Regulatory Focus™ > News Articles > New Drug for Non-Hodgkin's Lymphoma Denied Reimbursement in UK

New Drug for Non-Hodgkin's Lymphoma Denied Reimbursement in UK

Posted 12 April 2013 | By Alexander Gaffney, RAC

Draft guidance issued yesterday by the UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), does not recommend reimbursement for Cell Therapeutics' Pixuvri (pixantrone), a product intended to treat an aggressive form of non-Hodgkin's lymphoma (NHL). 

NICE concluded that there was insufficient evidence demonstrating that the drug offered an extension to life of an additional three months compared with current NHS treatment, and therefore did not meet the criteria to be considered as a life-extending, end-of-life treatment.  Moreover, the clinical trial evidence submitted to the NICE Appraisal Committee "highlighted a number of uncertainties" that called into question the actual benefit patients might receive from this treatment.

Pixuri received EU approval in May 2012 as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit of treatment with the drug has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to the prior therapy. As a result, the drug is conditionally approved for patients who have received at least two previous lines of treatment.

Prior to the approval of Pixuvri in the EU, there were no approved agents or standard of care for this disease. The drug was made available to patients in eight countries in the EU during the fourth quarter of 2012, and some patients in other countries have also started to receive the treatment.

Pixuri is now yet approved in the US.

Non-Hodgkin lymphoma is the sixth most common cancer in the UK, affecting 12,180 new patients in the UK during 2010.

NHL is caused by the abnormal proliferation of lymphocytes, cells that are key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms-aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

Consultation on the draft guidance is set to close on 1 May 2013.


Tags: UK

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