NICE does not recommend polatuzumab vedotin to treat lymphoma
NICE has formed a negative opinion for Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine to treat diffuse large B-cell lymphoma.
The UK National Institute for Health and Care Excellence (NICE) has announced its publication of draft guidance that does not recommend Roche’s Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine. The organisation has rejected an application that the treatment be recommended for adults with diffuse large B-cell lymphoma (DLBCL) that has relapsed or not responded to primary treatment and who cannot have a haematopoietic stem cell transplant.
Clinical trial evidence showed that the cancer became undetectable in around 40 percent of patients treated with polatuzumab vedotin with rituximab and bendamustine, compared with around 18 percent of patients treated with rituximab and bendamustine alone. Evidence also suggests that the combination treatment increases progression-free survival and overall survival compared with rituximab and bendamustine alone. However, there is substantial uncertainty in the submitted data.
The company submission lacks strong long-term evidence on remission with the treatment and the NICE committee found flaws in the methods used to calculate the background mortality, which led to unreliable results. Additionally, the organisation says that limitations in the data created uncertainty around the cost-effectiveness, leading to the negative decision.
…there is substantial uncertainty in the submitted data”
Consultees now have the opportunity to comment on the released draft recommendations until 18 March 2020, NICE has announced.
The draft guidance can be found here.