NICE backs GSK’s leukaemia drug Arzerra following price cut
pharmafile | November 4, 2014 | News story | Sales and Marketing | Arzerra, CLL, GSK, NHS, NICE, leukaemia
NICE has recommended that GlaxoSmithKline’s Arzerra be prescribed under the NHS for patients with chronic lymphocytic leukaemia (CLL), after a price cut from the manufacturer.
Four years ago, Arzerra (ofatumumab) was rejected by NICE as a treatment for patients with CLL that is refractory to treatment with fludarabine and alemtuzumab, after the agency calculated it would cost nearly four times as much as best supportive care.
The latest draft recommendation from NICE is that ofatumumab – when given in combination with chlorambucil as a first-line therapy – is a cost-effective use of NHS resources in people who are ineligible for fludarabine-based therapy and cannot be treated with bendamustine.
Arzerra – an anti-CD20 antibody originally developed by Denmark’s Genmab – has been available since 2009 for CLL patients whose disease is refractory to fludarabine/alemtuzumab, but GSK and Genmab secured EU approval for the drug in previously untreated patients earlier this year.
The drug was cleared by the European Medicines Agency (EMA) for the new indication on the back of data showing that Arzerra plus chlorambucil improved progression-free survival (PFS) to 22 months – compared to 13 months with chlorambucil alone.
Sir Andrew Dillon, NICE chief executive, says: “The key aim of first treatment for people with untreated CLL is to prevent the disease from progressing and delay time to next treatment. The information provided by GSK … showed that ofatumumab with chlorambucil is a clinically effective treatment option for those people unable to take fludarabine combination therapy or bendamustine.”
Swinging the decision was that GSK has agreed to provide ofatumumab to the NHS at a reduced price, says NICE, adding that the company has agreed with the Department of Health (DH) that the size of the discount will remain confidential.
A rival CLL drug – Roche’s Gazyvaro (obinutuzumab) – was rejected by NICE a month ago after the agency decided its efficacy did not warrant its cost. Meanwhile two other drugs – Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib) – have been approved for CLL but have not yet been recommended by NICE in this indication.
Once tipped as a $800m-plus product, Arzerra’s sales performance has disappointed since launch, in part because it has had to compete with Roche’s anti-CD20 blockbuster Rituxan/MabThera (rituximab) and also because it failed to show efficacy in non-Hodgkin’s lymphoma (NHL), a much larger indication than CLL.
The drug brought in £42m in the first nine months of 2014, down 20% and despite the approval for first-line use. GSK and Genmab have also reported positive interim results from the PROLONG study of Arzerra as maintenance treatment for relapsed CLL.
GSK is in the processing of transferring rights to Arzerra and other products in its oncology portfolio to Novartis under the terms of its asset-swap deal which will see it take over the latter’s vaccines business.
Phil Taylor
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