NICE rejects Roche’s Polivy combo in relapsed or refractory diffuse large B-cell lymphoma

pharmafile | February 26, 2020 | News story | Manufacturing and Production, Research and Development, Sales and Marketing NHS, NICE, Polivy, Roche 

It has been revealed that UK drug watchdog NICE has chosen to reject Roche’s Polivy (polatuzumab vedotin), used alongside rituximab and bendamustine, in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for haematopoietic stem cell transplant.

A high-grade form of non-Hodgkin lymphoma, DLBCL often features the materialisation of painless lumps in the armpit, neck or groin.

In clinical studies, the combo caused cancer to become undetectable for around 40% of patients compared to around 18% with bendamustine and rituximab alone, while the combo also demonstrated benefit in progression-free survival and overall survival, but data uncertainty made these benefits difficult to accurately determine.

A key reason for the rejection was said to be a lack of data from Roche on the treatment’s strong, long-term efficacy in remission, as well as concerns around the unreliable methods used to determine background mortality.

The decision means that cost-effectiveness of the therapy could not be accurately determined, meaning it will not now be made available for routine use on the NHS in England and Wales.

Rahul Doshi, Roche’s Haematology Franchise Lead, commented on the ruling: “People with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options, especially those who are not candidates for haematopoietic stem cell transplant. Whilst the decision is disappointing, we will now have an opportunity to respond to NICE and continue to explore all potential funding options to work towards a positive final decision. Our goal is to make Polivy available for all eligible patients as soon as possible.”

Matt Fellows

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