NICE asks for more data on Opdivo

The National Institute for Health and Care Excellence has published draft guidelines recommending that Bristol Myers-Squibb provide more information on Opdivo’s effectiveness for treating classical Hodgkin lymphoma.

The independent appraisal committee said it currently minded not to recommend the immunotherapy as an option for patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.

While it recognised Opdivo (nivolumab) as an innovative and promising treatment, the evidence presented was highly uncertain due to immature data and did not reflect how the drug would be used in UK clinical practice.

As such, NICE is requesting that BMS provides a revised analysis on the drug’s cost-effectiveness that takes into account the committee’s concerns at the next appraisal meeting, particularly with regard to its effectiveness compared to the current standard of care.

The analyses should also explore the use of UK data for standard of care (for example, from the Haematological Malignancy Research Network) and a range of subsequent allogeneic stem cell transplant rates for both nivolumab and standard of care that are higher than those used in the Cheah and Perrot studies and are from UK data, the Institute stressed.

The drug approved approval in this setting in Europe in November last year, based on an integrated analysis of data from the Phase II CheckMate -205 and the Phase I CheckMate -039 trials, which showed an objective response rate of 66 percent, including a complete response rate of six percent. At 12 months, the progression-free survival rate was 57 percent.

The company has agreed a patient access scheme with the Department of Health, under which the drug would be provided at a simple discount to the drug’s list price at the point of purchase or invoice.

If ultimately approved by NICE for NHS use, around 31 patients with classical Hodgkin lymphoma would be eligible for treatment in the first year if Opdivo were recommended for NHS use.