UPDATED: NICE turns down Opdivo for lung cancer

Bristol-Myers Squibb ($BMY) has gotten more bad news in its efforts to grow lung cancer sales. England's cost watchdog has turned it down, although the regulator did offer up a tidbit of support.

NICE has told the company that the immuno-oncology treatment is not cost effective enough for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). But in a sliver of hope, NICE told the drugmaker it should seek approval through the country’s Cancer Drugs Fund for patients that test for the PD-L1 biomarker. Those patients represent about a third of all people who suffer from NSCLC.

“If the company puts forward a CDF proposal, nivolumab could be made available to some patients with lung cancer whilst more evidence is gathered on its value,” Carole Longson, director of the Health Technology Evaluation Centre at NICE said in a statement.

BMS said in an emailed statement said today: "NICE has said it would consider funding Opdivo through its Cancer Drugs Fund, however, it will apply restrictions that could deny treatment for up to two thirds of patients, which is inconsistent with the clinical evidence.     
"This recommendation is disappointing for advanced lung cancer patients who are waiting for breakthrough, and potentially life-extending medicines on the NHS. The decision to deny access also deepens inconsistencies in access of Opdivo across tumor types because it is available on the NHS for patients with advanced melanoma."

According to NICE calculations, Opdivo was going to cost about £73,500 per quality of life year (QALY) for squamous NSCLC and £150,000 for non-squamous NSCLC, which the watchdog said was well beyond its cost boundaries for coverage. 

That was despite a discount offered by BMS. The company earlier had offered a cost-sharing deal: England’s National Health Service would pay for 26 weeks of treatment, or about £31,000 ($45,000). The next 26 weeks, if needed, would be covered by the company. Because Thursday’s decision is draft guidance, BMS still has a chance to make its case, of offer a greater discount to win approval.

NICE last week took a similar position on Opdivo’s main competitor, Merck’s Keytruda, saying it also was too expensive. But NICE didn’t suggest that Merck go the cancer fund route for Keytruda.

Opdivo and Keytruda, which are designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, have both won multiple approvals and are expected to generate many billions of dollars in revenues for their makers. Both drugs have been approved in the U.S. as a second line treatment for lung cancer but both companies had hoped to hit the jackpot by getting them approved as a first-line use. However, Bristol-Myers was gut punched in August when Opdivo failed to meet goals for use as a first-line treatment for lung cancer.

The news was devastating to the BMS share price, knocking about 30% off the company’s market cap. Share this morning were trading early at about $50, compared to $75.32 a share before the news of the trial failure. BMS still expects Opdivo to perform in combination with other cancer drugs as a first-line treatment against lung cancer but the failure has left Keytruda in the pole position for the indication.

In June, Merck reported that its PD-1 checkpoint inhibitor Keytruda met its goals in a new trial in previously untreated non-small cell lung cancer (NSCLC) patients, beating chemotherapy at holding off advance of the cancer and extending patients’ lives.

So far, Opdivo is still far outpacing Keytruda in sales. In H1 of this year, Opdivo recorded sales of $1.58 billion while Keytruda had brought in $563 million. That is because as a second line treatment, Keytruda is only approved in the U.S. for patients with who test positive for certain levels of the PD-L1 biomarker, while Opdivo can be used for any patient.  

Bristol-Myers also said today that the EU had recommended approval of Opdivo for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. 

- get the NICE guidance here and here
more from PharmaTimes
here's the BMS release on the EU recommendation

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Bristol-Myers' Opdivo far outpaced Merck's Keytruda again in Q2. What gives?