Nice requests more Opdivo data
NICE publishes draft guidelines recommending that Bristol Myers-Squibb provide more data on Opdivo’s effectiveness for treating classical Hodgkin lymphoma.
The committee said its current position is to not 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 recognises Opdivo as an innovative and promising treatment, evidence presented was very uncertain due to immature data and lacked indication on how the drug would be used in UK clinical practice.
Therefore, NICE is requesting that BMS provides a revised analysis on the drug’s cost-effectiveness that considers the committee’s concerns at the next appraisal meeting, particularly regarding its effectiveness compared to the current standard of care.
The institute also stressed that the analyses should also explore the use of UK data for standard of care 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 drug received 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. Results showed an objective response rate of 66 %, including a complete response rate of 6%. At 12 months, the progression-free survival rate was 57%.
BMS 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 use.