NICE Recommends Against Pfizer's Xalkori
NICE issues draft recommendations for lung cancer drug
NICE, the healthcare guidance body, has issued final draft guidance on crizotinib (Xalkori, Pfizer) for previously treated anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer. The draft guidance does not recommend crizotinib.
Crizotinib is a tyrosine kinase inhibitor (TKI) - it works by blocking enzymes which can stimulate cancers to grow. Crizotinib blocks a specific enzyme called anaplastic lymphoma kinase (ALK) which is present in some non-small-cell lung cancers.
Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “During the consultation on the draft guidance, Pfizer, the manufacturer of the drug, submitted further information for the committee to consider. This included a patient access scheme which involves providing the drug to the NHS at a discounted price. A revised cost-effectiveness analysis was also submitted for the Committee to consider.
“We have already recommended a number of treatments for the various stages of non-small-cell lung cancer. However, although the independent committee that considered the evidence found crizotinib to be clinically effective treatment for ALK-positive non-small-cell lung cancer, even when the manufacturer's discount had been applied, crizotinib could not be considered a cost-effective use of NHS resources.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking crizotinib will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
Notes to Editors
About the guidance
1. The draft guidance/guidance will be available on the NICE website from 16 August 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.
2. Treatment with crizotinib resulted in a median gain of 5.1 months in progression free survival compared with docetaxel. The exact magnitude of the overall survival gain was uncertain because of the immaturity of the 1007 trial data and the impact of crossover in the trial
3. The Committee concluded that the cost per QALY on which to base a decision for crizotinib compared with docetaxel would be more than £100,000 per QALY gained, and for crizotinib compared with best supportive care would be more than £50,200 per QALY gained.
4. Acquisition cost is £4689 for 1 pack of 60×200 mg (or 250 mg) capsules (30-day supply). Assuming treatment until disease progression, the cost of a course of treatment would be between £37,512 and £46,890. Assuming treatment after disease progression, the cost of a course of treatment would be £51,579.
5. The manufacturer of crizotinib has agreed a patient access scheme with the Department of Health. This involves a discount applied to the list price of crizotinib. The level of the discount is commercial in confidence.
6. The Committee accepted that the supplementary advice from NICE for life-extending treatments could be considered for crizotinib compared with chemotherapy, even though there was considerable uncertainty in the exact overall survival gain, and therefore in the resulting ICER.
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Posted: August 2013