NICE rejects Roche's Polivy combination in advanced lymphoma

England’s NHS should not fund Roche’s Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine for adults with a form of advanced lymphoma, NICE has said in first draft guidance.

The cost-effectiveness body has been assessing the new combination therapy 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.

In England DLBCL is usually treated first with chemotherapy, and this combination would provide an alternative for relapsed patients, as an alternative to a fresh round of chemo and prior to treatment with CAR-T therapies, from Novartis or Gilead.

NICE noted that there is no “standard of care” at this stage of the disease as there is a lack of evidence to show which chemotherapy regimen is most beneficial.

NICE said in this first draft that clinical trial evidence showed the cancer became undetectable in around 40% of patients treated with the combination, compared with around 18% 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 NICE cited “substantial uncertainty” in data submitted by Roche, saying that it lacks strong long-term evidence on remission with the treatment.

NICE’s committee of advisers said they had found flaws in the methods used to calculate background mortality, which led to unreliable results.

The Polivy combination also does not qualify for the Cancer Drugs Fund, which reimburses promising oncology drugs on an interim basis until further supporting evidence is available from clinical trials.

DLBCL is a fast growing, high grade form of non-Hodgkin lymphoma. Patients often have painless lumps in the neck, armpit or groin but may sometimes feel symptoms in other parts of the body such as the stomach or bowel.

NICE is consulting on the draft guidance until 18 March, during which time Roche could drop its price further, or submit further evidence.