BMS wins NICE reversal, Opdivo granted second-line lung cancer approval

Nearly a year after first being rejected by England's cost watchdog NICE, Bristol-Meyers Squipbb's Opdivo has been approved as second-line treatment in lung cancer.

Bristol-Myers Squibb finally discovered the password to get NICE to open the gates to the kingdom for Opdivo as a treatment for lung cancer: “managed access agreement.”

England’s drug cost gatekeeper today agreed to fund the immuno-oncology drug as a second line treatment for lung cancer through the country’s cancer drug fund, but under strict conditions.

In addition to a confidential discount, the NICE said treatment with Opdivo (nivolumab) must be stopped after two years of interrupted use, or before. Meanwhile, BMS will continue to collect data which NICE will use to determine the real-world effectiveness of the drug and whether to continue to pay for it.  

“We know that nivolumab is clinically effective for some people with lung cancer but the full extent of its benefit is not clear,” Carole Longson, director of the NICE Centre for Health Technology Evaluation, said in a statement. “This new deal means that we can give patients access to what we know is a promising treatment whilst more evidence is gathered on its value.”

RELATED: NICE turns down Opdivo for lung cancer

The deal was hammered out almost a year after NICE first rejected the drug for approval as too expensive. In the meantime, Opdivo lost a potential market lead to its primary competitor, Keytruda. Merck’s drug won not only an approval for previously treated patients but in June as a first line use in lung cancer. Through a similar managed access agreement, Keytruda also will be evaluated in two years for its real-world results.

RELATED: BMS loses its lung cancer lead to Merck as Opdivo data come up short

The fact that Keytruda is approved as a first-line treatment for lung cancer in the U.S. as well as the U.K., while Opdivo flopped as a monotherapy in previously untreated patients gave Merck’s drug a big boost in gaining market share from Opdivo. An analyst's report released in July showed Keytruda gaining momentum against its arch rival.

RELATED: FDA slaps enrollment hold on 2 Tecentriq studies after Keytruda myeloma trial deaths

Both of the drugs, and other immuno-oncology offerings, have won quick acceptance and approvals for treating a number of conditions. The newest battleground is in combination treatments but those efforts ran into a hurdle in June. The FDA put a hold on some combination trials of the specialized drugs in treating multiple myeloma after some deaths were reported in Keytruda's combo trials with Celgene medications.