UK’s NICE reconsiders backing for lymphoma drug Pixuvri

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has launched a second consultation on draft guidance for Pixuvri (pixantrone), a drug to treat an aggressive form of lymphoma made by US biotech firm Cell Therapeutics (Nasdaq: CTIC).

Earlier this year, NICE declined to recommend use of the drug under the National Health Service after an independent committee of experts concluded there was insufficient evidence to show that pixantrone is more effective than current NHS treatments and it does not represent good value for money for the health service (The Pharma Letter April 11).

Decision follows submission of patient access scheme

The draft guidance examines the clinical and cost effectiveness of pixantrone as a treatment for adults with aggressive non-Hodgkin’s B-cell lymphoma whose cancer has either returned after treatment (relapsed) or become resistant to current therapy (refractory), and who have already received at least two lines of treatment. The consultation comes after Cell Therapeutics submitted a patient access scheme to the independent Appraisal Committee to make pixantrone more cost-effective for the NHS.

Sir Andrew Dillon, NICE’s chief executive, said: “Following the submission of the manufacturer’s patient access scheme, the independent Appraisal Committee considered how this scheme might affect the cost-effectiveness of the treatment. New draft guidance has been produced and, in line with our process to be as transparent as possible, we are consulting once more to give organisations the opportunity to comment.”

He continued: “Unfortunately, the committee concluded that this scheme – the details of which are confidential in accordance with the agreement between the company and the Department of Health – does not overcome the uncertainties in the evidence for the drug’s clinical effectiveness over and above current treatments for this disease.”

Consultees, including the company, health care professionals and members of the public are now able to comment on this draft guidance via the NICE website. The consultation is open until November 4, 2013, and any comments received will be fully considered by the Committee.

Assessment of QALY

In this third draft of guidance, the NICE Appraisal Committee noted that cost-effectiveness calculations including the patient access scheme (the details of which are commercial-in-confidence) would most likely result in the treatment’s incremental cost-effectiveness ratio (ICER) of £30,700 (£$48,957) per QALY gained. The committee concluded that because this was above the range normally considered to be cost-effective (usually £20,000-£30,000 per QALY gained), coupled with substantial uncertainty relating to the effectiveness of the treatment compared with other treatments, pixantrone is not be recommended as a cost-effective use of NHS resources.