-small cell lung cancer (NSCLC).

Both Opdivo and Keytruda are approved for second-line treatment after chemotherapy in NSCLC patients, but Merck is the first to present first-line data.