NICE, the healthcare guidance body, has issued new draft guidance on crizotinib (Xalkori, Pfizer) for previously treated anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer. The draft guidance does not recommend crizotinib.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. NICE is appraising the drug for those patients whose cancer test positive for the ALK enzyme.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "When assessing the cost effectiveness of a treatment, NICE appraisal committees will take numerous factors into account. These include how effective the drug is, its side effects, the effect it can have on the patient's quality of life and also the financial cost. This enables them to determine the cost of using the drug to provide a year of the best quality of life available or quality adjusted life year (QALY).

"Appraisal committees will normally recommend treatments that cost around £20,000 to £30,000 per QALY or less. If a drug meets the criteria to be considered under NICE's supplementary advice for end of life treatments, then a higher cost per QALY may be accepted. There is no set threshold cost per QALY of drugs that meet the end of life criteria, but since the supplementary advice was introduced, the highest cost per QALY of a recommended drug has been around £50,000."

The Committee concluded that the most plausible cost per QALY would lie somewhere between £63,800 and £181,100 for crizotinib compared with docetaxel, and between £51,700 and £80,500 for crizotinib compared with best supportive care.

Andrew Dillon continued: "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 if the supplementary advice to the Committee for life-extending treatments had applied, crizotinib could not be considered a cost-effective use of NHS."

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Ends

Notes to Editors

About the guidance

1. The draft guidance will be available on the NICE website from 27 March 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 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 most plausible ICERs would lie somewhere between £63,800 and £181,100 per QALY gained for crizotinib compared with docetaxel, and between £51,700 and £80,500 per QALY gained for crizotinib compared with best supportive care.

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 drug does not meet the criteria to be considered under end-of-life.

6. SMC is in the process of appraising the drug for this condition.

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
• social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.

3. NICE produces standards for patient care:

• quality standards - these describe high-priority areas for quality improvement in a defined care or service area
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
• CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.